Publications by authors named "Odile Launay"

254 Publications

Public trust on regulatory decisions: The European Medicines Agency and the AstraZeneca COVID-19 vaccine label.

Vaccine 2021 Jun 4. Epub 2021 Jun 4.

Université de Paris, Faculté de Medicine, Inserm, CIC 1417, F-CRIN, Innovative Clinical Research Network in Vaccinology (I-REIVAC), and Assistance Publique-Hôpitaux de Paris, CIC Cochin Pasteur, Hôpital Cochin Paris, Paris, France.

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http://dx.doi.org/10.1016/j.vaccine.2021.05.095DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8190873PMC
June 2021

Efficacy of COVID-19 vaccines: From clinical trials to real life.

Therapie 2021 May 12. Epub 2021 May 12.

F-CRIN IREIVAC/COVIREIVAC, 75679 Paris, France; Université de Paris, Inserm CIC 1417, Assistance publique - Hôpitaux de Paris, hôpital Cochin, 75679 Paris, France.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has rapidly spread around the globe leading to the COVID-19 pandemic. To mitigate the effects of the virus on public health and the global economy, vaccines were rapidly developed. In less than one year, with respect to usual clinical development rules, several vaccines have been put on the market and mass vaccination campaigns have been deployed. During the phase I to phase III clinical trials, most of these vaccines have demonstrated both their safety and efficacy. Despite questions remain about the impact of virus variants and the duration of the immune response, messenger RNA (mRNA)-based and adenoviral vectored vaccines have demonstrated an overall efficacy from 70 to 95% in both phase III trials and real life. In addition, all these vaccines also reduce the severe forms of the disease and might strongly impact the mortality which could change the course of the pandemic.
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http://dx.doi.org/10.1016/j.therap.2021.05.004DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8114590PMC
May 2021

An open-label randomized controlled trial of the effect of lopinavir/ritonavir, lopinavir/ritonavir plus IFN-β-1a and hydroxychloroquine in hospitalized patients with COVID-19.

Clin Microbiol Infect 2021 May 26. Epub 2021 May 26.

CHR Metz-Thionville, Service de Réanimation Polyvalente, Ars-Laquenexy, France.

Objectives: We evaluated the clinical, virological and safety outcomes of lopinavir/ritonavir, lopinavir/ritonavir-interferon (IFN)-β-1a, hydroxychloroquine or remdesivir in comparison to standard of care (control) in coronavirus 2019 disease (COVID-19) inpatients requiring oxygen and/or ventilatory support.

Methods: We conducted a phase III multicentre, open-label, randomized 1:1:1:1:1, adaptive, controlled trial (DisCoVeRy), an add-on to the Solidarity trial (NCT04315948, EudraCT2020-000936-23). The primary outcome was the clinical status at day 15, measured by the WHO seven-point ordinal scale. Secondary outcomes included quantification of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in respiratory specimens and pharmacokinetic and safety analyses. We report the results for the lopinavir/ritonavir-containing arms and for the hydroxychloroquine arm, trials of which were stopped prematurely.

Results: The intention-to-treat population included 583 participants-lopinavir/ritonavir (n = 145), lopinavir/ritonavir-IFN-β-1a (n = 145), hydroxychloroquine (n = 145), control (n = 148)-among whom 418 (71.7%) were male, the median age was 63 years (IQR 54-71), and 211 (36.2%) had a severe disease. The day-15 clinical status was not improved with the investigational treatments: lopinavir/ritonavir versus control, adjusted odds ratio (aOR) 0.83, (95% confidence interval (CI) 0.55-1.26, p 0.39), lopinavir/ritonavir-IFN-β-1a versus control, aOR 0.69 (95%CI 0.45-1.04, p 0.08), and hydroxychloroquine versus control, aOR 0.93 (95%CI 0.62-1.41, p 0.75). No significant effect of investigational treatment was observed on SARS-CoV-2 clearance. Trough plasma concentrations of lopinavir and ritonavir were higher than those expected, while those of hydroxychloroquine were those expected with the dosing regimen. The occurrence of serious adverse events was significantly higher in participants allocated to the lopinavir/ritonavir-containing arms.

Conclusion: In adults hospitalized for COVID-19, lopinavir/ritonavir, lopinavir/ritonavir-IFN-β-1a and hydroxychloroquine improved neither the clinical status at day 15 nor SARS-CoV-2 clearance in respiratory tract specimens.
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http://dx.doi.org/10.1016/j.cmi.2021.05.020DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8149166PMC
May 2021

Antibodies Elicited by the GMMA Vaccine in Adults Trigger Complement-Mediated Serum Bactericidal Activity: Results From a Phase 1 Dose Escalation Trial Followed by a Booster Extension.

Front Immunol 2021 4;12:671325. Epub 2021 May 4.

GSK Vaccines Institute for Global Health, Siena, Italy.

is the second most deadly diarrheal disease among children under five years of age, after rotavirus, with high morbidity and mortality in developing countries. Currently, no vaccine is widely available, and the increasing levels of multidrug resistance make a high priority for vaccine development. The single-component candidate vaccine against (1790GAHB), developed using the GMMA technology, contains the O antigen (OAg) portion of lipopolysaccharide (LPS) as active moiety. The vaccine was well tolerated and immunogenic in early-phase clinical trials. In a phase 1 placebo-controlled dose escalation trial in France (NCT02017899), three doses of five different vaccine formulations (0.06/1, 0.3/5, 1.5/25, 3/50, 6/100 µg of OAg/protein) were administered to healthy adults. In the phase 1 extension trial (NCT03089879), conducted 2-3 years following the parent study, primed individuals who had undetectable antibody levels before the primary series received a 1790GAHB booster dose (1.5/25 µg OAg/protein). Controls were unprimed participants immunized with one 1790GAHB dose. The current analysis assessed the functionality of sera collected from both studies using a high-throughput luminescence-based serum bactericidal activity (SBA) assay optimized for testing human sera. Antibodies with complement-mediated bactericidal activity were detected in vaccinees but not in placebo recipients. SBA titers increased with OAg dose, with a persistent response up to six months after the primary vaccination with at least 1.5/25 µg of OAg/protein. The booster dose induced a strong increase of SBA titers in most primed participants. Correlation between SBA titers and anti- LPS serum immunoglobulin G levels was observed. Results suggest that GMMA is a promising OAg delivery system for the generation of functional antibody responses and persistent immunological memory.
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http://dx.doi.org/10.3389/fimmu.2021.671325DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8129577PMC
May 2021

Effect of Internet use for searching information on vaccination on the uptake of human papillomavirus vaccine in France: A path-analysis approach.

Prev Med 2021 Aug 11;149:106615. Epub 2021 May 11.

INSERM CIC 1417, F-CRIN, I REIVAC, Assistance Publique- Hôpitaux de Paris, Hôpital Cochin, Paris, France; Université de Paris, Faculté de médecine Paris Descartes, Paris, France.

Internet is a popular source of information regarding vaccination. This study aimed to determine whether there is a negative association between Internet use among French vaccine-hesitant mothers and HPV vaccine uptake by their daughters, and to gain insight into the pathways that would link Internet use to the lack of HPV vaccine uptake. We conducted a pooled cross-sectional analysis across the 2015, 2016, 2017 and 2018 Vaccinoscopie® Survey. Multivariate logistic regression and path models were used in the analysis. The study sample included a total of 2038 respondent mothers. Of those, 89 (4.4%) declared having never been in the situation of searching for information regarding a vaccination they had hesitated about, leaving 1949 mothers for the present analysis. Approximately 24% (466/1949) of the mothers declared using the Internet as a source of vaccine information. In multivariate logistic regression adjusted for physician recommendation of HPV vaccination, attitudes towards vaccines in general, perception of HPV vaccine usefulness, maternal level of education, region of residence, and the survey year, the use of Internet by the mothers was significantly associated with a lower HPV vaccination among their daughters (adjusted odds ratio (aOR), 0.66; 95% confidence interval (CI), 0.47-0.91). Path analysis further confirmed the negative effect of Internet use (β = -0.10, standard error (SE) = 0.02, P < 0.0001), highlighting how the Internet plays a detrimental role in HPV vaccine uptake through a lower perceived level of HPV vaccine usefulness, a lower perceived level of information on childhood vaccination, and unfavorable attitudes towards vaccination in general.
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http://dx.doi.org/10.1016/j.ypmed.2021.106615DOI Listing
August 2021

Why should the meningococcal B vaccine be recommended, and therefore reimbursed, for infants in France?

Infect Dis Now 2021 May 10. Epub 2021 May 10.

Conseil national professionnel de pédiatrie, centre hospitalier intercommunal de Créteil, Créteil, France. Electronic address:

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http://dx.doi.org/10.1016/j.idnow.2021.05.001DOI Listing
May 2021

Assisted reproductive technology outcomes in women with a chronic viral disease.

AIDS 2021 06;35(7):1073-1081

Université de Paris, Faculté de Médecine.

Objective: The aim of this study was to evaluate the cumulative live birth rate in women undergoing in-vitro fertilization/intracytoplasmic-sperm-injection (IVF/ICSI) according to the type of chronic viral infection [HIV, hepatitis-B virus (HBV) and hepatitis-C virus (HCV)].

Design: A cohort study.

Setting: A tertiary-care university hospital.

Participants: Women with a chronic viral illness HIV, HBV or HCV- were followed until four IVF/ICSI cycles had been completed, until delivery or until discontinuation of the treatment before the completion of four cycles.

Main Outcome Measures: The primary outcome was the cumulative live birth rate after up to four IVF/ICSI cycles.

Results: A total of 235 women were allocated to the HIV-infected group (n = 101), the HBV-infected group (n = 114) and the HCV-infected group (n = 20). The cumulative live birth rate after four cycles was significantly lower in the HIV-infected women than in those with HBV [39.1%, 95% confidence interval (95% CI): 17.7-60.9 versus 52.8%, 95% CI: 41.6-65.5, respectively; P = 0.004]. Regarding the obstetrical outcomes, the mean birth weight was lower in the HIV-infected women than in those with HBV or HCV. Multivariate analysis indicated that the age, the anti-Müllerian hormone and the number of cycles performed were significantly associated with the chances of a live birth.

Conclusion: HIV-infected women had lower cumulative live birth rate than women with chronic hepatitis, and this was due to less favourable ovarian reserve parameters. These findings underscore the need to better inform practitioners and patients regarding fertility issues and the importance of early fertility assessment. However, larger studies are necessary to gain more in-depth knowledge of the direct impact of HIV on live birth rates.
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http://dx.doi.org/10.1097/QAD.0000000000002859DOI Listing
June 2021

Multiple sclerosis: Is there a risk of worsening after yellow fever vaccination?

Mult Scler 2021 Apr 19:13524585211006372. Epub 2021 Apr 19.

Department of Neurology Pitié-Salpêtrière Hospital, APHP-6, Sorbonne University, Paris, France.

Background: Yellow fever vaccine (YFV) is not advised for multiple sclerosis (MS) patients because of the potential risk of post-vaccine relapses.

Objective: To assess the risk of relapsing-remitting multiple sclerosis (RR-MS) worsening after YFV.

Methods: Non-interventional observational retrospective, exposed/non-exposed cohort study nested in the French national cohort including MS.

Results: 128 RR-MS were included. The 1-year annualized relapse rate (ARR) following YFV did not differ between exposed: 0.219 (0.420) and non-exposed subjects: 0.208 (0.521) ( = 0.92). Time to first relapse was not different between groups (adjusted hazard ratio (HR) = 1.33; 95% confidence interval (CI) = 0.53-3.30, = 0.54).

Conclusion: These results suggest that YFV does not worsen the course of RR-MS.
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http://dx.doi.org/10.1177/13524585211006372DOI Listing
April 2021

Accelerated phase Ia/b evaluation of the malaria vaccine candidate PfAMA1 DiCo demonstrates broadening of humoral immune responses.

NPJ Vaccines 2021 Apr 14;6(1):55. Epub 2021 Apr 14.

Biomedical Primate Research Centre, Rijswijk, The Netherlands.

Plasmodium falciparum apical membrane antigen 1 (PfAMA1) is a candidate malaria vaccine antigen expressed on merozoites and sporozoites. PfAMA1's polymorphic nature impacts vaccine-induced protection. To address polymorphism, three Diversity Covering (DiCo) protein sequences were designed and tested in a staggered phase Ia/b trial. A cohort of malaria-naive adults received PfAMA1-DiCo adjuvanted with Alhydrogel® or GLA-SE and a cohort of malaria-exposed adults received placebo or GLA-SE adjuvanted PfAMA1 DiCo at weeks 0, 4 and 26. IgG and GIA levels measured 4 weeks after the third vaccination are similar in malaria-naive volunteers and placebo-immunised malaria-exposed adults, and have a similar breadth. Vaccination of malaria-exposed adults results in significant antibody level increases to the DiCo variants, but not to naturally occurring PfAMA1 variants. Moreover, GIA levels do not increase following vaccination. Future research will need to focus on stronger adjuvants and/or adapted vaccination regimens, to induce potentially protective responses in the target group of the vaccine.
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http://dx.doi.org/10.1038/s41541-021-00319-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8046791PMC
April 2021

Assessment of SARS-CoV-2 infection by Reverse transcription-PCR and serology in the Paris area: a cross-sectional study.

BMJ Paediatr Open 2020 29;4(1):e000887. Epub 2020 Dec 29.

Université Paris Est, IMRB-GRC GEMINI, Créteil, France.

Background: Several studies indicated that children seem to be less frequently infected with SARS-CoV-2 and are potentially less contagious than adults. To examine the spread of SARS-CoV-2, we combined both Reverse transcription-PCR testing and serology in children in the most affected region in France, Paris, during the COVID-19 epidemic.

Methods: From 14 April 2020 to 12 May 2020, we conducted a cross-sectional, prospective, multicentre study. Healthy controls and pauci-symptomatic children from birth to age 15 years were enrolled by 27 ambulatory paediatricians. A nasopharyngeal swab was taken for detection of SARS-CoV-2 by Reverse transcription-PCR and a microsample of blood for micromethod serology.

Results: Among the 605 children, 322 (53.2%) were asymptomatic and 283 (46.8%) were symptomatic. Reverse transcription-PCR and serology results were positive for 11 (1.8%) and 65 (10.7%) children, respectively, with no significant difference between asymptomatic and pauci-symptomatic children. Only three children were Reverse transcription-PCR-positive without any antibody response detected. The frequency of Reverse transcription-PCR SARS-CoV-2 positivity was significantly higher for children with positive than negative serology results (12.3% vs 0.6%, p<0.001). Contact with a person with confirmed COVID-19 increased the odds of Reverse transcription-PCR positivity (OR 7.8, 95% CI 1.5 to 40.7) and serology positivity (OR 15.1, 95% CI 6.6 to 34.6).

Conclusion: In an area heavily affected by COVID-19, after the peak of the first epidemic wave and during the lockdown, the rate of children with Reverse transcription-PCR SARS-CoV-2 positivity was very low (1.8%), but that of serology positivity was higher (10.7%). Most children with positive Reverse transcription-PCR results also had positive serology results.

Trial Registration Number: NCT04318431.
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http://dx.doi.org/10.1136/bmjpo-2020-000887DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7778737PMC
December 2020

Online mis/disinformation and vaccine hesitancy in the era of COVID-19: Why we need an eHealth literacy revolution.

Hum Vaccin Immunother 2021 Feb 24:1-3. Epub 2021 Feb 24.

Inserm Cic 1417, F-crin, I Reivac; Assistance Publique- Hôpitaux de Paris, Hôpital Cochin, Paris, France.

The quality of online health information is cause for concern in general, and the spread of mis/disinformation on the benefits and risks of vaccines has certainly been fueling vaccine hesitancy. In the wake of the COVID-19 pandemic, we have entered an era of unprecedented "infodemic." There has never been a more urgent time to address the long-standing question of how to overcome the deleterious influence of exposure to online mis/disinformation on vaccine uptake. eHealth literacy, a skill set including media literacy, is key to navigating the web in search for health information and processing the one encountered through social media. Studies assessing the impact of increasing eHealth literacy on behavioral attitudes and health outcomes in the general population are relatively scarce to date. Yet for many reasons, leveraging eHealth literacy skills, and more specifically, media literacy, could be of great value to help mitigate the detrimental effects of erroneous information on vaccination decision-making. In this paper, we make the case that eHealth and media literacies should be viewed as fundamental skills that have the potential to empower citizens to better recognize online mis/disinformation and make informed decisions about vaccination as any other health matters.
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http://dx.doi.org/10.1080/21645515.2021.1874218DOI Listing
February 2021

Attitudes of hospital physicians toward childhood mandatory vaccines in France: A cross-sectional survey.

Hum Vaccin Immunother 2021 Feb 22:1-8. Epub 2021 Feb 22.

INSERM, F-CRIN, Innovative Clinical Research Network in VACcinology (I-REIVAC), Paris, France.

: Due to a decades-long crisis of confidence in vaccination, in 2017 France extended the number of mandatory early childhood vaccines from 3 to 11.: To describe the opinions of hospital staff physicians (HSPs) regarding this measure, quantify the proportion who would have preferred measures based on education, and study the factors associated with the latter opinion.: Cross-sectional nationwide survey with a standardized questionnaire in 2018-2019 among HSPs in 14 French public hospitals. The factors associated with HSPs' preference for education and persuasion over mandatory vaccination were analyzed with simple and multiple Poisson regressions.: The analyses included 1,795 HSPs (participation rate of 86%). Among them, 84% considered the extension of mandatory childhood vaccination essential given the epidemiological context at the time; in a later question, 40% would have preferred education and persuasion. Multiple regressions showed that the latter tended to be younger and less trustful of sources of information about vaccination. They were more likely to think that information on the rationale behind the national vaccination policy lacked clarity and that the extension of mandatory vaccines was not essential, even in the current epidemiologic situation.: Although most HSPs agreed that the extension of mandatory childhood vaccines was essential, some were ambivalent about its coercive philosophy. Further research is necessary to better understand the reasons of this ambivalence. A fraction did not understand the French vaccination strategy well. Efforts to explain its details to HSPs and an overhaul of their initial training on vaccination are still needed.
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http://dx.doi.org/10.1080/21645515.2020.1870393DOI Listing
February 2021

The French general population's attitudes toward lockdown against COVID-19: a fragile consensus.

BMC Public Health 2020 Dec 18;20(1):1920. Epub 2020 Dec 18.

Inserm CIC 1417, Faculté de Médecine Paris Descartes, Univ Paris, AP-HP, Hôpital Cochin, Paris, France.

Background: In March 2020, as the coronavirus disease 2019 (COVID- 19) pandemic was spreading across the globe, many countries have implemented unprecedented lockdown measures. But how populations did react to these measures? We examined the case of France. Our aims were threefold: assessing some aspects of their impact on French's daily living conditions; investigating their attitudes toward the lockdown; investigating the factors associated with these attitudes.

Methods: A cross-sectional online survey was carried out 10 days after the nationwide lockdown (from March 27th to March 29th 2020), among a representative sample of the mainland French population aged 18 and over. A quota sampling method was applied to achieve a sample of 1012 respondents. We used a cluster analysis to obtain contrasted attitudinal profiles, and logistic regressions to investigated which factors were associated to these profiles.

Results: After 10 days of lockdown, there were already significant consequences regarding respondents' living conditions and mental health. Most respondents supported the current lockdown. However, it appeared as a stopgap measure due to a lack of alternatives, and a large majority acknowledged its heavy drawbacks. We found three contrasted attitudinal profiles: full support (38%), strong but critical support (31%), limited support (31%). Regarding respondents' SES, low-income and low-education respondents were more likely to display critical or limited support to the lockdown, as well as those who reported deteriorated living conditions or psychological distress.

Conclusions: In France, the large public support to the lockdown was fragile. First, it was a critical consensus anchored in current controversies and recent social struggles. Second, it was weaker among people with a lows SES, especially since the lockdown have exacerbated preexisting social inequalities.
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http://dx.doi.org/10.1186/s12889-020-10048-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7746918PMC
December 2020

SARS-COV-2 IgG antibody response in pregnant women at delivery.

J Gynecol Obstet Hum Reprod 2020 Dec 10;50(7):102041. Epub 2020 Dec 10.

Université Paris-Saclay, 94804 Villejuif, France; Laboratoire de Virologie, AP-HP, Hôpital Paul-Brousse, F-94804 Villejuif, France.

Background: The prevalence of COVID-19 infection during pregnancy is not known. COVIPREG is a prospective French multicenter study to assess the seroprevalence at the time of delivery and the maternal and neonatal impact of COVID-19 infection during pregnancy. In order to study factors associated with poor outcomes after COVID-19 Infection during pregnancy and adapt the sample size of the study, a preliminary assessment of the prevalence of SARS-CoV-2 IgG was planned after 500 inclusions in a one perinatal center of Paris area.

Objectives: To assess the prevalence of SARS-CoV-2 IgG antibody response in pregnant women at the time of delivery during the COVID-19 pandemia.

Study Design: A prospective observational study at Cochin hospital (Level III maternity). Patients admitted for delivery were offered to participate to the study. Each patient participating to the study was tested for anti-SARS-CoV-2-IgG antibodies using a commercially available ELISA.

Results: Among the 529 patients included in the COVIPREG study between April 29 and June 26, 529 were assessed for SARS-CoV-2 IgG antibody response and 25 had a positive test, ie 4.7 % with a confidence interval at 95 % [3.0 %-6.9 %]).

Conclusions: Four months after the beginning of the infection in Paris, the seroprevalence of SARS-CoV-2 IgG in pregnant women at the time of delivery is low. Studies evaluating the impact of COVID-19 infection during pregnancy should take this information in account in order to adapt the sample size.
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http://dx.doi.org/10.1016/j.jogoh.2020.102041DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7831450PMC
December 2020

Persistence of monocyte activation under treatment in people followed since acute HIV-1 infection relative to participants at high or low risk of HIV infection.

EBioMedicine 2020 Dec 26;62:103129. Epub 2020 Nov 26.

Université Paris-Saclay, UVSQ, Inserm, CESP, 94807 Villejuif, France; Service de Santé Publique, AP-HP, Hôpital de Bicêtre, Le Kremlin-Bicêtre, France. Electronic address:

Background: Interpretation of the increase in certain inflammatory markers in virally suppressed HIV-infected individuals must rely on an appropriate uninfected control group well characterized for non-HIV-related factors that contribute to chronic inflammation, e.g. smoking, alcohol consumption, or being overweight. We compared the inflammatory profiles of HIV-infected participants under long-term antiretroviral therapy (ART) with those of two HIV-uninfected groups with contrasting health behaviours.

Methods: We studied 150 HIV-infected participants (42 women, 108 men) under long-term ART (median, 6 years) followed in the ANRS PRIMO cohort since acute/early HIV-1 infection (AHI) diagnosis. Sex and age-matched controls were sampled from i) the ANRS IPERGAY pre-exposure prophylaxis trial among men at high risk for HIV infection and with high frequencies of non-HIV factors of inflammation ii) the ANRS COHVAC cohort of volunteers in vaccine trials with a low-risk profile for HIV infection. We measured the plasma levels of ten inflammatory markers.

Findings: After adjusting for smoking, alcohol use and body mass index, both HIV-infected men and women had higher levels of sCD14, sCD163, sTNFRII and I-FABP than their high-risk IPERGAY and low-risk COHVAC counterparts. Hierarchical clustering showed a subset of 15 PRIMO participants to have an inflammatory profile similar to that of most HIV-negative participants. These participants already had favourable markers at AHI diagnosis.

Interpretation: Long-term ART, even when initiated at a low level of immunodeficiency, fails to normalize monocyte/macrophage activation and gut epithelial dysfunction. Persistent inflammation under treatment may be related to an increased inflammatory profile since AHI.

Funding: ANRS and Paris-Saclay University.
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http://dx.doi.org/10.1016/j.ebiom.2020.103129DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7704414PMC
December 2020

Safety and immunogenicity of a two-dose heterologous Ad26.ZEBOV and MVA-BN-Filo Ebola vaccine regimen in adults in Europe (EBOVAC2): a randomised, observer-blind, participant-blind, placebo-controlled, phase 2 trial.

Lancet Infect Dis 2021 04 17;21(4):493-506. Epub 2020 Nov 17.

University Bordeaux, INSERM, Bordeaux Population Health Research Center, UMR 1219, INSERM, CHU Bordeaux, Bordeaux, France; CIC, EUCLID/F-CRIN Clinical Trials Platform, F-33000, Bordeaux, France; Inria SISTM team, F-33405, Talence, France. Electronic address:

Background: To address the unmet medical need for an effective prophylactic vaccine against Ebola virus we assessed the safety and immunogenicity of three different two-dose heterologous vaccination regimens with a replication-deficient adenovirus type 26 vector-based vaccine (Ad26.ZEBOV), expressing Zaire Ebola virus glycoprotein, and a non-replicating, recombinant, modified vaccinia Ankara (MVA) vector-based vaccine, encoding glycoproteins from Zaire Ebola virus, Sudan virus, and Marburg virus, and nucleoprotein from the Tai Forest virus.

Methods: This randomised, observer-blind, placebo-controlled, phase 2 trial was done at seven hospitals in France and two research centres in the UK. Healthy adults (aged 18-65 years) with no history of Ebola vaccination were enrolled into four cohorts. Participants in cohorts I-III were randomly assigned (1:1:1) using computer-generated randomisation codes into three parallel groups (randomisation for cohorts II and III was stratified by country and age), in which participants were to receive an intramuscular injection of Ad26.ZEBOV on day 1, followed by intramuscular injection of MVA-BN-Filo at either 28 days (28-day interval group), 56 days (56-day interval group), or 84 days (84-day interval group) after the first vaccine. Within these three groups, participants in cohort II (14:1) and cohort III (10:3) were further randomly assigned to receive either Ad26.ZEBOV or placebo on day 1, followed by either MVA-BN-Filo or placebo on days 28, 56, or 84. Participants in cohort IV were randomly assigned (5:1) to receive one dose of either Ad26.ZEBOV or placebo on day 1 for vector shedding assessments. For cohorts II and III, study site personnel, sponsor personnel, and participants were masked to vaccine allocation until all participants in these cohorts had completed the post-MVA-BN-Filo vaccination visit at 6 months or had discontinued the trial, whereas cohort I was open-label. For cohort IV, study site personnel and participants were masked to vaccine allocation until all participants in this cohort had completed the post-vaccination visit at 28 days or had discontinued the trial. The primary outcome, analysed in all participants who had received at least one dose of vaccine or placebo (full analysis set), was the safety and tolerability of the three vaccination regimens, as assessed by participant-reported solicited local and systemic adverse events within 7 days of receiving both vaccines, unsolicited adverse events within 42 days of receiving the MVA-BN-Filo vaccine, and serious adverse events over 365 days of follow-up. The secondary outcome was humoral immunogenicity, as measured by the concentration of Ebola virus glycoprotein-binding antibodies at 21 days after receiving the MVA-BN-Filo vaccine. The secondary outcome was assessed in the per-protocol analysis set. This study is registered at ClinicalTrials.gov, NCT02416453, and EudraCT, 2015-000596-27.

Findings: Between June 23, 2015, and April 27, 2016, 423 participants were enrolled: 408 in cohorts I-III were randomly assigned to the 28-day interval group (123 to receive Ad26.ZEBOV and MVA-BN-Filo, and 13 to receive placebo), the 56-day interval group (124 to receive Ad26.ZEBOV and MVA-BN-Filo, and 13 to receive placebo), and the 84-day interval group (117 to receive Ad26.ZEBOV and MVA-BN-Filo, and 18 to receive placebo), and 15 participants in cohort IV were assigned to receive Ad26.ZEBOV and MVA-BN-Filo (n=13) or to receive placebo (n=2). 421 (99·5%) participants received at least one dose of vaccine or placebo. The trial was temporarily suspended after two serious neurological adverse events were reported, one of which was considered as possibly related to vaccination, and per-protocol vaccination was disrupted for some participants. Vaccinations were generally well tolerated. Mild or moderate local adverse events (mostly pain) were reported after 206 (62%) of 332 Ad26.ZEBOV vaccinations, 136 (58%) of 236 MVA-BN-Filo vaccinations, and 11 (15%) of 72 placebo injections. Systemic adverse events were reported after 255 (77%) Ad26.ZEBOV vaccinations, 116 (49%) MVA-BN-Filo vaccinations, and 33 (46%) placebo injections, and included mostly mild or moderate fatigue, headache, or myalgia. Unsolicited adverse events occurred after 115 (35%) of 332 Ad26.ZEBOV vaccinations, 81 (34%) of 236 MVA-BN-Filo vaccinations, and 24 (33%) of 72 placebo injections. At 21 days after receiving the MVA-BN-Filo vaccine, geometric mean concentrations of Ebola virus glycoprotein-binding antibodies were 4627 ELISA units (EU)/mL (95% CI 3649-5867) in the 28-day interval group, 10 131 EU/mL (8554-11 999) in the 56-day interval group, and 11 312 mL (9072-14106) in the 84-day interval group, with antibody concentrations persisting at 1149-1205 EU/mL up to day 365.

Interpretation: The two-dose heterologous regimen with Ad26.ZEBOV and MVA-BN-Filo was safe, well tolerated, and immunogenic, with humoral and cellular immune responses persisting for 1 year after vaccination. Taken together, these data support the intended prophylactic indication for the vaccine regimen.

Funding: Innovative Medicines Initiative and Janssen Vaccines & Prevention BV.

Translation: For the French translation of the abstract see Supplementary Materials section.
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http://dx.doi.org/10.1016/S1473-3099(20)30476-XDOI Listing
April 2021

Attitudes about COVID-19 Lockdown among General Population, France, March 2020.

Emerg Infect Dis 2021 01 12;27(1). Epub 2020 Nov 12.

Because the effectiveness of a coronavirus disease lockdown in curbing coronavirus disease spread depends on public support, acquiring real-time information about the way populations reacted to the lockdown is crucial. In France, such public support remained fragile among low-income persons, probably because the lockdown exacerbated preexisting social inequalities and conflicts.
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http://dx.doi.org/10.3201/eid2701.201377DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7774552PMC
January 2021

Safety, immunogenicity, and efficacy of a Clostridioides difficile toxoid vaccine candidate: a phase 3 multicentre, observer-blind, randomised, controlled trial.

Lancet Infect Dis 2021 02 15;21(2):252-262. Epub 2020 Sep 15.

Sanofi Pasteur, Swiftwater, PA, USA.

Background: In the absence of a licensed vaccine, Clostridioides (formerly Clostridium) difficile infection represents a substantial health burden. The aim of this study was to evaluate the efficacy, immunogenicity, and safety of a toxoid vaccine candidate.

Methods: We did a phase 3 multicentre, observer-blind, randomised, controlled trial at 326 hospitals, clinics, and clinical research centres in 27 countries in the USA, Canada, Latin America, Europe, and the Asia-Pacific region. We included adults aged 50 years or older who were considered to be at an increased risk of C difficile infection because they had previously had two hospital stays (each ≥24 h in duration) and had received systemic antibiotics in the previous 12 months (risk stratum 1), or because they were anticipating being admitted to hospital for 72 h or more for elective surgery within 60 days of enrolment (risk stratum 2). Eligible participants were stratified by geographical region and the two risk strata, and randomly assigned (2:1), with a fixed block size of three, to receive either a C difficile toxoid vaccine candidate, containing toxoids A and B (C difficile vaccine candidate group), or a placebo vaccine (placebo group). Participants, investigators, and personnel responsible for collecting safety data and analysing blood and stool samples were masked to group assignment. Personnel responsible for study product preparation and administration were not masked to group assignment. One dose (0·5 mL) of C difficile vaccine candidate or placebo vaccine was administered intramuscularly on days 0, 7, and 30. The primary outcome was the efficacy of the vaccine in preventing symptomatic C difficile infection, defined as having three or more loose stools in a period of 24 h or less, loose stools for 24 h or more, and a PCR-positive test for C difficile toxin B in a loose stool sample, within 3 years after the final vaccine dose. The primary outcome was measured in the modified intention-to-treat population (ie, all participants who received at least one injection of the assigned vaccine). The safety of the vaccine was assessed in the safety analysis set (ie, all participants who had received at least one injection, analysed according to the product received). This study is registered with WHO/ICTRP, number U111-1127-7162, and ClinicalTrials.gov, number NCT01887912, and has been terminated.

Findings: Between July 30, 2013, and Nov 17, 2017, we enrolled and randomly assigned 9302 participants to the C difficile vaccine candidate group (n=6201) or to the placebo group (n=3101). 6173 (99·5%) participants in the C difficile vaccine candidate group and 3085 (99·5%) participants in the placebo group received at least one dose of the vaccine. The study was terminated after the first planned interim analysis because of futility. In the C difficile vaccine candidate group, 34 C difficile infections were reported over 11 697·2 person-years at risk (0·29 infections per 100 person-years [95% CI 0·20-0·41]) compared with 16 C difficile infections over 5789·4 person-years at risk in the placebo group (0·28 infections per 100 person-years [0·16-0·45]), indicating a vaccine efficacy of -5·2% (95% CI -104·1 to 43·5). In the C difficile vaccine candidate group, 2847 (46·6%) of 6113 participants reported an adverse event within 30 days of injection compared with 1282 (41·9%) of 3057 participants in the placebo group. The proportion of participants who had an adverse event leading to study discontinuation was 4·8% in both groups (296 participants in the C difficile vaccine candidate group and 146 participants in the placebo group). 1662 (27·2%) participants in the C difficile vaccine candidate group reported at least one serious adverse event compared with 851 (27·8%) participants in the placebo group.

Interpretation: In adults at risk for C difficile infection, a bivalent C difficile toxoid vaccine did not prevent C difficile infection. Since the C difficile vaccine candidate met the criteria for futility, the study was terminated and clinical development of this vaccine candidate was stopped.

Funding: Sanofi Pasteur.
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http://dx.doi.org/10.1016/S1473-3099(20)30331-5DOI Listing
February 2021

[Human papillomavirus vaccination : pharmacovigilance data].

Rev Prat 2020 01;70(1):96-98

CIC Cochin-Pasteur, Hopital Cochin, Paris, France.

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January 2020

Design and content validation of a survey questionnaire assessing the determinants of human papillomavirus (HPV) vaccine hesitancy in France: A reactive Delphi study.

Vaccine 2020 09 25;38(39):6127-6140. Epub 2020 Jul 25.

INSERM, Sorbonne Université, Institut Pierre Louis d'Épidémiologie et de Santé Publique, Paris, France.

Introduction: This study aimed to develop and undertake a preliminary validation of a French Survey Questionnaire for the Determinants of HPV Vaccine Hesitancy (FSQD-HPVH).

Methods: We undertook an electronic-based Delphi consultation among a panel of Francophone experts in two rounds. Round 1 consisted of the assessment of a structured questionnaire comprising of three parts ((i) Contextual influences, (ii) Individual and group influences, and (iii) Vaccine/vaccination-specific issues), in line with the WHO Strategic Advisory Group of Experts (SAGE) Vaccine Hesitancy (VH) Model of Determinants. Items included in this questionnaire were based on a literature review. Definitions of the factors included in the SAGE model were provided in the questionnaire. The panel of experts was asked to score each item using a 3-point Likert scale, in which 1 meant "Essential", 2 "Useful but not essential", and 3 "Not necessary". The panel was also invited to comment on the clarity/comprehension of the questions and suggest reformulations/additional items. Lawshe's Content Validity Ratio (CVR) was computed to assess the level of consensus for each statement. Only items upon which agreement was not reached in Round 1 (CVR < 0.6) and newly proposed items were submitted for evaluation in Round 2, using the same procedure.

Results: Fifteen experts completed the two rounds. Of 83 items evaluated in Round 1, 35 (42%) had a CVR ≥ 0.6 and were accepted without modification. In Round 2, 66 items were submitted to the same panel and consensus was reached for 22 (33%) items using the threshold of 0.6. The final FSQD-HPVH version includes 57 items.

Conclusion: This study developed a survey instrument for the evaluation of HPV VH in France with good content validity. It will be used to assess the determinants of HPV VH, the first step towards an evidence-based approach to improving HPV vaccination rates in France.
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http://dx.doi.org/10.1016/j.vaccine.2020.07.027DOI Listing
September 2020

Global Perspectives on Immunization During Pregnancy and Priorities for Future Research and Development: An International Consensus Statement.

Front Immunol 2020 24;11:1282. Epub 2020 Jun 24.

Immunization Action Coalition, St. Paul, MN, United States.

Immunization during pregnancy has been recommended in an increasing number of countries. The aim of this strategy is to protect pregnant women and infants from severe infectious disease, morbidity and mortality and is currently limited to tetanus, inactivated influenza, and pertussis-containing vaccines. There have been recent advancements in the development of vaccines designed primarily for use in pregnant women (respiratory syncytial virus and group B vaccines). Although there is increasing evidence to support vaccination in pregnancy, important gaps in knowledge still exist and need to be addressed by future studies. This collaborative consensus paper provides a review of the current literature on immunization during pregnancy and highlights the gaps in knowledge and a consensus of priorities for future research initiatives, in order to optimize protection for both the mother and the infant.
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http://dx.doi.org/10.3389/fimmu.2020.01282DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7326941PMC
April 2021

Optimal priming of poxvirus vector (NYVAC)-based HIV vaccine regimens for T cell responses requires three DNA injections. Results of the randomized multicentre EV03/ANRS VAC20 Phase I/II Trial.

PLoS Pathog 2020 06 26;16(6):e1008522. Epub 2020 Jun 26.

Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland.

DNA vectors have been widely used as a priming of poxvirus vaccine in prime/boost regimens. Whether the number of DNA impacts qualitatively or quantitatively the immune response is not fully explored. With the aim to reinforce T-cell responses by optimizing the prime-boost regimen, the multicentric EV03/ANRS VAC20 phase I/II trial, randomized 147 HIV-negative volunteers to either 3xDNA plus 1xNYVAC (weeks 0, 4, 8 plus 24; n = 74) or to 2xDNA plus 2xNYVAC (weeks 0, 4 plus 20, 24; n = 73) groups. T-cell responses (IFN-γ ELISPOT) to at least one peptide pool were higher in the 3xDNA than the 2xDNA groups (91% and 80% of vaccinees) (P = 0.049). In the 3xDNA arm, 26 (37%) recipients developed a broader T-cell response (Env plus at least to one of the Gag, Pol, Nef pools) than in the 2xDNA (15; 22%) arms (primary endpoint; P = 0.047) with a higher magnitude against Env (at week 26) (P<0.001). In both groups, vaccine regimens induced HIV-specific polyfunctional CD4 and CD8 T cells and the production of Th1, Th2 and Th17/IL-21 cytokines. Antibody responses were also elicited in up to 81% of vaccines. A higher percentage of IgG responders was noted in the 2xDNA arm compared to the 3xDNA arm, while the 3xDNA group tended to elicit a higher magnitude of IgG3 response against specific Env antigens. We show here that the modulation of the prime strategy, without modifying the route or the dose of administration, or the combination of vectors, may influence the quality of the responses.
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http://dx.doi.org/10.1371/journal.ppat.1008522DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7319597PMC
June 2020

Influenza immunisation in pregnancy is efficacious and safe, but questions remain.

Lancet Respir Med 2020 06;8(6):533-534

Inserm, F-CRIN, Réseau Innovative Clinical Research in Vaccinology, Paris, France; FHU PREMA, Hôpital Cochin, Paris 75014, France; Inserm, CIC Cochin Pasteur, Hôpital Cochin, Paris 75014, France; Assistance Publique Hôpitaux de Paris, Hôpital Cochin, Paris 75014, France; Université de Paris, Paris, France. Electronic address:

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http://dx.doi.org/10.1016/S2213-2600(20)30034-5DOI Listing
June 2020

Recommendation of HPV vaccination to boys in France - An unhappy coïncidence with the WHO call to pause the implementation of this vaccination in boys.

Vaccine 2020 05 15;38(23):3919-3921. Epub 2020 Apr 15.

INSERM CIC 1417, F-CRIN, I REIVAC, Assistance Publique- Hôpitaux de Paris, Hôpital Cochin, Paris, France; INSERM, Sorbonne Université, Institut Pierre Louis d'Épidémiologie et de Santé Publique, Paris, France; Université de Paris, Faculté de médecine Paris Descartes, Paris, France. Electronic address:

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http://dx.doi.org/10.1016/j.vaccine.2020.04.017DOI Listing
May 2020

Non-influenza respiratory viruses in adult patients admitted with influenza-like illness: a 3-year prospective multicenter study.

Infection 2020 Aug 13;48(4):489-495. Epub 2020 Feb 13.

Université Rennes-I, Service Des Maladies Infectieuses et de Réanimation Médicale, Hôpital Pontchaillou, CHU Pontchaillou, 2 rue Henri Le Guilloux, 35033, Rennes Cedex, France.

Purpose: To describe the burden, and characteristics, of influenza-like illness (ILI) associated with non-influenza respiratory viruses (NIRV).

Methods: We performed a prospective, multicenter, observational study of adults admitted with ILI during three influenza seasons (2012-2015). Patients were screened for picornavirus, respiratory syncytial virus (RSV), coronavirus, human metapneumovirus, adenovirus, bocavirus, parainfluenza virus, and influenza, by PCR on nasopharyngeal samples. We excluded patients coinfected with NIRV and influenza.

Results: Among 1421 patients enrolled, influenza virus was detected in 535 (38%), and NIRV in 215 (15%), mostly picornavirus (n = 61), RSV (n = 53), coronavirus 229E (n = 48), and human metapneumovirus (n = 40). In-hospital mortality was 5% (NIRV), 4% (influenza), and 5% (no respiratory virus). As compared to influenza, NIRV were associated with age (median, 73 years vs. 68, P = 0.026), chronic respiratory diseases (53% vs. 45%, P = 0.034), cancer (14% vs. 9%, P = 0.029), and immunosuppressive drugs (21% vs. 14%, P = 0.028), and inversely associated with diabetes (18% vs. 25%, P = 0.038). On multivariable analysis, only chronic respiratory diseases (OR 1.5 [1.1-2.0], P = 0.008), and diabetes (OR 0.5 [0.4-0.8], P = 0.01) were associated with NIRV detection.

Conclusions: NIRV are common in adults admitted with ILI during influenza seasons. Outcomes are similar in patients with NIRV, influenza, or no respiratory virus.
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http://dx.doi.org/10.1007/s15010-019-01388-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7095392PMC
August 2020

PRIMVAC vaccine adjuvanted with Alhydrogel or GLA-SE to prevent placental malaria: a first-in-human, randomised, double-blind, placebo-controlled study.

Lancet Infect Dis 2020 05 4;20(5):585-597. Epub 2020 Feb 4.

Centre national de recherche et de formation sur le paludisme, Ouagadougou, Burkina Faso.

Background: PRIMVAC is a VAR2CSA-derived placental malaria vaccine candidate aiming to prevent serious clinical outcomes of Plasmodium falciparum infection during pregnancy. We assessed the safety and immunogenicity of PRIMVAC adjuvanted with Alhydrogel or glucopyranosyl lipid adjuvant in stable emulsion (GLA-SE) in French and Burkinabe women who were not pregnant.

Methods: This first-in-human, randomised, double-blind, placebo-controlled, dose escalation trial was done in two staggered phases, a phase 1A trial in 18-35-year-old women who were malaria naive in a hospital in France and a subsequent phase 1B trial in women who were naturally exposed to P falciparum and nulligravid in the clinical site of a research centre in Burkina Faso. Volunteers were recruited into four sequential cohorts receiving PRIMVAC intramuscularly at day 0, 28, and 56: two cohorts in France receiving 20 μg or 50 μg of PRIMVAC and then two in Burkina Faso receiving 50 μg or 100 μg of PRIMVAC. Volunteers were randomly assigned (1:1) to two groups (PRIMVAC adjuvanted with either Alhydrogel or GLA-SE) in France and randomly assigned (2:2:1) to three groups (PRIMVAC adjuvanted with either Alhydrogel, GLA-SE, or placebo) in Burkina Faso. Randomisation was centralised, using stratification by cohort and blocks of variable size, and syringes were masked by opaque labels. The primary endpoint was the proportion of participants with any grade 3 or higher adverse reaction to vaccination up until day 35. Safety at later time points as well as humoral and cellular immunogenicity were assessed in secondary endpoints. This trial is registered with ClinicalTrials.gov, NCT02658253.

Findings: Between April 19, 2016, and July 13, 2017, 68 women (18 in France, 50 in Burkina Faso) of 101 assessed for eligibility were included. No serious adverse event related to the vaccine occurred. PRIMVAC antibody titres increased with each dose and seroconversion was observed in all women vaccinated with PRIMVAC (n=57). PRIMVAC antibody titres reached a peak (geometric mean 11 843·0, optical density [OD] 1·0, 95% CI 7559·8-18 552·9 with 100 μg dose and GLA-SE) 1 week after the third vaccination (day 63). Compared with Alhydrogel, GLA-SE tended to improve the PRIMVAC antibody response (geometric mean 2163·5, OD 1·0, 95% CI 1315·7-3557·7 with 100 μg dose and Alhydrogel at day 63). 1 year after the last vaccination, 20 (71%) of 28 women who were vaccinated with PRIMVAC/Alhydrogel and 26 (93%) of 28 women who were vaccinated with PRIMVAC/GLA-SE still had anti-PRIMVAC antibodies, although antibody magnitude was markedly lower (452·4, OD 1·0, 95% CI 321·8-636·1 with 100 μg dose and GLA-SE). These antibodies reacted with native homologous VAR2CSA expressed by NF54-CSA infected erythrocytes (fold change from baseline at day 63 with 100 μg dose and GLA-SE: 10·74, 95% CI 8·36-13·79). Limited cross-recognition, restricted to sera collected from women that received the 100 μg PRIMVAC dose, was observed against heterologous VAR2CSA variants expressed by FCR3-CSA (fold change from baseline at day 63: 1·49, 95% CI 1·19-1·88) and 7G8-CSA infected erythrocytes (1·2, 1·08-1·34).

Interpretation: PRIMVAC adjuvanted with Alhydrogel or GLA-SE had an acceptable safety profile, was immunogenic, and induced functional antibodies reacting with the homologous VAR2CSA variant expressed by NF54-CSA infected erythrocytes. Cross-reactivity against heterologous VAR2CSA variants was limited and only observed in the higher dose group. An alternate schedule of immunisation, antigen dose, and combinations with other VAR2CSA-based vaccines are envisaged to improve the cross-reactivity against heterologous VAR2CSA variants.

Funding: Bundesministerium für Bildung und Forschung, through Kreditanstalt für Wiederaufbau, Germany; Inserm, and Institut National de Transfusion Sanguine, France; Irish Aid, Department of Foreign Affairs and Trade, Ireland.
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http://dx.doi.org/10.1016/S1473-3099(19)30739-XDOI Listing
May 2020

Vaccine effectiveness against influenza A(H3N2) and B among laboratory-confirmed, hospitalised older adults, Europe, 2017-18: A season of B lineage mismatched to the trivalent vaccine.

Influenza Other Respir Viruses 2020 05 5;14(3):302-310. Epub 2020 Feb 5.

Epiconcept, Paris, France.

Background: Influenza A(H3N2), A(H1N1)pdm09 and B viruses co-circulated in Europe in 2017-18, predominated by influenza B. WHO-recommended, trivalent vaccine components were lineage-mismatched for B. The I-MOVE hospital network measured 2017-18 seasonal influenza vaccine effectiveness (IVE) against influenza A(H3N2) and B among hospitalised patients (≥65 years) in Europe.

Methods: Following the same generic protocol for test-negative design, hospital teams in nine countries swabbed patients ≥65 years with recent onset (≤7 days) severe acute respiratory infection (SARI), collecting information on demographics, vaccination status and underlying conditions. Cases were RT-PCR positive for influenza A(H3N2) or B; controls: negative for any influenza. "Vaccinated" patients had SARI onset >14 days after vaccination. We measured pooled IVE against influenza, adjusted for study site, age, sex, onset date and chronic conditions.

Results: We included 3483 patients: 376 influenza A(H3N2) and 928 B cases, and 2028 controls. Most (>99%) vaccinated patients received the B lineage-mismatched trivalent vaccine. IVE against influenza A(H3N2) was 24% (95% CI: 2 to 40); 35% (95% CI: 6 to 55) in 65- to 79-year-olds and 14% (95% CI: -22 to 39) in ≥80-year-olds. Against influenza B, IVE was 30% (95% CI: 16 to 41); 37% (95% CI: 19 to 51) in 65- to 79-year-olds and 19% (95% CI: -7 to 38) in ≥80-year-olds.

Conclusions: IVE against influenza B was similar to A(H3N2) in hospitalised older adults, despite trivalent vaccine and circulating B lineage mismatch, suggesting some cross-protection. IVE was lower in those ≥80 than 65-79 years. We reinforce the importance of influenza vaccination in older adults as, even with a poorly matched vaccine, it still protects one in three to four of this population from severe influenza.
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http://dx.doi.org/10.1111/irv.12714DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7182608PMC
May 2020

Seasonal influenza vaccine uptake and vaccine refusal among pregnant women in France: results from a national survey.

Hum Vaccin Immunother 2020 05 14;16(5):1093-1100. Epub 2019 Nov 14.

Obstetrical, Perinatal and Pediatric Epidemiology Research Team (Epopé), CRESS, INSERM, INRA, Université de Paris, Paris, France.

Pregnant women and infants are at high risk for severe influenza and many countries, including France, recommend annual influenza immunization during pregnancy. We aimed to estimate influenza vaccination and refusal rates and assess associated factors among pregnant women during the 2015-16 season in France. We used data from a national representative sample of women who gave birth in March 2016 and were interviewed before hospital discharge (N = 11,752). In the multivariable analysis, robust Poisson regression models were used to study associations with maternal characteristics and prenatal care characteristics. Influenza vaccine coverage among pregnant women was 7.4% (95% confidence interval [CI]: 6.9-7.9). Only 24.9% (95% CI: 24.2-25.7) of women said that they received a care provider proposal for vaccination and 70.4% (95% CI: 68.7-72.0) of these declined it. Vaccine uptake was associated with low parity (prevalence ratio [PR] = 2.1; 95% CI: 1.4-3.2 for parity 0 vs ≥ 3), high educational level (PR = 2.5; 95% CI: 2.0-3.2), healthcare occupation during pregnancy (PR = 1.8; 95% CI: 1.5-2.1) and preexisting conditions at risk for influenza (PR = 1.7; 95% CI: 1.3-2.2). Women were more frequently vaccinated when their main care provider was a general practitioner. Multiparae women and those with medium or low educational level were significantly more likely than others to decline influenza vaccine after a provider proposal. Influenza vaccine coverage is very low in France, mainly because of infrequent care provider proposals and also frequent women's refusals. Effective interventions should be designed to promote vaccination among medical professionals and reduce vaccine hesitancy among pregnant women.
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http://dx.doi.org/10.1080/21645515.2019.1688035DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7227616PMC
May 2020

Alternative hepatitis B vaccine strategies in healthy non-responders to a first standard vaccination scheme.

Lancet Infect Dis 2020 01 16;20(1):7-8. Epub 2019 Oct 16.

Université de Paris, faculté de médecine, Paris, France; Inserm, F-CRIN, Innovative clinical research network (I-REIVAC), Paris, France; Assistance Publique Hopitaux de Paris, CIC Cochin Pasteur, Paris, France. Electronic address:

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http://dx.doi.org/10.1016/S1473-3099(19)30582-1DOI Listing
January 2020

Vaccination in adult liver transplantation candidates and recipients.

Clin Res Hepatol Gastroenterol 2020 04 10;44(2):126-134. Epub 2019 Oct 10.

Inserm, CIC 1417, F-CRIN, Innovative clinical research network in vaccinology (I-REIVAC), 75014 Paris, France; Université de Paris, 75014 Paris, France; Assistance Publique-Hôpitaux de Paris, CIC Cochin Pasteur, Hôpital Cochin Paris, 75014 Paris, France. Electronic address:

In patients with chronic liver disease and liver transplant recipients, cirrhosis-associated immune dysfunction syndrome and immunosuppressant drug regimens required to prevent graft rejection lead to a high risk of severe infections, associated with acute liver decompensation, graft loss and increased mortality. In addition to maintain their global health status, vaccination represents a major preventive measure against specific infectious risks of particular concern in this population, such as invasive pneumococcal diseases, influenza or viral hepatitis A and B. However, immunization in this setting raises several issues: i) recommended vaccination schedules rely on sparse immunogenicity data without clinical efficacy and effectiveness trials designed for this specific population; ii) dynamics of immunosuppression makes timing of immunization challenging; iii) live attenuated vaccines are contraindicated after transplantation; and iv) vaccines tolerance is poorly known in cirrhotic patients. This review outlines the rational for vaccination in adult liver transplant candidates and recipients and available data regarding immunization in this specific population.
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http://dx.doi.org/10.1016/j.clinre.2019.08.007DOI Listing
April 2020