Publications by authors named "Gui-Fan Li"

3 Publications

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Immunogenicity and safety of a severe acute respiratory syndrome coronavirus 2 inactivated vaccine in healthy adults: randomized, double-blind, and placebo-controlled phase 1 and phase 2 clinical trials.

Chin Med J (Engl) 2021 Apr 28;134(11):1289-1298. Epub 2021 Apr 28.

NHC Key Laboratory of Enteric Pathogenic Microbiology (Jiangsu Provincial Center for Disease Control and Prevention), Nanjing, Jiangsu 210009, China.

Background: The significant morbidity and mortality resulted from the infection of a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) call for urgent development of effective and safe vaccines. We report the immunogenicity and safety of an inactivated SARS-CoV-2 vaccine, KCONVAC, in healthy adults.

Methods: Phase 1 and phase 2 randomized, double-blind, and placebo-controlled trials of KCONVAC were conducted in healthy Chinese adults aged 18 to 59 years. The participants in the phase 1 trial were randomized to receive two doses, one each on Days 0 and 14, of either KCONVAC (5 or 10 μg/dose) or placebo. The participants in the phase 2 trial were randomized to receive either KCONVAC (at 5 or 10 μg/dose) or placebo on Days 0 and 14 (0/14 regimen) or Days 0 and 28 (0/28 regimen). In the phase 1 trial, the primary safety endpoint was the proportion of participants experiencing adverse reactions/events within 28 days following the administration of each dose. In the phase 2 trial, the primary immunogenicity endpoints were neutralization antibody seroconversion and titer and anti-receptor-binding domain immunoglobulin G seroconversion at 28 days after the second dose.

Results: In the phase 1 trial, 60 participants were enrolled and received at least one dose of 5-μg vaccine (n = 24), 10-μg vaccine (n = 24), or placebo (n = 12). In the phase 2 trial, 500 participants were enrolled and received at least one dose of 5-μg vaccine (n = 100 for 0/14 or 0/28 regimens), 10-μg vaccine (n = 100 for each regimen), or placebo (n = 50 for each regimen). In the phase 1 trial, 13 (54%), 11 (46%), and seven (7/12) participants reported at least one adverse event (AE) after receiving 5-, 10-μg vaccine, or placebo, respectively. In the phase 2 trial, 16 (16%), 19 (19%), and nine (18%) 0/14-regimen participants reported at least one AE after receiving 5-, 10-μg vaccine, or placebo, respectively. Similar AE incidences were observed in the three 0/28-regimen treatment groups. No AEs with an intensity of grade 3+ were reported, expect for one vaccine-unrelated serious AE (foot fracture) reported in the phase 1 trial. KCONVAC induced significant antibody responses; 0/28 regimen showed a higher immune responses than that did 0/14 regimen after receiving two vaccine doses.

Conclusions: Both doses of KCONVAC are well tolerated and able to induce robust immune responses in healthy adults. These results support testing 5-μg vaccine in the 0/28 regimen in an upcoming phase 3 efficacy trial.

Trial Registration: http://www.chictr.org.cn/index.aspx (No. ChiCTR2000038804, http://www.chictr.org.cn/showproj.aspx?proj=62350; No. ChiCTR2000039462, http://www.chictr.org.cn/showproj.aspx?proj=63353).
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http://dx.doi.org/10.1097/CM9.0000000000001573DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8183795PMC
April 2021

A cross-sectional seroepidemiology study of seven major enteroviruses causing HFMD in Guangdong, China.

J Infect 2021 Apr 16. Epub 2021 Apr 16.

National Institutes for Food and Drug Control, No.31, Huatuo Street, Beijing, P.R. China. Electronic address:

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http://dx.doi.org/10.1016/j.jinf.2021.04.011DOI Listing
April 2021

Vaccine profile of PPV23: Beijing Minhai Biotech 23-valent pneumococcal vaccine.

Expert Rev Vaccines 2016 Nov 4;15(11):1351-1359. Epub 2016 Oct 4.

Jiangsu Provincial Center for Disease Control and Prevention, Vaccine Clinical Evaluation Department, Nanjing, PR China.

: Diseases caused by are a major public health problem worldwide, which can be effectively prevented by the 23-valent pneumococcal polysaccharide vaccines (PPV23).: The Beijing Minhai PPV23 showed good safety and immunogenicity profiles in clinical trials. The immunogenicity of Beijing Minhai PPV23 was non-inferior to other licensed PPVs. Although PPV23 has been proved to be highly efficient and cost-effective, and was recommended for vaccination in high-risk populations in industrialized countries, the coverage of PPV23 vaccination was relatively low in developing countries.: The low vaccination proportions of PPV23 in China have not been improved in recent decades. Most of the populations with indications for receiving PPV23 were not aware of the possible benefits of PPV23. Moreover, PPV23 had some limitations, which called for the development of a new generation of vaccines against pneumococcal infection.
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http://dx.doi.org/10.1080/14760584.2016.1239536DOI Listing
November 2016