Publications by authors named "Feng Cai Zhu"
Background: The Oka varicella vaccine strain remains neurovirulent and can establish lifelong latent infection, raising safety concerns about vaccine-related herpes zoster. In this study, we aimed to evaluate the immunogenicity and safety of a skin-attenuated and neuro-attenuated varicella vaccine candidate (v7D vaccine).
Methods: We did this randomised, double-blind, controlled, phase 2a clinical trial in Jiangsu, China.
Introduction: The global spread of COVID-19 has prompted the development of vaccines. A recombinant adenovirus type-5 vectored COVID-19 vaccine (Ad5-nCoV) developed by Chinese scientists has been authorized for use as a prime and booster dose in China and several other countries.
Areas Covered: We searched published articles as of 4 May 2023, on PubMed using keywords related to Adenovirus vector, vaccine, and SARS-CoV-2.
Article Synopsis
- A study compared the immunogenicity of a new HPV vaccine, Cecolin 9, produced by E. coli, with the established Gardasil 9, focusing on various HPV types including 6, 11, 16, 18, and others.
- Conducted in China, the randomized trial included 487 healthy women aged 18-26, who received three doses of either vaccine, and measured antibody responses to determine effectiveness.
- Results showed both vaccines achieved a 100% seroconversion rate, with Cecolin 9 demonstrating comparable or superior antibody levels for several HPV types, suggesting it may be an effective alternative to Gardasil 9.
Background: The certification of immunogenicity consistency at different production scales is indispensable for the quality control of vaccines.
Research Design And Methods: A randomized, double-blind immunobridging trial in healthy adults aged 18-59 was divided into Scale A (50 L and 800 L) and Scale B (50 L and 500 L) based on vaccine manufacturing scales. Eligible participants in Scale A were randomly assigned to receive the single-dose recombinant adenovirus type-5 vectored COVID-19 vaccine (Ad5-nCoV) of different scales at a 1:1 ratio, as was Scale B.
Article Synopsis
- This analysis evaluated how effective one or two doses of the Ad5-nCoV vaccine are in generating antibodies against SARS-CoV-2, comparing results from low and high-dose groups.
- It was found that a two-dose regimen led to higher levels of neutralizing antibodies 28 days post-vaccination, but the duration and decay rates of these antibodies varied significantly between the two regimens.
- The study indicated that while the one-dose regimen had higher initial rates of certain neutralizing antibodies, the two-dose regimen showed improved longevity for RBD-binding antibodies, suggesting a nuanced relationship between the dosing schedule and antibody response.
Article Synopsis
- Older adults (60+) show weaker immune responses to two doses of COVID-19 vaccines; a study tests if a different type of vaccine (Convidecia) can improve immunity when given as a booster after an inactivated vaccine (CoronaVac).
- The trial involved 199 participants aged 60+, comparing the effects of a third dose of either Convidecia or CoronaVac after receiving two doses of CoronaVac, assessing antibody levels and side effects.
- Results indicated that the heterologous booster (Convidecia) significantly increased neutralizing antibodies against various COVID-19 variants compared to the homologous booster (CoronaVac), demonstrating better efficacy in older adults.
Background: Aerosolised Ad5-nCoV is one of the first licensed mucosal respiratory vaccine against SARS-CoV-2 in the world; however, the safety profile of this vaccine has not been reported in a large population yet.
Methods: This multicentre, open-label phase 3 trial, done in 15 centres in six provinces (Jiangsu, Hunan, Anhui, Chongqing, Yunnan, Shandong) in China, aimed to evaluate the safety and immunogenicity of aerosolised Ad5-nCoV in healthy adults (members of the general population with no acute febrile disorders, infectious disease, serious cardiovascular diseases, serious chronic diseases or progressive diseases that cannot be controlled) at least 18 years old, who had received two doses of inactivated COVID-19 vaccine as their primary regimen. This study contained a non-randomly assigned safety cohort and a centrally randomly assigned (1:1) immunogenicity subcohort.
Background: A safe and highly efficacious ()-produced HPV 16/18 bivalent vaccine has been prequalified by the World Health Organization. Here, we conducted a single-center, open-label, dose-escalation phase 1 clinical trial to evaluate the safety and immunogenicity of the second-generation nonavalent HPV 6/11/16/18/31/33/45/52/58 vaccine.
Method: Twenty-four eligible volunteers aged 18-45 years were enrolled in January 2019 in Dongtai, China and received 0.
Background: Heterologous boosting is suggested to be of use in populations who have received inactivated COVID-19 vaccines. We aimed to assess the safety and immunogenicity of a heterologous vaccination with the mRNA vaccine CS-2034 versus the inactivated BBIBP-CorV as a fourth dose, as well as the efficacy against the SARS-CoV-2 omicron (BA.5) variant.
View Article and Find Full Text PDFBackground: An orally aerosolized adenovirus type-5 vector-based coronavirus disease 2019 (COVID-19) vaccine (Ad5-nCoV) has recently been authorized for boosting immunization in China. Our study aims to assess the environmental impact of the use of aerosolized Ad5-nCoV.
Methods: We collected air samples from rooms, swabs from the desks on which the vaccine nebulizer was set, mask samples from participants, and blood samples of nurses who administered the inoculation in the clinical trials.
Background: We assessed the safety and immunogenicity of a core-shell structured lipopolyplex (LPP) based COVID-19 mRNA vaccine, SW-BIC-213, as a heterologous booster in healthy adults.
Methods: We conducted an open-labeled, two-centered, and three-arm randomised phase 1 trial. Healthy adults, who had completed a two-dose of inactivated COVID-19 vaccine for more than six months, were enrolled and randomized to receive a booster dose of COVILO (inactivated vaccine) (n = 20) or SW-BIC-213-25μg (n = 20), or SW-BIC-213-45μg (n = 20).
Background: Aerosolised Ad5-nCoV is the first approved mucosal respiratory COVID-19 vaccine to be used as a booster after the primary immunisation with COVID-19 vaccines. This study aimed to evaluate the safety and immunogenicity of aerosolised Ad5-nCoV, intramuscular Ad5-nCoV, or inactivated COVID-19 vaccine CoronaVac given as the second booster.
Methods: This is an open-label, parallel-controlled, phase 4 randomised trial enrolling healthy adult participants (≥18 years) who had completed a two-dose primary immunisation and a booster immunisation with inactivated COVID-19 vaccines (CoronaVac only) at least 6 months before, in Lianshui and Donghai counties, Jiangsu Province, China.
Background: The efficacy of SARS-CoV-2 vaccines in preventing severe COVID-19 illness and death is uncertain due to the rarity of data in individual trials. How well the antibody concentrations can predict the efficacy is also uncertain. We aimed to assess the efficacy of these vaccines in preventing SARS-CoV-2 infections of different severities and the dose-response relationship between the antibody concentrations and efficacy.
View Article and Find Full Text PDFBackground: The demonstration of batch-to-batch consistency is indispensable for quality control of vaccines.
Methods: We conducted a randomized, double-blind, parallel-controlled trial to evaluate the immunogenicity consistency of a single shot of Ad5-nCoV in healthy adults who had not previously received any COVID-19 vaccine. All eligible participants were randomly assigned equally to receive one of the three consecutive batches of Ad5-nCoV (5 × 10 viral particles/vial, 0.
Article Synopsis
- A phase 3 trial investigated the long-term efficacy and safety of a bivalent HPV 16 and 18 vaccine produced by E. coli, showing it was well tolerated and effective against HPV-associated high-grade genital lesions and persistent infection over 66 months.
- The trial involved 7372 eligible women aged 18-45, who were randomly assigned to receive either the HPV vaccine or a control hepatitis E vaccine, with strict exclusion criteria to ensure accurate results.
- The findings indicated 100% efficacy against high-grade genital lesions and 97.3% against persistent HPV infection in the vaccinated group, with serious adverse events occurring at similar rates in both groups.
Background: Due to waning immunity and protection against infection with SARS-CoV-2, a third dose of a homologous or heterologous COVID-19 vaccine has been proposed by health agencies for individuals who were previously primed with two doses of an inactivated COVID-19 vaccine.
Methods: We did a randomised, open-label, controlled trial to evaluate the safety and immunogenicity of heterologous boost immunisation with an orally administered aerosolised adenovirus type-5 vector-based COVID-19 vaccine (Ad5-nCoV) in Chinese adults (≥18 years old) who had previously received two doses of an inactivated SARS-CoV-2 vaccine-Sinovac CoronaVac. Eligible participants were randomly assigned (1:1:1) to receive a heterologous booster vaccination with a low dose (1·0 × 10 viral particles per mL; 0·1 mL; low dose group), or a high dose (1·0 × 10 viral particles per mL; 0·2 mL; high dose group) aerosolised Ad5-nCoV, or a homologous intramuscular vaccination with CoronaVac (0·5 mL).
Background: Staphylococcus aureus is an important pathogen that causes hospital and community infections. To control Staphylococcus aureus infection and reduce the usage of antibiotics, we evaluated the safety and immunogenicity of a recombinant five-antigen Staphylococcus aureus vaccine (rFSAV) in healthy adults.
Methods: We conducted a randomized, double-blind, placebo-controlled phase 1a study and a randomized, open-label phase 1b study.
This study comprehensively evaluated and compared three human rabies vaccines. Seven electronic databases were systematically searched. The Cochrane Handbook v5.
View Article and Find Full Text PDFMutations and transient conformational movements of the receptor binding domain (RBD) that make neutralizing epitopes momentarily unavailable present immune escape routes for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). To mitigate viral escape, we developed a cocktail of neutralizing antibodies (NAbs) targeting epitopes located on different domains of spike (S) protein. Screening of a library of monoclonal antibodies generated from peripheral blood mononuclear cells of COVID-19 convalescent patients yielded potent NAbs, targeting the N-terminal domain (NTD) and RBD domain of S, effective at concentrations.
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