Safety and immunogenicity of Zika virus vaccine: A systematic review of clinical trials.

Autor: Yeasmin M; Department of Virology, National Institute of Laboratory Medicine and Referral Center, Dhaka, Bangladesh., Molla MMA; Department of Virology, National Institute of Laboratory Medicine and Referral Center, Dhaka, Bangladesh.; College of Graduate Studies, State University of New York Upstate Medical University, Syracuse, New York, USA., Masud HMAA; Department of Microbiology, Faculty of Biological Sciences, University of Chittagong, Chattogram, Bangladesh., Saif-Ur-Rahman KM; Health Systems and Population Studies Division, icddr, b, Dhaka, Bangladesh.; Evidence Synthesis Ireland and Cochrane Ireland, Galway, Ireland.; College of Medicine, Nursing and Health Sciences, National University of Ireland, Galway, Ireland.
Jazyk: angličtina
Zdroj: Reviews in medical virology [Rev Med Virol] 2023 Jan; Vol. 33 (1), pp. e2385. Date of Electronic Publication: 2022 Aug 20.
DOI: 10.1002/rmv.2385
Abstrakt: Several phase-1 clinical trials have been performed to evaluate the safety and efficacy of candidate anti-Zika vaccines. In this systematic review, we systematically evaluated the safety and immunogenicity of candidate vaccines, which would aid researchers in formulating an effective vaccination strategy for phase-2 trials based on current evidence. A literature search was conducted using the electronic databases MEDLINE through Pubmed, Web of Science, and Cochrane Database for relevant studies on candidate anti-zika vaccines. Studies on animal models were excluded from our study. Healthy individuals who were administered candidate Zika vaccines to evaluate the immune response and adverse events (AEs) compared to placebo were considered. Data were extracted, tabulated, and analysed using Microsoft Excel, while the risk of bias plots were generated using tidyverse and Robvis packages in R-studio. A total of five phase-1 clinical trials were included in our analysis comprising of studies on inactivated, viral vector, and DNA vaccines. Immunogenicity ranged from 10% to 100% after vaccination with the lowest seroconversion rate (10%) and geometric mean titre (GMT) (6.3; 95% confidence interval (CI):3.7-10.8) observed among recipients of single-dose inactivated anti-zika vaccine (ZPIV). For DNA vaccines, the seroconversion rate ranged from 60% to 100% with the highest seroconversion rate (100%) and GMT (2871; 95% CI:705.3-11688) observed among recipients of three shots of high dose GLS-5700 vaccine. For viral vector vaccine (Ad26.ZIKV.001) seroconversion rate (100%) and GMT peaked after two shots with both low and high-dose vaccines. In all those studies AEs were mostly local including injection site pain, erythema, and itching. The most common systemic AEs included fever, myalgia, nausea, and fatigue. In phase-1 clinical trials, all candidate vaccines were found to be highly immunogenic and relatively safe, especially when administered in higher doses and with the help of needle-free devices.
(© 2022 The Authors. Reviews in Medical Virology published by John Wiley & Sons Ltd.)
Databáze: MEDLINE
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