PMID- 35986594
OWN - NLM
STAT- MEDLINE
DCOM- 20230118
LR  - 20230411
IS  - 1099-1654 (Electronic)
IS  - 1052-9276 (Print)
IS  - 1052-9276 (Linking)
VI  - 33
IP  - 1
DP  - 2023 Jan
TI  - Safety and immunogenicity of Zika virus vaccine: A systematic review of clinical 
      trials.
PG  - e2385
LID - 10.1002/rmv.2385 [doi]
LID - e2385
AB  - 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.
CI  - (c) 2022 The Authors. Reviews in Medical Virology published by John Wiley & Sons 
      Ltd.
FAU - Yeasmin, Mahmuda
AU  - Yeasmin M
AD  - Department of Virology, National Institute of Laboratory Medicine and Referral 
      Center, Dhaka, Bangladesh.
FAU - Molla, Md Maruf Ahmed
AU  - Molla MMA
AUID- ORCID: 0000-0002-5062-9144
AD  - Department of Virology, National Institute of Laboratory Medicine and Referral 
      Center, Dhaka, Bangladesh.
AD  - College of Graduate Studies, State University of New York Upstate Medical 
      University, Syracuse, New York, USA.
FAU - Masud, H M Abdullah Al
AU  - Masud HMAA
AD  - Department of Microbiology, Faculty of Biological Sciences, University of 
      Chittagong, Chattogram, Bangladesh.
FAU - Saif-Ur-Rahman, K M
AU  - Saif-Ur-Rahman KM
AD  - Health Systems and Population Studies Division, icddr, b, Dhaka, Bangladesh.
AD  - Evidence Synthesis Ireland and Cochrane Ireland, Galway, Ireland.
AD  - College of Medicine, Nursing and Health Sciences, National University of Ireland, 
      Galway, Ireland.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PT  - Review
PT  - Systematic Review
DEP - 20220820
PL  - England
TA  - Rev Med Virol
JT  - Reviews in medical virology
JID - 9112448
RN  - 0 (Vaccines, DNA)
RN  - 0 (Viral Vaccines)
RN  - 0 (Antibodies, Viral)
SB  - IM
MH  - Animals
MH  - *Zika Virus
MH  - *Zika Virus Infection/prevention & control
MH  - *Vaccines, DNA/adverse effects
MH  - *Viral Vaccines
MH  - Vaccination
MH  - Antibodies, Viral
PMC - PMC10077998
OTO - NOTNLM
OT  - clinical trial
OT  - vaccine
OT  - vaccine safety
OT  - zika virus
COIS- No conflict of interest declared.
EDAT- 2022/08/21 06:00
MHDA- 2023/01/19 06:00
PMCR- 2023/04/06
CRDT- 2022/08/20 03:52
PHST- 2022/07/01 00:00 [revised]
PHST- 2022/04/04 00:00 [received]
PHST- 2022/08/03 00:00 [accepted]
PHST- 2022/08/21 06:00 [pubmed]
PHST- 2023/01/19 06:00 [medline]
PHST- 2022/08/20 03:52 [entrez]
PHST- 2023/04/06 00:00 [pmc-release]
AID - RMV2385 [pii]
AID - 10.1002/rmv.2385 [doi]
PST - ppublish
SO  - Rev Med Virol. 2023 Jan;33(1):e2385. doi: 10.1002/rmv.2385. Epub 2022 Aug 20.