PMID- 34959492
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20211231
IS  - 2076-0817 (Print)
IS  - 2076-0817 (Electronic)
IS  - 2076-0817 (Linking)
VI  - 10
IP  - 12
DP  - 2021 Nov 24
TI  - Safety and Seroconversion of Immunotherapies against SARS-CoV-2 Infection: A 
      Systematic Review and Meta-Analysis of Clinical Trials.
LID - 10.3390/pathogens10121537 [doi]
LID - 1537
AB  - Clinical trials evaluating the safety and antibody response of strategies to 
      manipulate prophylactic and therapeutic immunity have been launched. We aim to 
      evaluate strategies for augmentation of host immunity against severe acute 
      respiratory syndrome coronavirus-2 (SARS-CoV-2) infection. We searched clinical 
      trials registered at the National Institutes of Health by 25 May 2021 and 
      conducted analyses on inoculated populations, involved immunological processes, 
      source of injected components, and trial phases. We then searched PubMed, Embase, 
      Scopus, and the Cochrane Central Register of Controlled Trials for their 
      corresponding reports published by 25 May 2021. A bivariate, random-effects 
      meta-analysis was used to derive the pooled estimate of seroconversion and 
      adverse events (AEs). A total of 929,359 participants were enrolled in 389 
      identified trials. The working mechanisms included heterologous immunity, active 
      immunity, passive immunity, and immunotherapy, with 62.4% of the trials on 
      vaccines. A total of 9072 healthy adults from 27 publications for 22 clinical 
      trials on active immunity implementing vaccination were included for 
      meta-analyses. The pooled odds ratios (ORs) of seroconversion were 13.94, 84.86, 
      106.03, and 451.04 (all p < 0.01) for vaccines based on protein, RNA, viral 
      vector, and inactivated virus, compared with that of respective placebo/control 
      treatment or pre-vaccination sera. The pooled ORs for safety, as defined by the 
      inverse of systemic adverse events (AEs) were 0.53 (95% CI = 0.27-1.05; p = 
      0.07), 0.35 (95% CI = 0.16-0.75; p = 0.007), 0.32 (95% CI = 0.19-0.55; p < 
      0.0001), and 1.00 (95% CI = 0.73-1.36; p = 0.98) for vaccines based on protein, 
      RNA, viral vector, and inactivated virus, compared with that of placebo/control 
      treatment. A paradigm shift from all four immune-augmentative interventions to 
      active immunity implementing vaccination was observed through clinical trials. 
      The efficacy of immune responses to neutralize SARS-CoV-2 for these vaccines was 
      promising, although systemic AEs were still evident for RNA-based and viral 
      vector-based vaccines.
FAU - Ma, Kevin Sheng-Kai
AU  - Ma KS
AUID- ORCID: 0000-0002-9394-4144
AD  - Center for Global Health, Perelman School of Medicine, University of 
      Pennsylvania, Philadelphia, PA 19104, USA.
AD  - Graduate Institute of Biomedical Electronics and Bioinformatics, College of 
      Electrical Engineering and Computer Science, National Taiwan University, Taipei 
      10617, Taiwan.
AD  - Department of Dentistry, Chung Shan Medical University and Chung Shan Medical 
      University Hospital, Taichung 40201, Taiwan.
FAU - Lee, Chien-Chang
AU  - Lee CC
AD  - Department of Emergency Medicine, National Taiwan University Hospital, Taipei 
      10002, Taiwan.
FAU - Liu, Ko-Jiunn
AU  - Liu KJ
AD  - National Institute of Cancer Research, National Health Research Institutes, 
      Zhunan Township, Miaoli County 35053, Taiwan.
FAU - Wei, James Cheng-Chung
AU  - Wei JC
AUID- ORCID: 0000-0002-1235-0679
AD  - Department of Allergy, Immunology and Rheumatology, Chung Shan Medical University 
      Hospital, Taichung 40201, Taiwan.
FAU - Lee, Yuan-Ti
AU  - Lee YT
AUID- ORCID: 0000-0003-4577-4379
AD  - School of Medicine, Chung Shan Medical University, Taichung 40201, Taiwan.
AD  - Division of Infectious Diseases, Department of Internal Medicine, Chung Shan 
      Medical University Hospital, Taichung 40201, Taiwan.
FAU - Wang, Li-Tzu
AU  - Wang LT
AD  - Department of Obstetrics & Gynecology, National Taiwan University Hospital & 
      College of Medicine, Taipei 10002, Taiwan.
LA  - eng
GR  - 109-2326-B-002-016-MY3 to L.T.W./Ministry of Science and Technology (Taiwan)/
GR  - 108-2813-C-040-040-B to K.S.M./Ministry of Science and Technology (Taiwan)/
GR  - CSH-2020-C-011 to Y.T.L./Chung Shan Medical University Hospital (Taiwan)/
GR  - 1577_2021 to K.S.M./International Team for Implantology/
PT  - Journal Article
PT  - Review
DEP - 20211124
PL  - Switzerland
TA  - Pathogens
JT  - Pathogens (Basel, Switzerland)
JID - 101596317
PMC - PMC8706687
OTO - NOTNLM
OT  - active immunity
OT  - coronavirus disease 2019 (COVID-19)
OT  - heterologous immunity
OT  - passive immunity
OT  - severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
COIS- The authors declare no competing interests.
EDAT- 2021/12/29 06:00
MHDA- 2021/12/29 06:01
PMCR- 2021/11/24
CRDT- 2021/12/28 01:03
PHST- 2021/10/10 00:00 [received]
PHST- 2021/11/17 00:00 [revised]
PHST- 2021/11/19 00:00 [accepted]
PHST- 2021/12/28 01:03 [entrez]
PHST- 2021/12/29 06:00 [pubmed]
PHST- 2021/12/29 06:01 [medline]
PHST- 2021/11/24 00:00 [pmc-release]
AID - pathogens10121537 [pii]
AID - pathogens-10-01537 [pii]
AID - 10.3390/pathogens10121537 [doi]
PST - epublish
SO  - Pathogens. 2021 Nov 24;10(12):1537. doi: 10.3390/pathogens10121537.