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Review
. 2024 Aug 2;12(8):879.
doi: 10.3390/vaccines12080879.

Efficacy, Safety, and Immunogenicity of Subunit Respiratory Syncytial Virus Vaccines: Systematic Review and Meta-Analysis of Randomized Controlled Trials

Yuhang Wu  1 , Yuqiong Lu  1 , Yuwei Bai  1 , Bingde Zhu  1 , Feng Chang  1 , Yun Lu  1
Affiliations
Review

Efficacy, Safety, and Immunogenicity of Subunit Respiratory Syncytial Virus Vaccines: Systematic Review and Meta-Analysis of Randomized Controlled Trials

Yuhang Wu et al. Vaccines (Basel). .

Abstract

Background: Respiratory syncytial virus (RSV) is garnering increasing attention, with a growing number of subunit RSV vaccines under active clinical investigation. However, comprehensive evidence is limited.

Methods: We conducted a comprehensive search across PubMed, Embase, the Cochrane Library, Web of Science, and ClinicalTrials.gov from database inception to 12 January 2024, focusing on published randomized controlled trials (RCTs).

Results: A total of 17 studies were included, encompassing assessments of efficacy (5 studies), safety (17 studies), and immunogenicity (12 studies) of RSV subunit vaccines. The pooled risk ratio (RR) for RSV-associated acute respiratory infection (RSV-ARI) with subunit vaccines was 0.31 (95% CI: 0.23-0.43), for RSV-associated lower respiratory tract infection (RSV-LRTI), it was 0.32 (95% CI: 0.22-0.44), and for severe RSV-LRTI (RSV-SLRTI), it was 0.13 (95% CI: 0.06-0.29). There was no significant difference in serious adverse events (SAEs) between the vaccine and placebo groups, with a pooled RR of 1.05 (95% CI: 0.98-1.14). The pooled standardized mean difference (SMD) for the geometric mean titer (GMT) of neutralizing antibodies was 2.89 (95% CI: 2.43-3.35).

Conclusion: Subunit RSV vaccines exhibit strong efficacy, favorable safety profiles, and robust immunogenicity. Future research should focus on the cost-effectiveness of various vaccines to enhance regional and national immunization strategies.

Keywords: efficacy; immunogenicity; meta-analysis; respiratory syncytial virus vaccines; safety.

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Conflict of interest statement

The authors declare no conflicts of interest in this work.

Figures

Figure 1
Figure 1
PRISMA flow diagram.
Figure 2
Figure 2
Forest plot of efficacy in vaccine and placebo groups of RSV-ARI [27,28,33].
Figure 3
Figure 3
Forest plot of efficacy in vaccine and placebo groups of RSV-LRTI [21,27,31,33].
Figure 4
Figure 4
Forest plot of efficacy in vaccine and placebo groups of RSV-SLRTI [21,27,31].
Figure 5
Figure 5
Forest plot of SAEs in vaccine and placebo groups [17,19,20,21,22,26,27,29,30,31,32,33].
Figure 6
Figure 6
Forest plot of GMT values of log-transformed neutralizing antibodies [17,20,22,23,25,26,27,28,29,30,31,32].
See this image and copyright information in PMC

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