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Meta-Analysis
. 2024;121(3):271-282.
doi: 10.1159/000536031. Epub 2024 Jan 29.

Respiratory Syncytial Virus Maternal Vaccination in Infants below 6 Months of Age: Meta-Analysis of Safety, Immunogenicity, and Efficacy

Muhammad Pradhika Mapindra  1 , Muhammad Pradhiki Mahindra  2 , Paul McNamara  3   4 , Malcolm G Semple  3   5 , Howard Clark  1 , Jens Madsen  1
Affiliations
Meta-Analysis

Respiratory Syncytial Virus Maternal Vaccination in Infants below 6 Months of Age: Meta-Analysis of Safety, Immunogenicity, and Efficacy

Muhammad Pradhika Mapindra et al. Neonatology. 2024.

Abstract

Introduction: Severe respiratory syncytial virus (RSV) disease is most prevalent during infancy, particularly in those born prematurely, who benefit least from maternal antibody transfers. Maternal immunization is an attractive prevention leading to vaccine clinical trials. This meta-analysis aimed to evaluate recent maternal RSV vaccine trials.

Methods: Following PRISMA-P guidelines for systematic reviews and registered at <ext-link ext-link-type="uri" xlink:href="https://www.crd.york.ac.uk/prospero" xmlns:xlink="http://www.w3.org/1999/xlink">https://www.crd.york.ac.uk/prospero</ext-link>, this study shortlisted six randomized clinical trials of suitable quality from four databases. Meta-analysis evaluated vaccine safety, immunogenicity, and efficacy in infants and their mothers.

Results: From random-effects and fixed-effects meta-analysis between trial and control arms, the maternal post-vaccination geometric antibody (Ab) titers showed pooled standard mean differences (SMDs [95% CI]) at delivery of (4.14 [2.91-5.37]), (3.95 [2.79-5.11]), and (12.20 [7.76, 16.64]) for RSV neutralizing Ab A, B, and F IgG, respectively. Vaccine administration was more likely than placebo to cause local pain, erythema, swelling, and systemic myalgia. Furthermore, the Ab levels in infants at birth showed pooled SMDs of each RSV A (3.9 [2.81-4.99]), RSV B (1.86 [1.09-2.62]), and RSV F IgG (2.24 [1.24-3.23]). The overall reduction of RSV-related lower respiratory tract infections and hospitalizations in the first 6 months of life was 52% and 48%, respectively.

Conclusions: Not only does antenatal RSV vaccination look safe and immunogenic in vaccinated mothers, but it also reliably provides effective antibody levels in infants and diminishes RSV-related severe disease in infants under 6 months of age.

Keywords: Infant; Maternal vaccination; Respiratory syncytial virus; Respiratory tract infections.

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Conflict of interest statement

The authors have no conflicts of interest to declare.

Figures

Fig. 1.
Fig. 1.
Flow chart of study selection and inclusion in this study.
Fig. 2.
Fig. 2.
Risk-of-bias graph of the included studies.
Fig. 3.
Fig. 3.
Risk-of-bias summary of the included studies. Green = low-risk bias; blank = unclear-risk bias, red = high-risk bias.
Fig. 4.
Fig. 4.
Forest plots of local site reaction following vaccine administration within 1-week monitoring: local pain (a); local swelling (b); local erythema (c).
Fig. 5.
Fig. 5.
Forest plots of systemic reactions following vaccine administration within 1-week monitoring: fatigue (a); headache (b); vomiting (c).
Fig. 6.
Fig. 6.
Forest plots of systemic reactions following vaccine administration within 1-week monitoring: general muscle pain (a); general joint pain (b).
Fig. 7.
Fig. 7.
Forest plots of vaccine efficacy: MA-RSV (a); RSV-associated hospitalizations (b).
See this image and copyright information in PMC

References

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