Children’s Nutrition Research Center Staff Publications

Language

English

Publication Date

12-13-2022

Journal

The Journal of Infectious Diseases

DOI

10.1093/infdis/jiac253

PMID

35732186

PMCID

PMC10205613

PubMedCentral® Posted Date

6-23-2022

PubMedCentral® Full Text Version

Post-print

Abstract

Background: This United States-based study compared 2 candidate vaccines: RSV/ΔNS2/Δ1313/I1314L, attenuated by NS2 gene-deletion and temperature-sensitivity mutation in the polymerase gene; and RSV/276, attenuated by M2-2 deletion.

Methods: RSV-seronegative children aged 6-24 months received RSV/ΔNS2/Δ1313/I1314L (106 plaque-forming units [PFU]), RSV/276 (105 PFU), or placebo intranasally. Participants were monitored for vaccine shedding, reactogenicity, and RSV serum antibodies, and followed over the subsequent RSV season.

Results: Enrollment occurred September 2017 to October 2019. During 28 days postinoculation, upper respiratory illness and/or fever occurred in 64% of RSV/ΔNS2/Δ1313/I1314L, 84% of RSV/276, and 58% of placebo recipients. Symptoms were generally mild. Cough was more common in RSV/276 recipients than RSV/ΔNS2/Δ1313/I1314L (48% vs 12%; P = .012) or placebo recipients (17%; P = .084). There were no lower respiratory illness or serious adverse events. Eighty-eight and 96% of RSV/ΔNS2/Δ1313/I1314L and RSV/276 recipients were infected with vaccine (shed vaccine and/or had ≥4-fold rises in RSV antibodies). Serum RSV-neutralizing titers and anti-RSV F IgG titers increased ≥4-fold in 60% and 92% of RSV/ΔNS2/Δ1313/I1314L and RSV/276 vaccinees, respectively. Exposure to community RSV during the subsequent winter was associated with strong anamnestic RSV-antibody responses.

Conclusions: Both vaccines had excellent infectivity and were well tolerated. RSV/276 induced an excess of mild cough. Both vaccines were immunogenic and primed for strong anamnestic responses.

Clinical trials registration: NCT03227029 and NCT03422237.

Keywords

Child, Humans, Antibodies, Neutralizing, Antibodies, Viral, Cough, Respiratory Syncytial Virus Infections, Respiratory Syncytial Virus Vaccines, Respiratory Syncytial Virus, Human, Respiratory Syncytial Viruses, Vaccines, Attenuated, respiratory syncytial virus, RSV, live-attenuated viral vaccine, neutralizing antibodies, immunogenicity, RNA regulatory protein M2-2

Published Open-Access

yes

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