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- Title
Safety and Immunogenicity of a ChAd155-Vectored Respiratory Syncytial Virus Vaccine in Infants 6–7 Months of age: A Phase 1/2 Randomized Trial.
- Authors
Sáez-Llorens, Xavier; Norero, Ximena; Mussi-Pinhata, Marisa Márcia; Luciani, Kathia; Cueva, Ignacio Salamanca de la; Díez-Domingo, Javier; Lopez-Medina, Eduardo; Epalza, Cristina; Brzostek, Jerzy; Szymański, Henryk; Boucher, François D; Cetin, Benhur S; Leon, Tirza De; Dinleyici, Ener Cagri; Gabriel, Miguel Ángel Marín; Ince, Tolga; Macias-Parra, Mercedes; Langley, Joanne M; Martinón-Torres, Federico; Rämet, Mika
- Abstract
Background Respiratory syncytial virus (RSV) is a common cause of lower respiratory tract infections in infants. This phase 1/2, observer-blind, randomized, controlled study assessed the safety and immunogenicity of an investigational chimpanzee-derived adenoviral vector RSV vaccine (ChAd155-RSV, expressing RSV F, N, and M2-1) in infants. Methods Healthy 6- to 7-month-olds were 1:1:1-randomized to receive 1 low ChAd155-RSV dose (1.5 × 1010 viral particles) followed by placebo (RSV_1D); 2 high ChAd155-RSV doses (5 × 1010 viral particles) (RSV_2D); or active comparator vaccines/placebo (comparator) on days 1 and 31. Follow-up lasted approximately 2 years. Results Two hundred one infants were vaccinated (RSV_1D: 65; RSV_2D: 71; comparator: 65); 159 were RSV-seronaive at baseline. Most solicited and unsolicited adverse events after ChAd155-RSV occurred at similar or lower rates than after active comparators. In infants who developed RSV infection, there was no evidence of vaccine-associated enhanced respiratory disease (VAERD). RSV-A neutralizing titers and RSV F-binding antibody concentrations were higher post–ChAd155-RSV than postcomparator at days 31, 61, and end of RSV season 1 (mean follow-up, 7 months). High-dose ChAd155-RSV induced stronger responses than low-dose, with further increases post–dose 2. Conclusions ChAd155-RSV administered to 6- to 7-month-olds had a reactogenicity/safety profile like other childhood vaccines, showed no evidence of VAERD, and induced a humoral immune response. Clinical Trials Registration. NCT03636906.
- Subjects
RESPIRATORY syncytial virus; VIRAL vaccines; IMMUNE response; RESPIRATORY syncytial virus infections; INFANTS; HUMAN metapneumovirus infection; NEUTRALIZATION tests
- Publication
Journal of Infectious Diseases, 2024, Vol 229, Issue 1, p95
- ISSN
0022-1899
- Publication type
Article
- DOI
10.1093/infdis/jiad271