AI Article Synopsis
- A study was conducted to evaluate the safety and immune response of a new RSV vaccine (ChAd155-RSV) in infants aged 6-7 months, comparing different doses and an active comparator.* -
- The trial involved 201 infants, with results indicating that the vaccine had a safety profile comparable to existing childhood vaccines, and did not lead to adverse respiratory effects associated with RSV infections.* -
- Higher doses of the ChAd155-RSV vaccine produced stronger immune responses, with increased antibody levels observed after vaccination, especially following the second dose.*
Article 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.
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| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC10786261 | PMC |
| http://dx.doi.org/10.1093/infdis/jiad271 | DOI Listing |
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