*207689 (GUARDIAN): A Phase II Trial of ChAd155-RSV in Infants
Research type
Research Study
Full title
A phase II, randomized, observer-blinded, controlled, multicenter trial to evaluate safety, reactogenicity, efficacy, and immunogenicity of GSK Biologicals’ respiratory syncytial virus (RSV) investigational vaccine based on the RSV viral proteins F, N, and M2-1 encoded by chimpanzee-derived adenovector (ChAd155-RSV) (GSK3389245A) when administered intramuscularly according to a 2-dose schedule to infants aged 3 to 7 months at first intervention administration
IRAS ID
290273
Contact name
Jonathan Garstang
Contact email
Sponsor organisation
GlaxoSmithKline Biologicals SA
Eudract number
2019-003782-18
Clinicaltrials.gov Identifier
IND Number, 16999
Duration of Study in the UK
2 years, 5 months, 5 days
Research summary
RSV is a highly contagious human pathogen that causes respiratory tract infections in people of all ages. During the first year of life, 50-70% of infants are infected with RSV and most children have had an RSV infection by their second birthday. Although RSV hospitalization rates decrease after 6 months of age, a considerable number of RSV infections in children of 6-15 months of age still require medical attention.
Infection with RSV does not confer full protective immunity. Symptomatic RSV reinfections are common later in life and continue throughout adulthood. These re-infections generally go undiagnosed because they usually present as common acute upper respiratory tract infections. However, in more vulnerable persons, re-infections can also lead to severe disease. To date, no vaccine is available against RSV and treatment of RSV disease is largely symptomatic and supportive care.
GSK’s investigational RSV vaccine (ChAd155-RSV) is being developed for active immunization of infants for the prevention of any lower respiratory tract infection associated with RSV (e.g. bronchiolitis and broncho-pneumonia). This approach is expected to offer active immunity from 2 weeks after vaccination up to at least 1 year after.
This study will be investigating the safety and efficacy of ChAd155-RSV when administered in two doses to infants aged 3 to 7 months. Participants will be monitored for the next two RSV ‘seasons’ to record any incidents of lower respiratory tract infections and any adverse events potentially related to the vaccine (a typical RSV season in the UK lasts from October to February). Participants will also be tested for antibodies known to neutralise the two most prevalent strains of RSV. Each participant is expected to stay in the trail for a duration of approximately 24 months
REC name
London - Dulwich Research Ethics Committee
REC reference
21/FT/0004
Date of REC Opinion
18 Jan 2021
REC opinion
Unfavourable Opinion