Phase 2a Study of RSVpreF Vaccination and RSV Challenged in Healthy Adults
Research type
Research Study
Full title
A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Immunogenicity and Efficacy of A Respiratory Syncytial Virus Vaccine (RSVpreF) in A Virus Challenge Model in Healthy Adults
IRAS ID
1003426
Contact name
Golam Kabir
Contact email
Eudract number
2020-003887-21
Research summary
Summary of Research
Respiratory Syncytial Virus (RSV) is a common virus that affects all human age groups
and can cause a range of respiratory disease such as bronchitis and lower respiratory
infections including bronchiolitis and pneumonia. These serious illnesses affect infants,
certain adults who are older (especially if they are ≥65), have chronic heart or lung
disease or have a weakened immune system.
There is no current vaccine approved for the prevention of RSV infection.
The purpose of this research study is to test the effects of an experimental vaccine,
RSVpreF, and whether it may be useful in preventing RSV infection using a human viral
challenge model. The RSV challenge model is developed to help understanding the RSV
disease and assess if new vaccines work by testing them in participants deliberately
infected with the virus.
This is a randomised, placebo-controlled, double-blind Phase 2a human challenge study,
to be conducted in healthy male and female participants aged 18-50 years old, who have
been pre-screened to have low immunogenicity to the RSV virus and for susceptibility to
RSV infection.
Approximately 62 (up to 72) participants will be vaccinated to account for withdrawals
between vaccination and challenge. Participants will be randomised 1:1 to receive
vaccine or placebo.Summary of Results
In this human challenge study, RSVpreF immunization was highly effective against mild to moderate RSV illness in healthy adults, with significantly reduced viral loads detectable by using qRT-PCR and no infectious virus shed. RSVpreF brought out large increases in neutralizing antibody titers and a substantial increase in RSV F-specific CD4+ T-cell (TH1) responses at 1-month after immunization, similar to those observed in previous clinical studies. RSVpreF was safe and well tolerated, consistent with previous clinical studies.REC name
North West - Haydock Research Ethics Committee
REC reference
20/NW/0384
Date of REC Opinion
3 Nov 2020
REC opinion
Further Information Favourable Opinion