RSV challenge study to evaluate efficacy of MVA-BN RSV vaccine
Research type
Research Study
Full title
A Phase 2a, Randomised, Double-Blinded, Placebo-Controlled Study to Assess the Safety, Immunogenicity and Efficacy of the Recombinant MVA-BN-RSV Vaccine against Respiratory Syncytial Virus Infection in the Virus Challenge Model in Healthy Adult Participants
IRAS ID
1003478
Contact name
Golam Kabir
Contact email
Eudract number
2020-004814-36
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.
This is an exploratory proof-of-concept randomised, Phase 2a, double-blind, placebocontrolled study to evaluate the safety, immunogenicity and efficacy of a recombinant RSV vaccine (MVA-BN-RSV) against RSV-A Memphis 37b infection in healthy
participants.
The study will 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. 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
A total of 74 participants (36 in the MVA-BN-RSV group and 38 in the placebo group) were randomised in this study. One participant in the placebo group withdrew from the study between screening and before vaccination. A total of 73 participants were vaccinated (36 participants in the MVA-BN-RSV group and
37 participants in the placebo group); all 73 participants were included in the SAF analysis set.
Ten participants (5 per treatment group), who were vaccinated, discontinued the study prior to viral challenge. One of these participants in the MVA-BN-RSV group discontinued after Day 0 and came back for the Day 155 follow-up visit and his end-of-study status was recorded as completed.A total of 63 participants were inoculated with the challenge virus (31 participants in the MVA-BN-RSV group and 32 participants in the placebo group); all 63 participants were included in the ITTc analysis set.
Two participants discontinued the study after inoculation prior to the end of the study: One participant
(MVA-BN-RSV) discontinued the study prior to completing the quarantine period due to participant withdrawal. This participant did not complete Day 10 and was therefore not included in the primary analysis.
One participant (placebo) was lost to follow-up after completing the quarantine period and was included in the primary analysis. Two other participants (1 in each treatment group) did not complete the quarantine period but came back for the Day 28 and Day 155 follow-up visits and their end-of-study status was recorded as completed. The participant in the MVA-BN-RSV group completed Day 10 and was therefore included in the primary analysis. The participant in the placebo group did not complete Day 10 and was therefore not included in the primary analysis.A total of 62 participants (31 per treatment group) were reported as completing the study; 61 participants
(30 in the MVA-BN-RSV group and 31 in the placebo group) were included in the PP analysis set and contributed to the primary analysis. No major protocol deviations were identified in this study.REC name
HSC REC A
REC reference
20/NI/0145
Date of REC Opinion
23 Dec 2020
REC opinion
Further Information Favourable Opinion