Phase I Vaccine Study of pEVAC_PS
Research type
Research Study
Full title
A phase I safety, immunogenicity and dose escalation study of the candidate pan-Sarbeco Coronavirus vaccine pEVAC_PS in SARS-CoV-2 immunised UK healthy adult volunteers
IRAS ID
304756
Contact name
Saul Faust
Contact email
Sponsor organisation
University Hospital Southampton NHS Foundation Trust
Eudract number
2021-002227-38
ISRCTN Number
ISRCTN87813400
Duration of Study in the UK
1 years, 6 months, 31 days
Research summary
There is currently no licensed vaccine that can protect across the whole range of Sarbeco Coronoaviruses, which affect humans, including SARS-Cov2 which caused COVID-19. Variants of SARS-Cov2 have somewhat evaded the immune response given by immunisation or by previous infection.
We are proposing a Phase I study with a primary objective to assess the safety and immune response of a new vaccine against all Sarbeco Coronaviruses.
This will be a single centre (University Hospital Southampton), first in human, open label, adaptive dose escalation study. We aim to recruit a total of 36 healthy volunteers (aged 18 to 50), who will receive 2 vaccinations intradermally (ID), one month apart. Participants will be in the study for up to 12 months, with up to 11 visits, including screening, vaccination, and follow-up visits.
During Stage 1, 6 participants will be enrolled into Group 1 at the lowest dose (0.2mg ID). Depending on the immune response, further participants will be enrolled during Stage 2:
Good Response: 12 additional participants into Group 1 at the same dose. Further good immune responses will halt the study, enabling a review and determination of a reduced dose.
Inadequate Response: 9 participants will receive 0.4mg ID (Group 2a) and 9 participants will receive 0.8mg ID (Group 2b) instead.
Very Poor/No Response: 9 participants will receive 0.8mg ID (Group 2a) and 9 participants will receive 1.2mg ID (Group 2b) instead.
Stage 3: If a good immune response is seen from both doses used in Group 2a and Group 2b, the dose with the best safety and immune response profile will be used in Group 3 where 12 participants will be enrolled.
However, if an inadequate response is seen from Stage 1 and from Stage 2, 12 participants will be enrolled into Group 2c and will receive a dose of 1.2mg ID.REC name
South Central - Berkshire Research Ethics Committee
REC reference
21/SC/0337
Date of REC Opinion
29 Sep 2021
REC opinion
Favourable Opinion