Group B Streptococcus Vaccine Study in Healthy Female Volunteers
Research type
Research Study
Full title
A two-part, Phase 1, randomised, double-blind, placebo-controlled, parallel group study to evaluate the safety, tolerability and immunogenicity of a dose range of Group B Streptococcus vaccine (GBS-NN) in healthy female volunteers aged 18 to 40.
IRAS ID
177027
Contact name
David Bell
Contact email
Sponsor organisation
MinervaX Aps
Eudract number
2014-004542-10
Duration of Study in the UK
1 years, 7 months, 28 days
Research summary
This is a 2 part phase 1, randomised, double-blind, placebo-controlled, parallel group study to evaluate the safety, tolerability and immune response of dose ranges of a potential new vaccine in healthy female volunteers aged 18 to 40.
All cohorts in Part A will incorporate sentinel dosing in each group for the primary dose only. In Part B sentinel dosing is not required. In both parts volunteers will be screened 28 days prior to vaccine administration.
Part A will randomise up to 70 healthy female volunteers to receive one of up to 7 dosing regimens of the test vaccine or placebo on one or two occasions (10 volunteers in each cohort, 8 randomised to receive the study vaccine and 2 to placebo).
Part B will randomise up to 240 healthy female volunteers to receive one of 3 dosing regimens (80 volunteers in each cohort, up to 60 randomised to receive the study vaccine and 20 to placebo).
Volunteers will attend the clinic on an outpatient basis, (no overnight stays required). They will stay in the clinic on one occasion for 8 hours and return on another 7 occasions in Part A and 12 in Part B. They may receive one or two vaccine doses during the study. In both Parts a booster dose will or will not be administered approximately 4 weeks after the initial dose, depending on the dose regimen chosen. If administered volunteers will remain in the study unit for at least 4 hours post-dose.
In Part A each volunteer will be involved in the study for approximately 12 weeks, excluding the 28 day screening period and the 6 month safety follow up phone call.
In Part B, each volunteer will be involved in the study for approximately 1 year, excluding the 28 day screening period.
REC name
HSC REC A
REC reference
15/NI/0048
Date of REC Opinion
14 Apr 2015
REC opinion
Further Information Favourable Opinion