Two dose Group B Streptococcus Vaccine study in healthy females
Research type
Research Study
Full title
A Phase I, randomised, double-blind, placebo-controlled, parallel group study to evaluate the safety, tolerability and immunogenicity of two doses of Group B Streptococcus vaccine (GBS-NN/NN2 with Alhydrogel®) in healthy female subjects aged 18 to 40.
IRAS ID
243541
Contact name
Annelize Koch
Contact email
Sponsor organisation
MinervaX Aps
Eudract number
2017-003781-27
Duration of Study in the UK
0 years, 7 months, 15 days
Research summary
The purpose of this study is to evaluate the safety, tolerability and immune response of a newly developed GBS-NN/NN2 vaccine in healthy females. This vaccine is being developed with the intention of vaccinating pregnant women during the late stages of pregnancy which will provide immune protection for the unborn child against Group B streptococcus (GBS).
GBS is a bacterium which is usually found within the vagina and bowels of women and usually causes no harm. However, in pregnant women, the GBS can be passed onto the unborn child and this can cause life threatening infections such as meningitis and sepsis in the newborn.
The current treatment methods for this include giving antibiotic treatment during labour. However, this is becoming increasingly ineffective and so there is a need to develop new methods which do not require antibiotics and a vaccine is considered to be an effective method.
This study will compare two doses of the GBS-NN/NN2 vaccine against placebo. Safety data will be evaluated for the lowest dose prior to proceeding the higher dose in Group 2. This study will be conducted in healthy female volunteers at Simbec, a research facility located in South Wales, UK.
REC name
Wales REC 1
REC reference
18/WA/0084
Date of REC Opinion
7 Mar 2018
REC opinion
Favourable Opinion