A follow on study of GBS-NN/NN2 vaccine in healthy female volunteers
Research type
Research Study
Full title
A follow-on study to assess the safety and immunogenicity of a booster dose of GBS-NN/NN2 vaccine 1 to 5 years after participants in study MVX0002 have completed the primary vaccination course
IRAS ID
294826
Contact name
Helen Philpott
Contact email
Sponsor organisation
MinervaX Aps
Eudract number
2021-000435-31
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 7 months, 17 days
Research summary
Summary of Research
The purpose of this study is to investigate the GBS-NN/NN2 vaccine.
The main objectives of this study are as follows:
- To determine the safety of a booster dose of GBS-NN/NN2 vaccine when it is administered as a single dose on one occasion, evaluating safety up to 6 months after the booster dose.
- To evaluate the overall immune response in participants who receive the vaccine, by measuring responses specific to key proteins in the vaccine.
GBS-NN/NN2 has been evaluated in a previous first-in-human study (MVX0002) and therefore, this is a follow on study to evaluate the safety and immune response of receiving a booster dose of the vaccine approximately 1-5 years after the first vaccination course. The study will therefore include participants who previously completed the MVX0002 study (includes participants who received the active GNS-NN/NN2 and the placebo – containing no active drug).In this study, all participants will receive a dose of the GBS-NN/NN2 vaccine (regardless of whether they received the active drug or placebo in the MVX0002 study). GBS-NN/NN2 vaccine will be administered in the form of a single injection into the muscle at the top of the arm.
Blood samples will be taken at set time points throughout the study in order to measure the immune response of the vaccine in the body, how this changes over time and how this compares between participants.
A total of up to 40 female participants are needed for this study. 20 to 30 participants who received the active GBS-NN/NN2 vaccine in the MVX0002 study will be enrolled, in addition to up to 10 participants who received the placebo (containing no active GBS-NN/NN2) in the MVX0002 study. If sufficient numbers of placebo participants from the MVX0002 study are not available, new female participants (who did not complete the MVX0002 study) may also be enrolled.
Summary of Results
The purpose of this study was to investigate the GBS-NN/NN2 vaccine.
The main objectives of this study were as follows:
- To determine the safety of a booster dose of GBS-NN/NN2 vaccine when it was administered as a single dose on one occasion, evaluating safety up to 6 months after the booster dose, in comparison with individuals who were receiving a first dose of the GBS-NN/NN2 vaccine.
- To evaluate the overall immune response in participants who received the vaccine, by measuring responses specific to key proteins in the vaccine.
As well as evaluating the above, the study also evaluated, as exploratory objectives, a range of other cellular immune responses in the body.
The study vaccine (GBS-NN/NN2) was previously evaluation in a first-in-human study (MVX0002) and therefore, this study was considered a follow on to this previous study in order to evaluate the safety and immune response of receiving a booster dose of the vaccine approximately 1-5 years after the first vaccination course and comparing these data with data from individuals who had not previously received the GBS-NN/NN2 vaccine. The study included participants who previously completed the MVX0002 study.
In this study, all participants received a dose of the GBS-NN/NN2 vaccine (regardless of whether they received the active drug or placebo in the MVX0002 study, and the vaccine was administered in the form of a single injection into the muscle at the top of the arm.
Blood samples were taken at set time points throughout the study in order to measure the immune response of the vaccine in the body, how this changed over time and how this compared between participants who received GBS-NN/NN2 in the MVX0002 study (for whom the GBS-NN/NN2 vaccination in this study was a booster dose) and those who received placebo previously or did not participate in the MVX0002 study (for whom the GBS-NN/NN2 vaccination in this study was a first dose).
The results have been analysed to determine if there are any significant differences in the safety profile of GBS-NN/NN2 after a booster dose, the immune response in the body and whether there are any differences between participants who were receiving the first dose of GBS-NN/NN2 versus those who were receiving a booster dose.
The purpose of the data generated in this study was to provide further information and guidance to support the study sponsor in development of the study vaccine.
With respect to the safety objectives of the study, it was determined that the vaccine dose administered was considered to be safe and well tolerated across all participants in the study (both booster dose and first dose participants) up to 6-months post-vaccine administration. All of the reported side effects in the study were considered to be mild to moderate in severity and resolved before the study completed (within 7 days of vaccine administration). In addition, all reported effects were considered to be aligned to the typical side effects associated with intramuscular vaccine administration i.e., pain/soreness at the injection site, headache, flu-like symptoms. Further to this, there were no observable differences between the safety profiles of participants who previously received GBS-NN/NN2 and participants who previously received placebo or were vaccine naïve, during the study.
With respect to the other objectives of the study, the following outcomes were reported:
- The immune response to the vaccine was significantly greater in individuals who had previously received the vaccine (booster dose) in the previous study when compared with individuals for whom the dose in this study was a first dose.
- In participants who had received the GBS-NN/NN2 vaccine previously, it was noted that a single dose of the vaccine within this current study boosted the overall immune response.
- In participants who had received the GBS-NN/NN2 vaccine previously, it was noted that the overall immune response to the vaccine reduced by approximately 70%-78% over the 2.5-year period from the levels observed following vaccine administration in the previous study.
In summary, the data gathered during the study was considered sufficient to meet the objectives of the study and warrant further clinical trials and investigations of the study drug.
REC name
Wales REC 1
REC reference
21/WA/0133
Date of REC Opinion
16 Jun 2021
REC opinion
Further Information Favourable Opinion