CompletedPhase 1

Study to Assess a Booster Dose of GBS-NN/NN2 Vaccine

United Kingdom27 participantsStarted 2021-08-17

Plain-language summary

This is an open label booster vaccine follow-up study. Participants who had received a primary course of GBS-NN/NN2 or placebo in Study MVX0002 will be invited to return to receive a booster dose (or first dose in the case of placebo or vaccine naïve participants) 1 to 5 years after the completion of the primary course of vaccination. All participants will receive a single dose of GBS-NN/NN2 containing 50μg of each fusion protein.

Who can participate

Age range

18 Years – 40 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Women who have participated in study MVX0002, with GBS-NN/NN2 vaccine and received active vaccine or placebo (unless it is necessary to recruit vaccine naïve participants to bolster the number of participants who received placebo in MVX0002).
. Able to voluntarily provide written informed consent to participate in the study.
. Healthy female participants aged 18-40 years (vaccine naïve participants only).
. Female participant of childbearing potential willing to use a highly effective method of contraception (in addition to a condom for male partners), if applicable (unless of non-childbearing potential or where abstaining from sexual intercourse is in line with the preferred and usual lifestyle of the participant) from the first dose until completion of the Day 85 visit. A woman is considered of childbearing potential, i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. For the purposes of this study, this definition of a female of childbearing potential applies to all females in the study i.e., those who participated in the MVX0002 study and those who are considered vaccine naïve.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Treatment Emergent Adverse Events

Timeframe: 12 weeks (Day 85)

Trial details

NCT IDNCT05005247

SponsorMinervax ApS

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-08-05

Results submitted2024-01-23

View on ClinicalTrials.gov More Group B Streptococcus Infection trials

Plain-language summary

Who can participate

Age range

18 Years – 40 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Women who have participated in study MVX0002, with GBS-NN/NN2 vaccine and received active vaccine or placebo (unless it is necessary to recruit vaccine naïve participants to bolster the number of participants who received placebo in MVX0002).
. Able to voluntarily provide written informed consent to participate in the study.
. Healthy female participants aged 18-40 years (vaccine naïve participants only).
. Female participant of childbearing potential willing to use a highly effective method of contraception (in addition to a condom for male partners), if applicable (unless of non-childbearing potential or where abstaining from sexual intercourse is in line with the preferred and usual lifestyle of the participant) from the first dose until completion of the Day 85 visit. A woman is considered of childbearing potential, i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. For the purposes of this study, this definition of a female of childbearing potential applies to all females in the study i.e., those who participated in the MVX0002 study and those who are considered vaccine naïve.

Study to Assess a Booster Dose of GBS-NN/NN2 Vaccine

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Study to Assess a Booster Dose of GBS-NN/NN2 Vaccine

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria