Group B Streptococcus InfectionNCT06280157
A Follow up Study of Group B Streptococcus (GBS)-NN/NN2 Vaccine in Healthy Volunteers
An observational study of Group B Streptococcus Infection, run by Minervax ApS at 1 site in United Kingdom.
Trial summary
The goal of this follow-up study is to investigate the persistence of the immune response induced by the GBS-NN/NN2 vaccine in women who have participated in study MVX0002, and/or in study MVX0003 with GBS-NN/NN2 vaccine and received 1, 2 or 3 doses of GBS-NN/NN2. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Group B Streptococcus Infection
- What is being tested?
- GBS-NN/NN2
- How many people
- 29 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Jan 2024to 1 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: A minimum of 20 and a maximum of 55 female participants, all of whom received previous vaccination with GBS-NN/NN2 in the MVX0002 and MVX0003 studies, will be recruited.
Who may be able to join
- Women who have participated in study MVX0002, and/or in study MVX0003 with GBS-NN/NN2 vaccine and received 1, 2 or 3 doses of GBS-NN/NN2.
- Able to voluntarily provide written informed consent to participate in the study.
- Participant must be fit to participate in the study, as assessed by the investigator.
- Participant must be able to comply with study procedures and provide at least 2 blood samples.
Who cannot join
- Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or MinervaX employees, including their family members.
- Any known or suspected immunocompromising or immune suppressive condition (including conditions caused by certain immunocompromising/immunosuppressive medication), unless the condition is expected to normalise within 12 weeks after enrolment. If this is the case, then the subject can be enrolled but the blood sampling will be postponed until the condition has normalised.
- Received systemic steroids in the 6 weeks before any blood sampling (inhaled and topical steroids are acceptable).
- Received blood, blood products, plasma derivatives or any immunoglobulin preparations in the 12 weeks before any blood sampling.
- While participants who are enrolled on this study will also be eligible for participation in other clinical trials which may be ongoing during the overall period of participation in this study, they are not allowed to participate in another vaccine study nor in a study involving a licensed or investigational drug which is known or suspected to have an impact on the immune response (immune compromising/suppressing/stimulating).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Simbec-Orion Clinical Pharmacology
Merthyr Tydfil, Pentrebach Merthyr Tydfil CF48 4DR
About this study
Official title: A Long-term Follow-up Study to Assess the Persistence of Immunoglobin G (IgG) Antibodies to the GBS-NN/NN2 Vaccine After Vaccination With the GBS-NN/NN2 Vaccine in MVX0002 and/or in MVX0003
The goal of this follow-up study is to investigate the persistence of the immune response induced by the GBS-NN/NN2 vaccine in women who have participated in study MVX0002, and/or in study MVX0003 with GBS-NN/NN2 vaccine and received 1, 2 or 3 doses of GBS-NN/NN2. The main question it aims to answer is to determine the persistence of the immune response induced by the GBS-NN/NN2 vaccine by measuring antibody concentrations.
Participants who had received a primary course of GBS-NN/NN2 in Study MVX0002 and/or MVX0003 will be invited to return to have a single yearly blood sample of approximately 10 mL collected 2 to 5 years after the completion of the previous vaccination.
Read the detailed description
This is a follow-up study to investigate the persistence of the immune response induced by the GBS-NN/NN2 vaccine. No vaccine or placebo will be administered. A single 10 mL blood sample will be collected from participants, every year, for a maximum of 4 years. Participants who had received a primary course of GBS-NN/NN2 in Study MVX0002 and/or MVX0003 will be invited to return to have a single yearly blood sample of approximately 10 mL collected 2 to 5 years after the completion of the previous vaccination.
Only participants that received two doses GBS-NN/NN2 in MVX0002 and all participants that received a single dose in MVX0003 will be eligible.
Hence, participants will have received:
One dose of GBS-NN/NN2 prior to this study, i.e., participants from MVX0003 who had not received GBS-NN/NN2 in MVX0002 and received a single dose in MVX0003.
Or two doses of GBS-NN/NN2 prior to this study, i.e., participants from MVX0002 who had received two doses of GBS-NN/NN2 in MVX0002 and did not take part in MVX0003.
Or three doses of GBS-NN/NN2 prior to this study, i.e., participants from MVX0003 who had received two doses of GBS-NN/NN2 in MVX0002 and received a single dose in MVX0003.
- Conditions
- Group B Streptococcus Infection
- Being tested
- GBS-NN/NN2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GBS-NN/NN2Biological
GBS-NN/NN2 containing 50 μg of GBS-NN and 50 μg of GBS/NN2
| Study group | Role | What they receive |
|---|---|---|
| One dose of GBS-NN/NN2 | Participants who participated in study MVX003 and had received one dose of GBS-NN/NN2 prior to this study. Receives: Biological: GBS-NN/NN2 | |
| Two doses of GBS-NN/NN2 | Participants who participated in study MVX002 and had received two doses of GBS-NN/NN2 prior to this study. Receives: Biological: GBS-NN/NN2 | |
| Three doses of GBS-NN/NN2 | Participants who participated in study MVX002 and MVX003 and had received three doses of GBS-NN/NN2 prior to this study. Receives: Biological: GBS-NN/NN2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibody Concentration Specific for GBS-NN and GBS-NN2
Pharmacodynamic (PD) blood samples (10 mL) for antibody concentration specific for GBS-NN and GBS-NN2 will be collected during the study.
Measured: Baseline (Year 0), Years 1, 2, 3, 4
Ig G Antibody Responses Specific to Alpha like proteins (Alp): AlpCN
Pharmacodynamic (PD) blood samples (10 mL) for antibody concentration specific for AlpCN, RibN, Alp1N and Alp2/3N will be collected during the study
Measured: Baseline (Year 0), Years 1, 2, 3, 4
Ig G Antibody Responses Specific to Alp: RibN
Pharmacodynamic (PD) blood samples (10 mL) for antibody concentration specific for AlpCN, RibN, Alp1N and Alp2/3N will be collected during the study
Measured: Baseline (Year 0), Years 1, 2, 3, 4
Ig G Antibody Responses Specific to Alp: Alp1N
Pharmacodynamic (PD) blood samples (10 mL) for antibody concentration specific for AlpCN, RibN, Alp1N and Alp2/3N will be collected during the study
Measured: Baseline (Year 0), Years 1, 2, 3, 4
Ig G Antibody Responses Specific to Alp: Alp2-3N
Pharmacodynamic (PD) blood samples (10 mL) for antibody concentration specific for AlpCN, RibN, Alp1N and Alp2/3N will be collected during the study
Measured: Baseline (Year 0), Years 1, 2, 3, 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start18 Jan 2024
- Primary completion1 Dec 2025
- Study completion1 Dec 2025
Why it stopped: Based on data collected in the trial, the primary endpoint could be concluded.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Group B Streptococcus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minervax ApS
- Sponsor type
- University, hospital or other
- Collaborators
- Simbec-Orion Group
- Responsible party
- Sponsor
- Investigators
- Ebbe Englev, Study director, Study Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06280157
- Sponsor's protocol ID
- MVX0007
- Other IDs
- 332126
- Status last verified
- Feb 2026
- First submitted
- 19 Feb 2024
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long-term Follow-up Study to Assess the Persistence of Immunoglobin G (IgG) Antibodies to the GBS-NN/NN2 Vaccine After Vaccination With the GBS-NN/NN2 Vaccine in MVX0002 and/or in MVX0003
- ClinicalTrials.gov ID
- NCT06280157
- Acronym / sponsor ID
- MVX0007
- Conditions
- Group B Streptococcus Infection
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Based on data collected in the trial, the primary endpoint could be concluded.
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Minervax ApSUniversity, hospital or other
- Collaborators
- Simbec-Orion Group
- Study start
- 18 Jan 2024 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this follow-up study is to investigate the persistence of the immune response induced by the GBS-NN/NN2 vaccine in women who have participated in study MVX0002, and/or in study MVX0003 with GBS-NN/NN2 vaccine and received 1, 2 or 3 doses of GBS-NN/NN2. The main question it aims to answer is to determine the persistence of the immune response induced by the GBS-NN/NN2 vaccine by measuring antibody concentrations.
Participants who had received a primary course of GBS-NN/NN2 in Study MVX0002 and/or MVX0003 will be invited to return to have a single yearly blood sample of approximately 10 mL collected 2 to 5 years after the completion of the previous vaccination.
Detailed description
This is a follow-up study to investigate the persistence of the immune response induced by the GBS-NN/NN2 vaccine. No vaccine or placebo will be administered. A single 10 mL blood sample will be collected from participants, every year, for a maximum of 4 years. Participants who had received a primary course of GBS-NN/NN2 in Study MVX0002 and/or MVX0003 will be invited to return to have a single yearly blood sample of approximately 10 mL collected 2 to 5 years after the completion of the previous vaccination.
Only participants that received two doses GBS-NN/NN2 in MVX0002 and all participants that received a single dose in MVX0003 will be eligible.
Hence, participants will have received:
One dose of GBS-NN/NN2 prior to this study, i.e., participants from MVX0003 who had not received GBS-NN/NN2 in MVX0002 and received a single dose in MVX0003.
Or two doses of GBS-NN/NN2 prior to this study, i.e., participants from MVX0002 who had received two doses of GBS-NN/NN2 in MVX0002 and did not take part in MVX0003.
Or three doses of GBS-NN/NN2 prior to this study, i.e., participants from MVX0003 who had received two doses of GBS-NN/NN2 in MVX0002 and received a single dose in MVX0003.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| One dose of GBS-NN/NN2 | – | Biological: GBS-NN/NN2Participants who participated in study MVX003 and had received one dose of GBS-NN/NN2 prior to this study. |
| Two doses of GBS-NN/NN2 | – | Biological: GBS-NN/NN2Participants who participated in study MVX002 and had received two doses of GBS-NN/NN2 prior to this study. |
| Three doses of GBS-NN/NN2 | – | Biological: GBS-NN/NN2Participants who participated in study MVX002 and MVX003 and had received three doses of GBS-NN/NN2 prior to this study. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- A minimum of 20 and a maximum of 55 female participants, all of whom received previous vaccination with GBS-NN/NN2 in the MVX0002 and MVX0003 studies, will be recruited.
Key inclusion criteria (4 listed)
- Women who have participated in study MVX0002, and/or in study MVX0003 with GBS-NN/NN2 vaccine and received 1, 2 or 3 doses of GBS-NN/NN2.
- Able to voluntarily provide written informed consent to participate in the study.
- Participant must be fit to participate in the study, as assessed by the investigator.
- Participant must be able to comply with study procedures and provide at least 2 blood samples.
Key exclusion criteria (5 listed)
- Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or MinervaX employees, including their family members.
- Any known or suspected immunocompromising or immune suppressive condition (including conditions caused by certain immunocompromising/immunosuppressive medication), unless the condition is expected to normalise within 12 weeks after enrolment. If this is the case, then the subject can be enrolled but the blood sampling will be postponed until the condition has normalised.
- Received systemic steroids in the 6 weeks before any blood sampling (inhaled and topical steroids are acceptable).
- Received blood, blood products, plasma derivatives or any immunoglobulin preparations in the 12 weeks before any blood sampling.
- While participants who are enrolled on this study will also be eligible for participation in other clinical trials which may be ongoing during the overall period of participation in this study, they are not allowed to participate in another vaccine study nor in a study involving a licensed or investigational drug which is known or suspected to have an impact on the immune response (immune compromising/suppressing/stimulating).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GBS-NN/NN2GBS-NN/NN2 containing 50 μg of GBS-NN and 50 μg of GBS/NN2 | Biological | One dose of GBS-NN/NN2, Three doses of GBS-NN/NN2, Two doses of GBS-NN/NN2 |
Primary outcome
Antibody Concentration Specific for GBS-NN and GBS-NN2
Time frame: Baseline (Year 0), Years 1, 2, 3, 4
Pharmacodynamic (PD) blood samples (10 mL) for antibody concentration specific for GBS-NN and GBS-NN2 will be collected during the study.
Ig G Antibody Responses Specific to Alpha like proteins (Alp): AlpCN
Time frame: Baseline (Year 0), Years 1, 2, 3, 4
Pharmacodynamic (PD) blood samples (10 mL) for antibody concentration specific for AlpCN, RibN, Alp1N and Alp2/3N will be collected during the study
Ig G Antibody Responses Specific to Alp: RibN
Time frame: Baseline (Year 0), Years 1, 2, 3, 4
Pharmacodynamic (PD) blood samples (10 mL) for antibody concentration specific for AlpCN, RibN, Alp1N and Alp2/3N will be collected during the study
Ig G Antibody Responses Specific to Alp: Alp1N
Time frame: Baseline (Year 0), Years 1, 2, 3, 4
Pharmacodynamic (PD) blood samples (10 mL) for antibody concentration specific for AlpCN, RibN, Alp1N and Alp2/3N will be collected during the study
Ig G Antibody Responses Specific to Alp: Alp2-3N
Time frame: Baseline (Year 0), Years 1, 2, 3, 4
Pharmacodynamic (PD) blood samples (10 mL) for antibody concentration specific for AlpCN, RibN, Alp1N and Alp2/3N will be collected during the study
Results and safety
The study was stopped early (reason given: Based on data collected in the trial, the primary endpoint could be concluded.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Group B Streptococcus Infection
Not yet recruitingPhase 2/3
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A Follow-up Trial of GBS-NN/NN2 Vaccine in Healthy Pregnant Women
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Preparing for Maternal GBS Vaccine Trials in Africa
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ebbe Englev study director
Study Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Group B Streptococcus Infection, run by Minervax ApS at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Based on data collected in the trial, the primary endpoint could be concluded.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antibody Concentration Specific for GBS-NN and GBS-NN2 (time frame: Baseline (Year 0), Years 1, 2, 3, 4). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.