Group B Streptococcal InfectionsPhase 1NCT05782179

Study to Evaluate the Safety, Tolerability and Immunogenicity of Three Doses of GBS Vaccine in Elderly Participants

A Phase 1 study testing GBS-NN/NN2 in people with Group B Streptococcal Infections, run by Minervax ApS at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The study is a randomised, double-blind, placebo-controlled, parallel group study to evaluate the safety, tolerability and immunogenicity of three doses of GBS NN/NN2 with Alhydrogel® (Recombinant protein vaccine against Group B Streptococcus) in elderly participants aged 55 to 75.Participants will be followed up to 6… Read more about this study

Who is it for?: Ages 55 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Group B Streptococcal Infections
What is being tested?: GBS-NN/NN2
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 90 participants
Where: 1 siteBelgium
Study dates: 1 Mar 2023to 23 May 2024
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 55 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Participants aged 55 to 75 years.
Body mass index (BMI) ≥18 and ≤30 kg/m2 for healthy participants, ≥ 30 to ≤45 kg/m2 for obese participants and ≥18 to ≤45 kg/m2 for type 2 diabetic participants.
Able to voluntarily provide written informed consent to participate in the study.
Female participants must be post-menopausal.
Participants capable and willing to follow trial schedule and procedures.

Who cannot join

Participants who have received a GBS vaccine previously.
Participants with history or presence of significant (as evaluated by the investigator) cardiovascular disease, pulmonary, hepatic, gallbladder or biliary tract, renal, haematological, gastrointestinal, endocrine, immunologic, dermatological, neurological, psychiatric, autoimmune disease or current infection.
NOTE: Patients with type 2 diabetes are to be recruited for Cohort 3 and Cohort 4.
Laboratory values at screening which are deemed by the investigator to be clinically significantly abnormal.
Current or history of drug or alcohol abuse per investigator judgement.
Positive for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.

Show all 21Show fewer

Participants currently participating in a clinical trial.
Participants receiving an investigational drug, vaccine or device during the 90 days preceding the initial dose in this study.
Any significant illness during the 4 weeks preceding the vaccination visit, per investigator judgement.
Participants with a history of severe allergic reactions after previous vaccination.
Participants who have received any vaccine within 30 days of first IMP administration, or who are planning to receive any vaccine (eg, travel vaccines) up to 30 days after each vaccination.
NOTE: Exceptions could be made for emergency vaccinations (eg, tetanus) or vaccination campaigns (eg, SARS, CoV-2 or influenza) which will be permitted not less than 7 days before or after study vaccination.
Participants receiving immunosuppressive therapy or immunoglobulins in the 6 months prior to screening.
Participants within a 7-day period after an acute infection in the 7 days preceding vaccination, as per investigator judgement, or with fever (oral temperature >37.9°C) in the 72 hours preceding vaccination.
Participants who have received antipyretics/analgesics treatment within 72 hours prior to dosing.
Participants on chronic medications that are likely to affect the assessments specified in the protocol (eg, anticoagulant therapy, systemic steroids).
NOTE: Chronic medications such as antihypertensives, bronchodilators, statins that do not affect the immune system, will be permitted and allowed to continue during the study at the discretion of the investigator. Treatment for diabetes will be continued as required for the diabetic participants recruited. Non-steroidal anti-inflammatory drugs or paracetamol will be permitted for the treatment of headache or other symptoms during the study. Use of over the counter (OTC) vitamins and dietary supplements is allowed.
Participants with skin defects and/or tattoos at the proposed site of vaccine administration.
Donation of blood or blood products within 90 days prior to first study vaccination.
Participants who, in the opinion of the Investigator, are unsuitable for participation in the study.
Involvement in the planning and/or conduct of the study (applies to both Sponsor personnel and/or personnel at the study centre or Clinical Research Organisation [CRO]).

Trial locations and contacts

1 site in 1 country.

Belgium1 site

University Hospital Ghent - Centrum voor Vaccinologie (CEVAC) department
Ghent, 9000

Other trials in Belgium

About this study

Official title: A Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Safety, Tolerability and Immunogenicity of Three Doses of Group B Streptococcus Vaccine (GBS NN/NN2 With Alhydrogel®) in Elderly Participants Aged 55 to 75

Read the detailed description

Sixty (60) healthy older adult participants aged 55 to 75 years will be randomised in two cohorts; 30 obese and/or diabetic participants aged 55 to 75 years will be randomised in two cohorts.

Participants will be involved in the study for approximately one year including screening and safety follow-up.

Eligible participants will be administered a dose of GBS-NN/NN2 or placebo on three occasions: the first dose will be administered on Day 1, followed by the second and third doses 4 and 24 weeks later, respectively.

Conditions: Group B Streptococcal Infections
Being tested: GBS-NN/NN2, Placebo
Medical subject headings: Streptococcal Infections

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 bound to alhydrogel as an adjuvant
PlaceboBiological
Normal Saline 0.9 %

Study groups in NCT05782179
Study group	Role	What they receive
Cohort 1 - Active	Experimental	Cohort 1 (30 healthy older adult) will receive three injections, each consisting of 50 μg of GBS-NN and 50 μg of GBS NN2 bound to aluminium hydroxide in a 4:1 ratio (investigational medicinal product or placebo). Receives: Biological: GBS-NN/NN2
Cohort 1 - Placebo	Placebo comparator	Cohort 1 (30 healthy older adult) will receive three injections, each consisting of 50 μg of GBS-NN and 50 μg of GBS NN2 bound to aluminium hydroxide in a 4:1 ratio (investigational medicinal product or placebo). Receives: Biological: Placebo
Cohort 2 - Active	Experimental	Cohort 2 (30 healthy older adult) will receive three injections, each consisting of 125 μg of GBS-NN and 125 μg of GBS NN2 bound to aluminium hydroxide in a 4:1 ratio (investigational medicinal product or placebo). Receives: Biological: GBS-NN/NN2
Cohort 2 - Placebo	Placebo comparator	Cohort 2 (30 healthy older adult) will receive three injections, each consisting of 125 μg of GBS-NN and 125 μg of GBS NN2 bound to aluminium hydroxide in a 4:1 ratio (investigational medicinal product or placebo). Receives: Biological: Placebo
Cohort 3 - Active	Experimental	Cohort 3 (15 obese and/or diabetic older adults) will receive three injections, each consisting of 50 μg of GBS-NN and 50 μg of GBS NN2 bound to aluminium hydroxide in a 4:1 ratio (investigational medicinal product or placebo). Receives: Biological: GBS-NN/NN2
Cohort 3 - Placebo	Placebo comparator	Cohort 3 (15 obese and/or diabetic older adults) will receive three injections, each consisting of 50 μg of GBS-NN and 50 μg of GBS NN2 bound to aluminium hydroxide in a 4:1 ratio (investigational medicinal product or placebo). Receives: Biological: Placebo
Cohort 4 - Active	Experimental	Cohort 4 (15 obese and/or diabetic older adults) will receive three injections, each consisting of 125 μg of GBS-NN and 125 μg of GBS NN2 bound to aluminium hydroxide in a 4:1 ratio (investigational medicinal product or placebo). Receives: Biological: GBS-NN/NN2
Cohort 4 - Placebo	Placebo comparator	Cohort 4 (15 obese and/or diabetic older adults) will receive three injections, each consisting of 125 μg of GBS-NN and 125 μg of GBS NN2 bound to aluminium hydroxide in a 4:1 ratio (investigational medicinal product or placebo). Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety and Tolerability of the GBS-NN/NN2 Vaccine for 4 Weeks After Each Dose of Vaccine
- Safety and tolerability as determined by the occurrence of Adverse Events (AEs) consisting of local and systemic reactogenicity within 7 days after vaccination
- Unsolicited AEs, including adverse events of special interest (AESIs), Medically attended adverse events (MAAEs) and Serious adverse events (SAEs) within 28 days after each vaccination
- AESIs, MAAEs, ARs/SARs leading to withdrawal from the study.
Measured: Up to 28 days after each vaccination

Secondary outcomes (5)

Geometric Mean Antibody Concentration in μg/mL for Antibodies to the Four Individual Alps
Geometric mean antibody concentration in μg/mL for antibodies to the four individual Alps (Alp 1, Alp2/3, Rib and AlpC) to evaluate IgG antibody response to the GBS-NN/NN2 vaccine at Day 197 (principal immunological endpoint).
Measured: Day 197
Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps
Geometric mean fold increase in antibody concentration for antibodies to the four individual Alps (Alp 1, Alp2/3, Rib and AlpC) to evaluate IgG antibody responses induced by the three vaccine doses, on a 0-, 1- and 6-month regimen, in older adult participants 4 weeks after each vaccination.
Measured: 4 weeks after each vaccination (Days 29, 57 and 197)
Seroconversion Rate at Any Time Post Vaccination
Seroconversion rate (proportion of participants with a 4-fold increase above baseline - pre dose concentration) at any time post vaccination to assess whether pre existing antibody levels affect the vaccine-induced antibody response.
Measured: Up to 6 months after last vaccination
Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps
Proportion of participants achieving antibody concentrations for antibodies to the four individual Alps (Alp 1, Alp2/3, Rib and AlpC) above specific thresholds (>1, >2, >4, and >8 µg/mL) at Days 29, 57, 169, and 197, to evaluate the immune response up to 6 months following the third dose.
Measured: Up to day 197
Long-term Safety Profile of the GBS-NN/NN2 Vaccine Between Day 57 (28 Days Post Second Injection) to Day 168 and 6 Months Following the Third Dose (Safety Endpoint)
- Proportion of participants with any SAE from between Day 57 (28 days post second injection) to Day 168 and 28 days after third vaccination (Day 197) up to Day 365.
- Proportion of participants with MAAEs, AESIs, ARs/SARs requiring a medical consultation, and or leading to withdrawal from the study from 28 days after third vaccination (Day 197) up to Day 365.
Measured: Up to day 365

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 202323 May 2024

First posted23 Mar 2023
Study start1 Mar 2023
Primary completion14 Dec 2023
Study completion23 May 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Group B Streptococcal InfectionsStudies 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: Interventional
Phase: Phase 1
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 90 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05782179
Sponsor's protocol ID: MVX0006
Other IDs: 2022-003681-20
Status last verified: Sep 2025
First submitted: 23 Feb 2023
Last updated: 5 Sep 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruitingPhase 2/3
A Follow-up Trial of GBS-NN/NN2 Vaccine in Healthy Pregnant Women
Streptococcus Agalactiae Infection, Neonatal Sepsis
RecruitingObservational study
Preparing for Maternal GBS Vaccine Trials in Africa
Group B Streptococcus, Invasive Bacterial Diseases (IBD)
RecruitingObservational study
mulTiplex Immunoassay qualiTy assuRance Panel
Group B Strep Infection
Active, not recruitingPhase 1/2
Phase I/II Study to a Assess the GBS-06 Vaccine Manufactured by Inventprise, Inc., in Healthy, Non-Pregnant, Adult Women of Childbearing Age.
Group B Streptococcal Infections

All Group B Streptococcal Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Safety, Tolerability and Immunogenicity of Three Doses of Group B Streptococcus Vaccine (GBS NN/NN2 With Alhydrogel®) in Elderly Participants Aged 55 to 75
ClinicalTrials.gov ID: NCT05782179
Acronym / sponsor ID: MVX0006
Conditions: Group B Streptococcal Infections
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 90 participants (actual)
Lead sponsor: Minervax ApSUniversity, hospital or other
Collaborators: IQVIA Pty Ltd
Study start: 1 Mar 2023 (actual)
Primary completion: 14 Dec 2023 (actual)
Study completion: 23 May 2024 (actual)
First posted: 23 Mar 2023 (actual)
Results: Posted 5 Sep 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Sixty (60) healthy older adult participants aged 55 to 75 years will be randomised in two cohorts; 30 obese and/or diabetic participants aged 55 to 75 years will be randomised in two cohorts.

Participants will be involved in the study for approximately one year including screening and safety follow-up.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 8

Arm	Type	Receives
Cohort 1 - Active	Experimental	Biological: GBS-NN/NN2Cohort 1 (30 healthy older adult) will receive three injections, each consisting of 50 μg of GBS-NN and 50 μg of GBS NN2 bound to aluminium hydroxide in a 4:1 ratio (investigational medicinal product or placebo).
Cohort 1 - Placebo	Placebo comparator	Biological: PlaceboCohort 1 (30 healthy older adult) will receive three injections, each consisting of 50 μg of GBS-NN and 50 μg of GBS NN2 bound to aluminium hydroxide in a 4:1 ratio (investigational medicinal product or placebo).
Cohort 2 - Active	Experimental	Biological: GBS-NN/NN2Cohort 2 (30 healthy older adult) will receive three injections, each consisting of 125 μg of GBS-NN and 125 μg of GBS NN2 bound to aluminium hydroxide in a 4:1 ratio (investigational medicinal product or placebo).
Cohort 2 - Placebo	Placebo comparator	Biological: PlaceboCohort 2 (30 healthy older adult) will receive three injections, each consisting of 125 μg of GBS-NN and 125 μg of GBS NN2 bound to aluminium hydroxide in a 4:1 ratio (investigational medicinal product or placebo).
Cohort 3 - Active	Experimental	Biological: GBS-NN/NN2Cohort 3 (15 obese and/or diabetic older adults) will receive three injections, each consisting of 50 μg of GBS-NN and 50 μg of GBS NN2 bound to aluminium hydroxide in a 4:1 ratio (investigational medicinal product or placebo).
Cohort 3 - Placebo	Placebo comparator	Biological: PlaceboCohort 3 (15 obese and/or diabetic older adults) will receive three injections, each consisting of 50 μg of GBS-NN and 50 μg of GBS NN2 bound to aluminium hydroxide in a 4:1 ratio (investigational medicinal product or placebo).
Cohort 4 - Active	Experimental	Biological: GBS-NN/NN2Cohort 4 (15 obese and/or diabetic older adults) will receive three injections, each consisting of 125 μg of GBS-NN and 125 μg of GBS NN2 bound to aluminium hydroxide in a 4:1 ratio (investigational medicinal product or placebo).
Cohort 4 - Placebo	Placebo comparator	Biological: PlaceboCohort 4 (15 obese and/or diabetic older adults) will receive three injections, each consisting of 125 μg of GBS-NN and 125 μg of GBS NN2 bound to aluminium hydroxide in a 4:1 ratio (investigational medicinal product or placebo).

Who may qualify

Ages: 55 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Participants aged 55 to 75 years.
Body mass index (BMI) ≥18 and ≤30 kg/m2 for healthy participants, ≥ 30 to ≤45 kg/m2 for obese participants and ≥18 to ≤45 kg/m2 for type 2 diabetic participants.
Able to voluntarily provide written informed consent to participate in the study.
Female participants must be post-menopausal.
Participants capable and willing to follow trial schedule and procedures.

Key exclusion criteria (21 listed)

Participants who have received a GBS vaccine previously.
Participants with history or presence of significant (as evaluated by the investigator) cardiovascular disease, pulmonary, hepatic, gallbladder or biliary tract, renal, haematological, gastrointestinal, endocrine, immunologic, dermatological, neurological, psychiatric, autoimmune disease or current infection.
NOTE: Patients with type 2 diabetes are to be recruited for Cohort 3 and Cohort 4.
Laboratory values at screening which are deemed by the investigator to be clinically significantly abnormal.
Current or history of drug or alcohol abuse per investigator judgement.

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 bound to alhydrogel as an adjuvant	Biological	Cohort 1 - Active, Cohort 2 - Active, Cohort 3 - Active, Cohort 4 - Active
PlaceboNormal Saline 0.9 %	Biological	Cohort 1 - Placebo, Cohort 2 - Placebo, Cohort 3 - Placebo, Cohort 4 - Placebo

Primary outcome

Safety and Tolerability of the GBS-NN/NN2 Vaccine for 4 Weeks After Each Dose of Vaccine
Time frame: Up to 28 days after each vaccination
* Safety and tolerability as determined by the occurrence of Adverse Events (AEs) consisting of local and systemic reactogenicity within 7 days after vaccination * Unsolicited AEs, including adverse events of special interest (AESIs), Medically attended adverse events (MAAEs) and Serious adverse events (SAEs) within 28 days after each vaccination * AESIs, MAAEs, ARs/SARs leading to withdrawal from the study.

5 secondary outcomes

Geometric Mean Antibody Concentration in μg/mL for Antibodies to the Four Individual Alps
Time frame: Day 197
Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps
Time frame: 4 weeks after each vaccination (Days 29, 57 and 197)
Seroconversion Rate at Any Time Post Vaccination
Time frame: Up to 6 months after last vaccination
Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps
Time frame: Up to day 197
Long-term Safety Profile of the GBS-NN/NN2 Vaccine Between Day 57 (28 Days Post Second Injection) to Day 168 and 6 Months Following the Third Dose (Safety Endpoint)
Time frame: Up to day 365

Results and safety

Results posted to the registry on 5 Sep 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Healthy Older Adult : GBS-NN/NN2 50 µg	24	24
Healthy Older Adult : GBS-NN/NN2 125 µg	24	24
Healthy Older Adult : Placebo	12	10
Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg	12	12
Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg	12	12
Obese and/or Diabetic Older Adult : Placebo	6	6

Primary outcome: Safety and Tolerability of the GBS-NN/NN2 Vaccine for 4 Weeks After Each Dose of Vaccine

Time frame: Up to 28 days after each vaccination. Count of participants. Unit: Participants

Measure	Healthy Older Adult : GBS-NN/NN2 50 µg n = 24	Healthy Older Adult : GBS-NN/NN2 125 µg n = 24	Healthy Older Adult : Placebo n = 12	Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg n = 12	Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg n = 12	Obese and/or Diabetic Older Adult : Placebo n = 6
Local Solicited AEs	23	21	5	10	10	2
Systemic Solicited AEs	12	14	6	8	7	4
Unsolicited AEs	17	16	10	9	9	4
AEs leading to withdrawal	0	0	2	0	0	0

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Healthy Older Adult : GBS-NN/NN2 50 µg	1 of 24 (4.2%)	17 of 24 (70.8%)	0 of 24
Healthy Older Adult : GBS-NN/NN2 125 µg	1 of 24 (4.2%)	16 of 24 (66.7%)	0 of 24
Healthy Older Adult : Placebo	2 of 12 (16.7%)	10 of 12 (83.3%)	0 of 12
Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg	1 of 12 (8.3%)	9 of 12 (75%)	0 of 12
Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg	0 of 12 (0%)	9 of 12 (75%)	0 of 12
Obese and/or Diabetic Older Adult : Placebo	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Group B Streptococcal Infections

Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruitingPhase 2/3
A Follow-up Trial of GBS-NN/NN2 Vaccine in Healthy Pregnant Women
Streptococcus Agalactiae Infection, Neonatal Sepsis
RecruitingObservational study
Preparing for Maternal GBS Vaccine Trials in Africa
Group B Streptococcus, Invasive Bacterial Diseases (IBD)
RecruitingObservational study
mulTiplex Immunoassay qualiTy assuRance Panel
Group B Strep Infection
Active, not recruitingPhase 1/2
Phase I/II Study to a Assess the GBS-06 Vaccine Manufactured by Inventprise, Inc., in Healthy, Non-Pregnant, Adult Women of Childbearing Age.
Group B Streptococcal Infections

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.

Geoff Kitson study director

gkitson@propharmapartners.uk.com

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GBS-NN/NN2 in people with Group B Streptococcal Infections, run by Minervax ApS at 1 site in Belgium.

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 5 inclusion and 21 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: finished, as of the sponsor's last update on 5 Sep 2025. 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 Belgium. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Safety and Tolerability of the GBS-NN/NN2 Vaccine for 4 Weeks After Each Dose of Vaccine (time frame: Up to 28 days after each vaccination). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05782179.

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 5 Sep 2025.