A Follow up Study of Group B Streptococcus (GBS)-NN/NN2 Vaccine in Healthy Volunteers

NCT06280157 | Terminated DMC

• 2 other identifiers: MVX0007332126
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Group B Streptococcus Infection

Outcome Measures

Primary Outcomes (5)

• 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.

  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

  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

  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

  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

  Baseline (Year 0), Years 1, 2, 3, 4

Study Arms (3)

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.

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.

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.

Biological: GBS-NN/NN2

Interventions

GBS-NN/NN2 BIOLOGICAL

GBS-NN/NN2 containing 50 μg of GBS-NN and 50 μg of GBS/NN2

One dose of GBS-NN/NN2; Three doses of GBS-NN/NN2; Two doses of GBS-NN/NN2

Eligibility Criteria

• Age: 18 Years - 40 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Minervax ApS: lead
• Simbec-Orion Group: collaborator

Study Sites (1)

Simbec-Orion Clinical Pharmacology

Merthyr Tydfil, Pentrebach Merthyr Tydfil CF48 4DR, United Kingdom

Location

Study Officials

• Ebbe Englev

  Study Director

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: February 28, 2024
• Study Start: January 18, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)