A Follow-up Trial of GBS-NN/NN2 Vaccine in Healthy Pregnant Women

NCT06592586 | Active Not Recruiting Phase 2 FDA Drug

• 2 other identifiers: MVX0082024-516364-28
• Study Type: interventional
• Target: 338
• Locations: 2 countries
• Sites: 6

Brief Summary

The main objective of the study is to evaluate the persistence of the immunoglobulin G (IgG) antibody responses, specific to Alpha-like protein CN (AlpCN), Ribosomal Protein N (RibN), Alpha-like protein 1N (Alp1N), and Alpha-like protein 2 and 3 (Alp2-3N), after a primary vaccination with GBS-NN/NN2 in all participants.

Conditions

Streptococcus Agalactiae Infection; Neonatal Sepsis; Pneumonia; Meningitis; Neonatal Infection; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Keywords

Immunology; Streptococcus agalactiae; Lancefield's Group B Streptococcus; Pregnancy

Outcome Measures

Primary Outcomes (1)

• All Participants: Concentration of IgG Antibodies to AlpN Proteins in Blood Serum

  Up to approximately 5 years

Secondary Outcomes (21)

• Concentration of IgG Antibodies to AlpN Proteins in Blood Serum Following GBS-NN/NN2 Booster Dose

  Pre-dose, 1 month pots-dose, at delivery, and 6 months post-delivery

• Difference in Concentration of IgG Antibodies Between Maternal and Cord Blood at Delivery Following GBS-NN/NN2 Booster Dose

  Up until delivery, approximately 5 years

• Concentration of IgG Antibodies to AlpN Proteins in Blood Serum at Delivery in the Absence of GBS-NN/NN2 Booster Dose

  Up until delivery, approximately 5 years

• Difference in Concentration of IgG Antibodies Between Maternal and Cord Blood at Delivery in the Absence of GBS-NN/NN2 Booster Dose

  Up until delivery, approximately 5 years

• Concentration of IgG Antibody to AlpN Proteins in Blood Serum of Offspring from Pregnant Participants who Received the GBS-NN/NN2 Booster Dose

  At delivery and at 1 and 3 months post-birth

Study Arms (3)

Non-Pregnant Participants: No GBS-NN/NN2 Booster Dose

NO INTERVENTION

Participants who received at least one dose of GBS-NN/NN2 during the parent studies but do not become pregnant during this study will not receive the GBS-NN/NN2 booster dose.

Pregnant Participants: GBS-NN/NN2 Booster Dose

EXPERIMENTAL

Participants who received at least one dose of GBS-NN/NN2 during the parent studies and, become pregnant during this study, and qualify, will receive become pregnant during this study will receive the GBS-NN/NN2 booster dose.

Biological: GBS-NN/NN2 vaccine

Pregnant Participants: No GBS-NN/NN2 Booster Dose

NO INTERVENTION

Participants who received at least one dose of GBS-NN/NN2 during the parent studies and, become pregnant during this study but do not qualify for receiving the GBS-NN/NN2 booster dose.

Interventions

GBS-NN/NN2 vaccine BIOLOGICAL

0.5 mL (50 μg GBS-NN +50 μg GBS-NN2 adsorbed to 0.5 mg aluminium as Alhydrogel®)

Pregnant Participants: GBS-NN/NN2 Booster Dose

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant living in Denmark or South Africa who has participated either in Trial MVX0004 (NCT05154578) or MVX0005 (NCT04596878) and has received at least 1 dose of the GBS-NN/NN2 vaccine.
• Participant who is able to read and understand and capable of giving personal signed informed consent.
• Participant who is willing and able to comply with scheduled visits, the investigational plan, and other trial procedures.
• Participant who is granting access to their trial-related medical records and to their trial materials from Trials MVX0004 or MVX0005, whatever is applicable.
• Participant who are expected to be available for the duration of the trial and who can be contacted by telephone during trial participation.

You may not qualify if:

• Any personnel involved in the conduct of the trial (and their family members), including, but not limited to, site staff members, MinervaX employees, and any vendor or contract research organisation (CRO) employees.
• Participant with confirmed Group B Streptococcus (GBS) infection since participation in Trial MVX0004 or MVX0005.
• Participant with any psychiatric condition, including recent (within the past year) active suicidal ideation/behaviour that may increase the risk of trial participation or, in the investigator's judgement, make the participant unsuitable for participation in the trial.
• Participant who participated in other trials involving investigational drug(s) or devices within 28 days prior to trial entry, and/or are participating in other trials involving investigational drug(s) or devices at trial entry, or plan to (continue to) participate in other trials involving investigational drug(s) or devices during this trial.
• Participant with known or suspected immunodeficiency or cancer or a family history of congenital or hereditary immunodeficiency.
• Participant receiving chronic administration (defined as more than 14 continuous days) of immunosuppressants or other immune-modifying drugs within 6 months prior to trial entry. An immunosuppressive dose of glucocorticoid will be defined as a systemic dose ≥10 mg of prednisone per day or equivalent. The use of topical, inhaled, and nasal glucocorticoids will be permitted.
• Participant who received blood, blood products, plasma derivatives, or any immunoglobulin preparations in the 12 weeks prior to trial entry or is planning to receive such products during this trial.
• Participant with current or history of drug or alcohol abuse, as judged by the investigator.
• Participant who received any marketed or investigational (other than GBS-NN/NN2 in the MVX0004 or MVX0005 Trial) GBS vaccines or who is planning to receive any marketed or investigational (other than GBS NN/NN2) GBS vaccines during this trial.

Sponsors & Collaborators

• Minervax ApS: lead

Study Sites (6)

Hvidovre Hospital - Department Of Obstetrics And Gynaecology

Copenhagen, Capital Region, 2650, Denmark

Location

Aarhus Universitetshospital

Aarhus N, Central Jutland, 8200, Denmark

Location

Sygehus Lillebælt - Kolding Sygehus

Kolding, Region Syddanmark, 6000, Denmark

Location

Sefako Makgatho Health Sciences University, Medunsa Clinical Research Unit (MeCRU)

Ga-Rankuwa, Gauteng, 0204, South Africa

Location

Wits Reproductive Health and HIV Institute (Wits RHI)

Johannesburg, Guateng Province, 2001, South Africa

Location

Setshaba Research Centre

Pretoria, Guateng Province, 0152, South Africa

Location

MeSH Terms

Conditions

Streptococcal Infections; Neonatal Sepsis; Pneumonia; Meningitis; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Condition Hierarchy (Ancestors)

Sepsis; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Neuroinflammatory Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2024
• First Posted: September 19, 2024
• Study Start: March 7, 2025
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): June 30, 2029
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

DK (3); ZA (3)