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

A Follow-up Trial to Assess the Persistence of the Immune Response to the Group B Streptococcus Vaccine (GBS-NN/NN2) After a Primary Vaccination of Healthy Pregnant Women, and to Assess Safety, Reactogenicity, and Immunogenicity of the GBS-NN/NN2 Vaccine When Administered During Follow-Up as a 1 Booster Dose During a New Pregnancy

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Infections; Pneumonia; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Meningitis; Neonatal Infection; Neonatal Sepsis; Streptococcus Agalactiae Infection
• Intervention / Treatment: Biological: GBS-NN/NN2 vaccine

• Study Type: Interventional
• Enrollment (Actual): 137
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Denmark
  • Capital Region
    • Copenhagen, Capital Region, Denmark, 2650
      • Hvidovre Hospital - Department Of Obstetrics And Gynaecology
  • Central Jutland
    • Aarhus N, Central Jutland, Denmark, 8200
      • Aarhus Universitetshospital
  • Region Syddanmark
    • Kolding, Region Syddanmark, Denmark, 6000
      • Sygehus Lillebælt - Kolding Sygehus
• South Africa
  • Gauteng
    • Ga-Rankuwa, Gauteng, South Africa, 0204
      • Sefako Makgatho Health Sciences University, Medunsa Clinical Research Unit (MeCRU)
  • Guateng Province
    • Johannesburg, Guateng Province, South Africa, 2001
      • Wits Reproductive Health and HIV Institute (Wits RHI)
    • Pretoria, Guateng Province, South Africa, 0152
      • Setshaba Research Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Participant living in Denmark or South Africa who has participated in Trial MVX0004 (NCT05154578) 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.
• Participant who is expected to be available for the duration of the trial and who can be contacted by telephone during trial participation.

Exclusion Criteria:

• 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.
• 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. Note: Human immunodeficiency virus (HIV) infection is not an exclusion criterion if HIV viral load is ≤1000 copies/mL and the participant has been on antiretroviral therapy for at least 3 months prior to screening and is clinically stable.
• 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 GBS vaccines (other than GBS-NN/NN2 in the MVX0004 Trial) or who is planning to receive any marketed or investigational (other than GBS NN/NN2) GBS vaccines during this trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Non-Pregnant Participants: No GBS-NN/NN2 Booster Dose; Participants who received at least one dose of GBS-NN/NN2 during the parent trial (MVX0004) who do not become pregnant during this trial will not receive a GBS-NN/NN2 booster dose.
Experimental: Pregnant Participants: GBS-NN/NN2 Booster Dose; Participants who received at least one dose of GBS-NN/NN2 during the parent trial (MVX0004) and, become pregnant during this trial, and qualify, will receive a GBS-NN/NN2 booster dose.	Biological: GBS-NN/NN2 vaccine; 0.5 mL (50 μg GBS-NN +50 μg GBS-NN2 adsorbed to 0.5 mg aluminium as Alhydrogel®)
No Intervention: Pregnant Participants: No GBS-NN/NN2 Booster Dose; Participants who received at least one dose of GBS-NN/NN2 during the parent trial (MVX0004) and, become pregnant during this trial but do not qualify for receiving a GBS-NN/NN2 booster dose.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
All Participants: Concentration of IgG Antibodies to AlpN Proteins in Blood Serum	Up to approximately 4 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of Participants Experiencing SAEs Among Pregnant Participants who Received the GBS-NN/NN2 Booster Dose	Up to approximately 6 months post-delivery
Concentration of IgG Antibodies to AlpN Proteins in Blood Serum in Pregnant Participants who Received the GBS-NN/NN2 Booster Dose	Pre-dose, 1 month post-dose, at delivery, and 6 months post-delivery
Concentration Ratio of IgG Antibodies Between Maternal and Cord Blood at Delivery in Pregnant Participants who Received the GBS-NN/NN2 Booster Dose and their Infant	At Delivery, at any time during the trial (Up to approximately 4 years)
Concentration of IgG Antibodies to AlpN Proteins in Blood Serum at Delivery in Pregnant Participants who did not Receive the GBS-NN/NN2 Booster Dose	At Delivery, at any time during the trial (Up to approximately 4 years)
Concentration Ratio of IgG Antibodies Between Maternal and Cord Blood at Delivery in Participants who did not Receive the of GBS-NN/NN2 Booster Dose	At Delivery, at any time during the trial (Up to approximately 4 years)
Concentration of IgG Antibody to AlpN Proteins in Blood Serum in Infants Born to Pregnant Participants who Received the GBS-NN/NN2 Booster Dose	At birth and at 1 and 3 months post-birth
Concentration of IgG Antibody to AlpN Proteins in Cord Blood in Infants Born to Pregnant Participants who did not Receive the GBS-NN/NN2 Booster Dose	At Delivery, at any time during the trial (Up to approximately 4 years)
All Participants: Number of Participants Experiencing Procedure-related Serious Adverse Events (SAEs)	Up to approximately 4 years
Number of Participants Experiencing Solicited Local and Systemic Adverse Events (AEs) Among Pregnant Participants who Received the GBS-NN/NN2 Booster Dose	Up to approximately Day 7 post-dose
Number of Participants Experiencing Unsolicited AEs Among Pregnant Participants who Received the GBS-NN/NN2 Booster Dose	Up to approximately Day 28 post-dose
Number of Participants Experiencing AEs of Special Interest (AESI) Among Pregnant Participants who Received the GBS-NN/NN2 Booster Dose	Up until delivery, at any time during the trial (Up to approximately 4 years)
Gestational Age (GA) of Infants Born to Pregnant Participants who Received the GBS-NN/NN2 Booster Dose	At Delivery, at any time during the trial (Up to approximately 4 years)
Weight of Infants Born from Pregnant Participants who Received the GBS-NN/NN2 Booster Dose	At Delivery, at any time during the trial (Up to approximately 4 years)
Length of Infants Born from Pregnant Participants who Received the GBS-NN/NN2 Booster Dose	At Delivery, at any time during the trial (Up to approximately 4 years)
Head Circumference of Infants Born from Pregnant Participants who Received the GBS-NN/NN2 Booster Dose	At Delivery, at any time during the trial (Up to approximately 4 years)
Apgar Score of Infants Born from Pregnant Participants who Received the GBS-NN/NN2 Booster Dose	At Delivery, at any time during the trial (Up to approximately 4 years)
Number of Infants Experiencing Unsolicited AEs Born from Pregnant Participants who Received the GBS-NN/NN2 Booster Dose	Up to 1 month post-birth
Number of Infants Experiencing Medically-attended AEs (MAAEs) Born from Pregnant Participants who Received the GBS-NN/NN2 Booster Dose	Up to 6 months post-birth
Number of Infants Experiencing SAEs Born from Pregnant Participants who Received the GBS-NN/NN2 Booster Dose	Up to 6 months post-birth
Number of Infants Experiencing AESIs Born from Pregnant Participants who Received the GBS-NN/NN2 Booster Dose	Up to 6 months post-birth

Collaborators and Investigators

• Sponsor: Minervax ApS

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2025
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): June 30, 2029

Study Registration Dates

• First Submitted: September 9, 2024
• First Submitted That Met QC Criteria: September 9, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): September 4, 2026
• Last Update Submitted That Met QC Criteria: September 1, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Immunology; Pregnancy; Streptococcus agalactiae; Lancefield's Group B Streptococcus
• Additional Relevant MeSH Terms: Neuroinflammatory Diseases; Nervous System Diseases; Pathologic Processes; Respiratory Tract Infections; Respiratory Tract Diseases; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Lung Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Neonatal Sepsis; Pneumonia; Infections; Meningitis; Bacterial Infections; Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections and Mycoses
• Other Study ID Numbers: MVX008; 2024-516364-28 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No