Immunogenicity and Safety of GBS-NN/NN2 in Pregnant Women

NCT05154578 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: MVX0004
• Study Type: interventional
• Target: 269
• Locations: 3 countries
• Sites: 10

Brief Summary

This is a phase II, multicentre, multinational, randomized, parallel group, placebo-controlled study of four vaccination regimens in healthy pregnant women. There will be 5 treatment groups; three groups of 60 participants will receive will receive two doses of GBS-NN/NN2 vaccine and one dose of placebo (saline); one group of 60 participants will receive one dose of GBS-NN/NN2 vaccine and two doses of placebo (saline), and one group of 30 participants will receive three doses of placebo (saline).

Conditions

Group B Streptococcal Infection

Outcome Measures

Primary Outcomes (1)

• Concentrations of Immunoglobulin (Ig) G Antibodies Specific to the AlpN Proteins in μg/mL in Cord Blood From Each Baby

  Concentrations of IgG antibodies specific to the AlpN proteins in μg/mL in cord blood from each baby at birth.

  Delivery

Secondary Outcomes (12)

• Injection Site Reactions in the Mother

  7 days following each injection

• Adverse Events Following the Vaccinations in the Mother

  To Day 84

• Clinically Significant Abnormal Laboratory Tests in the Mother

  To Day 84

• Clinically Significant Changes in Vital Signs in the Mother

  To Day 84

• Clinically Significant Changes in Physical Examination in the Mother

  To Day 84

Study Arms (5)

Group 1: 4 week dose interval; 2 doses

EXPERIMENTAL

Participants will receive one injection of placebo at 22 (±1) weeks GA, one injection of GBS-NN/NN2 at 26 (±1) weeks GA and one injection of GBS- NN/NN2 at 30 (±1) weeks GA

Biological: GBS-NN/NN2 Vaccine; Biological: Placebo

Group 2: early intervention; 4 week dose interval; 2 doses

EXPERIMENTAL

Participants will receive one injection of GBS-NN/NN2 at 22 (±1) weeks GA, one injection of GBS-NN/NN2 at 26 (±1) weeks GA and one injection of placebo at 30 (±1) weeks GA

Biological: GBS-NN/NN2 Vaccine; Biological: Placebo

Group 3: early intervention; 8 week dose interval; 2 doses

EXPERIMENTAL

Participants will receive one injection of GBS-NN/NN2 at 22 (±1) weeks GA, one injection of placebo at 26 (±1) weeks GA and one injection of GBS- NN/NN2 at 30 (±1) weeks GA

Biological: GBS-NN/NN2 Vaccine; Biological: Placebo

Group 4: single dose

EXPERIMENTAL

Participants will receive one injection of placebo at 22 (±1) weeks GA, one injection of GBS-NN/NN2 at 26 (±1) weeks GA, and one injection of placebo at 30 (±1) weeks GA.

Biological: GBS-NN/NN2 Vaccine; Biological: Placebo

Group 5: placebo

PLACEBO COMPARATOR

Participants will receive one injection of placebo at 22, 26 and 30 weeks (±1) GA

Biological: Placebo

Interventions

GBS-NN/NN2 Vaccine BIOLOGICAL

0.5 mL GBS-NN/NN2 containing 50 μg of GBS-NN and 50 μg of GBS-NN2 and 0.5 mg of aluminium, given by intramuscular injection.

Group 1: 4 week dose interval; 2 doses; Group 2: early intervention; 4 week dose interval; 2 doses; Group 3: early intervention; 8 week dose interval; 2 doses; Group 4: single dose

Placebo BIOLOGICAL

0.5 mL normal saline given by intramuscular injection

Also known as: Normal saline

Group 1: 4 week dose interval; 2 doses; Group 2: early intervention; 4 week dose interval; 2 doses; Group 3: early intervention; 8 week dose interval; 2 doses; Group 4: single dose; Group 5: placebo

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy pregnant woman above the legally defined age of consent at the time of screening
• Carrying a normal singleton pregnancy, and is at 21+0 to 23+6 weeks GA at the planned tme of the 1st vaccination, as established by first/second trimester ultrasound examination
• Properly informed about the study and has given written informed consent and parental consent (for her baby) in accordance with the International Conference on Harmonization Good Clinical Practice (ICH GCP) and local legislation prior to the first study intervention
• Grants access to her own and her baby's study related medical records

You may not qualify if:

• Previous vaccination with an investigational Group B Streptococcus (GBS) Vaccine
• BMI of \<17 or \>40 at the time of screening
• Human immunodeficiency virus (HIV), hepatitis B virus (HBV) and/or hepatitis C virus (HCV) positive or positive for syphilis
• Knowingly carrying, at screening, a malformed or genetically abnormal foetus, incl. renal pelvis dilation, single umbilical artery (screening will be undertaken after the ultrasound conducted for the detection of anomalies)
• Chronic or pregnancy induced hypertension at screening, \>1+ protein in urine regardless of blood pressure or 1+ protein in urine and hypertension
• Experienced a previous stillbirth prior to going into labour
• Gestational, type 1 or type 2 diabetes
• Potential placenta previa as per malformation ultrasound scan
• Rhesus negative and has anti-D antibodies or other potential harmful antibodies
• Known or suspected allergies to any components of the vaccine including to aluminium or aminoglycoside antibiotics, or an allergic reaction related to a previous vaccination
• Fever (temperature \>37.9°C) on the day of receiving the first dose or an acute infection in the 7 days before the first dose (the first dose can be delayed if gestational age permits)
• Received systemic steroids in the 6 weeks before the first dose (inhaled and topical steroids are acceptable)
• Any lesion (including tattoos) at the planned injection site that will impair the assessment of the injection site
• Received immunosuppressive medication, chemotherapy or radiotherapy in the 24 weeks before the first dose
• Received blood, blood products, plasma derivatives or any immunoglobulin preparations in the 12 weeks before the first dose

Sponsors & Collaborators

• Minervax ApS: lead
• Larix A/S: collaborator

Study Sites (10)

Aarhus University Hospital; Skejby

Aarhus, Denmark

Location

Hvidovre University Hospital

Hvidovre, Denmark

Location

Institut for Regional Sundhedsforskning

Kolding, Denmark

Location

ESRU Rahima Moosa Mother and Child Hospital

Johannesburg, South Africa

Location

Shandukani Research Clinic

Johannesburg, South Africa

Location

Wits Vaccines & Infectious Diseases Analytics

Johannesburg, South Africa

Location

Mecru Clinical Research Unit (MeCRU)

Pretoria, South Africa

Location

Setshaba Research Centre

Pretoria, South Africa

Location

St George's University Hospital

London, United Kingdom

Location

University Hospital Southampton

Southampton, United Kingdom

Location

Related Publications (1)

• Heath PT, Zuma-Gwala N, Helmig RB, Horne E, Kjaerbye-Thygesen A, Crusell MKW, Nchabeleng M, Strehlau R, Khalil MR, Jones CE, Biccler J, Dimsits J, Johannsson-Lindbom B, Oostvogels L, Madhi SA; MVX0004 study group. Immunogenicity and safety of a group B Streptococcus vaccine (GBS-AlpN) in pregnant women and their infants: a phase 2, multicentre, observer-blind, randomised, placebo-controlled study. Lancet Infect Dis. 2025 Dec 9:S1473-3099(25)00659-0. doi: 10.1016/S1473-3099(25)00659-0. Online ahead of print.

  PMID: 41386262 DERIVED

MeSH Terms

Conditions

Streptococcal Infections

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Cornelia Oostvogels/Chief Medical Officer (CMO)
• Organization: MinervaX

lio@minervax.com

00491515092821

Study Officials

• Jeannett Dimsits

  jdi@minervax.com

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized to one of 5 groups

Study Record Dates

• First Submitted: November 9, 2021
• First Posted: December 13, 2021
• Study Start: February 17, 2022
• Primary Completion: April 26, 2023
• Study Completion: October 18, 2023
• Last Updated: June 11, 2025
• Results First Posted: January 13, 2025

Record last verified: 2025-05

Locations

GB (2); DK (3); ZA (5)