A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial (MOTIVATION)

A Multicentre, Parallel-group, Observer-blind, Randomised, Placebo-controlled, Pivotal Trial Investigating the Safety and Immunogenicity of Group B Streptococcus Vaccine (GBS-NN/NN2) in Pregnant Women and Infants Born to Pregnant Women Vaccinated During Pregnancy

The main objective of the Phase 2 part of the trial is to assess the immunogenicity of GBS-NN/NN2 vaccine at birth in infant participants and to determine the occurrence of serious adverse events (SAEs) and adverse event of special interest (AESIs) after GBS-NN/NN2 vaccine administration compared to placebo, in both maternal and infant participants. The main objective of the Phase 3 part of the trial is to assess the ability of GBS-NN/NN2 vaccine to induce functional antibody titres protective against invasive GBS (iGBS) early-onset disease (EoD) in infant participants, to assess the ability of GBS-NN/NN2 vaccine to induce functional antibody titres protective against iGBS late-onset disease (LoD) in infant participants and to determine the occurrence of SAEs and AESIs after GBS-NN/NN2 vaccine administration compared to placebo, in both maternal and infant participants.

Study Overview

• Status: Not yet recruiting
• Conditions: Pneumonia; Meningitis; Neonatal Infection; Neonatal Sepsis; Streptococcus Agalactiae Infection
• Intervention / Treatment: Drug: GBS-NN/NN2 vaccine; Other: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 6600
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Cornelia (Lidia) Oostvogels, Chief Medical Officer; Phone Number: +49 151 50 92 58 21; Email: lio@minervax.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Maternal participant carrying a normal singleton pregnancy at 24 (-2/+3) weeks GA at the planned time of the first trial vaccination. GA must be based upon below criteria:

   • Last menstrual period (LMP) date corroborated by first or second trimester ultrasound examination, i.e., at or before screening.
   • First or second trimester ultrasound examination only, if LMP is unknown/uncertain.

2. Participants ≥18 to ≤49 years of age with a body mass index (BMI) of >17.5 to <40 kg/m^2 (as measured at any time during the first trimester or just prior to becoming pregnant).

3. Maternal participant having had a foetal anomaly ultrasound examination performed at ≥18 weeks GA with no significant foetal abnormalities observed can be included.

4. Maternal participant or legally acceptable representative (where required for the foetus/infant) who is willing to provide parental consent in accordance with International Council for Harmonisation (ICH) guidelines on Good Clinical Practice (GCP) and local legislation prior to the first dose.

5. Maternal participant who is willing and able to comply with scheduled visits, the investigational plan, trial procedures, and intent to deliver at a hospital or birthing facility where trial procedures can be followed and where standard of care based on country requirements can be delivered.

Exclusion Criteria:

1. Maternal participant having a history of anaphylactic reaction associated with a vaccine.

2. Maternal participant having a history of allergic reaction (e.g., rash, anaphylaxis) to any component of GBS-NN/NN2 vaccine including to aluminium hydroxide or aminoglycoside antibiotics.

3. Maternal participant having known syphilis, human immunodeficiency virus (HIV), and/or active hepatitis B virus (HBV) as assessed by serologic tests conducted during the current pregnancy (for HIV-positive maternal participants, it is acceptable that this was confirmed prior to pregnancy). Maternal participants living with an HIV viral load of <1000 copies/mL and who have been on antiretroviral therapy for at least 3 months prior to screening and are clinically stable may be included.

4. Maternal participant having a known or suspected infection during current pregnancy with toxoplasma, parvovirus B19, malaria, zika, rubella, varicella, cytomegalovirus, or genital herpes simplex, based on medical history and/or clinical presentation.

5. Maternal participant with a history of microbiologically proven invasive disease caused by GBS in the current pregnancy (e.g., isolation of GBS from a sterile site: blood, cerebrospinal fluid, or synovial fluid). This does not include asymptomatic bacteriuria or urinary tract infection unless associated with a positive blood culture.

6. Maternal participant having bleeding diathesis or a condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.

7. Maternal participant having 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 maternal participant unsuitable for participation in the trial.

8. 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 the trial.

9. Maternal participant having any lesion or tattoos at the planned injection site (at both arms) that will impair the assessment of the injection site.

10. Maternal participant knowingly carrying, at screening, a malformed or genetically abnormal foetus.

11. Maternal participant having current pregnancy complications or abnormalities at the time of consent that will increase the risk associated with the participation in and completion of the trial, including but not limited to the following:

    • Preeclampsia, eclampsia, or uncontrolled gestational hypertension.
    • Placental abnormality.
    • Polyhydramnios or oligohydramnios.
    • Significant bleeding or blood clotting disorder.
    • Maternal participant having endocrine disorders, like untreated hyperthyroidism or untreated hypothyroidism. This also includes diabetes mellitus type 1 or 2 antedating pregnancy or gestational, if uncontrolled.
    • Maternal participant having any signs of premature labour with the current pregnancy or having ongoing intervention (medical/surgical) in the current pregnancy to prevent preterm birth.

12. Maternal participant having had prior pregnancy complications or abnormalities at the time of consent, based on the investigator's judgement, that will increase the risk associated with the participation in and completion of the trial, including but not limited to the following:

    • Prior preterm delivery ≤34 weeks gestation.
    • Prior stillbirth or neonatal death.
    • Previous infant with a known genetic disorder or significant congenital anomaly.

13. Maternal participant having a known or suspected immunodeficiency or cancer or a family history of congenital or hereditary immunodeficiency. A maternal participant knowingly living with HIV may be included if on antiretroviral treatment for at least 3 months prior to screening, clinically stable, and with an HIV viral load of <1000 copies/mL.

14. Maternal participant having received chronic administration (defined as more than 14 continuous days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the first dose. An immunosuppressant 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. Receipt of corticosteroids for foetal lung maturation is permitted.

15. Maternal participant having an acute or chronic clinically significant abnormality or poorly controlled pre-existent co-morbidities. Example: Maternal participant with known non-well-controlled pre-existing arterial hypertension, prior to pregnancy, that, in the investigator's judgement, would make the maternal participant unsuitable for participation in the trial.

16. Maternal participant having received blood, blood products, plasma derivatives, or any immunoglobulin preparations in the 12 weeks before the first dose or plans to receive such products during the trial. Treatment with specific immunoglobulins to a rhesus negative maternal participant with a risk of incompatibility between maternal participant and foetus, is permitted.

17. Maternal participant having a known clinically significant anaemia at time of inclusion per investigator/site staff assessment.

18. Maternal participant who has received previous vaccination with any licensed or investigational GBS vaccine or planned receipt during participation in the trial (from the first to the last visit).

19. Maternal participant having received any other vaccine within 30 days of the first dose, or is planning to receive any vaccine (e.g., travel vaccines) between doses and up to 30 days after the second dose.

20. Maternal participant having current or history of drug or alcohol abuse, as judged by the investigator.

21. Infant participant will be a ward of the state or be released for adoption.

22. Infant participant has planned umbilical cord blood banking and/or donation.

23. Maternal participant having a pregnancy considered high risk by the investigator.

24. Any personnel involved in the conduct of the trial (and their family members), including but not limited to, site staff members, MinervaX ApS employees, and any vendor or contract research organisation (CRO) employees.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phase 2, Group 1: GBS-NN/NN2; Maternal participants will receive GBS-NN/NN2 vaccine 0.5 mL, intramuscular injection on Days 1 (gestational age [GA] 24 weeks [-2/+3 weeks]) and 57 (GA 32 weeks [±3 weeks]).	Drug: GBS-NN/NN2 vaccine; GBS-NN/NN2 contains 50 μg of each fusion protein (GBS-NN and GBS-NN2) in combination with 500 μg aluminium.
Placebo Comparator: Phase 2, Group 2: Placebo; Maternal participants will receive placebo vaccine 0.5 mL, intramuscular injection on Days 1 (GA 24 weeks [-2/+3 weeks]) and 57 (GA 32 weeks [±3 weeks]).	Other: Placebo; Placebo contains 0.9% sodium chloride.
Experimental: Phase 3, Group 3: GBS-NN/NN2; Maternal participants will receive GBS-NN/NN2 vaccine 0.5 mL, intramuscular injection on Days 1 (GA 24 weeks [-2/+3 weeks]) and 57 (GA 32 weeks [±3 weeks]).	Drug: GBS-NN/NN2 vaccine; GBS-NN/NN2 contains 50 μg of each fusion protein (GBS-NN and GBS-NN2) in combination with 500 μg aluminium.
Placebo Comparator: Phase 3, Group 4: Placebo; Maternal participants will receive placebo vaccine 0.5 mL, intramuscular injection on Days 1 (GA 24 weeks [-2/+3 weeks]) and 57 (GA 32 weeks [±3 weeks]).	Other: Placebo; Placebo contains 0.9% sodium chloride.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phase 2: Geometric Mean Antibody Titres Determined by Opsonophagocytic Killing Activity/Assay (OPkA) in Infant Participants	Functional antibody titres (determined by [alpha-like protein expressed on the surface of GBS] Alp strain-specific [Rib, Alp1, Alp2/3, and AlphaC] OPkA) in infant participants at birth.	At birth
Phase 2, Phase 3 and Overall: Number of Maternal Participants Experiencing SAEs		From screening until 6 months after delivery or pregnancy termination (up to approximately 12 months)
Phase 2, Phase 3 and Overall: Number of Infant Participants Experiencing SAEs		From birth to 12 months after birth
Phase 2, Phase 3 and Overall: Number of Maternal Participants Experiencing Pregnancy-related AESIs		From screening until 6 weeks after delivery or pregnancy termination (up to approximately 6.5 months)
Phase 2, Phase 3 and Overall: Number of Maternal Participants Experiencing Auto-immune AESIs		Day 1 up to 6 months post last vaccination
Phase 2, Phase 3 and Overall: Number of Infant Participants Experiencing AESIs		From birth to 12 months after birth
Phase 3: Number of Infant Participants with OPkA Antibody Titres Reaching Predefined Alp Strain-specific iGBS EoD Protective Thresholds	Functional antibody titres (determined by Alp strain-specific [Rib, Alp1, Alp2/3, and AlphaC] OPkA) reaching predefined Alp strain-specific iGBS EoD protective thresholds at birth.	At birth
Phase 3: Number of Infant Participants with OPkA Antibody Titres Reaching Predefined Alp Strain-specific iGBS LoD Protective Thresholds	Functional antibody titres (determined by Alp strain-specific [Rib, Alp1, Alp2/3, and AlphaC] OPkA) reaching predefined Alp strain-specific iGBS LoD protective thresholds at birth.	At birth

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phase 2, Phase 3 and Overall: Number of Maternal Participants Experiencing Medically-attended AEs (MAAEs)		up to 1 month (30 days) after delivery or pregnancy termination (up to approximately 12 months)
Phase 2, Phase 3 and Overall: Number of Infant Participants Experiencing MAAEs		From birth to 6 months of age
Phase 2 and Phase 3 (Reactogenicity/Unsolicited AE Subset): Number of Maternal Participants Experiencing Unsolicited AEs		Day 1 to Day 28, and from Day 57 to Day 85
Phase 2, Phase 3 and Overall: Number of Infant Participants Experiencing AEs		From birth to 1 month (30 days) of age
Phase 2 and Phase 3 (Reactogenicity/Unsolicited AE Subset): Number of Maternal Participants Experiencing Solicited Local and Systemic AEs		Day 1 to Day 7, and from Day 57 to Day 64
Phase 2: Geometric Mean Antibody Titres Determined by OPkA of Infant Participants		1 month and 3 months of age
Phase 2: Concentrations of IgG Antibody Specific to the AlpN Proteins in Blood Serum in Infant Participants	Concentrations of IgG antibodies specific to the AlpN proteins (RibN, Alp1N, Alp2/3N, and AlphaCN) in blood serum.	At birth, and at 1 and 3 months of age
Phase 2: Number of Seropositive Infant Participants with Quantifiable Functional Antibody Titres Determined by OPkA	Infant participants with quantifiable functional antibody titres (determined by Alp strain-specific [Rib, Alp1, Alp2/3, and AlphaC] OPkA) against all and each Alp strain.	At birth, and at 1 and 3 months of age
Phase 2: Concentrations of IgG Antibody Specific to the AlpN Proteins in Blood Serum in Maternal Participants	Concentrations of IgG antibodies specific to the AlpN proteins (RibN, Alp1N, Alp2/3N, and AlphaCN) in blood serum.	Day 1 (pre-dose), 4 weeks after first and second dose of GBS-NN/NN2 vaccine, and at time of delivery
Phase 3: Number of Infant Participants with OPkA Antibody Titres Reaching Predefined Alp Strain-specific iGBS Protective Thresholds (EoD and LoD)	Functional antibody titres (determined by Alp strain-specific [Rib, Alp1, Alp2/3, and AlphaC] OPkA) reaching predefined Alp strain-specific invasive group B streptococcus (iGBS) disease protective thresholds (overall, i.e., reaching both EoD and LoD protective thresholds) at birth.	At birth
Phase 3: Number of Infant Participants With Alp Strain-specific Functional Antibody OPkA titres-based Predicted Risk of iGBS EoD Caused by any Alp strain		At birth
Phase 3: Number of Infant Participants With Alp Strain-specific Functional Antibody OPkA titres-based Predicted Risk of iGBS LoD Caused by any Alp strain		At birth
Phase 3: Number of Infant Participants With Alp Strain-specific Functional Antibody OPkA titres-based Predicted Risk of iGBS (EoD and LoD) Caused by any Alp strain		At birth
Phase 3: Number of Infant Participants With Alp Strain-specific Functional Antibody OPkA titres-based Predicted Risk of iGBS EoD		At birth
Phase 3: Number of Infant Participants With Alp Strain-specific Functional Antibody OPkA titres-based Predicted Risk of iGBS LoD		At birth
Phase 3: Number of Infant Participants With Alp Strain-specific Functional Antibody OPkA titres-based Predicted Risk of iGBS (EoD and LoD)		At birth
Phase 3: Geometric Mean Antibody Titres Determined by OPkA of Infant Participants		At birth
Phase 3: Concentrations of IgG Antibody Specific to the AlpN Proteins in Blood Serum in Infant Participants	Concentrations of IgG antibodies specific to the AlpN proteins (RibN, Alp1N, Alp2/3N, and AlphaCN) in blood serum.	At birth
Phase 3: Number of Seropositive Infant Participants with Quantifiable Functional Antibody Titres Determined by OPkA	Infant participants with quantifiable functional antibody titres (determined by Alp strain-specific [Rib, Alp1, Alp2/3, and AlphaC] OPkA) against all and each Alp strain.	At birth
Phase 3: Concentrations of IgG Antibody Specific to the AlpN Proteins in Blood Serum in Maternal Participants	Concentrations of IgG antibodies specific to the AlpN proteins (RibN, Alp1N, Alp2/3N, and AlphaCN) in blood serum.	Day 1 (pre-dose), 4 weeks after second dose of GBS-NN/NN2 vaccine, and at time of delivery

Collaborators and Investigators

• Sponsor: Minervax ApS
• Investigators: Study Director: Cornelia Oostvogels, Minervax ApS

Study record dates

Study Major Dates

• Study Start (Estimated): November 30, 2026
• Primary Completion (Estimated): May 22, 2030
• Study Completion (Estimated): May 22, 2030

Study Registration Dates

• First Submitted: November 2, 2026
• First Submitted That Met QC Criteria: November 2, 2026
• First Posted (Actual): November 6, 2026

Study Record Updates

• Last Update Posted (Actual): November 6, 2026
• Last Update Submitted That Met QC Criteria: November 2, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Immunology; Pregnancy; Vaccine; Group B Streptococcus
• Additional Relevant MeSH Terms: Neuroinflammatory Diseases; Nervous System Diseases; Pathologic Processes; Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Lung Diseases; Infant, Newborn, Diseases; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Neonatal Sepsis; Pneumonia; Meningitis; Streptococcal Infections
• Other Study ID Numbers: MVX010; 2026-525385-21-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No