Streptococcus Agalactiae InfectionPhase 2/3MOTIVATIONNCT07922226
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
A Phase 2/3 study testing GBS-NN/NN2 vaccine in people with Streptococcus Agalactiae Infection and Neonatal Sepsis, run by Minervax ApS.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Streptococcus Agalactiae Infection, Neonatal Sepsis, Pneumonia
- What is being tested?
- GBS-NN/NN2 vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6,600 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2026to 22 May 2030
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
- 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).
- Maternal participant having had a foetal anomaly ultrasound examination performed at ≥18 weeks GA with no significant foetal abnormalities observed can be included.
- 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.
- 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.
Who cannot join
- Maternal participant having a history of anaphylactic reaction associated with a vaccine.
- 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.
- 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.
- 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.
- 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.
- Maternal participant having bleeding diathesis or a condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
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- 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.
- 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.
- Maternal participant having any lesion or tattoos at the planned injection site (at both arms) that will impair the assessment of the injection site.
- Maternal participant knowingly carrying, at screening, a malformed or genetically abnormal foetus.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Maternal participant having a known clinically significant anaemia at time of inclusion per investigator/site staff assessment.
- 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).
- 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.
- Maternal participant having current or history of drug or alcohol abuse, as judged by the investigator.
- Infant participant will be a ward of the state or be released for adoption.
- Infant participant has planned umbilical cord blood banking and/or donation.
- Maternal participant having a pregnancy considered high risk by the investigator.
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Streptococcus Agalactiae Infection, Neonatal Sepsis, Pneumonia, Meningitis, Neonatal Infection
- Being tested
- GBS-NN/NN2 vaccine, Placebo
- Keywords
- Immunology, Pregnancy, Group B Streptococcus, Vaccine
- Medical subject headings
- Streptococcal Infections, Neonatal Sepsis, Pneumonia, Meningitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GBS-NN/NN2 vaccineDrug
GBS-NN/NN2 contains 50 μg of each fusion protein (GBS-NN and GBS-NN2) in combination with 500 μg aluminium.
PlaceboOther
Placebo contains 0.9% sodium chloride.
| Study group | Role | What they receive |
|---|---|---|
| Phase 2, Group 1: GBS-NN/NN2 | Experimental | 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]). Receives: Drug: GBS-NN/NN2 vaccine |
| Phase 2, Group 2: Placebo | Placebo comparator | 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]). Receives: Other: Placebo |
| Phase 3, Group 3: GBS-NN/NN2 | Experimental | 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]). Receives: Drug: GBS-NN/NN2 vaccine |
| Phase 3, Group 4: Placebo | Placebo comparator | 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]). Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At birth
Phase 2, Phase 3 and Overall: Number of Maternal Participants Experiencing SAEs
Measured: 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
Measured: From birth to 12 months after birth
Phase 2, Phase 3 and Overall: Number of Maternal Participants Experiencing Pregnancy-related AESIs
Measured: 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
Measured: Day 1 up to 6 months post last vaccination
Phase 2, Phase 3 and Overall: Number of Infant Participants Experiencing AESIs
Measured: 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.
Measured: 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.
Measured: At birth
Secondary outcomes (20)
Phase 2, Phase 3 and Overall: Number of Maternal Participants Experiencing Medically-attended AEs (MAAEs)
Measured: 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
Measured: From birth to 6 months of age
Phase 2 and Phase 3 (Reactogenicity/Unsolicited AE Subset): Number of Maternal Participants Experiencing Unsolicited AEs
Measured: Day 1 to Day 28, and from Day 57 to Day 85
Phase 2, Phase 3 and Overall: Number of Infant Participants Experiencing AEs
Measured: 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
Measured: Day 1 to Day 7, and from Day 57 to Day 64
Phase 2: Geometric Mean Antibody Titres Determined by OPkA of Infant Participants
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: At birth
Phase 3: Number of Infant Participants With Alp Strain-specific Functional Antibody OPkA titres-based Predicted Risk of iGBS EoD
Measured: At birth
Phase 3: Number of Infant Participants With Alp Strain-specific Functional Antibody OPkA titres-based Predicted Risk of iGBS LoD
Measured: At birth
Phase 3: Number of Infant Participants With Alp Strain-specific Functional Antibody OPkA titres-based Predicted Risk of iGBS (EoD and LoD)
Measured: At birth
Phase 3: Geometric Mean Antibody Titres Determined by OPkA of Infant Participants
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 1 (pre-dose), 4 weeks after second dose of GBS-NN/NN2 vaccine, and at time of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study start30 Nov 2026 (estimated)
- Primary completion22 May 2030 (estimated)
- Study completion22 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Streptococcus Agalactiae InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 6,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minervax ApS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cornelia Oostvogels, Study director, Minervax ApS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07922226
- Sponsor's protocol ID
- MVX010
- Other IDs
- 2026-525385-21-00
- Acronym
- MOTIVATION
- Status last verified
- May 2026
- First submitted
- 2 Nov 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07922226
- Acronym / sponsor ID
- MOTIVATION / MVX010
- Conditions
- Streptococcus Agalactiae Infection, Neonatal Sepsis, Pneumonia, Meningitis, Neonatal Infection
- Keywords
- Immunology, Pregnancy, Group B Streptococcus, Vaccine
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 6,600 participants (estimated)
- Lead sponsor
- Minervax ApSUniversity, hospital or other
- Study start
- 30 Nov 2026 (estimated)
- Primary completion
- 22 May 2030 (estimated)
- Study completion
- 22 May 2030 (estimated)
- First posted
- 6 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Phase 2, Group 1: GBS-NN/NN2 | Experimental | Drug: GBS-NN/NN2 vaccineMaternal 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]). |
| Phase 2, Group 2: Placebo | Placebo comparator | Other: PlaceboMaternal 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]). |
| Phase 3, Group 3: GBS-NN/NN2 | Experimental | Drug: GBS-NN/NN2 vaccineMaternal 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]). |
| Phase 3, Group 4: Placebo | Placebo comparator | Other: PlaceboMaternal 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]). |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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:
- 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).
- Maternal participant having had a foetal anomaly ultrasound examination performed at ≥18 weeks GA with no significant foetal abnormalities observed can be included.
- 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.
- 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.
Key exclusion criteria (33 listed)
- Maternal participant having a history of anaphylactic reaction associated with a vaccine.
- 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.
- 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.
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GBS-NN/NN2 vaccineGBS-NN/NN2 contains 50 μg of each fusion protein (GBS-NN and GBS-NN2) in combination with 500 μg aluminium. | Drug | Phase 2, Group 1: GBS-NN/NN2, Phase 3, Group 3: GBS-NN/NN2 |
| PlaceboPlacebo contains 0.9% sodium chloride. | Other | Phase 2, Group 2: Placebo, Phase 3, Group 4: Placebo |
Primary outcome
Phase 2: Geometric Mean Antibody Titres Determined by Opsonophagocytic Killing Activity/Assay (OPkA) in Infant Participants
Time frame: At birth
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.
Phase 2, Phase 3 and Overall: Number of Maternal Participants Experiencing SAEs
Time frame: 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
Time frame: From birth to 12 months after birth
Phase 2, Phase 3 and Overall: Number of Maternal Participants Experiencing Pregnancy-related AESIs
Time frame: 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
Time frame: Day 1 up to 6 months post last vaccination
Phase 2, Phase 3 and Overall: Number of Infant Participants Experiencing AESIs
Time frame: 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
Time frame: At birth
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.
Phase 3: Number of Infant Participants with OPkA Antibody Titres Reaching Predefined Alp Strain-specific iGBS LoD Protective Thresholds
Time frame: At birth
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.
20 secondary outcomes
Phase 2, Phase 3 and Overall: Number of Maternal Participants Experiencing Medically-attended AEs (MAAEs)
Time frame: 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
Time frame: From birth to 6 months of age
Phase 2 and Phase 3 (Reactogenicity/Unsolicited AE Subset): Number of Maternal Participants Experiencing Unsolicited AEs
Time frame: Day 1 to Day 28, and from Day 57 to Day 85
Phase 2, Phase 3 and Overall: Number of Infant Participants Experiencing AEs
Time frame: 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
Time frame: Day 1 to Day 7, and from Day 57 to Day 64
Phase 2: Geometric Mean Antibody Titres Determined by OPkA of Infant Participants
Time frame: 1 month and 3 months of age
Phase 2: Concentrations of IgG Antibody Specific to the AlpN Proteins in Blood Serum in Infant Participants
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At birth
Phase 3: Number of Infant Participants With Alp Strain-specific Functional Antibody OPkA titres-based Predicted Risk of iGBS EoD
Time frame: At birth
Phase 3: Number of Infant Participants With Alp Strain-specific Functional Antibody OPkA titres-based Predicted Risk of iGBS LoD
Time frame: At birth
Phase 3: Number of Infant Participants With Alp Strain-specific Functional Antibody OPkA titres-based Predicted Risk of iGBS (EoD and LoD)
Time frame: At birth
Phase 3: Geometric Mean Antibody Titres Determined by OPkA of Infant Participants
Time frame: At birth
Phase 3: Concentrations of IgG Antibody Specific to the AlpN Proteins in Blood Serum in Infant Participants
Time frame: At birth
Phase 3: Number of Seropositive Infant Participants with Quantifiable Functional Antibody Titres Determined by OPkA
Time frame: At birth
Phase 3: Concentrations of IgG Antibody Specific to the AlpN Proteins in Blood Serum in Maternal Participants
Time frame: Day 1 (pre-dose), 4 weeks after second dose of GBS-NN/NN2 vaccine, and at time of delivery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cornelia Oostvogels study director
Minervax ApS
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing GBS-NN/NN2 vaccine in people with Streptococcus Agalactiae Infection and Neonatal Sepsis, run by Minervax ApS.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cornelia (Lidia) Oostvogels, Chief Medical Officer (+49 151 50 92 58 21, lio@minervax.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 2: Geometric Mean Antibody Titres Determined by Opsonophagocytic Killing Activity/Assay (OPkA) in Infant Participants (time frame: At birth). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.