ClinicalTrials.gg
Sign In
Not yet recruitingNCT07922226MOTIVATIONUpdated Nov 6, 2026

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

A Phase 2/3 interventional study of GBS-NN/NN2 vaccine and Placebo in Streptococcus Agalactiae Infection, Neonatal Sepsis and Pneumonia, sponsored by Minervax ApS. Not yet recruiting. Open to female participants aged 18 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-06.

Sponsored by Minervax ApS · Phase 2/3, Interventional, and Prevention

Updated Nov 6, 2026Newly registeredGo to Updates ↓
Phase
Phase 2/3
Study type
Interventional
Enrollment
6,600
Allocation
Randomized
Ages
18 Years to 49 Years
Sex
Female
01

Study 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 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.

02

Conditions studied

  • Streptococcus Agalactiae Infection
  • Neonatal Sepsis
  • Pneumonia
  • Meningitis
  • Neonatal Infection

Keywords

  • Immunology
  • Pregnancy
  • Group B Streptococcus
  • Vaccine
03

In context

Streptococcal Infections

146 studies on the registry are indexed under Streptococcal Infections; 14 are open to participants now.

This study's planned enrollment of 6,600 is above the median of 270 across 106 interventional studies indexed under Streptococcal Infections.

Browse Streptococcal Infections studies →

Lead sponsor

Minervax ApS is the lead sponsor of 10 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 49 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 (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 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

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, (HIV), and/or active 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 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 or other immune-modifying drugs within 6 months prior to the first dose. An immunosuppressant dose of 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 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.
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
6,600 participants (estimated)

Study arms

  • 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

  • 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

  • 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

  • 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

Interventions

  • DrugGBS-NN/NN2 vaccine

    GBS-NN/NN2 contains 50 μg of each fusion protein (GBS-NN and GBS-NN2) in combination with 500 μg aluminium.

  • OtherPlacebo

    Placebo contains 0.9% sodium chloride.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: At birth

  2. 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)

  3. Phase 2, Phase 3 and Overall: Number of Infant Participants Experiencing SAEs

    Time frame: From birth to 12 months after birth

  4. 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)

  5. 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

  6. Phase 2, Phase 3 and Overall: Number of Infant Participants Experiencing AESIs

    Time frame: From birth to 12 months after birth

  7. 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.

    Time frame: At birth

  8. 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.

    Time frame: At birth

Secondary outcomes

  1. 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)

  2. Phase 2, Phase 3 and Overall: Number of Infant Participants Experiencing MAAEs

    Time frame: From birth to 6 months of age

  3. 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

  4. Phase 2, Phase 3 and Overall: Number of Infant Participants Experiencing AEs

    Time frame: From birth to 1 month (30 days) of age

  5. 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

  6. Phase 2: Geometric Mean Antibody Titres Determined by OPkA of Infant Participants

    Time frame: 1 month and 3 months of age

  7. 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.

    Time frame: At birth, and at 1 and 3 months of age

  8. 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.

    Time frame: At birth, and at 1 and 3 months of age

  9. 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.

    Time frame: Day 1 (pre-dose), 4 weeks after first and second dose of GBS-NN/NN2 vaccine, and at time of delivery

  10. 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.

    Time frame: At birth

  11. 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

  12. 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

  13. 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

  14. Phase 3: Number of Infant Participants With Alp Strain-specific Functional Antibody OPkA titres-based Predicted Risk of iGBS EoD

    Time frame: At birth

  15. Phase 3: Number of Infant Participants With Alp Strain-specific Functional Antibody OPkA titres-based Predicted Risk of iGBS LoD

    Time frame: At birth

  16. 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

  17. Phase 3: Geometric Mean Antibody Titres Determined by OPkA of Infant Participants

    Time frame: At birth

  18. 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.

    Time frame: At birth

  19. 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.

    Time frame: At birth

  20. 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.

    Time frame: Day 1 (pre-dose), 4 weeks after second dose of GBS-NN/NN2 vaccine, and at time of delivery

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Nov 2026; primary completion for May 2030, 41 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 2, 2026
First posted
Nov 6, 2026
StartEst.
Nov 30, 2026
Primary completionEst.
May 22, 2030
CompletionEst.
May 22, 2030
Last update
Nov 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 6, 2026
Show all 1 update
  1. Nov 6, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07922226
Lead sponsor
Minervax ApS
Responsible party
Sponsor
First posted
Nov 6, 2026
Start date
Nov 30, 2026 (estimated)
Primary completion
May 22, 2030 (estimated)
Completion
May 22, 2030 (estimated)
Last update
Nov 6, 2026

Study contacts

Cornelia (Lidia) Oostvogels, Chief Medical Officer
Contact
lio@minervax.com
+49 151 50 92 58 21
Cornelia Oostvogels
study director · Minervax ApS

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Streptococcal Infections →

Other studies from this sponsor

Minervax ApS

Start the discussion