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Group B Streptococcal InfectionPhase 2NCT05154578

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

A Phase 2 study testing GBS-NN/NN2 Vaccine in people with Group B Streptococcal Infection, run by Minervax ApS at 10 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Any age, women onlyHealthy volunteers can take part
Conditions the study is for
Group B Streptococcal Infection
What is being tested?
GBS-NN/NN2 Vaccine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
269 participants
Where
10 sitesin 3 countries
Study dates
17 Feb 2022to 18 Oct 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 Any age
  • Women only
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 24Show fewer
  • 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
  • Anaemia, haemoglobin (<10 g/dL, 100 g/L, 6.2 mmol/L)
  • Currently breast feeding
  • Received any investigational medicinal product or vaccine in the 12 weeks or 5 half-lives before the first dose
  • Received an approved vaccine within the 4 weeks before the first dose or expects to receive an approved vaccine during the study. Routine vaccinations recommended during pregnancy (e.g., pertussis and influenza) are permitted but every effort should be made to separate routine vaccinations from the trial vaccinations by at least 7 days.
  • Known or suspected immunodeficiency or cancer (leukaemia, lymphoma), or a family history of congenital or hereditary immunodeficiency
  • History or presence of uncontrolled cardiovascular disease, pulmonary, hepatic, gall bladder or biliary tract, renal, haematological, gastrointestinal, endocrine, immunologic, dermatological, neurological, psychiatric, or autoimmune disease
  • History of, or current drug or alcohol abuse
  • In the opinion of the investigator not suitable for inclusion in the study
  • The pregnancy is considered high risk by treating physicians

Trial locations and contacts

10 sites in 3 countries.

10 sites in 3 countries

South Africa5 sites

  • ESRU Rahima Moosa Mother and Child Hospital

    Johannesburg

  • Shandukani Research Clinic

    Johannesburg

  • Wits Vaccines & Infectious Diseases Analytics

    Johannesburg

  • Mecru Clinical Research Unit (MeCRU)

    Pretoria

  • Setshaba Research Centre

    Pretoria

Other trials in South Africa

Denmark3 sites

  • Aarhus University Hospital; Skejby

    Aarhus

  • Hvidovre University Hospital

    Hvidovre

  • Institut for Regional Sundhedsforskning

    Kolding

Other trials in Denmark

United Kingdom2 sites

  • St George's University Hospital

    London

  • University Hospital Southampton

    Southampton

Other trials in United Kingdom

About this study

Official title: A Multicentre, Multinational, Parallel Group, Observer-blind, Randomised, Placebo-controlled Study on the Group B Streptococcus Vaccine (GBS-NN/NN2), Investigating the Immunogenicity and Safety of Four Vaccination Regimens in Pregnant Woman, Assessing IgG Specific to AlpN Proteins in Cord Blood and Maternal Blood, and the Safety Profile in Mother and Infant up to 6 Months Post-delivery

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).

Read the detailed description

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; Group 1 will receive one injection of placebo at 22 (±1) weeks gestational age (GA), one injection of GBS-NN/NN2 at 26 (±1) weeks GA and one injection of GBS- NN/NN2 at 30 (±1) weeks GA. Group 2 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.Group 3 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. Group 4 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.

Group 5 will receive an injection of placebo at 22, 26 and 30 weeks (±1) GA. Participants will attend the clinic for assessment visits up to delivery and for a further 3 visits at 28 (±4) days, 90 (±6) days and 180 (±14) days post delivery.

Babies will be also be assessed at delivery, and 28 (±4) days, 90 (±6) days and 180 (±14) days post delivery.

Being tested
GBS-NN/NN2 Vaccine, Placebo
Medical subject headings
Streptococcal Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GBS-NN/NN2 VaccineBiological

    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.

  • PlaceboBiological

    Also called Normal saline

    0.5 mL normal saline given by intramuscular injection

Study groups in NCT05154578
Study groupRoleWhat they receive
Group 1: 4 week dose interval; 2 dosesExperimentalParticipants 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
Receives: Biological: GBS-NN/NN2 Vaccine; Biological: Placebo
Group 2: early intervention; 4 week dose interval; 2 dosesExperimentalParticipants 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
Receives: Biological: GBS-NN/NN2 Vaccine; Biological: Placebo
Group 3: early intervention; 8 week dose interval; 2 dosesExperimentalParticipants 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
Receives: Biological: GBS-NN/NN2 Vaccine; Biological: Placebo
Group 4: single doseExperimentalParticipants 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.
Receives: Biological: GBS-NN/NN2 Vaccine; Biological: Placebo
Group 5: placeboPlacebo comparatorParticipants will receive one injection of placebo at 22, 26 and 30 weeks (±1) GA
Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Delivery

Secondary outcomes (12)

  1. Injection Site Reactions in the Mother

    Number of participants with solicited injection site reactions following vaccination

    Measured: 7 days following each injection

  2. Adverse Events Following the Vaccinations in the Mother

    Number of participants with solicited and other adverse events following the vaccinations

    Measured: To Day 84

  3. Clinically Significant Abnormal Laboratory Tests in the Mother

    Number of participants with clinically significant abnormal laboratory tests in the mother

    Measured: To Day 84

  4. Clinically Significant Changes in Vital Signs in the Mother

    Number of participants with clinically significant changes in vital signs (heart rate, blood pressure, oral temperature) in the mother

    Measured: To Day 84

  5. Clinically Significant Changes in Physical Examination in the Mother

    Number of participants with clinically significant changes in physical examination in the mother

    Measured: To Day 84

  6. Gestational Age

    Gestational age at birth

    Measured: Delivery

  7. Weight of the Baby

    Weight of the baby

    Measured: Delivery

  8. Length of the Baby

    Length of the baby

    Measured: Delivery

  9. Head Circumference of the Baby

    Head circumference of the baby

    Measured: Delivery

  10. Apgar Score in the Baby

    Apgar score in the baby (Appearance; Pulse; Grimace response; Activity; Respiration).

    Range 0 to 10 where high scores are good and low scores are bad.

    Measured: 1, 5 and 10 minutes

  11. Concentrations of IgG Antibodies Specific to the AlpN Proteins in μg/mL in Maternal Blood

    Concentrations of IgG antibodies specific to the AlpN proteins in μg/mL in maternal blood

    Measured: Delivery

  12. Concentrations of IgG Antibodies Specific to the AlpN Proteins in μg/mL in Blood From Each Baby

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

    Measured: 1 month, 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Dec 2021
  2. Study start17 Feb 2022
  3. Primary completion26 Apr 2023
  4. Study completion18 Oct 2023

Resources

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
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomized to one of 5 groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
269 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05154578
Sponsor's protocol ID
MVX0004
Status last verified
May 2025
First submitted
9 Nov 2021
Last updated
11 Jun 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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, Johansson-Lindbom B, Fischer PB, 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. 2026 May;26(5):486-496. doi: 10.1016/S1473-3099(25)00659-0. Epub 2025 Dec 9.

    PubMed 41386262

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GBS-NN/NN2 Vaccine in people with Group B Streptococcal Infection, run by Minervax ApS at 10 sites in 3 countries.

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 4 inclusion and 24 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: finished, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in South Africa, Denmark, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

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 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.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Concentrations of Immunoglobulin (Ig) G Antibodies Specific to the AlpN Proteins in μg/mL in Cord Blood From Each Baby (time frame: Delivery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05154578, which also lists 1 linked publication.

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 11 Jun 2025.

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