Group B Streptococcal InfectionPhase 2NCT04596878
Study of a Group B Streptococcus Vaccine in Pregnant Women Living With HIV and in Pregnant Women Who do Not Have HIV
A Phase 2 study testing GBS-NN/NN2 in people with Group B Streptococcal Infection, run by Minervax ApS at 3 sites in 2 countries.
Trial summary
A randomised, placebo-controlled, double-blind study to evaluate the safety, tolerability and immunogenicity of the GBS-NN/NN2 (Recombinant protein vaccine against Group B Streptococcus) vaccine in women living with HIV and women without HIV, and their newborn babies from vaccination up to delivery/birth. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Group B Streptococcal Infection
- What is being tested?
- GBS-NN/NN2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 19 Nov 2020to 11 May 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants at least 18 years old and not older than 40 years of age.
- Pregnant women who are between 26 weeks and 30 weeks (inclusive) gestation on the planned day of vaccination with a singleton, uncomplicated pregnancy. Gestational age to be determined on the following hierarchal basis with guidance to the GAIA (Global Alignment of Immunisation Safety Assessment in pregnancy) criteria:
- ultrasound estimate of gestational age,
- date of last menstrual period
- fundal height
- HIV status to be based on rapid, confirmatory test, unless a documented test of the participant being sero-positive for HIV and history documented in the notes.
- Women living with HIV, HIV viral load <1000, on antiretroviral therapy for at least 3 months prior to screening and clinically well.
- Expected to be available for the scheduled clinic visits for the duration of the study, agree to be contacted by telephone during study participation, and is willing to give parental consent for her infant to participate in the study
Who cannot join
- Women who are hepatitis B surface (HBSAg) and/or hepatitis C (HCV) positive
- Women who test positive for syphilis as per standard testing
- Women knowingly carrying, at screening, a malformed or genetically abnormal foetus based on ultrasound
- Women who have experienced a previous stillbirth prior to going into labour
- Women with placenta previa
- Women with documented chronic or pregnancy induced hypertension at screening
Show all 23Show fewer
- Women with 1+ protein in urine and hypertension defined as systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg) at ≥20 weeks of gestation in a woman with a previously normal blood pressure
- Women with >1+ of protein in urine (regardless of blood pressure)
- Women with gestational, type 1 or type 2 diabetes.
- Women with glycosuria on dipstick
- Women known to be allergic to any components of the vaccine, known to be allergic to aluminium or having had an allergic reaction to any previous vaccination.
- Women with history or presence of significant cardiovascular disease, pulmonary, hepatic, gallbladder or biliary tract, renal, haematological, gastrointestinal, endocrine, immunologic, dermatological, neurological, psychiatric, autoimmune disease, cognitive disorder or current infection and significant illness 4 weeks prior to randomization.
- Women with current or history of drug or alcohol abuse within the last two years.
- Women who have received a vaccine within 28 days of receiving the first dose of GBS NN/NN2 or placebo or who expect to require vaccination during the course of the study. (Vaccines recommended for administration during pregnancy e.g. tetanus toxoid, pertussis and influenza are permitted. Administration of concurrent vaccines must not be within 7 days of investigational vaccine.)
- Women who have a fever (axillary temperature >37.9°C) on the day of dosing or have had an acute infection in the 7 days before dosing.
- Women who have any bleeding disorders that prolong the bleeding time.
- Women who are receiving immunosuppressive medication, including systemic steroids (inhaled and topical steroids are acceptable).
- Women who have received blood or blood products and/or plasma derivatives or any immunoglobulin preparations in 12 weeks preceding screening.
- Women with severe anaemia, haemoglobin < 9g/dL (90 g/L) as per Sheffield grading system ( > Grade 1)
- Women who are currently breast feeding
- Women who are part of the study personnel or a close family member of study personnel.
- Women who in the opinion of the investigator are not suitable to participate in the study.
- Concurrent participation in another clinical trial during which subject will be exposed to an investigational product.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
South Africa2 sites
Empilweni Services and Research Unit (ESRU), Rahima Moosa Mother and Child Hospital
Johannesburg
University of the Witwatersrand, Johannesburg (Respiratory and Meningeal Pathogens Research unit)
Johannesburg
Uganda1 site
MUJHU Research Collaboration/MUJHU Care Ltd, Kawempe National Referral Hospital
Kawempe
About this study
Official title: A Multi-centre Study to Evaluate the Safety, Tolerability and Immunogenicity of Two Doses of a Group B Streptococcus Vaccine (GBS-NN/NN2) in Women Who Are Pregnant and Living With HIV and Women Who Are Pregnant and do Not Have HIV
A randomised, placebo-controlled, double-blind study to evaluate the safety, tolerability and immunogenicity of the GBS-NN/NN2 (Recombinant protein vaccine against Group B Streptococcus) vaccine in women living with HIV and women without HIV, and their newborn babies from vaccination up to delivery/birth. Mothers and babies will be followed up for 12 months post-delivery.
Read the detailed description
100 women who are pregnant and living with HIV will randomly receive two 0.5 mL (millilitre) intramuscular injections of GBS-NN/NN2 vaccine (80 women) or placebo (20 women).
100 women who are pregnant and do not have HIV will randomly receive two 0.5 mL intramuscular injections of GBS-NN/NN2 vaccine (80 women) or placebo (20 women).
Participants will be screened at 24 to 28 weeks gestation (Days -14 to Day -1) and the groups will be dosed in parallel. The first dose of vaccine or placebo will be administered at Day 0 and the second dose will be administered 28±2 days later. Delivery is anticipated to be approximately 10 to 14 weeks after the first dose of vaccine.
For the analysis of the immune response, the placebo groups will be combined. For safety, the placebo groups will be analysed separately and will be combined for comparison with the potential vaccine groups.
- Conditions
- Group B Streptococcal Infection
- Being tested
- GBS-NN/NN2, 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/NN2Biological
GBS-NN/NN2 bound to Alhydrogel as an adjuvant.
PlaceboBiological
Normal Saline 0.9%
| Study group | Role | What they receive |
|---|---|---|
| GBS-NN/NN2 in pregnant women living with HIV | Experimental | 2 doses of 0.5mL intramuscular injection GBS-NN/NN2 containing 50 µg GBS-NN and 50 µg NN2 administered 28 days apart in pregnant women living with HIV Receives: Biological: GBS-NN/NN2 |
| Placebo Comparator in pregnant women living with HIV | Placebo comparator | 2 doses of 0.5mL intramuscular injection 0.9% normal saline administered 28 days apart in pregnant women living with HIV Receives: Biological: Placebo |
| GBS-NN/NN2 in pregnant women who do not have HIV | Experimental | 2 doses of 0.5mL intramuscular injection GBS-NN/NN2 containing 50 µg GBS-NN and 50 µg NN2 administered 28 days apart in pregnant women who do not have HIV Receives: Biological: GBS-NN/NN2 |
| Placebo Comparator in pregnant women who do not have HIV | Placebo comparator | 2 doses of 0.5mL intramuscular injection 0.9% normal saline administered 28 days apart in pregnant women who do not have HIV Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment Emergent Adverse Events (TEAEs) in Maternal Participants
Incidence of all TEAEs in maternal participants from first vaccination up to 28 days post-delivery.
Measured: From first vaccination (26 to 30 weeks of gestation) up to 28 days post-delivery, up to 24 weeks
Incidence of Adverse Events (AEs) in Newborn Babies
Incidence of AEs in Newborn babies From birth to first visit after birth (visit 6).
Measured: From birth to first visit after birth (28±4 days post-delivery)
Number of Maternal Participants With Solicited Local AEs Within 7 Days After Each Study Vaccine Dose
Number of maternal participants with solicited local AEs within 7 Days after each study vaccine dose, defined as: injection site redness, bruising, swelling, itching, pain and tenderness. Injection-site redness was graded based on measurements in centimeter (cm) as grade 0 (no visible redness), grade 1 (mild; 0-2 cm), grade 2 (moderate; 2.1-5 cm) or grade 3 (severe; > 5 cm). Swelling was graded as grade 0 (no swelling detected), grade 1 (palpable "firmness" only), grade 2 (0-4 cm) or grade 3 (> 4 cm). Pain at the injection site was rated on a visual analogue scale of 0 to 10, where 0 is no pain and 10 is extreme pain/worst possible pain. Bruising, itching and tenderness were categorised as either yes (present) or no (absent).
Measured: For 7 days after each study vaccine dose (first vaccine administered at baseline, second vaccine administered 28 days post baseline)
Number of Maternal Participants With Solicited Systemic AEs Within 7 Days After Each Study Vaccine Dose
Number of maternal participants with solicited systemic AEs within 7 days after each study vaccine dose, defined as: headache, sore throat, "flu-like" symptoms, muscle aches, fever in the 72 hours post dose.
Measured: For 7 days after each study vaccine dose (first vaccine administered at baseline, second vaccine administered 28 days post baseline)
Gestational Age of Newborn Baby
Gestational age of newborn baby
Measured: At birth
Weight of Newborn Baby
Weight of newborn baby
Measured: At birth
Length of Newborn Baby
Length of newborn baby
Measured: At birth
Head Circumference of Newborn Baby
Head circumference of newborn baby
Measured: At birth
Apgar Score for Newborn Baby
APGAR (Appearance, Pulse, Grimace, Activity, Respiration) score of newborn baby were measured at 1, 5 and 10 minutes. The APGAR score is a rapid clinical assessment tool used immediately after birth to evaluate a newborn's physical condition. It evaluates five criteria : Appearance (skin color), Pulse (heart rate), Grimace (Reflex irritability), Activity (muscle tone), Respiration (breathing effort), each category is scored 0, 1, or 2, where 2 indicates optimal function. Total score ranges from 0 to 10:
7-10: Normal / Reassuring - baby adapting well 4-6: Moderately abnormal - may need assisted breathing or additional monitoring 0-3: Low - requires immediate resuscitation and urgent intervention
Measured: At birth
Transfer Rate (Baby/Mother) of IgG Antibody Concentrations
For each of the specific IgG antibody concentrations, the transfer rate is defined as concentration in baby at birth/concentration in mother at delivery, expressed as a percentage.
Measured: At delivery
Secondary outcomes (11)
Incidence of Significant Adverse Reactions in Mothers
Incidence of significant adverse reactions in maternal participants
Measured: From delivery to 6 months post-delivery
Developmental Milestones of Babies
Developmental milestones at 6 months were assessed using the Ages and Stages Questionnaire, Third Edition (ASQ-3), a validated developmental screening tool designed to evaluate early childhood development across 5 key domains: communication, gross motor, fine motor, problem solving, and personal-social. Each domain includes 6 items scored as Yes (10), Sometimes (5), or Not yet (0). Domain scores are calculated by summing item scores (range: 0-60 per domain); higher scores indicate better development. A total score (sum of all domains) may be calculated (range: 0-300), though interpretation relies primarily on domain scores. For each domain, the cut-offs are 29.65 for Communication, 22.25 for Gross Motor, 25.14 for Fine Motor, 27.72 for Problem Solving, and 25.34 for Personal-Social. Scores above these thresholds generally indicate development on schedule, while scores near the cutoff suggest monitoring, and scores below warrant additional assessment or referral.
Measured: At 6 months
Geometric Mean Antibody Concentration in Maternal Participants (4 Weeks)
Geometric mean IgG antibody concentration in the maternal participants specific to Alpha Like Protein 1 (Alp1), Alpha Like Protein 2 (Alp2), Alpha Like Protein C (AlpC) and Rib protein (Rib).
Measured: At 4 weeks post first injection and at 4 weeks post second injection
Geometric Mean Antibody Concentration in Maternal Blood at 6 Months Post-delivery
Geometric mean antibody concentration specific to Alp1, Alp2, AlpC and Rib in maternal blood at 6 months post-delivery
Measured: 6 months post-delivery
Geometric Mean Antibody Concentration in Infant Blood at 1, 2, and 3 Months Post-delivery
Geometric mean antibody concentration specific to Alp1, Alp2, AlpC and Rib in infant blood at 1, 2, and 3 months post-delivery
Measured: At 1, 2, and 3 months post-delivery
Geometric Mean Antibody Concentration in Newborns
Geometric mean antibody concentration specific to Alp1, Alp2, AlpC and Rib in newborn blood within 48 hours of birth.
Measured: Within 48 hours of birth.
Geometric Mean Antibody Concentration From Maternal Blood at Delivery
Geometric mean antibody concentration specific to Alp1, Alp2, AlpC and Rib from maternal blood at delivery
Measured: At delivery
Geometric Mean Fold Increase in Antibody Concentration in Maternal Blood
Geometric mean fold increase in IgG specific antibody concentration (Alp1, Alp2, AlpC and Rib) in maternal blood from baseline to 4 weeks after vaccination with the first and second dose.
Measured: At 4 weeks post first injection and at 4 weeks post second injection
Geometric Mean Fold Increase in Antibody Concentration in Maternal Blood
Geometric mean fold increase in IgG specific antibody concentration (Alp1, Alp2, AlpC and Rib) in maternal blood from baseline to delivery.
Measured: Baseline (Gestational Age 26 to 30 weeks) pre-vaccination to delivery, up to 24 weeks
Proportion of Mothers Achieving Vaccine Specific IgG Antibody Concentrations
Proportion of mothers achieving vaccine specific IgG antibody concentrations in maternal samples respectively, above pre-defined arbitrary thresholds (0.5, 1, 2 μg/mL).
Measured: At delivery
Proportion of Newborn Babies Achieving Vaccine Specific IgG Antibody Concentrations
Proportion of newborn babies achieving vaccine specific IgG antibody concentrations above pre-defined arbitrary thresholds (0.5, 1, 2 μg/mL).
Measured: At birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start19 Nov 2020
- Primary completion18 May 2022
- Study completion11 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Group B Streptococcal 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised, placebo controlled, double-blind, parallel group, multicentre study.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minervax ApS
- Sponsor type
- University, hospital or other
- Collaborators
- European and Developing Countries Clinical Trials Partnership (EDCTP)
- Responsible party
- Sponsor
- Investigators
- Cornelia Oostvogels, Study director, Minervax ApS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04596878
- Sponsor's protocol ID
- MVX0005
- Status last verified
- Jun 2026
- First submitted
- 14 Oct 2020
- Last updated
- 14 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Galiza EP, Khalil A, Heath PT. Update on Vaccines in Antenatal Care. Pediatr Infect Dis J. 2024 Feb 1;43(2):e60-e62. doi: 10.1097/INF.0000000000004183. Epub 2023 Dec 27. No abstract available.
PubMed 38190492
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre Study to Evaluate the Safety, Tolerability and Immunogenicity of Two Doses of a Group B Streptococcus Vaccine (GBS-NN/NN2) in Women Who Are Pregnant and Living With HIV and Women Who Are Pregnant and do Not Have HIV
- ClinicalTrials.gov ID
- NCT04596878
- Acronym / sponsor ID
- MVX0005
- Conditions
- Group B Streptococcal Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Minervax ApSUniversity, hospital or other
- Collaborators
- European and Developing Countries Clinical Trials Partnership (EDCTP)
- Study start
- 19 Nov 2020 (actual)
- Primary completion
- 18 May 2022 (actual)
- Study completion
- 11 May 2023 (actual)
- First posted
- 22 Oct 2020 (actual)
- Results
- Posted 14 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomised, placebo-controlled, double-blind study to evaluate the safety, tolerability and immunogenicity of the GBS-NN/NN2 (Recombinant protein vaccine against Group B Streptococcus) vaccine in women living with HIV and women without HIV, and their newborn babies from vaccination up to delivery/birth. Mothers and babies will be followed up for 12 months post-delivery.
Detailed description
100 women who are pregnant and living with HIV will randomly receive two 0.5 mL (millilitre) intramuscular injections of GBS-NN/NN2 vaccine (80 women) or placebo (20 women).
100 women who are pregnant and do not have HIV will randomly receive two 0.5 mL intramuscular injections of GBS-NN/NN2 vaccine (80 women) or placebo (20 women).
Participants will be screened at 24 to 28 weeks gestation (Days -14 to Day -1) and the groups will be dosed in parallel. The first dose of vaccine or placebo will be administered at Day 0 and the second dose will be administered 28±2 days later. Delivery is anticipated to be approximately 10 to 14 weeks after the first dose of vaccine.
For the analysis of the immune response, the placebo groups will be combined. For safety, the placebo groups will be analysed separately and will be combined for comparison with the potential vaccine groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Randomised, placebo controlled, double-blind, parallel group, multicentre study.
| Arm | Type | Receives |
|---|---|---|
| GBS-NN/NN2 in pregnant women living with HIV | Experimental | Biological: GBS-NN/NN22 doses of 0.5mL intramuscular injection GBS-NN/NN2 containing 50 µg GBS-NN and 50 µg NN2 administered 28 days apart in pregnant women living with HIV |
| Placebo Comparator in pregnant women living with HIV | Placebo comparator | Biological: Placebo2 doses of 0.5mL intramuscular injection 0.9% normal saline administered 28 days apart in pregnant women living with HIV |
| GBS-NN/NN2 in pregnant women who do not have HIV | Experimental | Biological: GBS-NN/NN22 doses of 0.5mL intramuscular injection GBS-NN/NN2 containing 50 µg GBS-NN and 50 µg NN2 administered 28 days apart in pregnant women who do not have HIV |
| Placebo Comparator in pregnant women who do not have HIV | Placebo comparator | Biological: Placebo2 doses of 0.5mL intramuscular injection 0.9% normal saline administered 28 days apart in pregnant women who do not have HIV |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Participants at least 18 years old and not older than 40 years of age.
- Pregnant women who are between 26 weeks and 30 weeks (inclusive) gestation on the planned day of vaccination with a singleton, uncomplicated pregnancy. Gestational age to be determined on the following hierarchal basis with guidance to the GAIA (Global Alignment of Immunisation Safety Assessment in pregnancy) criteria:
- HIV status to be based on rapid, confirmatory test, unless a documented test of the participant being sero-positive for HIV and history documented in the notes.
- Women living with HIV, HIV viral load <1000, on antiretroviral therapy for at least 3 months prior to screening and clinically well.
- Expected to be available for the scheduled clinic visits for the duration of the study, agree to be contacted by telephone during study participation, and is willing to give parental consent for her infant to participate in the study
Key exclusion criteria (23 listed)
- Women who are hepatitis B surface (HBSAg) and/or hepatitis C (HCV) positive
- Women who test positive for syphilis as per standard testing
- Women knowingly carrying, at screening, a malformed or genetically abnormal foetus based on ultrasound
- Women who have experienced a previous stillbirth prior to going into labour
- Women with placenta previa
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/NN2GBS-NN/NN2 bound to Alhydrogel as an adjuvant. | Biological | GBS-NN/NN2 in pregnant women living with HIV, GBS-NN/NN2 in pregnant women who do not have HIV |
| PlaceboNormal Saline 0.9% | Biological | Placebo Comparator in pregnant women living with HIV, Placebo Comparator in pregnant women who do not have HIV |
Primary outcome
Incidence of Treatment Emergent Adverse Events (TEAEs) in Maternal Participants
Time frame: From first vaccination (26 to 30 weeks of gestation) up to 28 days post-delivery, up to 24 weeks
Incidence of all TEAEs in maternal participants from first vaccination up to 28 days post-delivery.
Incidence of Adverse Events (AEs) in Newborn Babies
Time frame: From birth to first visit after birth (28±4 days post-delivery)
Incidence of AEs in Newborn babies From birth to first visit after birth (visit 6).
Number of Maternal Participants With Solicited Local AEs Within 7 Days After Each Study Vaccine Dose
Time frame: For 7 days after each study vaccine dose (first vaccine administered at baseline, second vaccine administered 28 days post baseline)
Number of maternal participants with solicited local AEs within 7 Days after each study vaccine dose, defined as: injection site redness, bruising, swelling, itching, pain and tenderness. Injection-site redness was graded based on measurements in centimeter (cm) as grade 0 (no visible redness), grade 1 (mild; 0-2 cm), grade 2 (moderate; 2.1-5 cm) or grade 3 (severe; > 5 cm). Swelling was graded as grade 0 (no swelling detected), grade 1 (palpable "firmness" only), grade 2 (0-4 cm) or grade 3 (> 4 cm). Pain at the injection site was rated on a visual analogue scale of 0 to 10, where 0 is no pain and 10 is extreme pain/worst possible pain. Bruising, itching and tenderness were categorised as either yes (present) or no (absent).
Number of Maternal Participants With Solicited Systemic AEs Within 7 Days After Each Study Vaccine Dose
Time frame: For 7 days after each study vaccine dose (first vaccine administered at baseline, second vaccine administered 28 days post baseline)
Number of maternal participants with solicited systemic AEs within 7 days after each study vaccine dose, defined as: headache, sore throat, "flu-like" symptoms, muscle aches, fever in the 72 hours post dose.
Gestational Age of Newborn Baby
Time frame: At birth
Gestational age of newborn baby
Weight of Newborn Baby
Time frame: At birth
Weight of newborn baby
Length of Newborn Baby
Time frame: At birth
Length of newborn baby
Head Circumference of Newborn Baby
Time frame: At birth
Head circumference of newborn baby
Apgar Score for Newborn Baby
Time frame: At birth
APGAR (Appearance, Pulse, Grimace, Activity, Respiration) score of newborn baby were measured at 1, 5 and 10 minutes. The APGAR score is a rapid clinical assessment tool used immediately after birth to evaluate a newborn's physical condition. It evaluates five criteria : Appearance (skin color), Pulse (heart rate), Grimace (Reflex irritability), Activity (muscle tone), Respiration (breathing effort), each category is scored 0, 1, or 2, where 2 indicates optimal function. Total score ranges from 0 to 10: 7-10: Normal / Reassuring - baby adapting well 4-6: Moderately abnormal - may need assisted breathing or additional monitoring 0-3: Low - requires immediate resuscitation and urgent intervention
Transfer Rate (Baby/Mother) of IgG Antibody Concentrations
Time frame: At delivery
For each of the specific IgG antibody concentrations, the transfer rate is defined as concentration in baby at birth/concentration in mother at delivery, expressed as a percentage.
11 secondary outcomes
Incidence of Significant Adverse Reactions in Mothers
Time frame: From delivery to 6 months post-delivery
Developmental Milestones of Babies
Time frame: At 6 months
Geometric Mean Antibody Concentration in Maternal Participants (4 Weeks)
Time frame: At 4 weeks post first injection and at 4 weeks post second injection
Geometric Mean Antibody Concentration in Maternal Blood at 6 Months Post-delivery
Time frame: 6 months post-delivery
Geometric Mean Antibody Concentration in Infant Blood at 1, 2, and 3 Months Post-delivery
Time frame: At 1, 2, and 3 months post-delivery
Geometric Mean Antibody Concentration in Newborns
Time frame: Within 48 hours of birth.
Geometric Mean Antibody Concentration From Maternal Blood at Delivery
Time frame: At delivery
Geometric Mean Fold Increase in Antibody Concentration in Maternal Blood
Time frame: At 4 weeks post first injection and at 4 weeks post second injection
Geometric Mean Fold Increase in Antibody Concentration in Maternal Blood
Time frame: Baseline (Gestational Age 26 to 30 weeks) pre-vaccination to delivery, up to 24 weeks
Proportion of Mothers Achieving Vaccine Specific IgG Antibody Concentrations
Time frame: At delivery
Proportion of Newborn Babies Achieving Vaccine Specific IgG Antibody Concentrations
Time frame: At birth
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38190492Galiza EP, Khalil A, Heath PT. Update on Vaccines in Antenatal Care. Pediatr Infect Dis J. 2024 Feb 1;43(2):e60-e62. doi: 10.1097/INF.0000000000004183. Epub 2023 Dec 27. No abstract available.
- 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. This study is not recruiting at the moment.
Cornelia Oostvogels study director
Minervax ApS
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GBS-NN/NN2 in people with Group B Streptococcal Infection, run by Minervax ApS at 3 sites in 2 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 8 inclusion and 23 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 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Africa, Uganda. 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 14 Jul 2026). 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?
Incidence of Treatment Emergent Adverse Events (TEAEs) in Maternal Participants (time frame: From first vaccination (26 to 30 weeks of gestation) up to 28 days post-delivery, up to 24 weeks). The study lists 10 primary outcomes in all. 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 NCT04596878, 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 14 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.