Study of a Group B Streptococcus Vaccine in Pregnant Women Living With HIV and in Pregnant Women Who do Not Have HIV

NCT04596878 | Completed Phase 2 Results DMC

• 1 other identifier: MVX0005
• Study Type: interventional
• Target: 200
• Locations: 2 countries
• Sites: 3

Brief 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. Mothers and babies will be followed up for 12 months post-delivery.

Conditions

Group B Streptococcal Infection

Outcome Measures

Primary Outcomes (10)

• 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.

  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).

  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).

  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.

  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

  At birth

• Weight of Newborn Baby

  Weight of newborn baby

  At birth

• Length of Newborn Baby

  Length of newborn baby

  At birth

• Head Circumference of Newborn Baby

  Head circumference of newborn baby

  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

  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.

  At delivery

Secondary Outcomes (11)

• Incidence of Significant Adverse Reactions in Mothers

  From delivery to 6 months post-delivery

• Developmental Milestones of Babies

  At 6 months

• Geometric Mean Antibody Concentration in Maternal Participants (4 Weeks)

  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

  6 months post-delivery

• Geometric Mean Antibody Concentration in Infant Blood at 1, 2, and 3 Months Post-delivery

  At 1, 2, and 3 months post-delivery

Study Arms (4)

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

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

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

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

Biological: Placebo

Interventions

GBS-NN/NN2 BIOLOGICAL

GBS-NN/NN2 bound to Alhydrogel as an adjuvant.

GBS-NN/NN2 in pregnant women living with HIV; GBS-NN/NN2 in pregnant women who do not have HIV

Placebo BIOLOGICAL

Normal Saline 0.9%

Placebo Comparator in pregnant women living with HIV; Placebo Comparator in pregnant women who do not have HIV

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Minervax ApS: lead
• European and Developing Countries Clinical Trials Partnership (EDCTP): collaborator

Study Sites (3)

Empilweni Services and Research Unit (ESRU), Rahima Moosa Mother and Child Hospital

Johannesburg, South Africa

Location

University of the Witwatersrand, Johannesburg (Respiratory and Meningeal Pathogens Research unit)

Johannesburg, South Africa

Location

MUJHU Research Collaboration/MUJHU Care Ltd, Kawempe National Referral Hospital

Kawempe, Uganda

Location

Related Publications (1)

• 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.

  PMID: 38190492 DERIVED

MeSH Terms

Conditions

Streptococcal Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: Cornelia Oostvogels/Chief Medical Officer (CMO)
• Organization: MinervaX

lio@minervax.com

00491515092821

Study Officials

• Cornelia Oostvogels

  Minervax ApS

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised, placebo controlled, double-blind, parallel group, multicentre study.

Study Record Dates

• First Submitted: October 14, 2020
• First Posted: October 22, 2020
• Study Start: November 19, 2020
• Primary Completion: May 18, 2022
• Study Completion: May 11, 2023
• Last Updated: July 14, 2026
• Results First Posted: July 14, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (2); UG (1)