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 DMC

• 1 other identifier: MVX0005
• Study Type: interventional
• Target: 205
• 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 6 months post-delivery.

Conditions

Group B Streptococcal Infection

Outcome Measures

Primary Outcomes (7)

• Incidence of treatment emergent adverse events

  Adverse events

  From vaccination up to delivery/birth

• 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 score for newborn baby

  At birth

• IgG (Immunoglobulin G) antibody concentration

  IgG antibody concentration specific to the GBS-NN/NN2 vaccine measured in maternal blood and cord blood

  At birth

Secondary Outcomes (7)

• 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

  At 4 weeks post first injection and at 4 weeks post second injection

• Geometric mean antibody concentration of cord and maternal blood

  At delivery

• Geometric mean fold increase in antibody concentration in maternal blood

  At 4 weeks post first injection and at 4 weeks post second injection

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 HBSAg and/or HCV (hepatitis C virus) 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, who are known to be allergic to aluminium or have had an allergic reaction to any previous vaccination.
• Women with HIV viral load \>1000 at screening.
• Women living with HIV who have been on antiretroviral therapy for less than 3 months prior to screening. (Women who are diagnosed with HIV between screening and dosing will not be eligible.)
• 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.

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

Study Officials

• Geoff Kitson

  gkitson@propharmapartners.uk.com

  STUDY DIRECTOR

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: August 23, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (2); UG (1)