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COMPLETED
NCT04596878
PHASE2

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

Sponsor: Minervax ApS

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2020-11-19

Completion Date

2023-05-11

Last Updated

2026-07-14

Healthy Volunteers

Yes

Interventions

BIOLOGICAL

GBS-NN/NN2

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

BIOLOGICAL

Placebo

Normal Saline 0.9%

Locations (3)

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

Johannesburg, South Africa

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

Johannesburg, South Africa

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

Kawempe, Uganda