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

Phase 2 Completed 200 enrolled Minervax ApS European and Developing Countries Clinical Trials Partnership (EDCTP) · collab

RandomizedParallel-groupDouble-blindPrevention

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.

Timeline

Start: 2020-11-19
Primary completion: 2022-05-18
Completion: 2023-05-11

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	GBS-NN/NN2	Vaccine	0.5 ml	Intramuscular

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

Summary

Timeline

Publications

Drugs

Indications