Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of A Multivalent Group B Streptococcus Vaccine In Healthy Nonpregnant Women And Pregnant Women And Their Infants

Summary

Phase 1/2, randomized, placebo-controlled, observer-blinded study will evaluate the safety, tolerability and immunogenicity of the investigational multivalent group B streptococcus vaccine administered at one dose level (various formulations) in healthy nonpregnant women (various formulations at one dose level), and then in healthy pregnant women (various formulations at three dose levels), and finally in healthy pregnant women at a selected dose level/formulation.

Timeline

Start

2019-01-14

Primary completion

2024-03-04

Completion

2024-03-04

Publications

• Cutland CL, Sawry S, Fairlie L, Barnabas S, Frajzyngier V, Roux JL, Izu A, Kekane-Mochwari KE, Vika C, De Jager J, Munson S, Jongihlati B, Stark JH, Absalon J. Obstetric and neonatal outcomes in South Africa. Vaccine. 2024 Feb 27;42(6):1352-1362. doi: 10.1016/j.vaccine.2024.01.054. Epub 2024 Feb 3.
• Madhi SA, Anderson AS, Absalon J, Radley D, Simon R, Jongihlati B, Strehlau R, van Niekerk AM, Izu A, Naidoo N, Kwatra G, Ramsamy Y, Said M, Jones S, Jose L, Fairlie L, Barnabas SL, Newton R, Munson S, Jefferies Z, Pavliakova D, Silmon de Monerri NC, Gomme E, Perez JL, Scott DA, Gruber WC, Jansen KU. Potential for Maternally Administered Vaccine for Infant Group B Streptococcus. N Engl J Med. 2023 Jul 20;389(3):215-227. doi: 10.1056/NEJMoa2116045.

Drugs

Indications