A TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A BOOSTER DOSE OF A GROUP B STREPTOCOCCUS 6 VALENT POLYSACCHARIDE CONJUGATE VACCINE (GBS6) IN HEALTHY ADULTS

Summary

This study is an extension to the completed first-in-human C1091001 study (NCT03170609) and is to evaluate the safety and immunogenicity of a single booster vaccine dose of GBS6, administered approximately 2 years or more after a primary GBS6 dose, to healthy adult males and nonpregnant women. The study will determine whether individuals who received a primary dose of GBS6 have additional benefit following a booster dose.

Timeline

Start

2020-02-11

Primary completion

2020-09-15

Completion

2020-09-15

Publications

• Jongihlati B, Segall N, Block SL, Absalon J, Perez J, Munson S, Sanchez-Pearson Y, Simon R, Silmon de Monerri NC, Radley D, McLaughlin LC, Gaylord M, Gruber WC, Jansen KU, Scott DA, Anderson AS. Safety and immunogenicity of a booster dose of a novel hexavalent group B streptococcus conjugate vaccine in healthy, non-pregnant adults: a phase 2, open-label extension of a phase 1/2 randomised controlled trial. Lancet Infect Dis. 2025 Oct;25(10):1138-1148. doi: 10.1016/S1473-3099(25)00216-6. Epub 2025 Jun 13.

Drugs

Indications