NCT06611371

Phase I/II Study to a Assess the GBS-06 Vaccine Manufactured by Inventprise, Inc., in Healthy, Non-Pregnant, Adult Women of Childbearing Age.

A Phase I/II, Observer-Blind, Randomized, Placebo-Controlled, Dose-Selection Study to Assess the Safety, Tolerability, and Immunogenicity of Hexavalent Group B Streptococcus Conjugate Vaccine Manufactured by Inventprise, Inc., in Healthy, Non-Pregnant, Adult Women of Childbearing Age (WOCBA) in the US and South Africa.

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 600 (actual)
• Sponsor: Inventprise Inc. · Industry
• Sex: Female
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

Summary

To assess the safety and tolerability of IVT GBS-06 vaccine administered as a single-dose regimen, at three dosage levels in healthy, non-pregnant, adult women of childbearing age (WOCBA).

Detailed description

This is a phase I/II, randomized, placebo-controlled, observer-blinded trial to evaluate the safety, tolerability, and immunogenicity of a multivalent GBS vaccine candidate in healthy, non-pregnant, adult WOCBA, 18-49 years of age, at two sites, one each in the US and South Africa. Approximately 600 participants will be randomized to receive a single dose of low, mid, or high concentration of IVT GBS-06, or a placebo (saline control) at Day (D)1, administered IM by injecting 0.5 mL into the deltoid muscle. The three dose levels denote the amount of capsular polysaccharide (CPS) for each of the six serotypes per 0.5 mL. These four study groups will be enrolled simultaneously to allow for parallel assessments of overall IVT GBS-06 safety and tolerability. Participants will be randomized in a 1:1:1:1 ratio to one of the dose levels or placebo. This study will utilize a sentinel-cohort design in which 20 participants overall (i.e., N=5 per treatment arm) at the US site will be randomized, vaccinated, and evaluated for safety prior to opening enrolment of additional participants in USA and in South Africa. This study targets representation from both study populations and therefore at least 220 participants will be recruited from each of the two sites and will allow competitive enrollment across the two study sites for the remaining 160 participants to reach 600 within target enrollment period.

Conditions

• Group B Streptococcal Infections

Interventions

Type	Name	Description
BIOLOGICAL	IVT GBS-06	Hexavalent Group B Streptococcus polysaccharide conjugate vaccine (serotypes Ia, Ib, II, III, V, and VII) administered as a single dose.
BIOLOGICAL	Placebo	0.9% sodium chloride

Timeline

• Start date: 2024-11-12
• Primary completion: 2025-08-26
• Completion: 2026-02-01
• First posted: 2024-09-24
• Last updated: 2025-11-18

Locations

2 sites across 2 countries: United States, South Africa

Regulatory

• FDA-regulated drug study