NGG-001 Study

Rationale

The NGG-001 study is designed to assess the safety and efficacy of the GSK Neisseria gonorrhoeae GMMA (NgG) investigational vaccine in preventing gonorrhoea in healthy adults aged 18 to 50. Gonorrhoea remains a significant global public health concern, and this vaccine aims to offer a promising solution for prevention. The study consists of two phases: Phase 1 will focus on the safety of the vaccine, and Phase 2 will assess its efficacy in preventing gonorrhoea among individuals at risk.

Primary Objectives (Phase 2)

1. Efficacy: To demonstrate the efficacy of the NgG vaccine in preventing gonorrhoea cases.
2. Safety: To evaluate the safety and reactogenicity following administration of the NgG vaccine.

Study Population

Healthy adults aged 18 to 50 years, considered at risk for gonorrhoea.

Intervention

Participants will receive either the GSK Neisseria gonorrhoeae GMMA (NgG) investigational vaccine or a placebo (saline). The NgG vaccine will be administered at different dosages (50, 25, and 12.5 µg of vaccine antigen per dose) according to a 2-dose schedule, with a 2-month interval between doses.

Sponsors/Donors

This study is sponsored by GlaxoSmithKline.

Investigators

Prof Sinead Delany-Moretlwe