*NGG-001
Research type
Research Study
Full title
A Phase 1/2, observer-blind, randomized, placebo-controlled multi-country study to assess safety and efficacy of GSK Neisseria gonorrhoeae GMMA (NgG) investigational vaccine when administered to healthy adults 18 to 50 years of age
IRAS ID
1005941
Contact name
Ilaria Galgani
Contact email
Sponsor organisation
GlaxoSmithKline Biologicals SA
Eudract number
2022-001060-10
Clinicaltrials.gov Identifier
Research summary
Gonorrhoea is a sexually transmitted disease caused by the Neisseria gonorrhoeae bacterium. It causes infections in the genitals (penis or vagina), anus, and throat. Gonorrhoea can be treated with antibiotics, but a vaccine that prevents the disease has not yet been discovered. This research is being conducted by GlaxoSmithKline and will test if the newly developed NgG vaccine is safe and helps protecting against gonorrhoea infection. In Phase 1, 24 participants will receive placebo or the NgG vaccine in three different doses. The aim is to identify which doses are safer to be studied in Phase 2. During Phase 2, the effect of the NgG vaccine will be studied using the dose(s) selected in Phase 1. The aim is to demonstrate that the vaccine can protect from gonorrhoea infection. Globally, 750 people will take part in Phase 2 and be randomly located to receive 2 injections of either the NgG vaccine or a placebo. In the UK, approximately 51 healthy adults who are at risk for gonococcal infections will be included in Phase 2. The study will be run at hospital sites and will last for about 15 months. After confirming eligibility, study procedures will include taking swabs, collecting blood, urine samples and completing a behaviour questionnaire. The participants will need to visit the clinic up to 10 times and any other time when they suspect being infected with gonorrhoea. There might be some risk associated with the usage of injectable vaccines and with the collection of samples leading to infections or causes of irritation or bleeding potentially associated with swabbing. Participants may or may not be benefited directly from this study because doctors are yet to find out how this vaccine works in people and if it protects against gonorrhoea. However, an indirect benefit can from the study evaluations/assessments.
REC name
London - London Bridge Research Ethics Committee
REC reference
22/LO/0830
Date of REC Opinion
30 Jan 2023
REC opinion
Further Information Favourable Opinion