Phase I Study Evaluating Safety and Immunogenicity of a Multivalent Gonorrhea Vaccine in Healthy Adults

The primary objective is to evaluate the safety and immunogenicity of a multivalent Gonorrhoea vaccine in healthy adult volunteers, specifically to determine the incidence and severity of adverse events following immunization and to quantify vaccine‑induced antibody responses, thereby establishing the initial risk‑benefit profile necessary for further clinical development.

The sponsor did not provide the total number of participants; consequently, the exact enrollment size is unavailable. The trial was planned to include healthy volunteers of both sexes, with eligibility limited to individuals meeting general health standards and without active infection or significant comorbid conditions. Although an age range code ("3") is listed, the corresponding age interval was not disclosed, and no specific lifestyle requirements such as diet, physical activity, or smoking status were detailed. The study focused on the disease Gonorrhea, and key inclusion criteria emphasized health status, while exclusion criteria omitted participants with current or recent infections related to the condition.

The Phase I safety and immunogenicity study of a multivalent Gonorrhea vaccine will enroll eligible adults after a screening visit to confirm inclusion criteria; participants will receive the investigational product according to a predefined dosing schedule and will be monitored through scheduled follow‑up visits to evaluate adverse events and immune responses, with a final end‑of‑study visit for comprehensive safety and immunogenicity assessment; the trial is planned to run from the estimated recruitment start on 15 July 2026 to the projected completion on 24 September 2027, resulting in participant involvement of approximately 12–14 months; early termination may occur if a participant experiences a serious vaccine‑related adverse event, fails to comply with the visit schedule, or withdraws consent.

Efficacy will be evaluated in participants with Gonorrhea according to the predefined criteria outlined in the study protocol.