Evaluation of Safety and Immunogenicity of DuoChol Oral Vaccine for Cholera Prevention in Healthy Adults Aged 18-45 in Sweden: A Phase I, Open-label, Randomized Study

The primary objective is to assess the safety and immunogenicity of the DuoChol oral cholera vaccine in healthy adults aged 18–45, thereby determining tolerability and the magnitude of the immune response that may correlate with protection against cholera.

The trial enrolled healthy volunteers of both sexes for evaluation of a preventive intervention against cholera. Participants were identified as adults within the age range denoted by code 3, although the specific age limits were not detailed. Recruitment focused on individuals without known chronic illnesses, reflecting a generally healthy population. Lifestyle factors such as diet, physical activity, and other habits were not described in the provided information. The sponsor did not provide the total number of participants enrolled in the study.

The study is a Phase I, open‑label, randomized, active‑controlled trial evaluating the safety and immunogenicity of the DuoChol oral vaccine in healthy adults aged 18–45. Participants undergo a screening visit to confirm eligibility, are then randomized to receive either the investigational vaccine or the active control, and attend a vaccination visit followed by scheduled follow‑up assessments (e.g., Days 7, 28, and 90) to collect safety data, blood samples, and monitor adverse events. The sequence concludes with an end‑of‑study visit that finalizes data collection. Participant involvement extends from the screening visit through the end‑of‑study visit, encompassing approximately three months of follow‑up. Early termination may occur if a serious adverse reaction, withdrawal of consent, or non‑compliance with visit schedules arises. Recruitment is planned from October 2025 to March 2026, providing preliminary safety and immunogenicity data for cholera prevention.

Efficacy will be assessed by evaluating outcomes related to the prevention of cholera disease in accordance with the study protocol.