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NCT07873346

PHASE4

Study on Changes in Gut Microbiota, Inflammatory Factors, and Bowel Habits Following Oral Administration of Recombinant B-subunit/Whole Cell Cholera Vaccine in a Community Population

Sponsor: Zhejiang Provincial Center for Disease Control and Prevention

View on ClinicalTrials.gov

Summary

This randomized, placebo-controlled clinical trial aims to investigate the effects of oral cholera vaccine administration on three aspects of gut health in healthy adult community members aged 18 years and older: (1) the composition and function of gut microbiota, (2) serum inflammatory cytokine levels, and (3) bowel habits. The study is designed as an exploratory/basic science investigation to generate hypotheses about how cholera vaccination may influence intestinal health in healthy populations. The findings from this study may provide valuable insights into vaccine-induced changes in the gut microbiome and immune responses, which could inform future research on oral vaccines and their extra-intestinal effects. Participants who agree to take part in this study will be asked to complete the following procedures at two time points: before receiving the study intervention (baseline) and 28 days after completing the full vaccine series. Approximately 200 healthy adults aged 18 years and older from the community will be enrolled in this study. Participants will be randomly assigned in a 1:1 ratio to one of two study groups: Intervention Group (Vaccine Group): receive the oral cholera vaccine according to the manufacturer's recommended schedule; Control Group (Placebo Group): receive a placebo that looks identical to the vaccine but contains no active ingredient. The study will measure the following outcomes to evaluate the effects of cholera vaccine:Gut Microbiota Changes, Serum Inflammatory Cytokine Levels and Bowel Habit Changes.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2026-10-20

Completion Date

2027-12-30

Last Updated

2026-10-14

Healthy Volunteers

Yes

Conditions

Bowel Habits Gut Microbiomes Inflamatory Markers

Interventions

DRUG

Receive recombinant B-subunit/whole-cell cholera vaccine

Participants in this group will receive the oral cholera vaccine according to the manufacturer's recommended schedule (3 dose, at 0d, 7d, 28d).

OTHER

Placebo

Participants in this group will receive a placebo that looks identical to the vaccine but contains no active ingredient (3 dose, at 0d, 7d, 28d).

Inclusion Criteria: 1. Local permanent residents aged 18 years or older, regardless of gender 2. Axillary temperature \<37°C on the day of vaccination 3. No prior history of cholera vaccine administration, or ≥2 years since the last dose of cholera vaccine 4. Ability to understand the study content and procedures, sign the informed consent form, and cooperate in completing the study Exclusion Criteria: 1. Individuals with febrile illness (axillary temperature ≥37.0℃ on the day of vaccination), other acute diseases, or diarrheal disease within 7 days before vaccination 2. Use of antibiotics within 14 days before vaccination, or requiring long-term antibiotic use 3. Severe hypertension, severe heart, liver, or kidney diseases, or severe infectious diseases such as AIDS or active tuberculosis 4. History or family history of convulsions, encephalopathy, psychosis, uncontrolled epilepsy, or other progressive neurological diseases; history of Guillain-Barré syndrome 5. Contraindications to vaccination, or history of allergic reactions to previous vaccinations 6. Receipt of blood products within 3 months before vaccination 7. Receipt of other investigational products within 30 days before vaccination 8. Receipt of any rotavirus vaccine within 12 months before vaccination 9. Receipt of a live attenuated vaccine within 14 days before vaccination, or an inactivated or subunit vaccine within 7 days before vaccination 10. Females who are pregnant, lactating, or planning to become pregnant during the study 11. Individuals who, in the investigator's judgment, are unsuitable for participation due to medical, psychological, social, or other conditions that may compromise compliance with the study protocol or affect the ability to provide informed consent 12. Allergic reaction or serious adverse event causally related to the study vaccine at the first or second vaccination 13. Occurrence of any of the exclusion criteria for the first oral vaccination after enrollment (except for antibiotic use after the first dose)

Locations (1)

Ningbo Haishu District Dongqiao Town Health Center

Ningbo, Zhejiang, China