A Post-marketing Observational Study of Oral Cholera Vaccine

NCT07300462 | Enrolling By Invitation Phase 4

• 1 other identifier: OCV-YJFA-2024-001
• Study Type: interventional
• Target: 6,000
• Locations: 1 country
• Sites: 5

Brief Summary

Chinese survey data indicate that the incidence rate of diarrhea in the general population ranges from 0.17 to 0.70 episodes per person-year, whereas among children under five years of age, the rate is significantly higher, ranging from 2.50 to 3.38 episodes per person-year. Over recent decades, rapid economic development has contributed substantially to the reduction of mortality associated with infectious diseases. However, emerging challenges-such as increasing antimicrobial resistance and heightened population mobility-have complicated efforts in infectious disease prevention and control. In a phase III clinical trial of the recombinant B subunit/bacterial whole-cell cholera vaccine (enteric-coated capsule), a statistically significant difference was observed in the overall incidence of diarrhea between the vaccinated group (12.9%) and the control group (26.7%) (P \< 0.01). Findings from similar vaccine studies conducted in Sweden have demonstrated cross-protection against diarrhea caused by enterotoxigenic Escherichia coli (ETEC) and other intestinal pathogens. Specifically, the vaccine conferred a 50% protection rate against Salmonella enterica infections, 82% against mixed infections involving ETEC and Salmonella, and 71% against mixed infections involving ETEC and other pathogens. Evidence from relevant studies suggests that the recombinant B subunit/bacterial whole-cell cholera vaccine may offer protective benefits against non-cholera infectious diarrhea. Nevertheless, there remains a paucity of real-world effectiveness data, particularly in pediatric populations who bear a disproportionately high burden of diarrheal disease.

Conditions

Diarrhea

Keywords

IV

Outcome Measures

Primary Outcomes (1)

• the incidence of infectious diarrhea in the vaccinated group and placebo group

  Protective effect of recombinant subunit B/bacterial cholera vaccine (enteric-coated capsules) against infectious diarrhea due to enteropathogens (except Vibrio cholerae) (Day 7 after full immunization to the end of the study).

  The incidence of diarrhea in the experimental group and the control group within 180 days starting from 7 days after full immunization (the baseline day for diarrhea)

Study Arms (2)

Recombinant subunit B/bacterial cholera vaccine (enteric-coated capsules)

EXPERIMENTAL

Biological: Recombinant subunit B/bacterial cholera vaccine (enteric-coated capsules)

Recombinant B subunit/bacterial cholera vaccine (enteric-coated capsule) placebo

PLACEBO COMPARATOR

Biological: Placebo

Interventions

Recombinant subunit B/bacterial cholera vaccine (enteric-coated capsules) BIOLOGICAL

The participants in the experimental group will be given three oral doses of recombinant subunit B/bacterial cholera vaccine (enteric-coated capsules) on D0, D7, and D28 .

Recombinant subunit B/bacterial cholera vaccine (enteric-coated capsules)

Placebo BIOLOGICAL

The participants in the Control group will be given three oral doses of recombinant subunit B/bacterial cholera vaccine (enteric-coated capsules) Placebo on D0, D7, and D28 .

Recombinant B subunit/bacterial cholera vaccine (enteric-coated capsule) placebo

Eligibility Criteria

• Age: 2 Years - 14 Years
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age ≥ 2 years old, ≤ 14 years old, male or female.
• Not vaccinated against cholera.
• Obtain the consent of the study subject or guardian and sign the informed consent form.
• The subjects and their guardians were able to comply with the requirements of the clinical study protocol.
• Axillary temperature \< 37.0 °C was measured on the day of inoculation.

You may not qualify if:

• Patients with febrile illness (axillary temperature ≥ 37.0 °C on the day of vaccination), other acute diseases, and diarrhea within 7 days before vaccination.
• Use of antibiotics within 7 days prior to vaccination.
• Patients with gastric ulcer, abnormal gastric acid secretion and other gastric diseases or discomfort.
• History of allergy to vaccinations and oral medications.
• Patients with congenital malformations, developmental disorders, or severe chronic diseases.
• Suspected progressive neurological disorder, epilepsy, or long-term use of antibiotics.
• Received blood products within 3 months prior to vaccination.
• Received other investigational drugs within 30 days prior to vaccination.
• Received any Rotavirus vaccine within 12 months prior to vaccination.
• Live attenuated vaccine within 14 days or subunit or inactivated vaccine within 7 days prior to vaccination.
• Asthma requiring urgent treatment, hospitalization, intubation, oral or intravenous corticosteroids for unstable past two years.
• Patients with severe hypertension, heart, liver, kidney disease, and severe infectious diseases (acquired immunodeficiency syndrome and active tuberculosis).
• Has a malignancy, is active or has been treated without definitive cure, or has the potential to relapse during the study.
• Epilepsy, excluding epilepsy that has been discontinued within the past 3 years and has not recurred.
• Patients with coagulation disorders.

Sponsors & Collaborators

• Shanghai United Cell Biotechnology Co., Ltd: lead

Study Sites (5)

Anhui Provincial Center for Disease Control and Prevention

Hefei, Anhui, China

Location

National Institute for Communicable Disease Control and Prevention, China

Beijing, Beijing Municipality, China

Location

Hubei Provincial Center for Disease Control and Prevention

Wuhan, Hubei, China

Location

Jiangsu Provincial Center for Disease Control and Prevention

Nanjing, Jiangsu, China

Location

Shandong Provincial Center for Disease Control and Prevention

Jinan, Shandong, China

Location

MeSH Terms

Conditions

Diarrhea

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: December 23, 2025
• Study Start: April 10, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: July 10, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)