ive Oral VA 1.4 Cholera Vaccine Trial to Evaluate the Safety and Immunogenicity in Healthy Adults in Kolkata, India

Phase 1

Completed

• Registration Number: CTRI/2012/04/002582
• Lead Sponsor: Department of Biotechnology Ministry of Science and Technology Government of India

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 88

Inclusion Criteria

Males or non-pregnant females aged 18 years to 60 years who

1. The investigator believes will comply with the requirements of the protocol (i.e. available for follow-up visits and specimen collection).

2. Have given written informed consent obtained from the subjects.

3. Are healthy as determined by

a) Medical history

b) Physical examination

c) Clinical judgment of the investigator

Exclusion Criteria

1. Having ongoing serious chronic disease

2. For females of reproductive age: Pregnancy (or females planning to become pregnant during the study period (as determined by verbal screening)

3. Immunocompromising condition or therapy (for corticosteroids this would mean >=0.5 mg/kg/day)as determined through verbal screening and history of recent ARI, diabetes, repeated attacks of diarrhoea

4.Diarrhea (3 or more loose/watery stools within a 24-hour period)6 weeks prior to enrollment

5. One or two episodes of diarrhea lasting for more than 2 weeks in the past 6 months

6. One or two episodes of abdominal pain lasting for more than 2 weeks in the past 6 months

7. Intake of any anti-diarrhea medicine in the past week

8. Having abdominal pain or cramps, loss of appetite, nausea, general ill-feeling or vomiting in the past 24 hours

9. Having any acute disease one week prior to enrollment, with or without fever. Temperature >=38ºC warrants deferral of the vaccination pending recovery of the subject.

10. Receiving immunoglobulin or any blood product during the past 3 months

11. Receiving antibiotics in past 14 days

12. Receiving live or killed enteric vaccine in past 4 weeks

13. Receiving killed oral cholera vaccine

14. Subject belonging to a population/family at high risk for HIV/AIDS such as migrant workers, commercial vehicle drivers, parenteral drug users, sex workers. Also in case of doubt the subject will be excluded.

Study & Design

• Study Type: Interventional
• Study Design: Not specified