None listed
Conditions
Interventions
Intervention1: Live Oral Cholera Vaccine VA 1.4: Lyophilized single dose, Live Oral Cholera Vaccine VA 1.4 identical in all respects to VA 1.3 except that the Ampicillin resistance marker is absent. T
Sponsors
Department of Biotechnology Ministry of Science and Technology Government of India
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of adverse events e.g. diarrhea, vomiting, fever, abdominal pain or cramps, headache, loss of appetite, general ill feeling and rashTimepoint: Day 0,1,2,7 and 8 from the date of dosing. | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum vibriocidal antibody titre response (â?¥4 fold geometric mean folds rise) to serogroup 01, to show immunogenicity.Timepoint: Vibriocidal antibody titre will be measured in the sample taken on day 21 to compare with baseline titre and with titre on day 7. | — |
Countries
India
Contacts
Public ContactDr Dilip Mahalanabis
Society for Applied Studies, Kolkata
Outcome results
None listed