Immunogenicity of One Versus Two Doses of Killed Oral Cholera Vaccine
|Cholera Diarrhea Vibrio Infections||Biological: Killed bivalent whole cell oral cholera vaccine Biological: Heat Killed E. coli Placebo||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Immune Responses Following One Versus Two Doses of Killed Oral Cholera Vaccine in Eastern Kolkata, West Bengal, India|
- Proportion of subjects exhibiting 4-fold or greater rises in titers of serum vibriocidal antibodies, relative to baseline [ Time Frame: 14 days after each dose of vaccine or placebo ]
- Geometric mean serum vibriocidal titers compared to baseline [ Time Frame: 14 days after each dose ]
- Proportion of subjects with any of the following adverse events: immediate reactions within 30 minutes after each dose and up to 3 days after each dose and serious adverse events occurring throughout the trial. [ Time Frame: after dosing: 30 minutes to 3 days for adverse events, 28 days for serious adverse events ]
|Study Start Date:||June 2007|
|Study Completion Date:||August 2007|
|Primary Completion Date:||August 2007 (Final data collection date for primary outcome measure)|
Biological: Killed bivalent whole cell oral cholera vaccine
Each 1.5 mL dose, given orally, contains:
V. cholerae O1 Inaba El Tor strain Phil 6973 formalin killed, 600 Elisa units (EU) LPS V. cholerae O1 Ogawa classical strain Cairo 50 heat killed 300 EU LPS V. cholerae O1 Ogawa classical strain Cairo 50 formalin killed 300 EU LPS V. cholerae O1 Inaba classical strain Cairo 48 heat killed 300 EU LPS V. cholerae O139 strain 4260B formalin killed 600 EU LPS
Placebo Comparator: 2
Biological: Heat Killed E. coli Placebo
Heat Killed E.coli in an optical turbidity identical to cholera vaccine, given in a 1.5 mL oral dose.
Cholera is an important public health problem worldwide, particularly in endemic areas of the developing world. In 2004, 101 383 cholera cases and 2345 deaths were reported to the WHO. Provision of safe water and food, adequate sanitation and improved personal and community hygiene are the main public health interventions against cholera. These measures cannot be implemented in the near future in the most cholera-endemic areas.
Phase II trials of this reformulated killed oral cholera vaccine were performed in SonLa, Vietnam and Kolkata, India. Significant vibriocidal antibody responses were observed among vaccine recipients.
Distribution of 2 doses of the cholera vaccine is often difficult in field settings and limits its utility in emergency situations, since an interval of 2 weeks is usually required between doses. Recent data from Vietnam suggests that greater vibriocidal responses following 2 doses are elicited compared to previous formulations. Furthermore, in a study in Bangladesh comparing immune responses to the vaccine among children supplemented with vitamin A and zinc, seroconversion after the first dose was robust in all groups suggesting that one dose may be used in the control of cholera.
Data regarding the immune response following one dose of this reformulated vaccine is currently unavailable. If a single dose of this vaccine is confirmed to be immunogenic to recipients, then this vaccine may be used more extensively for public health purposes, especially during times of outbreaks.
The objective of this study is to confirm the safety of the killed oral cholera vaccine among adult and children volunteers.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00419133
|National Institute of Cholera and Enteric Diseases|
|Kolkata, West Bengal, India, 700010|
|Principal Investigator:||Sujit K Bhattacharya||National Institute of Cholera and Enteric Diseases, India|