Immunogenicity of One Versus Two Doses of Killed Oral Cholera Vaccine

International Vaccine Institute (IVI)

Status and phase

Completed

Phase 2

Conditions

Diarrhea

Cholera

Vibrio Infections

Treatments

Biological: Killed bivalent whole cell oral cholera vaccine

Biological: Heat Killed E. coli Placebo

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00419133

C-8IR

Details and patient eligibility

About

The purpose of this study is to compare the safety and immunogenicity of one and two doses of the killed oral cholera vaccine.

Full description

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.

Enrollment

160 patients

Sex

All

Ages

1 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy adult male and non-pregnant female adults aged 18-40 years and healthy children aged 1-17 years

All subjects must satisfy the following criteria at study entry:

Male or female adult residents aged 18-40 years or children aged 1- 17 years who the investigator believes will comply with the requirements of the protocol (i.e. available for follow-up visits and specimen collection)
For females of reproductive age, they must not be pregnant (as determined by verbal screening)
Written informed consent obtained from subjects or their guardians, and written assent for children aged 12-17 years.
Healthy subjects as determined by: medical history, physical examination, clinical judgement of the investigator.

Exclusion criteria

Ongoing serious chronic disease
Immunocompromising condition or therapy
Diarrhea (3 or more loose stools within a 24-hour period) 6 weeks prior to enrollment
one or two episodes of diarrhea lasting for more than 2 weeks in the past 6 months
one or two episodes of abdominal pain lasting for more than 2 weeks in the past 6 months
intake of any anti-diarrhoeal medicine in the past week
abdominal pain or cramps, loss of appetite, nausea, general ill-feeling or vomiting in the past 24 hours
acute disease one week prior to enrollment, with or without fever. Temperature > or = 38 degrees C (oral) or axillary temperature > or = 37.5 degrees C warrants deferral of the vaccination pending recovery of the subject
receipt of antibiotics in past 14 days
receipt of live or killed enteric vaccine in last month
receipt of killed oral cholear vaccine