Effect of Extended Dose Intervals on the Immune Response to Oral Cholera Vaccine

PHASE4CompletedINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

November 16, 2017

Primary Completion Date

October 16, 2019

Study Completion Date

December 1, 2020

Conditions
CholeraVibrio Cholerae Infection
Interventions
BIOLOGICAL

Oral Cholera Vaccine

Shanchol is a bivalent (O1 and O139 serotypes) vaccine using a heat-killed classical Inaba strain and a formalin-killed classical Ogawa strain produced by Sanofi. Shanchol requires no oral buffer for administration, is approved for persons greater than 1 year of age, and requires 2 doses at two-week intervals. It became World Health Organization (WHO) prequalified in 2011.

BIOLOGICAL

Adjusted Dose Oral Cholera Vaccine

The Adjusted Dose Oral Cholera Vaccine is given in two doses, with the second dose given at six months, rather than the manufacturer described 2 week interval between first and second dose.

Trial Locations (1)

Unknown

Center for Infectious Disease Research - Zambia, Lusaka

All Listed Sponsors
lead

Johns Hopkins Bloomberg School of Public Health

OTHER

NCT03373669 - Effect of Extended Dose Intervals on the Immune Response to Oral Cholera Vaccine | Biotech Hunter | Biotech Hunter