Evaluation of Buffer on Immune Response to Oral Polio Vaccine (OPV) in Bangladesh
The immunogenicity of oral polio vaccine (OPV) will be enhanced in Bangladeshi infants who receive bicarbonate buffer at the time of polio immunization.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Evaluation of the Effect of Buffer on the Immune Response to Oral Poliovirus Vaccine in Bangladesh: a Randomized Controlled Trial|
- Serologic response [ Time Frame: 4 weeks after last dose of OPV ] [ Designated as safety issue: No ]Serologic response rate for each polio virus serotype (1, 2, and 3) in OPV.
|Study Start Date:||April 2012|
|Study Completion Date:||December 2012|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
5 ml of oral buffer solution containing 64 mg of sodium bicarbonate plus 24 mg of sodium citrate. The buffer will be administered prior to each dose of OPV at 6, 10 and 14 weeks of age.
|No Intervention: Control|
The investigators will conduct a study to evaluate the impact of administering bicarbonate buffer on the serologic responses to oral polio vaccine (OPV) in Bangladeshi infants.
|Principal Investigator:||Neal A Halsey, MD||Johns Hopkins Bloomberg School of Public Health|