Polio
Conditions
Brief summary
Hypothesis: The immunogenicity of oral polio vaccine (OPV) will be enhanced in Bangladeshi infants who receive bicarbonate buffer at the time of polio immunization.
Detailed description
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.
Interventions
OTHERBuffer
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.
Sponsors
World Health Organization
Johns Hopkins Bloomberg School of Public Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Weeks to 8 Weeks
Healthy volunteers
Yes
Inclusion criteria
* infants who are 4-8 weeks old * residents of study area
Exclusion criteria
* received a blood transfusion or any other blood product (such as immune globulin) * likely to move out of study area within the next four months * currently enrolled or planning to enroll in another study * major congenital malformations * neurologic disorders * immunodeficiency
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serologic response | 4 weeks after last dose of OPV | Serologic response rate for each polio virus serotype (1, 2, and 3) in OPV. |
Countries
Bangladesh
Outcome results
None listed