Evaluation of Buffer on Immune Response to Oral Polio Vaccine (OPV) in Bangladesh

Johns Hopkins Bloomberg School of Public Health300 enrolled

Overview

Hypothesis: The immunogenicity of oral polio vaccine (OPV) will be enhanced in Bangladeshi infants who receive bicarbonate buffer at the time of polio immunization.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

300

Conditions

Polio

Interventions

BufferOTHER

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.

Eligibility

Sex: ALLMin age: 4 WeeksMax age: 8 WeeksHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Sylhet, Bangladesh

Outcomes

Primary Outcomes

Serologic response

Serologic response rate for each polio virus serotype (1, 2, and 3) in OPV.

Time frame: 4 weeks after last dose of OPV

Data from ClinicalTrials.gov

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