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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2012-12-31

Brief Summary

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Hypothesis:

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

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Detailed Description

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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.

Conditions

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Polio

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Buffer

Group Type EXPERIMENTAL

Buffer

Intervention Type OTHER

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.

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Buffer

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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

4 Weeks

Maximum Eligible Age

8 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes