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

Johns Hopkins Bloomberg School of Public Health

Status: Completed

Conditions: Polio

Treatments: Other: Buffer

Study type: Interventional

Funder types: Other

Identifiers

NCT01579825

IRB00003717

Details and patient eligibility

About

Hypothesis:

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

Full 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.

Enrollment: 300 patients

Sex: All

Ages: 4 to 8 weeks old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Buffer

Experimental group

Treatment:

Other: Buffer

Control

No Intervention group