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

Polio Clinical Trial

Official title:

Evaluation of the Effect of Buffer on the Immune Response to Oral Poliovirus Vaccine in Bangladesh: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01579825
• Other study ID #: IRB00003717
• Status: Completed
• Phase: N/A
• First received: April 16, 2012
• Last updated: April 24, 2013
• Start date: April 2012
• Est. completion date: December 2012

Study information

• Verified date: April 2012
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited Nations: World Health OrganizationBangladesh: Bangladesh Medical Research Council
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 8 Weeks

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Polio

Intervention

Other:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health	World Health Organization

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serologic response	Serologic response rate for each polio virus serotype (1, 2, and 3) in OPV.	4 weeks after last dose of OPV	No