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

Primary Purpose

Polio

Status
Completed
Phase
Not Applicable
Locations
Bangladesh
Study Type
Interventional
Intervention
Buffer
Sponsored by
Johns Hopkins Bloomberg School of Public Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Polio

Eligibility Criteria

4 Weeks - 8 Weeks (Child)All SexesAccepts 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Buffer

Control

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 16, 2012
Last Updated
April 24, 2013
Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
World Health Organization
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1. Study Identification

Unique Protocol Identification Number
NCT01579825
Brief Title
Evaluation of Buffer on Immune Response to Oral Polio Vaccine (OPV) in Bangladesh
Official Title
Evaluation of the Effect of Buffer on the Immune Response to Oral Poliovirus Vaccine in Bangladesh: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
World Health Organization

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polio

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Buffer
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Buffer
Intervention Description
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.
Primary Outcome Measure Information:
Title
Serologic response
Description
Serologic response rate for each polio virus serotype (1, 2, and 3) in OPV.
Time Frame
4 weeks after last dose of OPV

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Weeks
Maximum Age & Unit of Time
8 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neal A Halsey, MD
Organizational Affiliation
Johns Hopkins Bloomberg School of Public Health
Official's Role
Principal Investigator
Facility Information:
City
Sylhet
Country
Bangladesh

12. IPD Sharing Statement

Citations:
PubMed Identifier
25316860
Citation
Chandir S, Ahamed KU, Baqui AH, Sutter RW, Okayasu H, Pallansch MA, Oberste MS, Moulton LH, Halsey NA. Effect of buffer on the immune response to trivalent oral poliovirus vaccine in Bangladesh: a community based randomized controlled trial. J Infect Dis. 2014 Nov 1;210 Suppl 1:S390-7. doi: 10.1093/infdis/jiu378.
Results Reference
derived

Learn more about this trial

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

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