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

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ClinicalTrials.gov Identifier: NCT01579825
Recruitment Status : Completed
First Posted : April 18, 2012
Last Update Posted : April 25, 2013
Sponsor:
Collaborator:
World Health Organization
Information provided by (Responsible Party):
Johns Hopkins Bloomberg School of Public Health

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.


Condition or disease Intervention/treatment Phase
Polio Other: Buffer Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluation of the Effect of Buffer on the Immune Response to Oral Poliovirus Vaccine in Bangladesh: a Randomized Controlled Trial
Study Start Date : April 2012
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Buffer 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.
No Intervention: Control



Primary Outcome Measures :
  1. Serologic response [ Time Frame: 4 weeks after last dose of OPV ]
    Serologic response rate for each polio virus serotype (1, 2, and 3) in OPV.



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Ages Eligible for Study:   up to 8 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01579825


Locations
Bangladesh
Sylhet, Bangladesh
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
World Health Organization
Investigators
Principal Investigator: Neal A Halsey, MD Johns Hopkins Bloomberg School of Public Health

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT01579825     History of Changes
Other Study ID Numbers: IRB00003717
First Posted: April 18, 2012    Key Record Dates
Last Update Posted: April 25, 2013
Last Verified: April 2012