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

This study has been completed.
Sponsor:
Collaborator:
World Health Organization
Information provided by (Responsible Party):
Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT01579825
First received: April 16, 2012
Last updated: April 24, 2013
Last verified: April 2012
  Purpose

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 Intervention
Polio
Other: Buffer

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Johns Hopkins Bloomberg School of Public Health:

Primary Outcome Measures:
  • Serologic response [ Time Frame: 4 weeks after last dose of OPV ] [ Designated as safety issue: No ]
    Serologic response rate for each polio virus serotype (1, 2, and 3) in OPV.


Enrollment: 300
Study Start Date: April 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   up to 8 Weeks
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT01579825     History of Changes
Other Study ID Numbers: IRB00003717
Study First Received: April 16, 2012
Last Updated: April 24, 2013
Health Authority: United States: Institutional Review Board
United Nations: World Health Organization
Bangladesh: Bangladesh Medical Research Council

Additional relevant MeSH terms:
Poliomyelitis
Myelitis
Central Nervous System Viral Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Neuromuscular Diseases

ClinicalTrials.gov processed this record on August 28, 2014