NCT01579825

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

April 16, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 18, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

April 25, 2013

Status Verified

April 1, 2012

Enrollment Period

8 months

First QC Date

April 16, 2012

Last Update Submit

April 24, 2013

Conditions

Polio

Outcome Measures

Primary Outcomes (1)

  • Serologic response

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

    4 weeks after last dose of OPV

Study Arms (2)

Buffer

EXPERIMENTAL
Other: Buffer

Control

NO INTERVENTION

Interventions

BufferOTHER

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.

Buffer

Eligibility Criteria

Age4 Weeks - 8 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • infants who are 4-8 weeks old
  • residents of study area

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Sylhet, Bangladesh

Location

Related Publications (1)

  • 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.

    PMID: 25316860DERIVED

MeSH Terms

Conditions

Poliomyelitis

Interventions

Buffers

Condition Hierarchy (Ancestors)

MyelitisCentral Nervous System InfectionsInfectionsEnterovirus InfectionsPicornaviridae InfectionsRNA Virus InfectionsVirus DiseasesCentral Nervous System DiseasesNervous System DiseasesSpinal Cord DiseasesNeuroinflammatory DiseasesNeuromuscular Diseases

Intervention Hierarchy (Ancestors)

Laboratory ChemicalsSpecialty Uses of ChemicalsChemical Actions and Uses

Study Officials

  • Neal A Halsey, MD

    Johns Hopkins Bloomberg School of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2012

First Posted

April 18, 2012

Study Start

April 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

April 25, 2013

Record last verified: 2012-04

Locations

BA(1)