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CompletedNCT01579825Updated Apr 25, 2013

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

An interventional study of Buffer in Polio, sponsored by Johns Hopkins Bloomberg School of Public Health. Completed at 1 site in Bangladesh. Open to participants aged 4 Weeks to 8 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-04-25.

Sponsored by Johns Hopkins Bloomberg School of Public Health · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
4 Weeks to 8 Weeks
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Polio

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03

In context

Poliomyelitis

222 studies on the registry are indexed under Poliomyelitis; 11 are open to participants now.

This study's enrollment of 300 is below the median of 456 across 199 interventional studies indexed under Poliomyelitis.

Browse Poliomyelitis studies →

Lead sponsor

Johns Hopkins Bloomberg School of Public Health is the lead sponsor of 364 studies on the registry; 41 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
4 Weeks to 8 Weeks
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
300 participants (actual)

Study arms

  • Experimental
    Buffer

    Other: Buffer

  • No intervention
    Control

Interventions

  • OtherBuffer

    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.

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What researchers measure

Primary outcomes

  1. Serologic response

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

    Time frame: 4 weeks after last dose of OPV

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Study locations

1 site
  • Sylhet, Bangladesh
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References and documents

Publications

  • 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. PubMed 25316860 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 25, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01579825
Lead sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
World Health Organization
Responsible party
Sponsor
First posted
Apr 18, 2012
Start date
Apr 2012
Primary completion
Dec 2012
Completion
Dec 2012
Last update
Apr 25, 2013

Study contacts

Neal A Halsey, MD
principal investigator · Johns Hopkins Bloomberg School of Public Health

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.

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