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OpenTrials
Completed

NCT Number: NCT01579825

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

Hypothesis:

The immunogenicity of oral polio vaccine (OPV) will be enhanced in Bangladeshi infants who receive bicarbonate buffer at the time of polio immunization.

Completed

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Key information

Conditions

Polio Central Nervous System Diseases Central Nervous System Infections Enterovirus Infections Infections Myelitis Nervous System Diseases Neuroinflammatory Diseases Neuromuscular Diseases Picornaviridae Infections Poliomyelitis RNA Virus Infections Spinal Cord Diseases Virus Diseases

Age range

4 week–8 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sylhet, Bangladesh

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Buffer

Other

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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins Bloomberg School of Public Health

Other

Collaborators

  • World Health Organization

Registry information

Official study title

Evaluation of the Effect of Buffer on the Immune Response to Oral Poliovirus Vaccine in Bangladesh: a Randomized Controlled Trial

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Apr 18, 2012
Registry last updated
Apr 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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