Investigating the Mortality and the Morbidity Impact of Oral Polio Vaccine at Birth

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Bandim Health Project
ClinicalTrials.gov Identifier:
NCT00710983
First received: July 3, 2008
Last updated: November 14, 2013
Last verified: November 2013
  Purpose

Our group has discovered that routine vaccinations in childhood may have non-specific and sex-differential effects on overall mortality. The effects are so large that they may have marked effects on overall mortality and seriously distort female-to-male mortality rates in high-mortality settings. We recently experienced periods during which oral polio vaccine (OPV) was lacking. Hence, some children did not get the recommended OPV at birth. We were following all infants as a part of a vitamin A supplementation trial. Surprisingly, we discovered that not receiving OPV was associated with significantly lower mortality in boys, but not in girls. We bled a subgroup of the children. Receiving OPV at birth significantly dampened the immunological response to BCG given at birth in both sexes. Based on these observations, receiving OPV at birth may have two negative effects, first, it may increase male mortality, and second, it may interfere with immunity against tuberculosis. OPV at birth is given for logistic reasons, to boost polio immunity. There have been no polio cases in Guinea-Bissau for the last 10 years. Hence, there is every reason to test in a randomised trial whether not receiving OPV at birth is associated with 1) mortality, morbidity and growth and 2) immunological response to BCG.


Condition Intervention
Infant, Newborn
Healthy
Biological: Oral polio vaccine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Investigating the Mortality and the Morbidity Impact of Oral Polio Vaccine at Birth

Resource links provided by NLM:


Further study details as provided by Bandim Health Project:

Primary Outcome Measures:
  • Mortality by sex

Secondary Outcome Measures:
  • Morbidity, growth, immunology

Study Start Date: July 2008
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Oral polio vaccine
Biological: Oral polio vaccine
No Intervention: B
No oral polio vaccine

  Eligibility

Ages Eligible for Study:   up to 1 Month
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:Normal birth weight, no overt illness or gross malformations -

Exclusion Criteria:

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00710983

Locations
Guinea-Bissau
Bandim Health Project
Bissau, Guinea-Bissau
Sponsors and Collaborators
Bandim Health Project
Investigators
Principal Investigator: Peter Aaby, DMSc Bandim Health Project
  More Information

No publications provided

Responsible Party: Peter Aaby, Bandim Health Project
ClinicalTrials.gov Identifier: NCT00710983     History of Changes
Other Study ID Numbers: 2008-7041-122
Study First Received: July 3, 2008
Last Updated: November 14, 2013
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by Bandim Health Project:
Mortality
Morbidity
Growth
Immunology

ClinicalTrials.gov processed this record on April 17, 2014