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

Not Applicable

• Conditions: Healthy; Infant, Newborn
• Interventions: Biological: Oral polio vaccine

• Registration Number: NCT00710983
• Lead Sponsor: Bandim Health Project

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-07-03
• Study First Submitted QC: 2008-07-07
• Study First Posted: 2008-07-08
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-14
• Last Update Posted: 2013-11-15
• Primary Completion: 2014-06
• Study Completion: 2015-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Normal birth weight, no overt illness or gross malformations -

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Oral polio vaccine	Oral polio vaccine

Primary Outcome Measures

Name	Time	Method
Mortality by sex

Secondary Outcome Measures

Name	Time	Method
Morbidity, growth, immunology

Trial Locations

Locations (1)

Bandim Health Project; 🇬🇼 Bissau, Guinea-Bissau