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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00710983
• Other study ID #: 2008-7041-122
• Status: Active, not recruiting
• Phase: N/A
• First received: July 3, 2008
• Last updated: November 14, 2013
• Start date: July 2008
• Est. completion date: January 2015

Study information

• Verified date: November 2013
• Source: Bandim Health Project
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Est. completion date: January 2015
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 1 Month

Eligibility

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

Exclusion Criteria:

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Healthy
• Infant, Newborn

Intervention

Biological:
• Oral polio vaccine

Locations

Country	Name	City	State
Guinea-Bissau	Bandim Health Project	Bissau

Sponsors (1)

Lead Sponsor	Collaborator
Bandim Health Project

Country where clinical trial is conducted

Guinea-Bissau, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality by sex
Secondary	Morbidity, growth, immunology