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

NCT00710983 | Unknown

• 1 other identifier: 2008-7041-122
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Infant, Newborn; Healthy

Keywords

Mortality; Morbidity; Growth; Immunology

Outcome Measures

Primary Outcomes (1)

• Mortality by sex

Secondary Outcomes (1)

• Morbidity, growth, immunology

Study Arms (2)

A

ACTIVE COMPARATOR

Oral polio vaccine

Biological: Oral polio vaccine

B

NO INTERVENTION

No oral polio vaccine

Interventions

Oral polio vaccine BIOLOGICAL

A

Eligibility Criteria

• Age: Up to 1 Month
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

Sponsors & Collaborators

• Bandim Health Project: lead

Study Sites (1)

Bandim Health Project

Bissau, Guinea-Bissau

Location

Related Publications (2)

• Lund N, Andersen A, Hansen AS, Jepsen FS, Barbosa A, Biering-Sorensen S, Rodrigues A, Ravn H, Aaby P, Benn CS. The Effect of Oral Polio Vaccine at Birth on Infant Mortality: A Randomized Trial. Clin Infect Dis. 2015 Nov 15;61(10):1504-11. doi: 10.1093/cid/civ617. Epub 2015 Jul 28.

  PMID: 26219694 DERIVED

• Eriksen HB, Biering-Sorensen S, Lund N, Correia C, Rodrigues A, Andersen A, Ravn H, Aaby P, Jeppesen DL, Benn CS. Factors associated with thymic size at birth among low and normal birth-weight infants. J Pediatr. 2014 Oct;165(4):713-21. doi: 10.1016/j.jpeds.2014.06.051. Epub 2014 Jul 30.

  PMID: 25085521 DERIVED

MeSH Terms

Interventions

Poliovirus Vaccine, Oral

Intervention Hierarchy (Ancestors)

Poliovirus Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Peter Aaby, DMSc

  Bandim Health Project

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 3, 2008
• First Posted: July 8, 2008
• Study Start: July 1, 2008
• Primary Completion: June 1, 2014
• Study Completion: January 1, 2015
• Last Updated: November 15, 2013

Record last verified: 2013-11

Locations

GU (1)