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

NCT ID: NCT00710983

Last Updated: 2013-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2015-01-31

Brief Summary

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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

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Conditions

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Infant, Newborn Healthy

Keywords

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Mortality Morbidity Growth Immunology

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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A

Oral polio vaccine

Group Type ACTIVE_COMPARATOR

Oral polio vaccine

Intervention Type BIOLOGICAL

B

No oral polio vaccine

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Oral polio vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

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Exclusion Criteria

\-
Maximum Eligible Age

1 Month

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bandim Health Project

OTHER

Sponsor Role lead

Responsible Party

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Bandim Health Project

Principal Investigators

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Peter Aaby, DMSc

Role: PRINCIPAL_INVESTIGATOR

Bandim Health Project

Locations

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Bandim Health Project

Bissau, , Guinea-Bissau

Site Status

Countries

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Guinea-Bissau

References

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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.

Reference Type DERIVED
PMID: 26219694 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25085521 (View on PubMed)

Other Identifiers

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2008-7041-122

Identifier Type: -

Identifier Source: org_study_id