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CompletedPhase 4ACTRN12615000305527

Comparison of immune response of fractional doses, administered intradermally vs. full doses administered intramuscularly of inactivated poliovirus vaccine (IPV) in male adults in Camaguey, Cuba.

Sponsor

World Health Organization

Enrollment

600 participants

Start Date

Dec 4, 2014

Study Type

Interventional

Conditions

Poliomyelitis

Summary

To demonstrate the non-inferiority of boosting immune responses after administration of one and two intradermal IPV doses compared with one and two intramuscular IPV doses in healthy adults with history of vaccination with at least one dose of OPV.

Eligibility

Sex: MalesMin Age: 18 YearssMax Age: 30 Yearss

Inclusion Criteria5

  • Subjects have to fulfill all of the following criteria:
  • Males age 18 to 30, inclusive at the time of enrollment; and
  • in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator; and
  • must have received polio vaccinations with at least one dose of OPV according to the Cuban National Immunization Program as a child; and
  • willing to sign an informed consent form.

Exclusion Criteria15

  • IPV or OPV booster dose after the age of 12 years; or
  • Known or suspected exposure to wild poliovirus
  • known or suspected allergy against any of the vaccine components; or
  • history of unusual or severe reactions to any previous vaccination; or
  • known or suspected disease or use of medication that may influence the immune system; or
  • known or suspected immune deficiency, and/or known HIV infection; or
  • systemic treatment with corticosteroids or immunosuppressant within one month before screening or during the study; or
  • administration of plasma (including immunoglobulins) or blood products three months prior to the study during the study; or
  • blood donation within one month before screening; or
  • any vaccination within three months before screening and during the study until the last visit; or
  • history of any neurological disorder including epilepsy or febrile seizures; or
  • evidence of excessive alcohol use or drug use; or
  • any infectious disease; or
  • participation in another clinical trial within three months before enrollment.
  • Bleeding disorders or the usage of anticoagulants.

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Interventions

Subjects will receive two doses of intradermal injection of Salk IPV (20:32:64 DU/dose) 0.1 ml, 1 month apart

Subjects will receive two doses of intradermal injection of Salk IPV (20:32:64 DU/dose) 0.1 ml, 1 month apart

Locations(1)

Camaguey, Cuba

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ACTRN12615000305527

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