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.
- Conditions
- PoliomyelitisInfection - Other infectious diseasesPublic Health - Epidemiology
- Registration Number
- ACTRN12615000305527
- Lead Sponsor
- World Health Organization
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 600
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.
The exclusion criteria for vaccination are
* 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint is a boosting immune response, defined as the proportion (%) of subjects with a change from seronegative (reciprocal titer of less than 1:8 dilution) to seropositive after vaccine administration or an increase of four times or more in reciprocal titer for seropositive subjects (those with baseline reciprocal titer greater than 1:8)[At day 0 (baseline; visit 1), day 7 (after single dose; visit 2), day 28 (after single dose; visit 3) and day 56 (after two doses; visit 4)]
- Secondary Outcome Measures
Name Time Method The safety will be assessed by the number and intensity of local (e.g. redness, swelling ,infection) and systemic adverse reactions (e.g. fever)[Subjects will be observed during the first 60 minutes after vaccination in order to record the occurrence of acute reactions. <br>A diary will be given to each subject for reporting of adverse events in the first seven days after vaccination. Follow-up is done at 24 hours, 48 hours, 72 hours, and 7 days after vaccination]