Safety and immune response of polio vaccines in healthy adults
Safety and Immunogenicity of Sabin-IPV and adjuvanted Sabin-IPV in healthy adults
World Health Organization
30 participants
May 1, 2012
Interventional
Conditions
Summary
Rationale: To increase availability of inactivated poliovirus vaccines for developing countries for an acceptable price it is important that vaccines can be produced locally. Production of IPV based on wild poliovirus strains (Salk-IPV) has a high biosafety risk and is less suitable for local production in lower- and middle income countries. Netherlands Vaccine Institute is developing the production process of an inactivated poliovirus vaccine based on the attenuated Sabin-strains (Sabin-IPV) suitable for up scaling, training, and technology transfer to manufacturers in lower- and middle income countries. Objective: The main objective is safety evaluation of Sabin-IPV. The secondary objective is assessment of immunogenicity of Sabin-IPV in immunized adults.
Eligibility
Inclusion Criteria8
- Subjects must fulfill all of the following criteria:
- University student attending the Faculty of Chemistry and Pharmacology, Camaguey University, Camaguey
- Age 18 to 24, inclusive at the time of enrollment
- In good health as determined by the outcome of medical history, physical examination screening/baseline labs, and clinical judgment of the investigator
- Must have received polio vaccinations with OPV according to the Cuban National Immunization Program as a child
- Preferred: number (and date) of polio vaccinations known
- Willingness and ability to adhere to the study regimen
- Having a signed informed consent form
Exclusion Criteria16
- If body temperature >=38C this will lead to postponement of participation and vaccination. Screening may continue when the temperature has normalized.
- IPV or OPV booster dose after the age of 12 years
- Known or suspected allergy against any of the vaccine components
- History of unusual or severe reactions to any previous vaccination
- Known or suspected disease or use of medication that may influence the immune system
- Known or suspected immune deficiency
- Systemic treatment with corticosteroids within one month before screening
- Administration of plasma (including immunoglobulins) or blood products three months prior to the study
- Blood donation within one month before screening
- Any vaccination within three months before screening and during the study until the last visit
- History of any neurological disorder including epilepsy or febrile seizures
- Evidence of excessive alcohol use or drug use
- Any infectious disease
- Participation in another clinical trial within three months before screening
- Abnormal pre-treatment laboratory parameters which are clinically relevant according to the investigator
- Bleeding disorders or the usage of anticoagulants
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Subjects will receive a single intramuscular injection with 0.5 ml of one of the following vaccines: Arm 1: Sabin-IPV (20:32:64 DU/dose) Arm 2: Adjuvanted Sabin-IPV (10:16:32 DU/dose)
Locations(1)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12612000465853