None listed
Conditions
Brief 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.
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)
Sponsors
World Health Organization
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)
Eligibility
Sex/Gender
Male
Age
18 Years to 24 Years
Healthy volunteers
Yes
Inclusion criteria
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 criteria
Temporary exclusion criteria for vaccination: - If body temperature >=38C this will lead to postponement of participation and vaccination. Screening may continue when the temperature has normalized. The exclusion criteria for vaccination are: - 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 The exclusion criteria for blood collections are: - Bleeding disorders or the usage of anticoagulants
Outcome results
None listed