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Trial registered on ANZCTR


Trial ID
ACTRN12612000465853
Ethics application status
Approved
Date submitted
27/03/2012
Date registered
27/04/2012
Date last updated
27/04/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Safety and immune response of polio vaccines in healthy adults
Scientific title
Safety and Immunogenicity of Sabin-IPV and adjuvanted Sabin-IPV in healthy adults
Secondary ID [1] 280162 0
Nil known
Universal Trial Number (UTN)
U1111-1128-9786
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Poliomyelitis 286087 0
Condition category
Condition code
Infection 286281 286281 0 0
Other infectious diseases
Public Health 286365 286365 0 0
Epidemiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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)
Intervention code [1] 284489 0
Prevention
Comparator / control treatment
Controls will receive a single intramuscular injection with 0.5 ml of the following vaccine:

Control group: conventional (Salk-)IPV (40:8:32 DU/dose)
Control group
Active

Outcomes
Primary outcome [1] 286747 0
The primary endpoint for safety are the number and intensity of local and systemic adverse reactions.

1) Local reactions at injection site:
- Pain (Intensity: Mild to severe)
- Impaired movement of injected arm/leg (Intensity: Mild to severe)
- Redness/erythemia (Greatest diameter)
- Swelling (Greatest diameter)
- Solid disk underneath skin (Induration) (Greatest diameter)

2) General/systemic adverse events:
- Fever (Absolute temperature measured)(Intensity: Mild to severe)
- Headache (Intensity: Mild to severe)
- Fatigue (Intensity: Mild to severe)
- Muscle pain (myalgia) (Intensity: Mild to severe)
- Other adverse events (Nature and Intensity: Mild to severe)
Timepoint [1] 286747 0
Subjects will be observed during the first 30 minutes after vaccination in order to record the occurrence of acute reactions. A diary will be given to each subject for reporting of adverse events in the first four days after vaccination. The diary should be completed by the subject at 4-6 and 24 hours post-vaccination, and then every 24 hours during the first four days after vaccination or until adverse events have been resolved or further follow-up is not deemed necessary by the investigator. Serious adverse events will be reported until 6 months after vaccination.
Secondary outcome [1] 296584 0
The endpoint for immunogenicity is the level of neutralizing antibodies in serum (geometric mean titer (GMT)).
Timepoint [1] 296584 0
At 28 days after vaccination.

Eligibility
Key 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
Minimum age
18 Years
Maximum age
24 Years
Gender
Males
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A subject who fulfills all of the inclusion criteria and none of the exclusion criteria will be given a subject number. This number will correspond to a vaccination group in the randomization list produced by the statistician. Subjects will be randomly assigned in a 1:1:1 ratio to one of the vaccination groups (Salk-IPV, Sabin-IPV, or adjuvanted Sabin-IPV).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization will be performed using SAS version 9.1.3. SAS procedure plan will be used to randomly assign treatment to subject numbers with an appropriate block size. The output of this procedure will be used to prepare the randomization list. Subject numbers will be printed on the label of each vial with Investigational Medicinal Product (IMP). Each subject will receive a vial with his own subject number. If a vial is broken, the subject will be given the next number in the series and will get the corresponding vile.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 4206 0
Cuba
State/province [1] 4206 0
Camaguey

Funding & Sponsors
Funding source category [1] 284974 0
Other
Name [1] 284974 0
World Health Organization
Address [1] 284974 0
Avenue Appia 20
Geneva
CH-1211
Country [1] 284974 0
Switzerland
Primary sponsor type
Other
Name
World Health Organization
Address
Avenue Appia 20
Geneva
CH-1211
Country
Switzerland
Secondary sponsor category [1] 283841 0
None
Name [1] 283841 0
Address [1] 283841 0
Country [1] 283841 0
Other collaborator category [1] 260658 0
Other
Name [1] 260658 0
Instituto Pedro Kouri (IPK)
Address [1] 260658 0
Autopista Novia del Mediodia km 61/2 entre
Autopista Nacional y Carretera Central.
La Lisa, Ciudad Habana, Cuba
Country [1] 260658 0
Cuba

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286980 0
WHO Research Ethics Review Committee (WHO ERC)
Ethics committee address [1] 286980 0
Avenue Appia, 20
CH-1211 Geneva 27
Ethics committee country [1] 286980 0
Switzerland
Date submitted for ethics approval [1] 286980 0
14/10/2011
Approval date [1] 286980 0
06/02/2012
Ethics approval number [1] 286980 0
RPC446
Ethics committee name [2] 286983 0
IPK Ethics Committee
Ethics committee address [2] 286983 0
P.O. Box: 601 Marianao 13
Habana
Ethics committee country [2] 286983 0
Cuba
Date submitted for ethics approval [2] 286983 0
Approval date [2] 286983 0
06/12/2011
Ethics approval number [2] 286983 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33936 0
Address 33936 0
Country 33936 0
Phone 33936 0
Fax 33936 0
Email 33936 0
Contact person for public queries
Name 17183 0
Dr. Roland Sutter
Address 17183 0
Coordinator HQ/RAP Research, Policy and Product Development
World Health Organization
Avenue Appia 20,
Geneva CH-1211
Country 17183 0
Switzerland
Phone 17183 0
+41 22 79 14682
Fax 17183 0
Email 17183 0
sutterr@who.int
Contact person for scientific queries
Name 8111 0
Dr. Roland Sutter
Address 8111 0
Coordinator HQ/RAP Research, Policy and Product Development
World Health Organization
Avenue Appia 20,
Geneva CH-1211
Country 8111 0
Switzerland
Phone 8111 0
+41 22 79 14682
Fax 8111 0
Email 8111 0
sutterr@who.int