Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000169448
Ethics application status
Approved
Date submitted
4/12/2015
Date registered
10/02/2016
Date last updated
10/02/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Role of oral and inactivated poliovitus vaccines in inducing mucosal immunity - a trial in small children in Cuba
Scientific title
Comparison of mucosal immunity against polioviruses induced by inactivated poliovirus vaccine alone or in combination with bivalent oral poliovirus vaccine - a trial in small children in Cuba
Secondary ID [1] 288077 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
poliomyelitis 296941 0
Condition category
Condition code
Infection 297187 297187 0 0
Other infectious diseases
Public Health 297470 297470 0 0
Epidemiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
IPV: one dose (0.5 ml) of Inactivated poliovirus vaccine administered intramuscularly; tOPV: one dose (2 drops) of trivalent oral poliovirus vaccine administered orally; bOPV: one dose (2 drops) of bivalent poliovirus vaccine administered orally; all vaccines administered on-site by study staff

All Arms: blood collection at enrollment, 30 and 60 days post enrollment; stool collection 30, 37, 44 and 51 days post enrollment

Arm 1: IPV at enrollment; tOPV 30 days post enrollment
Arm 2: IPV+bOPV at enrollment, tOPV 30 days post enrollment
Arm 3: no vaccine at enrollment, tOPV 30 days post enrollment
Intervention code [1] 293388 0
Prevention
Comparator / control treatment
Arm 3 is reference arm.
Control group
Active

Outcomes
Primary outcome [1] 296792 0
difference in poliovirus shedding in stool
Timepoint [1] 296792 0
7 days after tOPV dose
Secondary outcome [1] 319371 0
difference in dynamic of poliovirus shedding after tOPV dose assessed by virus isolation in stool on days 14, 21 and 42 after tOPV dose
Timepoint [1] 319371 0
14, 21 and 42 days after tOPV challenge

Eligibility
Key inclusion criteria
Healthy infants born between June 1 and August 31, 2015 (>3rd percentile for height and weight) at enrollment living within the catchment’s area of the participating health centers will be eligible for enrollment to Arms 1 and 2.
Healthy infants born between November 1 and December 31, 2015 (>3rd percentile for height and weight) at enrollment living within the catchment’s area of the participating health centers will be eligible for enrollment to Arm 3.
Minimum age
3 Months
Maximum age
7 Months
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Infants <3 percentile for height and weight, residence outside the catchment’s area, or families expecting to move away during the study period, will be excluded. A diagnosis, suspicion or treatment of immunodeficiency disorder (either in the participant or in a member of the immediate family) will render the child ineligible for the study. Infants of mother age below legal age (<18 years) or with mentally incapacity will not be eligible to participate.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/02/2016
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment outside Australia
Country [1] 7394 0
Cuba
State/province [1] 7394 0
Camaguey

Funding & Sponsors
Funding source category [1] 292507 0
Other
Name [1] 292507 0
WHO
Country [1] 292507 0
Switzerland
Primary sponsor type
Other
Name
WHO
Address
World Health Organization
Avenue Appia 20
CH-1211 Geneva 27 Suisse
Country
Switzerland
Secondary sponsor category [1] 291216 0
None
Name [1] 291216 0
Address [1] 291216 0
Country [1] 291216 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293982 0
ERC Ministry of Health, Cuba
Ethics committee address [1] 293982 0
World Health Organization
Avenue Appia 20
CH-1211 Geneva 27 Suisse
Ethics committee country [1] 293982 0
Cuba
Date submitted for ethics approval [1] 293982 0
07/12/2015
Approval date [1] 293982 0
08/01/2016
Ethics approval number [1] 293982 0

Summary
Brief summary
This trial will assess whether inactivated polio vaccine given as an injection together with a live polio vaccine given orally is capable of inducing immunity against poliovirus in the intestinal mucosal space (so called mucosal immunity); this knowledge will be important when deciding on outbreak response strategies in cases of poliovirus outbreaks because only mucosal immunity is capable of stopping an outbreak by preventing infected individuals from excreting poliovirus in stool and infecting others
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 61990 0
Dr Sonia Resik
Address 61990 0
Autopista Novia del Mediodia, KM 6 1/2 La Lisa, La Habana, CUBA
Country 61990 0
Cuba
Phone 61990 0
+53 72553550
Fax 61990 0
Email 61990 0
sresik@ipk.sld.cu
Contact person for public queries
Name 61991 0
Dr Ondrej Mach
Address 61991 0
World Health Organization
Avenue Appia 20
CH-1211 Geneva 27 Suisse
Country 61991 0
Switzerland
Phone 61991 0
+41227911863
Fax 61991 0
Email 61991 0
macho@who.int
Contact person for scientific queries
Name 61992 0
Dr ondrej mach
Address 61992 0
World Health Organization
Avenue Appia 20
CH-1211 Geneva 27 Suisse
Country 61992 0
Switzerland
Phone 61992 0
+41227911863
Fax 61992 0
Email 61992 0
macho@who.int

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseDoes Simultaneous Administration of Bivalent (Types 1 and 3) Oral Poliovirus Vaccine and Inactivated Poliovirus Vaccine Induce Mucosal Cross-immunity to Poliovirus Type 2?.2018https://dx.doi.org/10.1093/cid/ciy604
N.B. These documents automatically identified may not have been verified by the study sponsor.