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Trial registered on ANZCTR


Registration number
ACTRN12610000525088
Ethics application status
Approved
Date submitted
22/06/2010
Date registered
25/06/2010
Date last updated
6/12/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Phase 1 randomized study to compare the safety and immune response of an oral rotavirus vaccine, RV3-BB, and placebo for the prevention of rotavirus disease in infants, children and male adults.
Scientific title
A Phase 1 double-blind, randomized study to compare the safety, tolerability and immunogenicity of oral RV3-BB Rotavirus vaccine and Placebo in infants, children and male adults.
Secondary ID [1] 252080 0
Murdoch Childrens Research Institute: MCRI-RV3-BB-001
Universal Trial Number (UTN)
U1111-1115-5828
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rotavirus gastroenteritis 257626 0
Condition category
Condition code
Public Health 257799 257799 0 0
Epidemiology
Infection 257824 257824 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Each 1 ml of live attenuated human rotavirus vaccine, RV3-BB, (at a concentration of 8.3 x 10^6 focus formatting units (FFU)/ml) is a cell free solution containing attenuated rotavirus particles in a 10% sucrose/cell culture medium.
When vaccine administered: Cohort 1: 1 ml oral dose administered once to male adults aged 18-50 years inclusive; Cohort 2: 1 ml oral dose administered once to male and female children aged 3-8 years inclusive; Cohort 3: 1 ml oral dose administered once to male and female infants aged 6-8 weeks inclusive.
Mode of administration: Oral sterile aqueous solution for oral administration.
Intervention code [1] 256704 0
Prevention
Comparator / control treatment
Placebo consisting of 1 ml sterile solution of cell culture medium and 10%sucrose
Control group
Placebo

Outcomes
Primary outcome [1] 258667 0
1. To assess the safety and tolerability of RV3-BB Vaccine (8.3 x 106 focus formatting units (FFU/ml)) in 3 age groups (adult males [18-50 years]; children [3-8 years] and infants [6-8 weeks]) compared to Placebo. Possible adverse events include:gastrointestinal events ie nausea, vomiting/possetting, diarrhoea/loose bowel actions, colic, abdominal discomfort/pain/cramps or systemic events, including unsettled/irritability, decreased appetite, arthalgia, headache and fever requiring antipyretic medication.
Timepoint [1] 258667 0
Safety will be assessed at day 7 and day 28 after vaccine administration. Solicited local and systemic adverse events (AE's) recorded until day 7 after vaccine administration and serious adverse events (SAE's) recoded until day 28.
Secondary outcome [1] 264644 0
1. To assess the effect of a single dose of RV3-BB Rotavirus Vaccine upon serologic markers of rotavirus immunity (immunoglobulin G (IgG) and immunoglobulin A (IgA), neutralising antibodies (NA's)).
Timepoint [1] 264644 0
Immunogenicity will be assessed at day 7 and day 28 after vaccine administration.
Secondary outcome [2] 264645 0
2. To determine the presence of RV3-BB Rotavirus Vaccine in faecal extracts, as a marker of viral replication.
Timepoint [2] 264645 0
Immunogenicity will be assessed at day 7 and day 28 after vaccine administration.

Eligibility
Key inclusion criteria
1. Must fit one of the age cohorts at the time of randomisation:
(a) Cohort 1: adult males, aged between 18 and 50 years inclusive; or
(b) Cohort 2: children (males and females) aged 3-8 years inclusive; or
(c) Cohort 3: infants (males and females) aged 6-8 weeks inclusive.
2. Participants must be in good health as determined by a baseline (Screening) medical history, physical examination, and haematology and clinical chemistry parameters which confirm the absence of a current or past significant disease state, and clinical judgement;
3. Participant or parent(s)/guardian(s) will be available for the duration of the study, and agrees to adhere to all protocol requirements;
4. Participant or parent(s)/guardian(s) have provided written informed consent prior to undergoing any study-related procedures;
5. Adult male participants must use a reliable method of contraception (i.e., condoms or abstinence) for the duration of the study, or be infertile or surgically sterile (e.g., as a result of vasectomy);
6. Participants must be able to provide a pre-vaccination sample of venous blood (up to 10 ml adults/10 ml children/5 ml infants) for safety and immunogenicity purposes.
Minimum age
6 Weeks
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Participants with a previous history of intussusception or other significant gastrointestinal disease;
- Participants with previous laboratory confirmed disease caused by rotavirus;
- Known or suspected disease of the immune system;
- Receipt of blood products within 12 weeks prior to study entry;
- Bleeding diathesis or condition associated with prolonged bleeding time;
- Significant evolving neurological disorder;
- Major known congenital malformation or genetically determined disease;
- Previous anaphylactic reaction to any vaccine or vaccine component;
- Participants for whom there is intent during the Study Period to immunise with any investigational or licensed vaccine (including live attenuated, inactivated or subunit vaccines) other than those specified in the protocol
- Previous vaccination with a Rotavirus Vaccine;
- Contraindication to immunisation with DTaP, DTP/Hib, Pnc7 or IPV/OPV;
- Participation in another investigational study;
- Murdoch Childrens Research Institute (MCRI), Royal Childrens Hospital (RCH), Royal Womens Hospital (RWH) employees with direct involvement with the study investigators or with direct involvement in the study.

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)
Potential study participants or parent(s)/guardian(s) will be required to provide written informed consent prior to any study-specific screening procedures being performed. Approximately 60 participants will be randomised to the study. Twenty participants will be randomised to each age cohort. The three age cohorts are:
1. Cohort 1 (adult males aged 18-50 years);
2. Cohort 2 (children aged 3-8 years);
3. Cohort 3 (infants aged 6-8 weeks).
Within each age cohort, participants will be randomised to one of two treatment groups, RV3-BB Rotavirus Vaccine (at a dose of 8.3 x 106 FFU/ml) or Placebo in a ratio of 1:1. Allocation concealment was done by RCH pharmacy with over labeling of the study vaccine. RCH Pharmacy received the randomization code from Trident Clinical research.
The study will proceed in three stages to ensure the safety of the participants. Commencing with Cohort 1, the 20 participants will be recruited and undergo study procedures. A safety review of the data for all 20 participants up to and including Day 28 will be conducted by an independent Data Safety Monitoring Board (DSMB). Assuming an acceptable safety profile is achieved at this time, the study will proceed to recruit the next age cohort. The procedure for the safety review between Cohorts 2 & 3 will proceed as described for progression from Cohort 1 to Cohort 2.
The total study period for each participant will be 4-5 weeks, depending on the duration of the Screening Period. During the Treatment Period, Study Vaccine (RV3-BB Rotavirus Vaccine or Placebo) will be administered at Visit 2 (Day 0). A follow-up visit will be performed at Day 7 (Visit 3) and an Exit Evaluation will be performed at Day 28 (Visit 4).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Within each age cohort, participants will be prospectively randomised to one of the two treatment groups (RV3-BB Rotavirus Vaccine or Placebo) in a 1:1 ratio, according to a randomisation schedule generated by the Trident Clinical Research Pty. Ltd. Sequence generation will be done by using a randomisation table created by a computer software (i.e., computerised sequence generation).A separate randomisation schedule will be generated for each age cohort, and will include additional blocks to accommodate replacement of participants in the event of incomplete vaccine administration.

The randomisation code will be kept on file by the Trident Clinical Reserch Pty. Ltd., a copy will be provided to and kept on file at the RCH Pharmacy and randomisation envelopes will be stored in the Study Files at MCRI/RCH in case of an emergency. The Study Monitor will not hold a copy of the randomisation code.

At the time of Screening, each participant will, in chronological order, be allocated a unique participant Screening Number.

At the time of randomisation, the participant will be assigned a unique Randomisation Number. Both the Screening and Randomisation Numbers will be used to identify the participant throughout the study period and on all study-related documentation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
This is a Phase I, double-blind, randomised, placebo controlled, parallel group study.
Phase
Phase 1
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
27/01/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257173 0
Government body
Name [1] 257173 0
National Health and Medical Research Council
Country [1] 257173 0
Australia
Primary sponsor type
Hospital
Name
Murdoch Childrens Research Institute
Address
Flemington Rd, Parkville VIC 3052
Country
Australia
Secondary sponsor category [1] 256432 0
None
Name [1] 256432 0
Address [1] 256432 0
Country [1] 256432 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259213 0
Royal Children's Human Research Ethics Committee
Ethics committee address [1] 259213 0
Ethics committee country [1] 259213 0
Australia
Date submitted for ethics approval [1] 259213 0
Approval date [1] 259213 0
18/01/2010
Ethics approval number [1] 259213 0
28048

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31323 0
Address 31323 0
Country 31323 0
Phone 31323 0
Fax 31323 0
Email 31323 0
Contact person for public queries
Name 14570 0
Professor Julie Bines
Address 14570 0
Royal Children's Hospital and Murdoch Childrens Research Institute
4th Floor, Front Entry Building
Royal Children’s Hospital
Flemington Road
Parkville, Victoria 3052
Country 14570 0
Australia
Phone 14570 0
613 9345 4137
Fax 14570 0
613 9345 6667
Email 14570 0
julie.bines@rch.org.au
Contact person for scientific queries
Name 5498 0
Dr Carl Kirkwood
Address 5498 0
Murdoch Childrens Research Institute
4th Floor, Front Entry Building
Royal Children’s Hospital
Flemington Road
Parkville, Victoria 3052
Country 5498 0
Australia
Phone 5498 0
613 8341 6439
Fax 5498 0
613 8341 6449
Email 5498 0
carl.kirkwood@mcri.edu.au

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
No additional documents have been identified.