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.
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.
Murdoch Childrens Research Institute
60 participants
Jan 27, 2010
Interventional
Conditions
Summary
The primary purpose of the study is to assess the safety and tolerability of one oral dose of a human rotavirus vaccine, RV3-BB, in three successive age groups starting with adult men aged 18-50 years, progressing to children aged 3-8 years and then infants 6-8 weeks. Assessing rotavirus immunity, via serologic markers and faecal extracts, is a secondary objective.
Eligibility
Inclusion Criteria9
- 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.
- 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;
- Participant or parent(s)/guardian(s) will be available for the duration of the study, and agrees to adhere to all protocol requirements;
- Participant or parent(s)/guardian(s) have provided written informed consent prior to undergoing any study-related procedures;
- 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);
- 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.
Exclusion Criteria13
- 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.
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Interventions
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.
Locations(1)
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ACTRN12610000525088