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.
- Conditions
- Public Health - EpidemiologyRotavirus gastroenteritisInfection - Other infectious diseases
- Registration Number
- ACTRN12610000525088
- Lead Sponsor
- Murdoch Childrens Research Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 60
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.
-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
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.[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 Measures
Name Time Method 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)).[Immunogenicity will be assessed at day 7 and day 28 after vaccine administration.];2.To determine the presence of RV3-BB Rotavirus Vaccine in faecal extracts, as a marker of viral replication.[Immunogenicity will be assessed at day 7 and day 28 after vaccine administration.]