Llama Antibody, Rotavirus Diarrhoea, Children
The investigators hypothesize that :
oral administration of VHH batch 203027 will be
- safe and tolerable for healthy Bangladeshi humans of all age groups (Part I)
- effective in reducing severity of diarrhoea in children with proven rotavirus infection (Part II). This entry only covers Part II.
|Male Children 6-24 Months Old With Rotaviral Diarrhoea Non-cholera Patients||Drug: VHH batch 203027 Drug: Placebo product||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
|Official Title:||Safety and Tolerability of a Novel Llama-derived Anti-rotavirus VHH Fragment in Human Volunteers (Part-I), and Its Effect on Severity and Duration of Rotavirus Diarrhoea in Children (Part II). (This Registration Only Covers Part II)|
- Diarrhoea severity (indicated by reduced stool volume) [ Time Frame: 4-5 days ]
The primary outcome measures of this study are to evaluate the efficacy of orally administered VHH batch 203027 by its ability to reduce:
(i) diarrhoea severity (indicated by reduced stool volume) (ii) diarrhoea duration, and (iii) duration of faecal excretion of rotavirus
- Secondary aim: The secondary aim is to compare the influence of the passive immunisation with VHH on serum concentrations of anti-rotavirus antibody on day 4 and 21. [ Time Frame: 4-5 days ]
|Study Start Date:||January 2006|
|Study Completion Date:||November 2009|
|Primary Completion Date:||September 2008 (Final data collection date for primary outcome measure)|
Active Comparator: VHH
The active substance is "VHH batch 203027".
Drug: VHH batch 203027
The active product is 165 mg of VHH batch 203027 and 835 mg maltodextrin with 0.5% (w/w) caramel colour in 10 mL ORS. The osmolality (concentration of the osmotically active substances in the solution such as sugar molecules, salts etc. ) of this solution will be around 60 mOsmol/kg. The mixture of the 165 mg of VHH batch 203027 and 835 mg maltodextrin (0.5% (w/w) caramel colour will be provided per sachet.
Placebo Comparator: Placebo
Drug: Placebo product
The Placebo treatment consisted of 1000 mg of maltodextrine with 5% (w/w) caramel colour in 10 mL ORS.
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01259765
|Dhaka, Bangladesh, 1212|
|Principal Investigator:||Shafiqul A Sarker, MD, Ph. D.||International Centre for Diarrhoeal Disease Research, Bangladesh|