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| [ Print-friendly version ] |
| A placebo controlled, single-blind, single oral dose study to determine the safety and immunogenicity of M01ZH09 typhoid vaccine (oral live S. typhi [Ty2 aroC- ssaV-] ZH9) in healthy paediatric subjects, aged five to 14 years inclusive, of Vietnamese origin |
| ISRCTN | ISRCTN91111837 |
| ClinicalTrials.gov identifier | |
| Public title | A placebo controlled, single-blind, single oral dose study to determine the safety and immunogenicity of M01ZH09 typhoid vaccine (oral live S. typhi [Ty2 aroC- ssaV-] ZH9) in healthy paediatric subjects, aged five to 14 years inclusive, of Vietnamese origin |
| Scientific title | |
| Acronym | MS01.08 |
| Serial number at source | 075596 |
| Study hypothesis | The purpose of the study is to determine the safety and immunogenicity of the oral vaccine M01ZH09 in healthy, paediatric, Asian subjects prior to initiating field trials in an endemic area. |
| Lay summary | |
| Ethics approval | The trial has received full ethical approval from the OXTREC committee (ref: 021-06) and the local Institutional Review Board (The Hospital for Tropical Diseases, Ho Chi Minh City, Viet Nam). The approval dates are 25th July 2006, for conditional approval, and final unconditional approval was received on the 18th October 2006. |
| Study design | Randomised, placebo-controlled, single-blind, single dose study. |
| Countries of recruitment | Viet Nam |
| Disease/condition/study domain | Typhoid fever prophylaxis |
| Participants - inclusion criteria |
1. Healthy paediatric subjects aged five to 14 years
2. Are able and willing to take part in the trial 3. Parents or guardians give written permission for their child’s participation, following a detailed explanation of the study |
| Participants - exclusion criteria |
1. Any clinically significant medical or psychiatric condition or abnormal laboratory results on screening, which preclude participation in the study
2. A body weight under 17 kg (five to ten year olds), or under 27 kg (11 to 14 year olds) 3. A confirmed pregnancy, or are breast feeding 4. A known hypersensitivity to two or more of the following antibiotics: ciprofloxacin, azithromycin or trimethoprim-sulfamethoxazole, or have used antibiotics/antibacterials within 14 days prior to administration of study medication 5. A known hypersensitivity to any component of the vaccine or bicarbonate solution, phenylketonuria or those who have experienced anaphylactic shock after any vaccination 6. Received Vivotif, in the last ten years or any other vaccine against S. typhi, in the last five years, or who have ever suffered from typhoid fever 7. Direct contact with patients in special care units or immuno-compromised individuals, a positive bacterial culture of their faecal sample, obtained at the screening visit, for any Salmonella species, a known impairment of immune function or family members who are Human Immunodeficiency Virus (HIV) positive 8. A significant acute febrile illness at time of dosing chronic diseases, a current problem of substance abuse or who are currently or recently involved in a clinical study |
| Anticipated start date | 26/01/2007 |
| Anticipated end date | 31/05/2007 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 150 |
| Interventions |
Subjects deemed eligible after screening will be randomised to receive an oral dose of either active vaccine or matching placebo.
Safety will be monitored by: 1. Diary recordings of body temperature 2. Assessment of Adverse Events (AEs) 3. Vital signs 4. Stool samples for microbiological analyses 5. Urine dipstick tests 6. Immunogenicity will be assessed in all subjects using an Enzyme-Linked ImmunoSorbent Assay (ELISA) method for serum Immunoglobulin G (IgG) and serum Immunoglobulin A (IgA) in all subjects. Enzyme-Linked Immunosorbent SPOT (ELISPOT) tests will be conducted on samples from subjects aged 11 to 14 years of age. |
| Primary outcome measure(s) | The proportion of subjects reporting Serious Adverse Events (SAEs) attributed to the study medication. |
| Secondary outcome measure(s) |
Safety - the proportion of subjects:
1. Experiencing an elevated body temperature, of 38.5°C or greater, in the 14 days following dosing, attributed to study medication 2. Demonstrating persistent faecal shedding of the vaccine strain 3. Withdrawn from the study due to adverse events, including bacteraemia, attributed to study medication 4. With clinically significant changes in laboratory parameters, from day zero to any time post dosing, which are attributed to study medication Immunogenicity: 1. Develop a positive immune response to S. typhi LipoPolySaccharide (LPS) as assessed by an increase in S. typhi LPS specific IgG 2. Develop a positive immune response to S. typhi LPS as assessed by an increase S.typhi LPS specific IgA 3. At day seven, have more than or equal to 4 Antibody-Secreting Cells (ASCs) per 10^6 Peripheral Blood Mononuclear Cells (PBMC), secreting IgA specific for S. typhi LPS detected by ELISPOT assay (subjects over ten years of age) |
| Sources of funding | The Wellcome Trust (UK) (grant ref: 075596) |
| Trial website | |
| Publications | 1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20668668 |
| Contact name | Prof Jeremy Farrar |
| Address |
The Hospital for Tropical Diseases
Oxford University Clinical Research Unit 190 Ben Ham Tu |
| City/town | Ho Chi Minh City |
| Zip/Postcode | District 5 |
| Country | Viet Nam |
| Tel | +84 (0)8 923 7954 |
| Fax | +84 (0)8 923 8904 |
| jfarrar@oucru.org | |
| Sponsor | Emergent Product Development UK Ltd (UK) |
| Address |
545 Eskdale Road
Winnersh Triangle |
| City/town | Wokingham |
| Zip/Postcode | RG41 5TU |
| Country | United Kingdom |
| Tel | +44 (0)118 944 3300 |
| Fax | +44 (0)118 944 3301 |
| clindev@ebsi.com | |
| Sponsor website: | http://www.emergentbiosolutions.com/ |
| Date applied | 17/01/2007 |
| Last edited | 07/12/2010 |
| Date ISRCTN assigned | 07/02/2007 |
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| © 2012 ISRCTN unless otherwise stated. | |
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