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
DOI https://doi.org/10.1186/ISRCTN91111837
Secondary identifying numbers 075596
Submission date
17/01/2007
Registration date
07/02/2007
Last edited
13/03/2013
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Jeremy Farrar
Scientific

The Hospital for Tropical Diseases
Oxford University Clinical Research Unit
190 Ben Ham Tu
Ho Chi Minh City
District 5
Viet Nam

Phone +84 (0)8 923 7954
Email jfarrar@oucru.org

Study information

Study designRandomised, placebo-controlled, single-blind, single dose study.
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typePrevention
Scientific title
Study acronymMS01.08
Study objectivesThe 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.
Ethics approval(s)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.
Health condition(s) or problem(s) studiedTyphoid fever prophylaxis
InterventionSubjects 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.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)M01ZH09 typhoid vaccine (oral live S. typhi [Ty2 aroC- ssaV-] ZH9)
Primary outcome measureThe proportion of subjects reporting Serious Adverse Events (SAEs) attributed to the study medication.
Secondary outcome measuresSafety - 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)
Overall study start date26/01/2007
Completion date31/05/2007

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit5 Years
Upper age limit14 Years
SexNot Specified
Target number of participants150
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment26/01/2007
Date of final enrolment31/05/2007

Locations

Countries of recruitment

  • Viet Nam

Study participating centre

The Hospital for Tropical Diseases
Ho Chi Minh City
District 5
Viet Nam

Sponsor information

Emergent Product Development UK Ltd (UK)
Industry

545 Eskdale Road
Winnersh Triangle
Wokingham
RG41 5TU
United Kingdom

Phone +44 (0)118 944 3300
Email clindev@ebsi.com
Website http://www.emergentbiosolutions.com/
ROR logo "ROR" https://ror.org/007nce146

Funders

Funder type

Charity

The Wellcome Trust (UK) (grant ref: 075596)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 26/07/2010 Yes No