Condition category
Infections and Infestations
Date applied
17/01/2007
Date assigned
07/02/2007
Last edited
13/03/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Jeremy Farrar

ORCID ID

Contact details

The Hospital for Tropical Diseases
Oxford University Clinical Research Unit
190 Ben Ham Tu
Ho Chi Minh City
District 5
Viet Nam
+84 (0)8 923 7954
jfarrar@oucru.org

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

075596

Study information

Scientific title

Acronym

MS01.08

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.

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.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Condition

Typhoid fever prophylaxis

Intervention

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.

Intervention type

Drug

Phase

Not Specified

Drug names

M01ZH09 typhoid vaccine (oral live S. typhi [Ty2 aroC- ssaV-] ZH9)

Primary outcome measures

The proportion of subjects reporting Serious Adverse Events (SAEs) attributed to the study medication.

Secondary outcome measures

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)

Overall trial start date

26/01/2007

Overall trial end date

31/05/2007

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Child

Gender

Not Specified

Target number of participants

150

Participant 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

Recruitment start date

26/01/2007

Recruitment end date

31/05/2007

Locations

Countries of recruitment

Viet Nam

Trial participating centre

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

Sponsor information

Organisation

Emergent Product Development UK Ltd (UK)

Sponsor details

545 Eskdale Road
Winnersh Triangle
Wokingham
RG41 5TU
United Kingdom
+44 (0)118 944 3300
clindev@ebsi.com

Sponsor type

Industry

Website

http://www.emergentbiosolutions.com/

Funders

Funder type

Charity

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20668668

Publication citations

  1. Results

    Tran TH, Nguyen TD, Nguyen TT, Ninh TT, Tran NB, Nguyen VM, Tran TT, Cao TT, Pham VM, Nguyen TC, Tran TD, Pham VT, To SD, Campbell JI, Stockwell E, Schultsz C, Simmons CP, Glover C, Lam W, Marques F, May JP, Upton A, Budhram R, Dougan G, Farrar J, Nguyen VV, Dolecek C, A randomised trial evaluating the safety and immunogenicity of the novel single oral dose typhoid vaccine M01ZH09 in healthy Vietnamese children., PLoS ONE, 2010, 5, 7, e11778, doi: 10.1371/journal.pone.0011778.

Additional files

Editorial Notes