Typhoid Fever Clinical Trial
Official title:
Understanding Typhoid Disease After Vaccination: a Single Centre, Randomised, Doubleblind, Placebo Controlled Study to Evaluate M01ZH09 in a Healthy Adult Challenge Model, Using Ty21a Vaccine as a Positive Control.
Verified date | December 2020 |
Source | University of Oxford |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Using an established model of human typhoid infection, whereby healthy adults are deliberately infected with typhoid-causing bacteria, the investigators will determine how effective a new oral typhoid vaccine (M01ZH09) is in preventing infection. A previously licensed oral typhoid vaccine (Ty21a) will be used to make sure the challenge model used works properly.
Status | Completed |
Enrollment | 99 |
Est. completion date | May 6, 2022 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion criteria: - Male or female aged 18 - 60 years inclusive and in good health. - Have an abdominal ultrasound scan result documented demonstrating no evidence of gallbladder pathology. - Willing to allow their general practitioner and/or hospital consultant (if relevant) and the Health Protection Unit to be notified of participation in the study. - Agree to refrain from blood donation in the future if diagnosed with typhoid fever. - Be willing to have 24-hour contact with study staff during the four weeks post-challenge. Exclusion Criteria: - Have previously received any typhoid vaccine, been resident in a typhoid endemic country for over 6 months, been diagnosed with probable or confirmed typhoid infection or been challenged with Salmonella Typhi or enrolled in a typhoid challenge study. - Have any known or suspected impairment or alteration of immune function. - History of significant cardiovascular disease. - History of significant respiratory disease. - History of significant endocrine disorder. - History of significant renal or bladder disease. - History of biliary tract disease. - History of significant gastrointestinal disease. - History of significant neurological disease. - History of significant metabolic disease. - History of significant haematological diagnosis. - History of psychiatric illness requiring hospitalisation, current known or suspected drug or alcohol misuse. - History of significant infectious disease. - History of non-benign cancer. - Presence of any implants or prostheses. - Hypersensitivity to any component of the vaccine or are hypersensitive to two or more of the following antibiotics: ciprofloxacin, azithromycin, ampicillin, trimethoprim sulfamethoxazole. - Female participant who is pregnant, lactating or who is unwilling to ensure that they or their partner use effective contraception one month prior to vaccination and continue to do so until two negative stool samples obtained a week apart, a minimum of 1 week after completion of antibiotic treatment have been obtained. - Current occupation involving: clinical or social work with direct contact with young children (defined as those attending pre-school groups, nursery or aged less than 2 years); highly susceptible patients or persons in whom typhoid infection would have particularly serious consequences (i.e. those who are immunocompromised or debilitated); care work involving the elderly. - Current occupation as a commercial food handler involving the preparation or serving of unwrapped foods not subjected to further heating. - Household contact with a young child (defined as above). - Household/close contact who is immunocompromised. - Scheduled elective surgery or other procedures requiring general anaesthesia during the vaccine/challenge period, at time of enrolment. - Participants who have taken part in other research involving an investigational product (IMP) within the 30 days prior to enrolment. - Have received blood, blood products and/or plasma derivatives including parenteral immunoglobulin preparations in the previous 3 months - Any other significant disease or disorder which, in the opinion of the investigator, may put the participants at risk because of participation in the study, may influence the result of the study, or affect the participant's ability to participate in the study. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Oxford Vaccine Group, Centre for Clinical Vaccinology and Tropical Medicine | Oxford |
Lead Sponsor | Collaborator |
---|---|
University of Oxford | Imperial College London, University of Maryland, Wellcome Trust |
United Kingdom,
Barton A, Hill J, Bibi S, Chen L, Jones C, Jones E, Camara S, Shrestha S, Jin C, Gibani MM, Dobinson H, Waddington C, Darton TC, Blohmke CJ, Pollard AJ. Genetic Susceptibility to Enteric Fever in Experimentally Challenged Human Volunteers. Infect Immun. 2022 Apr 21;90(4):e0038921. doi: 10.1128/iai.00389-21. Epub 2022 Mar 7. — View Citation
Blohmke CJ, Hill J, Darton TC, Carvalho-Burger M, Eustace A, Jones C, Schreiber F, Goodier MR, Dougan G, Nakaya HI, Pollard AJ. Induction of Cell Cycle and NK Cell Responses by Live-Attenuated Oral Vaccines against Typhoid Fever. Front Immunol. 2017 Oct 12;8:1276. doi: 10.3389/fimmu.2017.01276. eCollection 2017. — View Citation
Darton TC, Baker S, Randall A, Dongol S, Karkey A, Voysey M, Carter MJ, Jones C, Trappl K, Pablo J, Hung C, Teng A, Shandling A, Le T, Walker C, Molina D, Andrews J, Arjyal A, Basnyat B, Pollard AJ, Blohmke CJ. Identification of Novel Serodiagnostic Signatures of Typhoid Fever Using a Salmonella Proteome Array. Front Microbiol. 2017 Sep 19;8:1794. doi: 10.3389/fmicb.2017.01794. eCollection 2017. — View Citation
Darton TC, Blohmke CJ, Giannoulatou E, Waddington CS, Jones C, Sturges P, Webster C, Drakesmith H, Pollard AJ, Armitage AE. Rapidly Escalating Hepcidin and Associated Serum Iron Starvation Are Features of the Acute Response to Typhoid Infection in Humans. PLoS Negl Trop Dis. 2015 Sep 22;9(9):e0004029. doi: 10.1371/journal.pntd.0004029. eCollection 2015 Sep. — View Citation
Darton TC, Jones C, Blohmke CJ, Waddington CS, Zhou L, Peters A, Haworth K, Sie R, Green CA, Jeppesen CA, Moore M, Thompson BA, John T, Kingsley RA, Yu LM, Voysey M, Hindle Z, Lockhart S, Sztein MB, Dougan G, Angus B, Levine MM, Pollard AJ. Using a Human — View Citation
Darton TC, Jones C, Dongol S, Voysey M, Blohmke CJ, Shrestha R, Karkey A, Shakya M, Arjyal A, Waddington CS, Gibani M, Carter MJ, Basnyat B, Baker S, Pollard AJ. Assessment and Translation of the Antibody-in-Lymphocyte Supernatant (ALS) Assay to Improve the Diagnosis of Enteric Fever in Two Controlled Human Infection Models and an Endemic Area of Nepal. Front Microbiol. 2017 Oct 23;8:2031. doi: 10.3389/fmicb.2017.02031. eCollection 2017. — View Citation
Gibani MM, Voysey M, Jin C, Jones C, Thomaides-Brears H, Jones E, Baker P, Morgan M, Simmons A, Gordon MA, Cerundolo V, Pitzer VE, Angus B, Levine MM, Darton TC, Pollard AJ. The Impact of Vaccination and Prior Exposure on Stool Shedding of Salmonella Typhi and Salmonella Paratyphi in 6 Controlled Human Infection Studies. Clin Infect Dis. 2019 Apr 8;68(8):1265-1273. doi: 10.1093/cid/ciy670. — View Citation
Juel HB, Thomaides-Brears HB, Darton TC, Jones C, Jones E, Shrestha S, Sie R, Eustace A, Galal U, Kurupati P, Van TT, Thieu NTV, Baker S, Blohmke CJ, Pollard AJ. Salmonella Typhi Bactericidal Antibodies Reduce Disease Severity but Do Not Protect against Typhoid Fever in a Controlled Human Infection Model. Front Immunol. 2018 Jan 17;8:1916. doi: 10.3389/fimmu.2017.01916. eCollection 2017. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Diagnosis of typhoid fever | Typhoid fever defined as development of Gram negative bacteraemia after day 5 or temperature over 38C persisting for 12 hours or more.
Typhoid challenge defined as ingestion of virulent S. Typhi (Quailes strain). |
2 weeks after typhoid challenge |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04830371 -
Non-inferiority and Safety Study of EuTCV Compared to Typbar-TCV in Healthy 6 Months-45 Years Aged Participants
|
Phase 2/Phase 3 | |
Recruiting |
NCT04543877 -
WHNRC (Western Human Nutrition Research Center) Fiber Intervention Study
|
Early Phase 1 | |
Completed |
NCT02324751 -
Vaccines Against Salmonella Typhi
|
Phase 2 | |
Completed |
NCT01421693 -
Gatifloxacin Versus Ceftriaxone in the Treatment of Enteric Fever
|
Phase 4 | |
Completed |
NCT05579821 -
Evaluation Study of DPP® Typhoid Assay
|
||
Completed |
NCT02947295 -
Global Genomic and Proteomic Profiling of African Children With Typhoid Fever
|
||
Completed |
NCT00386789 -
Long Term Protection by and Persistence of Vi Antibodies Induced by Vi-rEPA Conjugate Vaccines in Vietnamese Children Injected at 2-5 Years or at 5-8 Years of Age
|
N/A | |
Completed |
NCT04801602 -
Commercial Typhoid Tests Validation Trial
|
||
Recruiting |
NCT06104345 -
Immune Response Elicited by Concomitant Administration of Oral Typhoid Fever (Vivotif®) and Cholera (Dukoral®) Vaccines
|
Phase 4 | |
Completed |
NCT01437267 -
Safety and Immunogenicity of Vi-CRM197 Vaccine Against S. Typhi in Children, Older Infants and Infants
|
Phase 2 | |
Completed |
NCT01438996 -
Extension Study of H01_04TP to Evaluate the Booster Response Induced by Vi-CRM197 in Adults
|
Phase 2 | |
Completed |
NCT01193907 -
Safety and Immunogenicity of Three Formulations of Vi-CRM197 Vaccine Against S. Typhi in Adults (18-40 Years Old)
|
Phase 2 | |
Recruiting |
NCT04349826 -
The Azithromycin and Cefixime Treatment of Typhoid in South Asia Trial (ACT-South Asia Trial)
|
Phase 4 | |
Completed |
NCT01608815 -
Study of a Single Dose of SP093 Typhoid Vi Polysaccharide Vaccine in Japanese Subjects
|
Phase 3 | |
Completed |
NCT01123941 -
Safety and Immunogenicity of Vi-CRM197 Vaccine Against S. Typhi in Adult (18-40 Years Old)
|
Phase 1 | |
Recruiting |
NCT05500482 -
Vellore Typhoid Vaccine Impact Trial
|
Phase 4 | |
Completed |
NCT03926455 -
Safety and Immunogenicity of Typhax, a Typhoid Vaccine
|
Phase 1 | |
Completed |
NCT01229176 -
Safety and Immunogenicity of Vi-CRM197 Vaccine Against S. Typhi in Adults, Children, Older Infants and Infants
|
Phase 2 | |
Completed |
NCT03956524 -
Safety and Tolerability of Typhoid Conjugate Vaccine (EuTCV) in Healthy Adults
|
Phase 1 | |
Completed |
NCT04154722 -
Comparison of Two Drugs Regimen in Treatment of Complicated Typhoid Fever in Children
|
Phase 4 |