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Cellular Immune Responses in Typhoid Fever Patients and Vaccinees

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03600025
Recruitment Status : Recruiting
First Posted : July 26, 2018
Last Update Posted : February 18, 2021
University of Oxford
Information provided by (Responsible Party):
International Centre for Diarrhoeal Disease Research, Bangladesh

Brief Summary:
Typhoid fever caused by Salmonella Typhi and Paratyphi causes over 21 million cases of febrile illness and 200,000 deaths are attributed to enteric fever each year. Typhoid fever is an enteric infection that results in febrile illness. Typhoid fever causes significant morbidity in the developing world especially young children.S. Typhi specific antibody responses are elicited in typhoid fever and following typhoid vaccination. Cross-reactive multifunctional CD+4 T cell mediated IL-17 responses have been shown in typhoid fever. As S. Typhi as an intracellular pathogen, cellular immune responses might be central to protection. S. Typhi peptide subunit vaccine elicits CD+4 T cell responses that correlate with protection in mice. The role of mucosal associated invariant T cell (MAIT) and natural killer (NK) cell responses in typhoid fever or following vaccination remain poorly understood. Transcriptome profiling of human immune responses to S. Typhi infection is not clearly understood. Establishing successful infection by S. Typhi evasion of T cell and neutrophil responses need to be investigated to better understand the correlates of protection.

Condition or disease Intervention/treatment Phase
Typhoid Fever Patients and Healthy Volunteers to Receive Typbar-TCV Vaccine Biological: Typbar-TCV vaccine Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Apparently healthy volunteers will receive typhoid vaccine one time point.
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Investigation of Innate Immune Responses to Salmonella Typhi in Typhoid Fever in Children and Adults Patients and Vaccinees in Dhaka, Bangladesh
Actual Study Start Date : July 15, 2018
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : December 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever Vaccines

Arm Intervention/treatment
Responses will be compared before and after vaccination
Biological: Typbar-TCV vaccine
vaccine will receive intramuscularly

Primary Outcome Measures :
  1. MAIT cells and NK cells in the typhoid vaccine recipients [ Time Frame: up to 30 days ]
  2. Roles of IL-21, IL-12. IL-15 and IL-18 in the activation of natural killer cells and generation of memory like NK cells in typhoid fever and vaccinees [ Time Frame: up to 30 days ]
  3. In vitro capacity of NETs to trap and kill S. Typhi [ Time Frame: up to 30 days ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   1 Year to 59 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Inclusion criteria 1. Apparently healthy

Exclusion Criteria:

  • 1. Previously history of illness in the last one month. 2. History of taking typhoid vaccine and history of typhoid fever. 3. History of taking any other live or killed enteric vaccine in the last 4 weeks.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03600025

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Contact: Md Saruar Bhuiyan, PhD 88029827001-10 ext 2422
Contact: Farhana Khanam, M.Phil 88029827001-10 ext 2433

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International Centre for Diarrheal Disease Research, Bangladesh (icddr,b) Recruiting
Dhaka, Bangladesh
Contact: Md S Bhuiyan, PhD         
Sponsors and Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
University of Oxford
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Responsible Party: International Centre for Diarrhoeal Disease Research, Bangladesh Identifier: NCT03600025    
Other Study ID Numbers: PR-17082
First Posted: July 26, 2018    Key Record Dates
Last Update Posted: February 18, 2021
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Typhoid Fever
Body Temperature Changes
Salmonella Infections
Enterobacteriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses