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CTRI Number  CTRI/2025/11/096904 [Registered on: 04/11/2025] Trial Registered Prospectively
Last Modified On: 31/10/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Understanding how the immune system fights malaria in the liver 
Scientific Title of Study   Mapping Plasmodium falciparum specific T cell epitopes in human liver tissue 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ravish Raju 
Designation  Professor and Head 
Affiliation  Christian Medical College Vellore 
Address  Department of Hepato Pancreato Biliary (HPB) Surgery, Christian Medical College Vellore

Vellore
TAMIL NADU
632004
India 
Phone  9790009898  
Fax    
Email  ravish@cmcvellore.ac.in   
 
Details of Contact Person
Scientific Query  
Name  Ravish Raju 
Designation  Professor and Head 
Affiliation  Christian Medical College Vellore 
Address  Department of Hepato Pancreato Biliary (HPB) Surgery, Christian Medical College Vellore

Vellore
TAMIL NADU
632004
India 
Phone  9790009898  
Fax    
Email  ravish@cmcvellore.ac.in   
 
Details of Contact Person
Public Query  
Name  Ravish Raju 
Designation  Professor and Head 
Affiliation  Christian Medical College Vellore 
Address  Department of Hepato Pancreato Biliary (HPB) Surgery, Christian Medical College Vellore

Vellore
TAMIL NADU
632004
India 
Phone  9790009898  
Fax    
Email  ravish@cmcvellore.ac.in   
 
Source of Monetary or Material Support  
Bill and Melinda Gates Foundation  
 
Primary Sponsor  
Name  Bill and Melinda Gates Foundation  
Address  500 Fifth Avenue North, Seattle, WA 98109, USA 
Type of Sponsor  Other [Philanthropic (Bill and Melinda Gates Foundation)] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ravish Sanghi Raju  Christian Medical College   Room No: 24503, Department of Hepatobiliary surgery, Division of Surgery
Vellore
TAMIL NADU 		 9790009898

ravish@cmcvellore.ac.in  
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Chritian Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Patients coming in for other hepatic, pancreatic and gallbladder illness 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  Adult patients who come to Christian Medical College Vellore, for hepatobiliary resections for certain disease conditions such as hepatobiliary carcinoma, liver metastasis secondary to other cancers or benign conditions requiring resections such as hydatid cystgallbladder polyps, hepatolithiasis will be recruited in the study. Among these study patients who reside in malaria endemic regions such as Jharkhand, Uttar Pradesh, West Bengal will be consented to participate in the study 
 
ExclusionCriteria 
Details  We will not include patients on immunosuppression prior to resection for over 6 months patients with liver cirrhosis acute or chronic liver disorders such as hepatitis C and hep B with cirrhosis. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To characterize the T resident memory cells from the liver biopsy samples by flow cytometry
To assess the T cell receptor sequencing data among Plasmodium falciparum-exposed individuals 		 24 months 
 
Secondary Outcome  
Outcome  TimePoints 
To determine an assay cutoff for malarial antibodies.  24 months 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/12/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   The development of a multi-stage malaria vaccine will likely benefit from the inclusion of CD8 T cell epitopes to induce tissue-resident memory (Trm) cells in the liver. The hepatic phase of the Plasmodium falciparum (Pf) life cycle represents a bottleneck in parasite development due to the small number of parasites that successfully infect hepatocytes. T cells play an important role in anti-Plasmodium immunity. CD4 T cells provide B cell help and eliminate parasites through the production of IFNg, whereas CD8 T cells can kill infected liver cells, as demonstrated in mice and NHPs. Additional support for the role of T cells comes from unpublished human studies with late-arresting sporozoites, although the relative contribution of CD4 and CD8 cells for protection and their target epitopes is still unknown. CD8 Trm cells are ideally suited for the identification of protective Pf target epitopes. This proposal aims to determine whether Trm cells in the livers of individuals living in Pf endemic areas in India target conserved Pf antigens. If so, single-cell-based TCR discovery work will be supported to identify Pf-reactive TCRs and determine their peptide specificity and HLA restriction pattern.  
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