| CTRI Number |
CTRI/2025/12/099553 [Registered on: 19/12/2025] Trial Registered Prospectively |
| Last Modified On: |
19/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Understanding Immunity to Measles, Mumps, and Rubella in South Indian Adults |
|
Scientific Title of Study
|
Charting the Path to Elimination: Insights into Immune Responses to Measles, Mumps, and Rubella in an Adult South Indian Community Cohort |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ramya Madhavan |
| Designation |
Assistant Professor |
| Affiliation |
Christian Medical College |
| Address |
Room no 5, The Wellcome Trust Research Laboratory,
Division of Gastrointestinal Sciences,
Christian Medical College,
Ida Scudder Road,
Vellore
Vellore
TAMIL NADU
632004
India |
| Phone |
9787724132 |
| Fax |
|
| Email |
ramya.m@cmcvellore.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ramya Madhavan |
| Designation |
Assistant Professor |
| Affiliation |
Christian Medical College |
| Address |
Room no 5, The Wellcome Trust Research Laboratory,
Division of Gastrointestinal Sciences,
Christian Medical College,
Ida Scudder Road,
Vellore
Vellore
TAMIL NADU
632004
India |
| Phone |
9787724132 |
| Fax |
|
| Email |
ramya.m@cmcvellore.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ramya Madhavan |
| Designation |
Assistant Professor |
| Affiliation |
Christian Medical College |
| Address |
Room no 5, The Wellcome Trust Research Laboratory,
Division of Gastrointestinal Sciences,
Christian Medical College,
Ida Scudder Road,
Vellore
Vellore
TAMIL NADU
632004
India |
| Phone |
9787724132 |
| Fax |
|
| Email |
ramya.m@cmcvellore.ac.in |
|
|
Source of Monetary or Material Support
|
| Stichting Blockchain for Impact Foundation |
|
|
Primary Sponsor
|
| Name |
Stichting Blockchain for Impact Foundation |
| Address |
Queens Tower, Delflandlaan 1, 1062 EA Amsterdam, the Netherlands |
| Type of Sponsor |
Other [A foundation registered under the laws of Netherlands.] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ramya Madhavan |
Christian Medical College |
Room no 5, The Wellcome Trust Research Laboratory,
Division of Gastrointestinal Sciences,
Christian Medical College,
Ida Scudder Road,
Vellore
Vellore
TAMIL NADU |
9787724132
ramya.m@cmcvellore.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL REVIEW BOARD (IRB) OFFICE OF RESEARCH CHRISTIAN MEDICAL COLLEGE VELLORE, INDIA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy volunteers more than 18 years of age |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Age 18–40 years,
Residing in VHDSS zones 3 or 4,
Providing informed consent
|
|
| ExclusionCriteria |
| Details |
Immunosuppression for less than 6 months
Chronic illness impacting immunity (e.g., HIV)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Evidence-based recommendations for targeted booster vaccination strategies.
Data-driven support for India’s measles and rubella elimination efforts.
Data-driven support to include Mumps in the National Immunisation Programme.
|
Eighteen months |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="250"
Sample Size from India="250"
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)
|
02/02/2026 |
| 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="1"
Months="6"
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
|
This study aims to evaluate long-term immunity to measles, mumps, and rubella (MMR) among adults in South India, a population often overlooked in immunization programs. Despite India’s efforts toward measles and rubella elimination, significant immunity gaps remain, with declining antibody levels in adults and recurring mumps outbreaks. The study will measure binding and neutralizing antibodies, memory T-cell responses, and CD4+ T-cell help functions in adults aged between 18–40 years. Using advanced assays, including pseudovirus neutralization and T–B cell co-culture, the study will provide comprehensive insights into both humoral and cellular immunity. The findings will inform evidence-based recommendations for targeted booster doses, guide inclusion of mumps in the National Immunisation Programme, and strengthen outbreak preparedness. By addressing critical immunity gaps, this research directly supports India’s national priorities in infectious disease control and contributes to achieving measles and rubella elimination while enhancing protection against mumps. |