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CTRI Number  CTRI/2024/06/068336 [Registered on: 05/06/2024] Trial Registered Prospectively
Last Modified On: 24/05/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device
Process of Care Changes 
Study Design  Single Arm Study 
Public Title of Study   Device for Painless injections 
Scientific Title of Study   Clinical evaluation of hollow microneedle device for painless intradermal vaccination  
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SANJEEV RAI B 
Designation  SENIOR SCIENTIST 
Affiliation  FATHER MULLER RESEARCH CENTRE 
Address  Father Muller Research Center Father Muller Road Kankanady
Kanksnady
Dakshina Kannada
KARNATAKA
575002
India 
Phone  9448133494  
Fax    
Email  raibs11@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR PRAVEEN KUMAR VEMULA 
Designation  Associate Professor  
Affiliation  Inst for Stem Cell Science and RegenerativeMedicine (inStem) 
Address  Department of Stem cell Research, InsTEM, UAS-GKVK Campus , Bellary Road, Bangalore

Bangalore
KARNATAKA
560065
India 
Phone  08067176395  
Fax    
Email  praveenv@instem.res.in  
 
Details of Contact Person
Public Query  
Name  Dr.Sanjeev Rai B 
Designation  Senior Scientist 
Affiliation  Father Muller Research Center 
Address  Dept. of Research, Father Muller Research Center, Father Muller campus, Kankanday, Mangalore.

Dakshina Kannada
KARNATAKA
575002
India 
Phone  09448133494  
Fax    
Email  raibs11@gmail.com  
 
Source of Monetary or Material Support  
MIDAS,DST_MAHE Hub. Office of DST Hub, Manipal Academy of Heigher Education. Manipal 576104 
 
Primary Sponsor  
Name  MIDAS, DST- MAHE Hub  
Address  Office of DST Hub ,Manipal Academy of Heigher Education, Manipal 
Type of Sponsor  Research institution and hospital 
 
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 
DRSANJEEV RAI   Father Muller Hospital  out patient department, Father Muller Medical college Hospital, Mangalore 575002
Dakshina Kannada
KARNATAKA 		 9448133494

raibs11@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Father Muller Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  adults, both sexes 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Intraderma vaccination  Intradernal inection is performed using hollow microneedles, and a visual observational scale is used to score the pain at a time 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Healthy Volunteers 
 
ExclusionCriteria 
Details  Recently vaccinated
patients with severe illnesses 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
PAIN ASSESSMENT of Hollow Microneddle vacination at the time of inection  on intradermal injection, we notice the pain perception by using universal pain at the time of inection once only 
 
Secondary Outcome  
Outcome  TimePoints 
Pain score assessment at the time of injection  at the time of injection 
 
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   Phase 1/ Phase 2 
Date of First Enrollment (India)   17/06/2024 
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="3"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [raibs11@gmail.com].

  6. For how long will this data be available start date provided 01-09-2027 and end date provided 01-08-2032?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

Hollow microneedles are produced by the Instem Research Center, a unit of IISc , Bangalore. Preclinical and benchtesting are conducted in Bangalore at the same institution. We at the Fathere Muller Research Center validate the efficacy and safety of the needle. We use humoid mankins available at our skill lab for validating the efficacy of injectability. Following following injection, volunteers are recruited after obtaining written consent. Anogue visual scales d used to assess the pain score. once the pain score is completed. the vaccination will be done using microdoses. The efficacy of microdose over the full dose is assessed.

 
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