A clinical study for assessment of safety and efficacy of single-dose of intravenously administered Dengue monoclonal antibody in Children more than or equal to 5 Years and Adults with Dengue.
Scientific Title of Study
A Phase III, Double-Blind, Randomized, Placebo-Controlled, Multicentric Study of Dengue Monoclonal Antibody in Children more than or equal to 5 Years and Adults with Dengue
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
Dengue-mAb-03, V 1.0, dated 04Jul2024
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Designation
Affiliation
Address
Phone
Fax
Email
Details of Contact Person Scientific Query
Name
Dr Prasad Kulkarni MD
Designation
Executive Director
Affiliation
Serum Institute of India Pvt. Ltd.
Address
Department of Clinical Research and Pharmacovigilance, Serum Institute of India Pvt. Ltd., 212/2, Off Soli Poonawalla Road, Hadapsar, Pune
Pune MAHARASHTRA 411028 India
Phone
912026993900
Fax
Email
drpsk@seruminstitute.com
Details of Contact Person Public Query
Name
Dr Prasad Kulkarni MD
Designation
Executive Director
Affiliation
Serum Institute of India Pvt. Ltd.
Address
Department of Clinical Research and Pharmacovigilance, Serum Institute of India Pvt. Ltd., 212/2, Off Soli Poonawalla Road, Hadapsar, Pune
Pune MAHARASHTRA 411028 India
Phone
912026993900
Fax
Email
drpsk@seruminstitute.com
Source of Monetary or Material Support
Serum Institute of India Pvt. Ltd., 212/2, Off Soli Poonawalla Road, Hadapsar, Pune - 411028, India
Primary Sponsor
Name
Serum Institute of India Pvt Ltd
Address
212-2, Off Soli Poonawalla Road,
Hadapsar, Pune 411028, India
Atharva Multispecialty Hospital and Research Centre
Atharva Multispecialty Hospital and Research
Centre, H-4/Comm-2 construction Div-21, UP Avas
Vikas Parishad Sector-E, Lucknow-226 003, Uttar Pradesh, India Lucknow UTTAR PRADESH
7905304034
vineetshukla38@gmail.com
Dr Mohan ME MD
BGS Global Institute of Medical Sciences
BGS Global Institute of Medical sciences, No.67, BGS Health & Education City, Uttarahalli Road, Kengeri, Bangalore Bangalore KARNATAKA
9900126444
drmohanbgsresearch@gmail.com
Dr Sanjay Lalwani
Bharti vidyapeeth (DU) Medical college Hospital and Research center
Clinical research unit, Paediatric OPD complex, Pune-Satara Road-Dhankawdi, Pune-411043 Pune MAHARASHTRA
8806666099
sanjay.k.lalwani@bhartividyapeeth.edu
Dr Arunkumar Radhakrishnan MD
Chettinad Hospital and Research Institute
Rajiv Gandhi Salai, Kelambakkam, Chengalpattu Dist Kancheepuram TAMIL NADU
044-47429211
drarunkumar.ct@gmail.com
Dr Monika Sharma MD
Christian Medical College and Hospital
Brown Road, Ludhiana - 141008 Ludhiana PUNJAB
9814861205
drsmonika@yahoo.com
Dr Anjali Rajan Pillay
CIMETs Inamdar Multispecialty Hospital
S no.15, Behind KPCT Mall, Fatima Nagar, Wanwadi, Pune-411040 Pune MAHARASHTRA
9923694453
anjalipillay91@gmail.com
Dr Vineet Jain MD
Clinical Research Centre - HIMSAR with SAS
Clinical Research Centre -HIMSAR with SAS Hamdard Institute of Medical Sciences and Research (HIMSR) with Society for Applied Studies (SAS), Hakeem Abdul Hameed Centenary Hospital (HAHCH),
Guru Ravidas Marg, Hamdard Nagar,
New Delhi 110 062, India New Delhi DELHI
9999074056
drvineet.himsr@gmail.com
Dr Sudhir Pawar MD
Department of Pharmacology, Lokmanya Tilak Municipal Medical College and General Hospital
Department of Pharmacology, 2nd Floor, College Building, Lokmanya Tilak Municipal Medical College and General Hospital, Dr Babasaheb Ambedkar Road, Sion, Mumbai-400022, Maharashtra, India Mumbai MAHARASHTRA
9869111630
dr.sudhirpawar@gmail.com
Dr Hajare Kashmira Rajendra MD
Dr. Hedgewar Hospital and Bharani Memorial Critical Care Unit
Research Department, Room No. 2, Ground Floor, Nanda Market, Dastur Nagar Road, Rajapeth, Amravati – 444606 Amravati MAHARASHTRA
8422936670
kash.hajare@rediffmail.com
Dr Sudha subhana Desai
Grant Medical Foundation Ruby Hall clinic
Hinjawadi, Rajiv gandhi Infotech Park, MIDC, Phase-1, Plot no P-33, Hinjawadi, Pune 411057 Pune MAHARASHTRA
9870149717
drsudha006@gmail.com
Dr Vishwajeet Vitthalrao Gaikwad
Imperial Multispecialty Hospital
GAT No 1193, Pingle Pride, Near Radha Swami Ashram, Chikhali Pune--411062 Pune MAHARASHTRA
Clinical Research Room, Department of General Medicine,
Rajendra Prasad Ward, King George Hospital, Maharanipeta, Visakhapatnam-530002
Visakhapatnam ANDHRA PRADESH
98480 16732
drdradhakrishnanresearch@gmail.com
Dr Sachin Shivnitwar
Lifepoint Multispeciality Hospital
Sr No 145/1, Mumbai- Banglore Highway, Near Hotel Sayaji, Wakad, Pune-411057 Pune MAHARASHTRA
8999285166
sachinshivnitwar94@gmail.com
Dr Sandeep Gupta MD
M. V. Hospital and Research Centre
M. V. Hospital and Research Centre, 314/30,
Mirza Mandi, Chowk
Lucknow, Uttar Pradesh - 226 003 Lucknow UTTAR PRADESH
9336077839
sandeepkumar.gupta@rediffmail.com
Dr Dinesh Agarwal MD
Marwari Hospitals
Sati Joymati Road, Athgaon
Guwahati - 781008 Kamrup ASSAM
9864061456
drdinesh944@gmail.com
Dr Aparna Kodre MD
Noble Hospital Pvt. Ltd.
153, Magarpatta City Road, Hadapsar,
Pune – 411013
Maharashtra, India Pune MAHARASHTRA
9850136436
draparnankodre@gmail.com
Dr Ganesh Bansod MD
Radiant Superspeciality Hospital Research Department
Radiant Superspeciality Hospital Research Department, 3rd Floor Rehab Building, Near Kalyan Nagar Square, Sabnis Plot, Amravati 444 606, Maharashtra India Amravati MAHARASHTRA
BGS Global Institute of Medical Sciences, Institutional Ethics Committee
Approved
ECRC Hospital Ethics Committee
Approved
Ethics Committee Inamdar Multispecialty Hospital
Approved
Imperial Ethics committee
Approved
Institutional Ethics Committee
Approved
Institutional Ethics committee Bharti vidyapeeth Deemed University
Approved
Institutional Ethics Committee Christian Medical College and hospital, Ludhiana
Approved
Institutional Ethics Committee For M.V. Hospital and Research Centre
Approved
Institutional Ethics Committee HIMSAR and Associated HAH Centenary Hospital, Delhi
Approved
Institutional Ethics Committee Human Research Lokmanya Tilak muncipal Medical College and General Hospital
Approved
Institutional Ethics Committee Swami Harshankranand JI Medical Hospital and Research center
Approved
Institutional Ethics Committee(IEC)-I Seth GS Medical College and KEM Hospital, Mumbai
Approved
Institutional Ethics Committee, King George Hospital,
Approved
Institutional Human Ethics Committee for Faculty Research
Approved
KIMS Kingsway Hospital Ethics committee
Approved
Lifepoint Research Ethics Committee
Approved
Noble Hospital Institutional Ethics Committee
Approved
Osmania Medical college Ethics committee
Approved
Poona Medical Research Foundation Institutional Ethics committee
Approved
Radiant Superspeciality Hospital Ethics committee
Approved
Radiant Superspeciality Hospital Ethics committee
Approved
Samvedna Hospital Ethics Committee
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: B978||Other viral agents as the cause ofdiseases classified elsewhere,
Intervention / Comparator Agent
Type
Name
Details
Intervention
Dengue-mAb - 6 mg/kg
Dengue-mAb 6mg/kg (0.24 mL/Kg) will be administered by IV infusion
Comparator Agent
Placebo
Placebo is the formulation containing all ingredients as Dengue-mAb except for active ingredient of Dengue-mAb. To be administerd 0.24 mL/kg
Inclusion Criteria
Age From
5.00 Year(s)
Age To
60.00 Year(s)
Gender
Both
Details
1. The study participants will be Children 5 years and adults.
2. Participants or parents who give written informed consent.
3. History of fever within 48 hours from onset.
4. Positive for dengue virus infection by NS1 test (rapid test).
5. Participants who are willing to be hospitalized post infusion for a period of at least 72 hours of afebrile period.
ExclusionCriteria
Details
1. Patient meets criteria for Severe Dengue
2. History or presence of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, neuropsychiatric, autoimmune, dermatologic or immunosuppressive disorders.
3. History of allergic disease, allergic reactions or known hypersensitivity to any component of the study product (Mild non-medication allergies allowed)
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Participant, Investigator and Outcome Assessor Blinded
Primary Outcome
Outcome
TimePoints
Viral Log Reduction [VLR] (overall) of infective dengue virus measured by NS1 ELISA based TCID50 test (NSET)
AND/OR
Time to clearance of fever
at 8 hours after IP administration
AND/OR
•apyrexia for 72 hours after IP administration
Secondary Outcome
Outcome
TimePoints
VLR of infective dengue virus measured by NSET (by serotype & baseline serostatus)
8 hours after IP administration
VLR of infective dengue virus measured by NSET (overall, by serotype & baseline serostatus)
at 24, 48 & 72 hours after IP administration
VLR of dengue viral load measured by qRT-PCR (overall, by serotype & baseline serostatus)
at 24 & 48 hours after IP administration
Trend of platelet count, leukocyte count & hematocrit
Day1 to day 8
Target Sample Size
Total Sample Size="500" Sample Size from India="500" 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 3
Date of First Enrollment (India)
01/06/2025
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 Yet Recruiting
Recruitment Status of Trial (India)
Open to Recruitment
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 is a Phase III, Double-Blind, Randomized, Placebo-Controlled, Multicentric Study of Dengue Monoclonal Antibody in Children more than or equal to 5 Years and Adults with Dengue. The Participant to be with fever onset within last 48 hours and positive for NS1 test. The participants will be administered either with Dengue-mAb or Placebo as per the randomization scheme in 1:1 proportion. Total 500 participants will be randomized on the study.