CTRI/2024/03/064910 [Registered on: 28/03/2024] Trial Registered Prospectively
Last Modified On:
17/06/2025
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Vaccine
Study Design
Other
Public Title of Study
A Phase III clinical trial to evaluate the efficacy and safety of a single dose of “Dengue Vaccine (DengiAll)" in Healthy Indian Adults.
Scientific Title of Study
A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Immunogenicity and Safety of Single dose of Dengue Tetravalent Vaccine, Live Attenuated (Recombinant, Lyophilized) – “DengiAll†of Panacea Biotec Limited in Healthy Indian Adults.
Department of Community and Family Medicine, AIIMS, Jodhpur -342005, Rajasthan Jodhpur RAJASTHAN
8003996903
pankajbhardwajdr@gmail.com
Dr Pradeep Aggarwal
All India Institute of Medical Sciences
Department of Community and Family Medicine, AIIMS, Rishikesh, Virbhadra Road, Shivaji Nagar, Near Barrage, Sturida Colony, Rishikesh
Dehradun UTTARANCHAL
9837215747
drpradeep_aggarwal@hotmail.com
Dr Rashmi Kundapur
All India Institute of Medical Sciences
Department of Community Medicine, All India Institute of Medical Sciences, Bibinagar, Hyderabad Hyderabad TELANGANA
9880496567
dr.rashmi.kundapur@gmail.com
Dr Teena Mary Joy
Amrita Institute of Medical Sciences
Department of Community Medicine, Amrita Institute of Medical Sciences, Kochi Ponekkara P.O. – 682041 Kerala Ernakulam KERALA
0484-6688070
teenatixon@gmail.com
Dr Pratish Kumar Tyagi
Amrita lnstitute of Medical Sciences and Research Centre
Amrita lnstitute of Medical Sciences and Research Centre, Amrita Vishwa Vidyapeetham, Faridabad Campus, Sector 88, Faridabad, Haryana 121002 Faridabad HARYANA
9870235593
pratishumar@fbd.amrita.edu
Dr Neelam Roy
Atal Bihari Vajpayee Institute of Medical Science and Dr Ram Manohar Lohia Hospital
Department of Community Medicine, ABVIMS and Dr. RML Hospital, New Delhi-110001 New Delhi DELHI
9958738661
drneelamroy@gmail.com
Dr Shantala G B
Bangalore Medical College and Research Institute
Department of Microbiology, Bangalore Medical College and Research Institute, K.R. Road, Fort, Bengaluru- 560002, Karnataka Bangalore KARNATAKA
9448178081
drshantalagb@gmail.com
Dr Deepshikha Kamra
Christian Medical College and Hospital
Department of Community Medicine, CMC, Brown Road, Ludhiana - 141008, Punjab, India
Ludhiana PUNJAB
9463034958
deepshikhakamra@gmail.com
Dr Shubhangi Kanitkar
Dr. D.Y.Patil Medical College Hospital and Research Centre
Department of Medicine, Dr. D.Y. Patil Medical College Hospital and Research Centre, Pimpri, Pune Pune MAHARASHTRA
9922430528
shubhangi.kanitkar@dpu.edu.in
Dr Jutika Ojha
Gauhati Medical College and Hospital
Department of Community Medicine, Gauhati Medical College and Hospital, Bhangagarh, Guwahati, Kamrup Metro, Assam Pin-781032 Kamrup ASSAM
9101019581
jutikaojah@gmail.com
Dr Krishna Pandey
ICMR - Rajendra Memorial Research Institute of Medical Sciences
Department of Health Research, Ministry of Health and Family Welfare, Govt. of India, ICMR-RMRIMS, Agamkuan, Patna - 800007, Bihar, India Patna BIHAR
9431042119
drkrishnapandey@yahoo.com
Dr Suman Kanungo
ICMR National Institute of Cholera and Enteric Diseases (ICMR-NICED)
Division of Epidemiology, P-33, C.I.T Road, Scheme XM, Beliaghata, Kolkata-700010, West Bengal
Kolkata WEST BENGAL
9903824322
sumankanungo@gmail.com
Dr Suchit Vasant Kamble
ICMR- National Institute of Translational Virology and AIDS Research (formerly ICMR NARI)
ICMR - National Institute of Translational Virology and AIDS Research (formerly ICMR NARI), 73, G Block MIDC, Bhosari, Pune-411026 Pune MAHARASHTRA
8605437978 91-20-27121071 skamble@nariindia.org
Prof Mohammad Shamim
Jawaharlal Nehru Medical College
Department of tuberculosis and respiratory diseases, Aligarh Muslim University, Aligarh, UP-202002
Aligarh UTTAR PRADESH
9412731835
mshameem@myamu.ac.in
Dr Haobijam NarendraKumar Singh
JN Institute of Medical Sciences
Department of Community Medicine, JN Institute of Medical Sciences, Porampat, Imphal Imphal East MANIPUR
8131855346
hnirendra10@gmail.com
Dr Anil Bilimale
JSS Medical College and Hospital JSS AHER
Department of Community Medicine, JSS Medical College and Hospital JSS AHER, Shivarathreeshwara Nagara, Bannimantap, Mysuru-570015 Mysore KARNATAKA
9880709226
anilbilimale@jssuni.edu.in
Dr Sonali Kar
Kalinga Institute of Medical Sciences (KIMS)
Department of Community Medicine, KIMS, Campus 5, KIIT University, Patia, Bhubaneswar, Odisha – 751024 Khordha ORISSA
9438423273
sonsam72@yahoo.co.uk
Dr Anil Jacob Purty
Pondicherry Institute of Medical Sciences (A unit of the Madras Medical Mission)
Department of Community Medicine, Pondicherry Institute of Medical Sciences (A unit of the Madras Medical Mission), Ganapathichettikulam, Kalapet, Puducherry – 605014
Pondicherry PONDICHERRY
9442233460
anilpurty@hotmail.com
Dr Savita Verma
Pt. B. D. Sharma, Postgraduate Institute of Medical Sciences
Department of Pharmacology, PGIMS, University of Health Sciences, Rohtak Haryana, 124001 Rohtak HARYANA
9812283746
savita_verma@hotmail.com
Dr Mithilesh Kumar
Rajendra Institute of Medical Sciences
Department of Community Medicines, RIMS, Ranchi-834009, Jharkhand
Ranchi JHARKHAND
9835808310
mithilesh2576@gmail.com
Dr Melvin George
SRM Medical College Hospital and Research Centre
Department of Clinical Pharmacology, SRM Medical College Hospital and Research Centre , Kattankulathur, Chengalpet- 603203 Kancheepuram TAMIL NADU
AIIMS BBN- institutional Ethics Committee All India Institute of Medical Sciences Bibinagar Bibinagar Hyderabad Metropolitan Region Hyderabad, Yadadri, Telangana - 508126 India
Approved
Ethics Committee ICMR, RMRIMS ICMR, Rajendra Memorial Research Institute of Medical Sciences, (RRIMS), Agamkuan, Patna, Bihar- 800007
Approved
Ethics Committee National AIDS Research Institute
Approved
Ethics Committee of BMCRI, Bangalore Medical College & Research Institute, Fort KR. Road, Bengaluru, Urban, Karnataka - 560002
Approved
Ethics Committee relating to Clinical Trial All India Institute of Medical Sciences Rishikesh Virbhadra Marg Pashulok Rishikesh Dehradun Uttarakhand -249203 India
Approved
Ethics Committee, Atal Bihari Vajpayee Institute of Medical Sciences (ABVIMS) & Dr. RMLHospital, Baba Kharakh Singh Marg, Central Delhi, Delhi – 110001
Approved
Ethics Committee, Dr. D.Y. Patil Vidyapeeth, Sant Tukaram Nagar, Pimpri, Pune, Maharashtra – 411018
Approved
Ethics Committee, SRM Medical College Hospital and Research Centre, SRM Nagar, Potheri, Kattankulathur, Chennai, Kanchipuram, Tamil Nadu – 603203
Approved
IEC, ICMR-NICEDICMR-NICEDP-33 CIT Road Scheme XM Beliaghata Kolkata West Bengal - 700010 India
Approved
Institute Ethics Committee Pondicherry Institute of Medical Sciences, No.20, Ganapathichettikulam Kalapet Puducherry (India) -605014 India
Approved
Institutional Ethics Committee Amrita Institute of Medical Sciences AIMS-Ponekkara Kochi Edappally Ernakulam Kerala -682041 India
Approved
Institutional Ethics Committee, Christian Medical College and Hospital Brown Road Ludhiana, Punjab - 141008 India
Approved
Institutional Ethics Committee, GMCH, Gauhati Medical College and Hospital, Guwahati, 2nd Floor, Gauhati Medical College Main Building, Narakasur Hill Top, Guwahati, Kamrup Metropolitan, Assam – 781032
Approved
Institutional Ethics Committee, Jawaharlal Nehru Medical College and Hospital, Aligarh Muslim University, Civil Line, Koil, Aligarh Uttar Pradesh – 202002
Approved
Institutional Ethics Committee, JNIMS Jawaharlal Nehru Institute of Medical Sciences Porompat Imphal East Imphal Imphal East Manipur - 795005 India
Approved
Institutional Ethics Committee, JSS Medical College, JSS Hospital, Mysore, JSS Medical College, Sri Shivarathreeshwara Nagara, Mysuru Mysore Mysuru (Mysore) Karnataka -570015
Approved
Institutional Ethics Committee, Pt. BD Sharma, PGIMS/UHS, Rohtak, Post Graduate Institute of Sciences, Rohtak, Haryana -124001, India
Approved
Institutional Ethics Committee, RIMS, Ranchi Rajendra Institute of Medical Sciences 4th Floor, Administrative Building Bariatu, Ranchi Jharkhand -834009
Approved
Institutional Ethics Committee-KIMS Kalinga Institute of Medical Sciences Kushabhadra campus (Campus 5) KIIT University, Patia Bhubaneswar Khordha Orissa - 751024 India
Approved
INSTITUTIONAL HUMAN ETHICS COMMITTEE All India Institute of Medical Sciences Basni Jodhpur Jodhpur Rajasthan -342005 India
Approved
lnstitute of Medical Sciences, Institutional Ethics Committee
1.Healthy adults between 18 to 60 years of age, in good health, based on medical history, clinical laboratory tests (protocol specified) and physical examination.
2.Participants willing to participate throughout the study period of 2 years (after signing written informed consent)
Inclusion Criteria for Women:
 Female with non-child bearing potential (Females having documented history of surgical sterilization or are postmenopausal - 12 months of amenorrhea after the last menstrual period)
 Female with child bearing potential is eligible if she:
has used an effective method of contraception or abstinence from at least 4 weeks prior to vaccination
AND
is willing to avoid pregnancies up to 90 days post vaccination by use of an effective method of contraception or abstinence
AND
has negative serum pregnancy test on the screening day and negative urine pregnancy test on the day of vaccination
ExclusionCriteria
Details
1. Women who are pregnant or breastfeeding.
2. Acute or chronic, clinically significant pulmonary, cardiovascular, endocrine, metabolic, gastrointestinal, neurological, hepatic, renal functional abnormality or any other systemic disorder, that are assessed by the investigator (based on medical history or physical examination) as being clinically unstable within the prior 4 weeks as evidenced by:
â–ª Hospitalization for the condition, including surgical interventions.
â–ª New significant organ function deterioration.
â–ª Needing addition of new treatments or major dose adjustments of current treatments (mild or moderate well-controlled comorbidities are allowed)
3. Any confirmed or suspected condition with impaired/altered function of immune system (e.g., immunodeficient or autoimmune conditions)
4. Known case of HIV, Hepatitis B, and Hepatitis C reported by the participant
5. History of any bleeding disorder
6. History of severe allergic reactions or anaphylaxis. History of allergy to any of the
component of Investigational Medicinal product
7. Any evidence of clinically significant acute illness or infection or fever within the past 3 days of study screening for study participation
8. Any evidence of clinically significant acute illness or infection or fever within the past 3 days of vaccination
9. Oral Temperature should not be ≥ 37.8°C (100°F) on the day of vaccination (temporary exclusion).
10. Any major surgery within the past 90 days prior to vaccination
11. Any abnormal laboratory value which is considered clinically significant by the Investigator or is grade III or higher.
12. Receipt of immunosuppressive therapy
13. History of intake of anti-cancer chemotherapy or radiation therapy at any time in the past
14. Chronic (> 14 days continuously) systemic corticosteroid therapy / within the past 90 days prior to vaccination or planned use through the study period (prednisone, or equivalent, ≥ 0.5 mg/kg per day).
15. Received any other immunosuppressive therapy prior to study entry within the past 90 days prior to vaccination or planned treatment during the trial duration. (Inhaled, intranasal, and topical steroids are allowed)
16. Have received blood products in the past 90 days prior to vaccination, including transfusions or immunoglobulin
17. Use of anticoagulant medication in the past 90 days prior to vaccination
18. Receipt of any vaccine in the past 4 weeks prior to study vaccination (vaccination can be planned 4 weeks after trial vaccination has been given)
19. Previous receipt of any Dengue vaccine (licensed or Experimental)
20. Current alcohol use or drug addiction that may interfere with the participants’ ability to comply with the trial procedures.
21. Concurrent/planned participation in any other clinical trial
22. Individuals who are part of study team or close family members of individuals conducting this study
23. Inability of participants to remain in follow-up for 2 years.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Sequentially numbered, sealed, opaque envelopes
Blinding/Masking
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
Primary Outcome
Outcome
TimePoints
To evaluate the efficacy of “DengiAll†among adults in preventing symptomatic laboratory confirmed dengue infection over a period of 2 years after vaccination
Febrile illness with laboratory confirmation of dengue determined by NS1-ELISA and/or rRT-PCR, occurring one month to 2 years post vaccination (vaccine or placebo).
Secondary Outcome
Outcome
TimePoints
1.To determine the safety of “DengiAll†in adults as assessed by the frequency of adverse events, graded by seriousness, causality and severity.
1a. All solicited AEs and Unsolicited AEs occurring within 28 days post vaccination, with respect to causality, seriousness, severity and frequency in
reactogenicity cohort.
1b. SAEs throughout the study duration post vaccination, with respect to causality,
severity and frequency among all participants.
1c. Related grade 3 and above unsolicited AEs through 28 days post-vaccination with respect to severity and frequency in all participants.
2. To assess the immunogenicity of “DengiAll†in comparison to the placebo using serum plaque reduction neutralization titer 50% (PRNT50) against dengue virus serotypes.
2a.The Geometric Mean Antibody serum plaque reduction neutralization titer 50 percent (PRNT50) to dengue virus serotypes in vaccinated and placebo arms on Days 0, 28, 56, 84 ,180, 1 year and 2 years post vaccination.
2b. Seroconversion and seropositivity rates by PRNT50 test to dengue virus serotypes on study days 28, 56, 84, 180, 1 year and 2 years post vaccination.
2c. Monovalent, bivalent, trivalent, and tetravalent seropositivity post vaccination.
3. To determine viremia in a subset of dengue naïve and exposed trial participants on Days 9 and Day 12 post vaccination.
3. Presence of Viremia for each serotype in a sub set of Dengue trial participants on Day 9 and Day 12 post vaccination.
4.To evaluate the efficacy of DengiAll among adults in preventing symptomatic laboratory confirmed dengue infection by dengue virus serotypes over a period of 2 years after vaccination
4. Febrile illness with laboratory confirmed dengue occurring one month to 2 years post vaccination.
5. To compare the incidence of laboratory confirmed severe dengue and dengue related deaths between DengiAll and placebo groups
5a. Incidence of Severe Dengue cases.
5b. Deaths among participants suffering from laboratory confirmed dengue and determined to be clinically related to dengue will be compared among vaccine and Placebo.
6. To evaluate the efficacy of DengiAll in preventing symptomatic laboratory confirmed dengue infection by baseline serostatus.
6. Febrile illness with laboratory confirmed dengue, occurring between one month and 2 years of vaccination, separately in baseline dengue seropositive and naïve individuals.
7. To assess the cell mediated immune responses post vaccination.
7a. The number of CD4, CD8 T cells and NK cells in whole blood of pre vaccination and post vaccination samples at Day 28, 180, 1 year and 2 years.
7b. T cell response for measurement of antigen specific cytokines and cytotoxic potential levels in PBMCs of pre vaccination and post vaccination samples at Day 28, 180, 1 year and 2 years.
8. Estimation of the ratio of Neutralizing Antibodies to Non Neutralizing Antibodies by NNT.
8. Ratio of the Neutralizing Antibodies to Non Neutralizing Antibodies by Net Neutralization Assay will be carried out on Day 28 and 84 in a subset of the immunogenicity cohort.
Target Sample Size
Total Sample Size="10335" Sample Size from India="10335" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
This will be a double-blind, multi-centric, placebo-controlled, randomized, single dose, two arm study. This study aims to evaluate the efficacy, immunogenicity, and safety of a single dose of Panacea’s ‘Dengue Tetravalent Vaccine, Live Attenuated (Recombinant, Lyophilized).
In this study, 10335
healthy adults will be enrolled. Participants will be screened, and eligible
participants will be enrolled in the study. The participant allocation ratio
for investigational vaccine and placebo is 2:1.
The enrolled participants
will be randomly selected into the following subsets:
1.Vaccine efficacy (VE) and Safety
2.Immunogenicity and Reactogenicity subset
3.Viremia subset
4.T cell immune response subset
The study duration per participant
will be for 2 years post vaccination.
All 10335 participants
will have 8 scheduled or planned visits per protocol
(Screening visit, Randomization/vaccination
visit and follow-up visits till 2 years post vaccination)
Participants
who belong to the viremia cohort will, in addition, have 2 more scheduled
visits.