| CTRI Number |
CTRI/2017/02/007923 [Registered on: 20/02/2017] Trial Registered Prospectively |
| Last Modified On: |
23/12/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Vaccine |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To evaluate the Safety and Immunogenicity of a single dose ‘Dengue Tetravalent Vaccine in healthy subjects. |
|
Scientific Title of Study
|
A Phase I/II, Double Blind, Placebo controlled, Randomized, Multicenter, prospective study to evaluate the Safety and Immunogenicity of a single dose ‘Dengue Tetravalent Vaccine, Live Attenuated (Recombinant, Lyophilized)’ in healthy subjects. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| PBL/CR/2014/05/CT/DEN Version Number 02 dated 03-06-16 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Lalitendu Mohanty |
| Designation |
GM-Clinical Research |
| Affiliation |
Panacea Biotec Ltd |
| Address |
B-1 Extn/G-3 Mohan Co-op. Indl. Estate Mathura Road
B-1 Extn/G-3 Mohan Co-op. Indl. Estate Mathura Road
South
DELHI
110044
India |
| Phone |
01141679000 |
| Fax |
01141578085 |
| Email |
lalitendumohanty@panaceabiotec.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lalitendu Mohanty |
| Designation |
GM-Clinical Research |
| Affiliation |
Panacea Biotec Ltd |
| Address |
B-1 Extn/G-3 Mohan Co-op. Indl. Estate Mathura Road
B-1 Extn/G-3 Mohan Co-op. Indl. Estate Mathura Road
DELHI
110044
India |
| Phone |
01141679000 |
| Fax |
01141578085 |
| Email |
lalitendumohanty@panaceabiotec.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Lalitendu Mohanty |
| Designation |
GM-Clinical Research |
| Affiliation |
Panacea Biotec Ltd |
| Address |
B-1 Extn/G-3 Mohan Co-op. Indl. Estate Mathura Road
B-1 Extn/G-3 Mohan Co-op. Indl. Estate Mathura Road
DELHI
110044
India |
| Phone |
01141679000 |
| Fax |
01141578085 |
| Email |
lalitendumohanty@panaceabiotec.com |
|
|
Source of Monetary or Material Support
|
| Panacea Biotec Ltd B-1 Extn/G-3, Mohan Co-op. Indl. Estate, Mathura Road South West DELHI India
|
|
|
Primary Sponsor
|
| Name |
Panacea Biotec Ltd |
| Address |
B-1 Extn/G-3, Mohan Co-op. Indl. Estate, Mathura Road South West DELHI India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr P Venugopal |
King George Hospital |
Professor, Department of Pediatrics
King George Hospital,
Visakhapatnam- 530002
Andhra Pradesh
Visakhapatnam
ANDHRA PRADESH |
09848027203
venugopal_kgh@yahoo.com |
| Dr Ajay Vardaan |
King George’s Medical University |
Department of Medicine, King George’s Medical University Lucknow 226003
Lucknow
UTTAR PRADESH |
9455519306
drajaymd12345@gmail.com |
| Dr Madhav Prabhu |
KLE Society’s Hospital and Medical Research Center |
Associate Professor, Department of Medicine, KLE Society’s Hospital and Medical Research Center, Nehru Nagar, Belgaum 590010, Karnataka
Belgaum
KARNATAKA |
9738462380
wiseman2380@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Ethic Committee, KLE Universitys |
Approved |
| Instutuional Ethic Committe, King geroge Medcial Universitys |
Approved |
| Instutuional Ethic Committe, King geroge hospital |
Approved |
| PIMS Institutional Ethics Committee Pondicherry |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Immunization against Dengue |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dengue Tetravalent Vaccine |
Attenuated (Recombinant, Lyophilized). The Vaccine is to be reconstituted with diluent (Sterile Water for Injection) before administration.
Single dose of 0.5 ml of Dengue Tetravalent Vaccine by Subcutaneous administration |
| Comparator Agent |
placebo |
The placebo is a lyophilized powder to be reconstituted with diluent (Sterile Water for Injection) before administration
Single dose of 0.5 ml of placebo Vaccine by Subcutaneous administration |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Healthy subjects in step wise two cohorts will be enrolled for the study:
Cohort 1 subjects ≥ 18 to ≤ 60 years old
Cohort 2 subjects ≥ 02 to <18 years old
Subjects “With previous exposure to dengue†as well as “Without previous exposure to dengue†will be enrolled in both the Cohorts.
2. Subject in good health, based on medical history, Clinical laboratory tests and physical examination.
3. Willingness to participate throughout the study period
of 3 years
Inclusion criteria for females:
4.1 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) or are pre-menarche girls)
4.2 Female with child bearing potential is eligible if:
-- Subject has used an effective method of contraception or abstinence from at least 4 weeks prior to vaccination
AND
--Subject is willing to avoid pregnancies up to 180 days post vaccination by use of an effective method of contraception or abstinence
AND
--Subject has negative serum pregnancy test on the screening day and negative urine pregnancy test on the day of vaccination
|
|
| ExclusionCriteria |
| Details |
1. Breastfeeding woman
2. Subjects who have any clinically significant chronic disease, which, in the opinion of the investigator would endanger the volunteer’s well-being or interfere with the evaluation of the study objectives.
3. Known impairment of the immune function, including, but not limited to: Diabetes Mellitus, Cancer, Autoimmune diseases, asthma, Asplenia etc.
4. Known seropositivity for HIV, hepatitis B, and hepatitis C reported by the subject.
5. History of any Bleeding Disorder
6. History of severe allergic reactions or anaphylaxis. History of allergy to any of the component of Investigational product.
7. Any evidence of clinically significant acute illness or infection or fever within past 3 days of study participation (Screening).
8. Any evidence of clinically significant |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Safety:
• Assessment of All AEs (solicited as well as Unsolicited) and SAEs occurring within 28 days post vaccination, with respect to causality, severity and frequency
|
Safety:
• Assessment of All AEs (solicited as well as Unsolicited) and SAEs occurring within 28 days post vaccination, with respect to causality, severity and frequency
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Determination of the serum plaque reduction neutralization titer 50% (PRNT50) to DEN1, DEN2, DEN3, and DEN4 viruses for each subject at Study Day 0, 28, and 90 post vaccination.
• Determination of the seroconversion rate (for subjects with preexisting antibodies) and seropositivity rate (for all subjects) by PRNT50 test to DENV-1, DENV-2, DENV-3, and DENV-4 viruses on Study Days 28 and 90 post vaccination
|
Day 0, 28 and 90 |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
20/02/2017 |
| 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="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study is a Phase I/II, Randomized,
placebo-controlled, double blind, multicenter, prospective study in normal
healthy subjects. The purpose of this study is to evaluate the safety,
reactogenicity, and immunogenicity of single dose of the ‘Dengue Tetravalent
Vaccine, Live Attenuated (Recombinant, Lyophilized)’. A placebo arm is included
in the study as a control to better assess vaccine-associated versus non
vaccine-associated adverse events. It is an age de-escalation study divided in
two cohorts-Cohort 1 (≥ 18 to ≤ 60 years) and cohort 2 (≥ 02 to < 18
years).There will be a DSMB meeting which will analyze the 28days post vaccination safety
data of the subjects of the first cohort and accordingly give its
recommendations for second cohort in adolescents and children.
|