| CTRI Number |
CTRI/2021/06/034014 [Registered on: 04/06/2021] Trial Registered Prospectively |
| Last Modified On: |
06/01/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Vaccine
Biological
Preventive |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Biological E’s CORBEVAX vaccine clinical study for protection against Covid-19 disease. |
|
Scientific Title of Study
|
A Prospective, multicentre, Phase II Seamlessly Followed by Phase III Clinical Study to Evaluate the Immunogenicity and Safety of Biological E’s CORBEVAX Vaccine for Protection Against COVID-19 Disease When Administered to COVID-19-Negative Adult Subjects. |
| Trial Acronym |
None |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BECT/COVID-19-PHASE-III/069 Ver: 2.1 dated:13.05.21 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Subhash Thuluva |
| Designation |
Vice President - Clinical Development |
| Affiliation |
Biological E.Limited |
| Address |
Clinical Development Dept, 2nd floor, Road No.35, Jubilee Hills
Hyderabad
TELANGANA
500033
India |
| Phone |
04071216248 |
| Fax |
04027675309 |
| Email |
subhash.thuluva@biologicale.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Subhash Thuluva |
| Designation |
Vice President - Clinical Development |
| Affiliation |
Biological E.Limited |
| Address |
Clinical Development Dept, 2nd floor, Road No.35, Jubilee Hills
TELANGANA
500033
India |
| Phone |
04071216248 |
| Fax |
04027675309 |
| Email |
subhash.thuluva@biologicale.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr TSA Kishore |
| Designation |
Associate Vice President - Clinical Development |
| Affiliation |
Biological E.Limited |
| Address |
Clinical Development Dept, 2nd floor, Road No.35, Jubilee Hills
Hyderabad
TELANGANA
500033
India |
| Phone |
04071216247 |
| Fax |
04027675309 |
| Email |
kishore.turaga@biologicale.com |
|
|
Source of Monetary or Material Support
|
| Biological E.Limited, 18/1&3, Azamabad, Hyderabad - 500020, Telangana, India. |
|
|
Primary Sponsor
|
| Name |
Biological ELimited |
| Address |
18/1&3, Azamabad, Hyderabad - 500020, Telangana, India. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 15 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ravi B Nagarajaiah |
Adichunchanagiri Hospital & Research Centre |
Dept of General Medicine,1st floor,B G Nagara Nagamangala Taluk, Mandya-571448
Mandya
KARNATAKA |
9448323893
ravibn972@yahoo.com |
| DrPNaveen Chander Reddy |
AIG Hospital |
4th floor, Plot No. 2/3/4/5, Survey No. 136/1, Mindspace Road, Gachibowli-500032,
Hyderabad
TELANGANA |
9848045814
drnaveen.reddy@aighospitals.com |
| Dr Chandramani Singh |
All India Institute of Medical Sciences |
Room No. 17 Department of Community & Family Medicine, Aurangabad Road Phulwari Sharif, Patna 801507.
Aurangabad
BIHAR |
09931733280
cmaiims57@gmail.com |
| Dr Swapnav Borthakur |
Down Town Hospital |
2nd floor of 3rd building, G. S. Road, Bormotoria, Dispur, Guwahati-781006
Dibrugarh
ASSAM |
9864038704
swapnav.bortharkar@gmail.com |
| Dr Anil Kumar Pandey |
ESIC Medical College and Hospital |
Room No. 440, 4th Floor, NH-3
behind BK Hospital
New Industrial Town-121001
Faridabad
HARYANA |
7042918222
drpandeyak@yahoo.co.in |
| Dr Shiva Narang |
Guru Teg Bahadur Hospital & UCMS |
Department of Medicine, Dilshad Garden, Delhi-110095,
North East
DELHI |
9899838807
shivanarang@gmail.com |
| Dr E Venkata Rao |
Institute of Medical Sciences & SUM Hospital |
Department of community Medicine, 3rd Floor,K-8, Kalinga Nagar, Ghatikia,Bhubaneswar-751003
Baleshwar
ORISSA |
9668443382
e.venkata.rao@gmail.com |
| Dr Madhav Prabhu |
KLES Dr. Prabhakar Kore Hospital and MRC |
Department of Medicine, Nehru Nagar,Belgavi-590010
Belgaum
KARNATAKA |
9738462380
wiseman2380@yahoo.com |
| Dr Manish Kumar Jain |
Maharaja Agrasen Superspeciality Hospital |
Department of
Pulmonology, Central Spine, Agrasen Aspatal Marg, Sector-7, Vidyanagar-302039
Jaipur
RAJASTHAN |
9414414834
doctormanishjain2@gmail.com |
| Dr Pajanivel Ranganadin |
Mahatma Gandhi Medical College& Research Institute |
1st floor, I block, Pondicherry-Cuddalore Road, ECRMain
Road, Pillayarkuppam-607402,
Pondicherry
PONDICHERRY |
9443493122
pajanivelr@mgmcri.ac.in |
| Dr Maulesh Tailor |
Pagarav Hospital & ICU |
Basement, Plot No. 512/1, Nr. G-6 Circle, Opp. SBI Bank, Sector-23, Gandhinagar-382023
Gandhinagar
GUJARAT |
9979867922
drmauleshtailor@yahoo.com |
| Dr Jitendra Singh Kushwaha |
Prakhar Hospital Pvt. Ltd |
Department of Medicine, 8/219, Arya Nagar Road, Khalasi Line, Arya Nagar, Kanpur-208002
Kanpur Nagar
UTTAR PRADESH |
844852240
dr.jskushwahacr@gmail.com |
| Dr Sanjay Kala |
Sarojini Naidu Medical College |
Ground floor, Transfusion medicine department, Moti Katra, Mantola, Agra-282003
Agra
UTTAR PRADESH |
9839210012
surgerygsvmmc@gmail.com |
| Dr A Venkateshwar Rao |
St.Theresas Hospital |
Room No. 5, Department of Medicine, Sanathnagar-500018
Hyderabad
TELANGANA |
9440040662
drvenkateshwarraoavula@gmail.com |
| Dr Sandeep Jain |
Tagore Hospital and Research Centre |
Ground floor,Tagore Lane, Sector-7, Shipra Path, Madhyam Marg, Mansarovar-302020
Jaipur
RAJASTHAN |
9414069583
drsandeeprjain@yahoo.co.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 15 |
| Name of Committee |
Approval Status |
| Ethical Committee, Mahatma Gandhi Medical College and Research Institute |
Approved |
| Ethics Committee downtown hospital |
Approved |
| Ethics Committee GSVM Medical College |
Approved |
| Ethics Committee, St. Theresa’s Hospital |
Approved |
| Guru Teg Bahadur Hospital Ethics Committee |
Approved |
| IEC ESIC Medical College and Hospital, |
Approved |
| IEC Prakhar Hospital Pvt Ltd |
Approved |
| IEC, All India Institute of Medical Sciences, Patna |
Approved |
| IEC, Maharaja Agrasen Hospital |
Approved |
| Institutional Ethics Committee of AH and RC Adichunchanagiri Hospital and Research Center |
Approved |
| Institutional Ethics Committee, IMS & SUM Hospital |
Approved |
| Institutional Ethics committee, KLES Dr. Prabhakar Kore Hospital |
Approved |
| Institutional Ethics Committee- AIG Hospital |
Approved |
| Pagarav Ethics committee |
Approved |
| Tagore Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Active immunization for the prevention of COVID-19 disease |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Biological E’s SARS-CoV-2 (COVID-19)Vaccine- CORBEVAX |
Dose: 0.5ml, Route of administration: Intramuscular injection, Frequency: Two doses at Day 0 and Day 28. |
| Comparator Agent |
None |
None |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion Criteria ONLY for Phase II:
1.Male or female (non-pregnant) subject between ≥ 18 to 55 years of age.
2.Subject seronegative to anti-SARS-CoV-2 antibody prior to enrolment.
Inclusion Criteria ONLY for Phase III:
1.Male or female subject between ≥ 18 to 80 years of age.
Inclusion Criteria for Phase II and Phase III:
1.Subject or their legally acceptable representative (LAR) is willing to provide a written informed consent for voluntary participation in the study.
2. Subject, in the opinion of the investigator, has ability to communicate and willingness to comply with the requirements of the protocol.
3.Subject is virologically seronegative to SARS-CoV-2 infection as confirmed by RT-PCR prior to enrolment.
4.Subject is seronegative to HIV 1 & 2, HBV and HCV infection prior to enrolment.
5.Subject is considered of stable health as judged by the investigator, determined by medical history and physical examination.
6.Female subject of child bearing potential must have a negative urine pregnancy test (UPT), and willingness to avoid becoming pregnant through use of an effective method of contraception or abstinence from the time of study enrolment until six weeks after the last dose of vaccination in the study.
7.Male subject, who is sexually active, must agree to use double-barrier contraception (e.g. condom with spermicide) with his female partner during the study period. Male subject should also agree to avoid semen donation or providing semen for in-vitro fertilization during the study duration.
8.Subject agrees not to participate in another clinical trial at any time during the total study period.
9.Subject agrees to refrain from blood donation during the course of the study.
10.Subject agrees to remain in the town where the study centre is located, for the entire duration of the study.
|
|
| ExclusionCriteria |
| Details |
1.History of vaccination with any investigational or approved vaccine against COVID-19 disease.
2.Subject living in the same household as that of any active COVID-19 positive individual at the time of enrolment.
3.History of receipt of any licensed vaccine within 1 month prior to screening, likely to impact on interpretation of the trial data (e.g., influenza vaccines);
4.Subjects with any clinically significant abnormal haematology and biochemical laboratory parameters tested at screening as judged by the investigator.
5.Subjects with Body temperature of ≥100.4°F (>38.0°C) or symptoms of an acute illness at the time of screening or prior to vaccination.
6.Pregnant women, nursing women or women of childbearing potential who are not actively avoiding pregnancy during the study.
7.Subjects with known current or chronic history of any of the following conditions, likely to affect participation in the study:
i.severe psychiatric conditions;
ii.any bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder);
iii.allergic disease or reactions likely to be exacerbated by any component of the study vaccine (BE CORBEVAX vaccine);
iv.neurological illness, and any other serious chronic illness requiring hospital specialist supervision.
8.Subjects requiring chronic administration (defined as more than 14 days in total) of immunosuppressant (e.g. corticosteroids, cytotoxic drugs or antimetabolites, etc.) or other immune-modifying drugs (e.g. interferons) during the period starting six months prior to the first vaccine dose including use of any blood products.
i.For corticosteroids, this will mean prednisone ≥0.5 mg/kg/day, or equivalent.
ii.Inhaled and topical steroids are allowed.
iii.Receipt of prohibited concomitant medication that may jeopardize the safety of the participant or interpretation of the data.
9.Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
10.Any medical condition that in the judgment of the investigator would make study participation unsafe.
11.Planned use of any investigational or non-registered product other than the study vaccine during the trial period or 3 months prior to enrolment.
12.Current or planned participation in prophylactic drug trials for the duration of the study.
13.Individuals who are part of the study team or close family members of individuals conducting the study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Proportion of subjects with solicited adverse reactions/symptoms
2.Proportion of subjects with unsolicited adverse events (AEs)
3.SAEs & MAAE in all subjects.
1.Anti-RBD IgG antibodies in terms of ratio of IgG1 to IgG4 anti-RBD titres.
2.Neutralizing antibody titre
3.Immunogenicity in terms of GMC/T
4.Proportion of subjects seroconverted in terms of ≥2-fold & ≥4-fold rise
5.Cell mediated immunity assessment in terms of cytokine expression from stimulated PBMCs (INF-γ, IL-4)
|
1.during first 60 minutes of post vaccination and subsequent 7 days.
2.28-day follow-up period after each dose.
3.At 6 and 12months post 2nd dose.
1.at day 42 vs baseline.
2.at baseline and again at day 42.
3.at baseline and again at day 42.
4.in baseline seronegative subjects and ≥2-fold rise in baseline seropositive subjects along with their GMFR at day 42
5.at baseline and at day 42 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
At Phase-II:
Anti-RBD IgG concentrations (GMC, Fold Rise, GMFR) |
At baseline, day 28, 42 and 56 and at 6 and 12 months post second dose. |
| Anti-RBD IgG subclass assessment in terms of ratio of IgG1 to IgG4 titres |
At day 42 & day 56. |
| Neutralizing antibody titre |
At baseline, day 28, 42, 56 and at 6 and 12 months post second dose. |
| Cell mediated immunity assessment in terms of cytokine expression from stimulated PBMCs (INF-γ, IL-4) |
At baseline and at day 42 |
At Phase-III:
Proportion of subjects with solicited adverse reactions/symptoms |
During first 60 minutes of post vaccination observation period and for subsequent 7 consecutive days |
| Proportion of subjects with unsolicited adverse events (AEs) |
During the 28-day follow up period after each dose |
| SAEs and MAAES |
During the entire study period |
| Safety follow-up visit |
At 6 and12 months post 2nd dose |
|
|
Target Sample Size
|
Total Sample Size="1268"
Sample Size from India="1268"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
07/06/2021 |
| 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="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a prospective, open-label, single
arm, phase II seamlessly followed by Phase III clinical study design to
evaluate the immunogenicity and safety of CORBEVAX vaccine for Protection
Against COVID-19 Disease When administered to COVID-19-Negative Adult Subjects between18-80 years of age. A
total of 1268 male and non-pregnant female adult, from moderate to high-risk
population with and without comorbidities will be enrolled across both phases
of the study. Subjects must be RT-PCR negative to SARS-CoV-2 antigen. A total of 100 subjects, aged 18 to 55 years, will be enrolled in Phase
II for safety assessment and a total of 1168 subjects, aged 18 to 80 years,
will be enrolled in Phase III to receive BioE’s SARS-CoV-2 vaccine (CORBEVAX). The study will be conducted in compliance with GSR 227(E), ICH and
Indian good clinical practice guidelines in force at the time of study conduct. |