| CTRI Number |
CTRI/2021/06/034442 [Registered on: 29/06/2021] Trial Registered Prospectively |
| Last Modified On: |
28/10/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Vaccine |
| Study Design |
Other |
|
Public Title of Study
|
Safety and efficacy of Monovalent and Bivalent Recombinant Protein Vaccines against COVID-19 in Adults 18 Years of Age and Older |
|
Scientific Title of Study
|
A parallel-group, Phase III, multi-stage, modified double-blind, multi-armed study to assess the efficacy, safety, and immunogenicity of two SARS-CoV-2 Adjuvanted Recombinant Protein Vaccines (monovalent and bivalent) for prevention against COVID-19 in adults 18 years of age and older |
|
Secondary IDs if Any
|
| Secondary ID |
Registry |
| 23143 |
Other |
| U1111-1264-3238 |
UTN |
| VAT00008 version No. 2.0 dated 16 Apr 2021 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
|
| Address |
|
| Phone |
|
| Fax |
|
| Email |
|
|
Details Contact Person
Scientific Query
|
| Name |
Dr Somnath Mangarule |
| Address |
4th Floor Vasantha Chambers Fateh Maidan Road
Basheer Bagh Hyderabad
Hyderabad
TELANGANA
500004
India |
| Phone |
04066301502 |
| Fax |
|
| Email |
Somnath.Mangarule@sanofi.com |
|
Details Contact Person
Public Query
|
| Name |
Dr Somnath Mangarule |
| Address |
4th Floor Vasantha Chambers Fateh Maidan Road
Basheer Bagh Hyderabad
TELANGANA
500004
India |
| Phone |
04066301502 |
| Fax |
|
| Email |
Somnath.Mangarule@sanofi.com |
|
|
Source of Monetary or Material Support
|
| Sanofi Pasteur Inc
Discovery Drive, Swiftwater, PA 18370-0187, USA |
|
|
Primary Sponsor
|
| Name |
Sanofi Healthcare India Private Limited |
| Address |
Sanofi House, CTS No.117-B, L&T Business Park,
Saki Vihar Road, Powai, Mumbai 400 072, India |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Colombia
Dominican Republic
Ghana
Honduras
India
Japan
Kenya
Mexico
Nigeria
Pakistan
Sri Lanka
Uganda
United States of America |
Sites of Study
Modification(s)
|
| No of Sites = 10 |
| Contact Person |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jinen Shah |
Aartham Multi Super Speciality Hospital |
Opp. Polytechnic, NR
Panjrapol cross road,
Ambawadi, Ahmedabad 380015, Gujarat, India
Ahmadabad
|
9724440891
Drjinen.shan21@gmail.com |
| Dr Chandramani Singh |
All India Institute of Medical Science (AIIMS) |
Dept. of Community and Family Medicine Phulwarisharif, Patna, Bihar- 801507, India
Patna
|
9931733280
cmaiims57@gmail.com |
| Dr Chandan Das |
Institute of Medical Sciences (IMS) & SUM Hospital |
K8, Kalinga Nagar, Ghatikia, Bhubaneswar-751003, Odisha, India
Khordha
|
9937063390
drchandan1204@gmail.com |
| Dr Veer Bahadur Singh |
Jawahar Lal Nehru Medical College |
Kala Bagh, Ajmer – 305001, Rajasthan
Ajmer
|
9414136888
Vbsingh2@rediffmail.com |
| Dr Amit Suresh Bhate |
Jeevan Rekha Hospital |
Dr. B R Ambedkar Road Belagavi- 590002
Belgaum
|
9695237796
dr.amitsureshbhate@gmail.com |
| Dr Manish Kumar Jain |
Maharaja Agrasen Supe speciality Hospital |
Central Spine, Agrasen Aspatal Marg Sector 7,
Vidhyadhar Nagar, Jaipur, Rajasthan – 302039, India
Jaipur
|
0141-2334609
doctormanishjain2@gmail.com |
| Dr Chinthaparthi Prabhakar Reddy |
Nizam’s Institute of Medical Sciences |
Department of Clinical Pharmacology & Therapeutics,
Panjagutta Hyderabad Telangana - 500082 India
Hyderabad
|
04023489091
cptnims@gmail.com |
| Dr JS Kushwaha |
Prakhar Hospital Private Ltd |
8/219 Arya Nagar, Kanpur – 208002, UP India
Kanpur Nagar
|
7905113329
dr.jskushwahacr@gmail.com |
| Dr Satyajit Mohapatra |
SRM Medical College Hospital & Research Centre |
SRM Nagar,Potheri, Tamil Nadu, 603211-India
Kancheepuram
|
9791161626
satyajitmp@gmail.com |
| Dr Nitin Khandelwal |
Vidarbha Institute of Medical Sciences |
Kamptee Rd, LIC Square, Mohan Nagar, Nagpur, Maharashtra 440001
Nagpur
|
9823109993
kniti74@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 10 |
| Name of Committee |
Approval Status |
| Aartham Ethics Committee_Dr. Jinen Shah |
Approved |
| Ethics Committee of Prakhar Hospital_Dr. JS Kushwaha |
Approved |
| IEC, Maharaja Agrasen Hospital_Dr. Manish Kumar Jain |
Approved |
| IEC_AIIMS Patna_Dr. Chandramani Singh |
Approved |
| IEC_IMS and SUM Hospital_Dr. Chandan Das |
Approved |
| IEC_Jeevan Rekha Hospital_Dr. Amit Suresh Bhate |
Approved |
| IEC_JLN Medical College_Dr. Veer Bahadur Singh |
Approved |
| IEC_SRM Medical College Hospital and Research Centre_Dr. Satyajit Mohapatra |
Approved |
| IEC_Vidharbha Institute of Medical Sciences_Dr. Nitin Khandelwal |
Approved |
| NIMS Institutional Ethics Committee_Dr. CP Reddy |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
COVID 19 |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bivalent Vaccine |
Recombinant adjuvanted COVID-19 bivalent vaccine [CoV2 PreS dTM ASO3 bivalent vaccine (D614 +B.1.351)] will be administered as two dose series at D01 and D22 in STAGE 2 Participants, by IM route |
| Intervention |
Monovalent vaccine |
Recombinant adjuvanted COVID-19 monovalent vaccine [CoV2 PreS dTM ASO3 monovalent vaccine (D614)] will be administered as two dose series at D01 and D22 in STAGE 1 Participants, by IM route |
| Comparator Agent |
Placebo |
0.9% normal saline placebo will be administered as two dose series at D01 and D22 in STAGE 1 and 2 Participants, by IM route |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Aged 18 years or older on the day of inclusion.
2. For persons living with HIV, stable HIV infection determined by participant currently on antiretroviral with CD4 count more than 200/mm3.
3. SARS-CoV-2 rapid serodiagnostic test performed at the time of enrollment to detect presence of SARS-CoV-2 antibodies.
4. Does not intend to receive an authorized/approved COVID-19 vaccine despite encouragement by the Investigator.
5. A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies:
•Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year or surgically sterile.
OR
•Is of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to the first study intervention administration until at least 12 weeks after the second study intervention administration.
A participant of childbearing potential must have a negative highly sensitive pregnancy test (urine or serum as required by local regulation) within 25 hours before any dose of study intervention.
6. Informed consent form has been signed and dated.
7. Able to attend all visits and to comply with all study procedures.
8. Covered by health insurance, only if required by local, regional or national regulations |
|
| ExclusionCriteria |
| Details |
1. Known systemic hypersensitivity to any of the vaccine components, or history of a life- threatening reaction to a vaccine containing any of the same substances.
2. Dementia or any other cognitive condition at a stage that could interfere with following the study procedures based on Investigator’s judgment.
3. Self-reported thrombocytopenia, contraindicating intramuscular (IM) vaccination based on Investigator’s judgment.
4. Bleeding disorder, or receipt of anticoagulants in the past 21 days preceding inclusion, contraindicating IM vaccination based on Investigator’s judgment.
5. Unstable acute or chronic illness that in the opinion of the Investigator or designee poses additional risk as a result of participation or that could interfere with the study procedures.
6. Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature more than equal to 38.0°C [more than equal to 100.4°F]). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided.
7. Receipt of any vaccine in the 30 days preceding or on the day of the first study vaccination or planned receipt of any vaccine between the first study vaccination and in the 30 days following the second study vaccination except for influenza vaccination, which may be received at any time in relation to study intervention.
8. Prior administration of a coronavirus vaccine (severe acute respiratory syndrome coronavirus 2 [SARS-CoV-2], SARS-CoV, Middle East Respiratory Syndrome [MERS-CoV]).
9. Receipt of solid-organ or bone marrow transplants in the past 180 days.
10. Receipt of anti-cancer chemotherapy in the last 90 days.
11. Participation at the time of study enrollment (or in the 30 days preceding the first study vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure.
12. Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.
13. Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (ie, parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study. |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Efficacy: Occurrences of symptomatic COVID-19
Safety: To assess the safety of the CoV2 preS dTM-AS03 vaccines compared to placebo |
More than equals to 14 days after the second injection |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Key Secondary Efficacy:
•Occurrences of SARS-CoV-2 infection
•Occurrence of severe COVID-19
Key Immunogenicity:
To compare the neutralizing antibody response 21 days after last vaccination (D43) to the D614G variant and B.1.351 variant between the monovalent and bivalent vaccines in SARS-CoV-2 naïve and non-naïve participants in the Random Immunogenicity Subcohort. |
More that equals to 14 days after the second injection |
|
|
Target Sample Size
|
Total Sample Size="37430"
Sample Size from India="3000" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
06/07/2021 |
| Date of First Enrollment (Global) |
26/05/2021 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NA |
|
Brief Summary
|
Background: In the VAT00008 efficacy study, the
antigen dose for both the monovalent and bivalent vaccines was determined based
on safety and immunogenicity data observed in the VAT00002 Phase II study,
results of nonclinical studies, and information on manufacturing capacity. The
interim data from the VAT00002 study were used to select the 10 µg dose for the
monovalent D614 vaccine to be tested in Stage 1 of the Phase III study; and for
Stage 2 of the Phase III study with the bivalent D614 + B.1.351 vaccine, a 5 µg
(D614 component) + 5 µg (B.1.351 component) antigen dose was selected. Purpose: This Phase III study is to assess the
efficacy, safety, and immunogenicity of two CoV2 preS dTM-AS03 vaccines
(monovalent and bivalent) in adults 18 years of age and older in a multi-stage
approach. Summary: VAT00008 will be a Phase III, randomized, modified
double-blind, placebo-controlled, multi-stage, multi‑center, multi-country
study to assess the efficacy, safety, and immunogenicity of two CoV2 preS
dTM-AS03 vaccines (monovalent and bivalent) for prevention against COVID-19 in
adults 18 years of age and older |
