CTRI Number |
CTRI/2020/11/029032 [Registered on: 10/11/2020] Trial Registered Prospectively |
Last Modified On: |
13/01/2021 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Vaccine Biological Preventive |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Biological E’s novel Covid-19 vaccine of SARS-CoV-2 for protection against Covid-19 disease. |
Scientific Title of Study
|
A prospective open label randomised phase-I seamlessly followed by phase-II
study to assess the safety, reactogenicity and immunogenicity of Biological E’s
novel Covid-19 vaccine containing Receptor Binding Domain of SARS-CoV-2 for
protection against Covid-19 disease when administered intramuscularly in a two
dose schedule (0, 28D) to healthy volunteers.
|
Trial Acronym |
None |
Secondary IDs if Any
|
Secondary ID |
Identifier |
BECT062/Covid-19-phase-I&II/CTP-01Ver: 1.1 dated:07.10.20 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
DrSubhash Thuluva |
Designation |
Vice President - Clinical Development |
Affiliation |
Biological E.Limited |
Address |
Clinical affairs & Pharmacovigilance 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 |
DrSubhash Thuluva |
Designation |
Vice President - Clinical Development |
Affiliation |
Biological E.Limited |
Address |
Clinical affairs & Pharmacovigilance 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 |
DrTSA Kishore |
Designation |
Associate Vice President |
Affiliation |
Biological E.Limited |
Address |
Clinical affairs & Pharmacovigilance 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 = 5 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
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
drcmsingh@aiimspatna.org |
Dr Puneet Misra |
All India Institute of Medical Sciences |
1st Floor, Room No. 14, Department of community Medicine, Ansari Nagar, New Delhi 110029. South DELHI |
09868397372
doctormisra@gmail.com |
Dr Venugopal |
King George Hospital |
1st Floor, Room No. 09,
Department of Paediatrics,
Collectorate Junction, Maharani Peta,530002.
Visakhapatnam ANDHRA PRADESH |
09866739808
fbnc.amc@gmail.com |
Dr A Venkateshwar Rao |
St. Theresa s Hospital |
1st Floor, Room No. 05, Erragadda Main Road
Czech Colony Sanath Nagar-500038 Hyderabad TELANGANA |
09440383778
drvenkateshwarraoavula@gmail.com |
Dr Shiv Narang |
UCMS & Guru Teg Bahadur Hospital, |
7th Floor, Room No. 27, Department of General Medicine,Dilshad Garden, Shahdara,110095.
North East DELHI |
09899838807
shivanarang@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
No of Ethics Committees= 5 |
Name of Committee |
Approval Status |
Ethics Committee, St. Theresa’s Hospital, Hyderabad |
Approved |
Guru Teg Bahadur Hospital Ethics Committee, Delhi |
Approved |
IEC, All India Institute of Medical Sciences, Patna |
Approved |
Institute Ethics Committee, All India Institute of Medical Sciences, New Delhi |
Submittted/Under Review |
Institutional Ethics Committee, King George Hospital, Visakhapatnam |
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 novel Covid-19 vaccine containing Receptor Binding Domain of SARS-CoV-2 |
With four formulations, BECOV2D, BECOV2C,BECOV2B and BECOV2A. 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 |
65.00 Year(s) |
Gender |
Both |
Details |
1.Ability and willingness to provide written or thumb printed informed consent prior to performing any study specific procedure.
2.Subject, in the opinion of the investigator, has ability to communicate and willingness to comply with the requirements of the protocol.
3.Participants of either gender between ≥18 to ≤55 years of age at phase-I and ≥18 to ≤65 years of age at phase-II at the time of 1st vaccination.
4.Participants virologically seronegative to SARS-CoV-2 infection by RT-PCR and anti-SARS-CoV-2 antibody prior to enrolment.
5.Participants seronegative to HIV 1 & 2, HBV and HCV infection prior to enrolment.
6.Participants considered of stable health as judged by the investigator, determined by medical history and physical examination with normal vital signs as defined in the protocol. [Normal vital signs defined as pulse rate of ≥60 to ≤100 bpm; blood pressure systolic of ≥90 mm Hg and <140 mm Hg; diastolic ≥ 60 mm Hg and <90 mm Hg; body temperature <100.4ºF prior to enrolment].
7.Female participants of child bearing potential negative to urine pregnancy test 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;
8.Agrees not to participate in another clinical trial at any time during the total study period.
9.Agrees to refrain from blood donation during the course of the study.
10.Agrees to remain in the town where the study centre is located, for the entire duration of the study.
11.Willing to allow storage and future use of collected biological samples for future research in an anonymised form.
|
|
ExclusionCriteria |
Details |
1.History of vaccination with any investigational vaccine against COVID-19 disease;
2.Seropositive to IgG antibodies against SARS CoV-2
3.Living in the same household of any COVID-19 positive person;
4.Pregnant women, nursing women or women of childbearing potential who are not actively avoiding pregnancy during clinical trials;
5.Seriously overweight (BMI ≥ 40 Kg/m2);
6.Use of any investigational or non-registered product other than the study vaccine during the trial period or 3 months prior to enrolment;
7.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);
8.Current or planned participation in prophylactic drug trials for the duration of the study.
9.Any clinically significant abnormal haematology and biochemical laboratory parameters tested at screening as judged by the investigator;
10.Body temperature of ≥100.4°F (>38.0°C) or symptoms of an acute illness at the time of screening or prior to vaccination;
11.History of severe psychiatric conditions likely to affect participation in the study;
12.History of any bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder);
13.History of allergic disease or reactions likely to be exacerbated by any component of the Biological E’s four COVID-19 vaccine formulations;
14.Chronic respiratory diseases, including asthma;
15.Chronic cardiovascular disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder and neurological illness;
16.Any other serious chronic illness requiring hospital specialist supervision;
17.Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units every week for at least one year;
18.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. For corticosteroids, this will mean prednisone ≥0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed;
19.Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required);
20.Any medical condition that in the judgment of the investigator would make study participation unsafe.
21.Individuals who are part of the study team or close family members of individuals conducting the study.
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
On-site computer system |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
Phase-I
1.any adverse reactions
2.any solicited symptoms
3.any unsolicited adverse events
4.Serious and other medically attended adverse events
Phase-II
1.Virus neutralizing antibody (NAb) assay against SARS-CoV-2 virus
2.Seroconversion rates in terms of proportion of subjects with ≥4-fold increase in neutralizing antibodies
3.Geometric mean titres and Geometric mean fold rise in neutralizing antibodies
|
Phase-I
1.within 2 hours of immediate post vaccination period;
2.within 7 consecutive days after each dose captured through subject diary;
3.at 6 months and 12 months post 2nd dose.
4.at 6 months and 12 months post 2nd dose
Phase-II
1.at baseline, 28, 42, 56 days and again at 6 months and 12 months post 2nd dose.
2.from baseline
3.from baseline
|
|
Secondary Outcome
|
Outcome |
TimePoints |
Phase-I
1.IgG antibodies against SARS-CoV-2 RBD antigen
2.Virus neutralizing antibody (NAb) assay against SARS-CoV-2 virus
3.Interferon-gamma cytokine levels
Phase-II
1.any adverse reactions
2.any solicited symptoms
3.any unsolicited adverse events
4.Serious and other medically attended adverse events in all study participants
5.IgG antibodies against SARS-CoV-2 RBD antigen
|
Phase-I
1 & 2.at baseline, 28, 42, 56 days and again at 6 months and 12 months post 2nd dose.
3.at baseline and again at Day 56.
Phase-II
1.within 2 hours (first 120 min) of immediate post vaccination period;
2.within 7 consecutive days after each dose captured through subject diary;
3.during 28 days after each dose of study vaccination;
4.at 6 months and 12 months post 2nd dose.
5.at baseline, 28, 42, 56 days and again at 6 months and 12 months post 2nd dose
|
|
Target Sample Size
|
Total Sample Size="360" Sample Size from India="360"
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)
|
16/11/2020 |
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 phase-I seamlessly followed by phase-II, open label, randomized trial to assess safety, tolerability, reactogenicity and immunogenicity of the Biological E’s 4 candidate vaccine formulations for preventive protection against COVID-19 disease in adult volunteers of either gender between 18-55 years of age in Phase-I and 18-65 years of age in phase-II. A total of 360 subjects of either gender would be enrolled into the study. 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. The aim of this phase-I seamlessly followed by phase-II is to select a preferred vaccine formulation among the 4 candidate formulations based on overall safety and immunogenicity considerations.
|