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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  
Name  Address 
None  None 
 
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  
Status 
Approved/Obtained 
 
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.


 
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