CTRI

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CTRI Number

CTRI/2020/07/026352 [Registered on: 04/07/2020] Trial Registered Prospectively

Last Modified On:

08/11/2020

Post Graduate Thesis

Type of Trial

Interventional

Type of Study

Vaccine

Study Design

Other

Public Title of Study

Novel Corona Virus-2019-nCov vaccine by intradermal route in healthy subjects.

Scientific Title of Study

A prospective, randomized, adaptive, phase I/II clinical study to evaluate the safety and immunogenicity of Novel Corona Virus -2019-nCov vaccine candidate of M/s Cadila Healthcare Limited by intradermal route in healthy subjects

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
NCOV 1002 Version 02 dated 02 July 2020	Protocol Number

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Ravindra Mittal
Designation	Senior Vice President
Affiliation	Cadila Healthcare Limited
Address	Zydus Corporate Park, Scheme No. 63, Survey No. 536, Nr. Vaishnodevi Circle, S.G. Highway. Ahmadabad GUJARAT 382481 India
Phone	07948040000
Fax
Email	r.mittal@zyduscadila.com

Details of Contact Person
Scientific Query

Name	Dr Kevinkumar Kansagra
Designation	Deputy General Manager
Affiliation	Cadila Healthcare Limited
Address	Zydus Research Center, Survey No. 396/403, Sarkhej-Bavla National Highway No.8A Moraiya, Ahmedabad - 382213 Ahmadabad GUJARAT 382213 India
Phone	02717665555
Fax
Email	kevinkumarkansagra@zyduscadila.com

Details of Contact Person
Public Query

Name	Dr Ravindra Mittal
Designation	Senior Vice President
Affiliation	Cadila Healthcare Limited
Address	Zydus Corporate Park, Scheme No. 63, Survey No. 536, Nr. Vaishnodevi Circle, S.G. Highway Ahmadabad GUJARAT 382481 India
Phone	07948040000
Fax
Email	r.mittal@zyduscadila.com

Source of Monetary or Material Support

Cadila Healthcare Limited, Zydus Corporate Park, Scheme No. 63, Survey No. 536, Khoraj (Gandhinagar), Near Vaishnodevi Circle, S-G Highway, Ahmedabad

Primary Sponsor

Name	Cadila Healthcare Ltd
Address	Zydus Corporate Park, 3rd Floor B Wing (NPD), Scheme No. 63, Survey No. 536, Khoraj (Gandhinagar), Near Vaishnodevi Circle, S-G Highway, Ahmedabad – 382 481,
Type of Sponsor	Pharmaceutical industry-Indian

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study
Modification(s)

No of Sites = 9
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Hari Shankar Gupta	VIMS Hospital	Kamptee Rd, LIC Square, Mohan Nagar, Nagpur, Maharashtra 440001 Nagpur MAHARASHTRA	9890924509 drhari_gupta@yahoo.com
Dr Parshottam Koradia	BAPS Pramukh Swami Hospital	Shri Pramukh Swami Maharaj Marg, Adajan char rasta. Adajan. Surat - 395 009 Gujarat, India Surat GUJARAT	9825312027 purushottam_koradia@yahoo.co.in
Dr Vipul Prajapati	GCS Medical College, Hospital & Research Centre	Opposite DRM office, Near Chamunda Bridge, Naroda Road, Ahmedabad – 380025, Gujarat Ahmadabad GUJARAT	9909912551 Prajapativipul1983@gmail.com
Dr Suresh Bhate	Jeevan Rekha Hospital	Dr. B.R. Ambedkar Road, Opp. Civil Hospital, Belagavi (Belgaum), Karnataka – 590002 Belgaum KARNATAKA	9845273830 drsureshgbhate@gmail.com
Dr Manish Kumar Jain	Maharaja Agrasen Superspeciality Hospital	Central Spine Agrasen Aspatal Marg, Sector No. - 7 Vidhyadhar Nagar, Jaipur, Rajasthan -302039 Jaipur RAJASTHAN	9414414834 doctormanishjain2@gmail.com
Dr Virendra Nath Tripathi	Prakhar Hospital Pvt. Ltd.	8/219, Arya Nagar, Kanpur, Uttar Pradesh 208002 Kanpur Nagar UTTAR PRADESH	9415050777 principalinvestigator1177@gmail.com
Dr Ajeet Pratap Singh	Rana Hospital Pvt. Ltd.	Rail Vihar, Medical College Road, Chargawa, Gorakhpur, Uttar Pradesh 273001 Gorakhpur UTTAR PRADESH	7652456810 ajeetpsingh1177@gmail.com
Dr Talati Kalpesh Chimanlal	Zydus Hospitals and Healthcare Research Pvt Ltd.	Zydus Hospitals Road, S.G. Highway, Thaltej, Ahmedabad, Gujarat 380054 Ahmadabad GUJARAT	9824014187 KALPESHTALATI@zydushospitals.com
Dr Taufik Momin	Zydus Research Centre	Survey No. 396/403, Opp. Sarvotam Hotel, Nr. Nova Petrochemicals, Sarkhej-Bavla N.H. No. 8A, Village: Moraiya, Ahmedabad 382213, Gujarat, India Ahmadabad GUJARAT Ahmadabad GUJARAT	02717665555 Taufik.Momin@zyduscadila.com

Details of Ethics Committee
Modification(s)

No of Ethics Committees= 9
Name of Committee	Approval Status
BAPS Pramukh Swami Hospital Ethics Committee, BAPS Pramukh Swami Hospital, Adajan Cross Road. Adajan. Surat-395009	Approved
Ethics Committee Prakhar Hospital Pvt Ltd. Prakhar Hospital Pvt. Ltd. 8/219, Arya Nagar, Kanpur, Uttar Pradesh 208002	Approved
IEC Maharaja Agrasen Hospital, Maharaja Agrasen Superspeciality Hospital, Central Spine, Agrasen Aspatal Marg, Sector No. - 7 Vidhyadhar Nagar, Jaipur, Rajasthan -302039	Approved
Instituional Ethics Committee Jeevan Rekha Hospital Dr. B R Ambedkar Road Belgavi-590002	Approved
Institutional Ethics Committee of VIMS, Mohan nagar, LIC Square, Kamptee Road, Nagpur 440001, Maharastra India.	Approved
Institutional Ethics Committee Rana Hospital Pvt. Ltd., Rail Vihar Medical College Road, Chargawa Gorakhpur-273001	Approved
Institutional Ethics Committee, GCS Medical College, Hospital and Research Centre, Opp DRM Office, Nr Chamunda Bridge, Naroda Road, Ahmedabad-380025	Approved
Sangini Hospital Ethics Committee,C/o Sangini Hospital, First Floor,Santorini Square, b/h Abhishree Complex, Opp. Star Bazar, Nr. Jodhpur Cross Roads, Satellite, Ahmedabad-380015, Gujarat,India	Approved
Zydus Hospital Ethics Commitee Zydus Hospitals and Healthcare Research Pvt Ltd., Zydus Hospitals Road, S.G. Highway, Thaltej, Ahmedabad, Gujarat 380054	Approved

Regulatory Clearance Status from DCGI

Status

Approved/Obtained

Health Condition / Problems Studied

Health Type	Condition
Healthy Human Volunteers	Healthy

Intervention / Comparator Agent
Modification(s)

Type	Name	Details
Intervention	nCov Vaccine	For Phase I: 1)Dose:-0.1 ml in either of arm for Arm 1 (1 mg) with Needle and Arm 2(1 mg) with Pharmajet. In Arm 3 (2mg) with Needle and Arm 4(2mg) with Pharmajet,in both arm dose will given..(2)Frequency:-single time at day 0 day 28 and day 56.(3)Route: Intradermal. For Phase II : (1)Dose:-0.1 ml in either of arm for Arm 1 (1 mg) with Needle and Arm 2(1 mg) with Pharmajet. In Arm 3 (2mg) with Needle and Arm 4(2mg) with Pharmajet,in both arm dose will given..(2)Frequency:-single time at day 0 day 28 and day 56.(3)Route: Intradermal.
Comparator Agent	Placebo in Phase Ii	1)Dose:-0.1 ml in either of arm for Arm 1 (1 mg) with Needle and Arm 2(1 mg) with Pharmajet. In Arm 3 (2mg) with Needle and Arm 4(2mg) with Pharmajet,in both arm dose will given.(2)Frequency:-single time at day 0, day 28 and day 56.(3)Route: Intradermal

Inclusion Criteria

Age From	18.00 Year(s)
Age To	55.00 Year(s)
Gender	Both
Details	1.Healthy male and non-pregnant, non-lactating female subjects between 18-55 years of age (both inclusive) 2.Body weight > 50 kg for male and > 45 kg for female and BMI within the range 18.5 - 29.9 kg/m2 (Both inclusive) 3.Able and willing to complete informed consent process with understanding of the purpose and procedures of the study 4.Subjects who, in the opinion of the Investigator, are healthy as determined by their pre study medical history, clinical examination, 12-lead ECG and clinical laboratory tests within the institutional normal range or judged as not clinically significant by the Investigator, including the following parameters: haematology, serum biochemistry, urinalysis, and serology 5.Subjects who can comply with trial procedures and who are available for the duration of follow up 6.Male subjects and female subjects of childbearing potential must practice highly effective contraception during the study and be willing and able to continue contraception for 90 days after administration of last study vaccine. For Phase II:- 1.Healthy subject of either gender ≥12 years of age 2.Informed consent from the adult subjects or from the parents of paediatric subjects. Additionally, assent from paediatric subjects (Audio video recording in case of vulnerable subject) 3.Adult subjects or parents of paediatric subjects literate enough to fill the diary card 4.Females of childbearing potential, must agree to use one of the approved contraception methods, from screening until completion of the follow-up visit and males will agree to use contraception.

ExclusionCriteria

Details

For Phase I
1.Febrile illness (temperature ≥ 38°C or 100.4°F) or any acute illness or infection within 4 weeks of enrolment
2.History of confirmed SARS-CoV-2 positive
3.History of contact with a confirmed active SARS-CoV-2 positive patient within 14 days
4.History of SARS/ MERS infection
5.Subjects positive for antibody and antigen against SARS-CoV-2.
6.Previous participation in any clinical trial of a SARS-CoV-2 candidate vaccine
7.Any clinically significant laboratory or ECG findings during screening or check-in
8.History or presence of significant smoking (10 cigarettes per day)
9.Systolic blood pressure more than 140 mmHg and less than 100 mmHg and diastolic blood pressure more than 90 mmHg and less than 60 mmHg.
10.History of, or positive screening test for, hepatitis C infection (defined as positive for hepatitis C virus antibody), hepatitis B infection (defined as positive for hepatitis B surface antigen), or human immunodeficiency virus I or II

For Phase II
1.Febrile illness (temperature ≥ 38°C or 100.4°F) or any acute illness or infection within 4 weeks of enrolment
2.History of confirmed SARS-CoV-2 positive
3.History of contact with a confirmed active SARS-CoV-2 positive patient within 14 days
4.History of SARS/ MERS infection
5.Subjects positive for antibodies against SARS-CoV-2 on antibody detection test at the time of screening
6.Previous participation in any clinical trial of a SARS-CoV-2 candidate vaccine
7.Past history of hypersensitivity reaction or any serious adverse event after any vaccination
8.Subjects with thrombocytopenia or any coagulation disorder, or subjects on anticoagulation therapy

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Other

Blinding/Masking

Outcome Assessor Blinded

Primary Outcome

Outcome	TimePoints
Phase I:-To evaluate the safety of Novel Corona Virus-2019-nCov Vaccine Candidate of M/s Cadila Healthcare Limited by intradermal route in healthy subjects. Phase II:-To evaluate the immunogenicity of Novel Corona Virus-2019-nCov Vaccine Candidate of M/s Cadila Healthcare Limited by intradermal route in healthy subjects compared to placebo.	Phase I: Day 0 and Day 84 Phase II: Day 0 and Day 224

Secondary Outcome

Outcome	TimePoints
Phase I:-1)To evaluate the safety of Novel Corona Virus-2019-nCov Vaccine Candidate of M/s Cadila Healthcare Limited by intradermal route in healthy subjects. Phase II:-1)To evaluate the safety of Novel Corona Virus-2019-nCov Vaccine Candidate of M/s Cadila Healthcare Limited by intradermal route in healthy subjects compared to placebo.	Phase I: Day 0 and Day 84 Phase II: Day 0 and Day 224

Target Sample Size

Total Sample Size="1048"
Sample Size from India="1048"
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)

13/07/2020

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="0"
Days="0"

Recruitment Status of Trial (Global)
Modification(s)

Not Applicable

Recruitment Status of Trial (India)

Closed to Recruitment of Participants

Publication Details

NIL

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was first reported in January, 2020. The virus is highly transmissible between humans and has spread rapidly, causing the COVID-19 pandemic. Patients infected with SARS-CoV-2, especially older patients and those with pre-existing respiratory or cardiovascular conditions are at greater risk for severe complications, including severe pneumonia, acute respiratory distress syndrome, multiple organ failure, and in some cases, death.

In the absence of effective prevention measures, current management to control the epidemic is the enforcement of quarantine, isolation, and physical distancing. Effective vaccines against COVID-19 are urgently needed to reduce the enormous burden of mortality and morbidity associated with SARS-CoV-2 infection.