CTRI/2020/07/026352 [Registered on: 04/07/2020] Trial Registered Prospectively
Last Modified On:
02/11/2023
Post Graduate Thesis
No
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
Secondary IDs if Any
Secondary ID
Registry
NCOV 1002 Version 02 dated 02 July 2020
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study) Modification(s)
Name
Dr Ravindra Mittal
Address
Zydus Corporate Park, Scheme No. 63, Survey No. 536, Nr. Vaishnodevi Circle, S.G. Highway.
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"
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.
