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

Cadila Healthcare Ltd0 sites1,048 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

April 13, 2021

Last Updated

2 years ago

Study Type

Interventional

Sponsor

•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

•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.