India’s second COVID-19 vaccine’s human trials have begun

In accordance with the Clinical Trial Registry- India (CTRI), the drug trial is based on two standards — inclusion and exclusion.

 

Zydus Cadila, Indian pharmaceutical giant company has commenced with the phase 1, 2 clinical trials to assess the safety and antigenicity of coronavirus vaccine prospect by intradermal (injection) course in 1,048 subjects following the approval that the pharma giant received from Drugs Controller General of India (DCGI) previously this month.

As stated by Clinical Trial Registry- India (CTRI), this study is primarily focused on two criteria — inclusion and exclusion.

The inclusion criteria are then separated into two distinct phases. 

In phase 1, the company has chosen healthy males and females (non-pregnant and non-lactating) within 18-55 years of age.

The volunteers have to follow the trial process and should be available for the follow-up time period. The subjects should also be able and be prepared to fulfil an informed approval procedure with an understanding of the objective and process of the study, it stated.

With regard to phase 2, healthy participants of either gender aged 12 or more will be chosen.

The company has to obtain informed approval from adult volunteers or from the parents of pediatric volunteers. 

Then comes the exclusion criterion which too is segregated into phases 1 and 2, respectively.

Considering the exclusion criteria, participants are not permitted if they have a febrile illness (temperature >= 38degC or 100.4degF) or any sort of acute illness or infection in the past four weeks of enrolment, having a history of confirmed coronavirus case or even of any sort of contact with a COVID-19 confirmed sufferer within 14 days time period or history of SARS/MERS infection, individual positive for antibody and antigen against coronavirus, any individual who has earlier taken part in any clinical test of a COVID candidate vaccine, record of hepatitis C, B infection or human immunodeficiency virus I or II, record or presence of substantial smoking (>10 cigarettes per day), the previous record of hypersensitivity reaction or any severe adverse impact after any vaccination and volunteers with thrombocytopenia or any coagulation disorder, or volunteers on anticoagulation therapy, it informed.

The phase 1 trials, from Day 0 to 84, will be performed to assess the safety of the COVID-19 vaccine candidate by intradermal course in healthy participants. In phase 2, which will be conducted from 0 to 224 days time period, the immunogenicity of the COVID-19 vaccine participants by the intradermal course in healthy subjects in opposition to placebo will be assessed.

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