The clinical study is based on two criteria -- inclusion and exclusion. (Representational)
Indian pharmaceutical giant Zydus Cadila has initiated the phase 1, 2 clinical trial to evaluate the safety and immunogenicity of coronavirus vaccine candidate by intradermal (injection) route in 1,048 subjects after the pharma company got approval from Drugs Controller General of India (DCGI) earlier this month.
According to the Clinical Trial Registry- India (CTRI), the clinical study is based on two criteria -- inclusion and exclusion.
The inclusion criteria is divided into two phases.
In phase 1, the company has selected healthy males and females (non-pregnant and non-lactating) between 18-55 years of age.
The volunteers have to comply with trial procedures and should remain available for the duration of follow-up. The participants should be able and willing to complete an informed consent process with an understanding of the purpose and procedures of the study, it said.
For phase 2, healthy volunteers of either gender aged 12 or above will be selected.
The company has to get informed consent from the adult subjects or from the parents of pediatric subjects.
The next is the exclusion criterion which is also divided into phase 1 and 2, respectively.
In the exclusion criteria -- subjects are not allowed having -- febrile illness (temperature >= 38degC or 100.4degF) or any acute illness or infection within four weeks of enrolment, having story of confirmed coronavirus case or history of contact with a COVID-19 confirmed patient within 14 days or history of SARS/MERS infection, individual positive for antibody and antigen against coronavirus, person who has previously participated in any clinical trial of a COVID candidate vaccine, history of hepatitis C, B infection or human immunodeficiency virus I or II, history or presence of significant smoking (>10 cigarettes per day), past history of hypersensitivity reaction or any serious adverse event after any vaccination and subjects with thrombocytopenia or any coagulation disorder, or subjects on anticoagulation therapy, it stated.
The phase 1 trials, from Day 0 to 84, will be conducted to evaluate the safety of the COVID-19 vaccine candidate by intradermal route in healthy subjects. In phase 2, which will run from 0 to 224 days, the immunogenicity of COVID-19 vaccine candidates by intradermal route in healthy subjects compared to placebo will be evaluated.
The World Health Organisation (WHO) said that the coronavirus outbreak was first reported in China last late December in 2019. Being a highly transmissible virus between humans, it took the shape of a pandemic. As of July 15, globally there have been 13,119,239 confirmed cases of COVID-19, including 573,752 deaths reported to the global health body.
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 the infection.
The death count due to COVID-19 rose to 24,309 and the total number of cases climbed to 9,36,181 in India, after it registered 582 fatalities and a record single-day spike of 29,429 cases till Wednesday 8 am, according to the Union Health Ministry.
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