The clinical study is based on two criteria – inclusion and exclusion. (Representative)
New Delhi:
Indian pharmaceutical giant Zydus Cadila launched phase 1 and 2 clinical trials to assess the safety and immunogenicity of the intradermal (injection) coronavirus vaccine candidate in 1,048 subjects after the pharmaceutical company obtained approval from the Drugs Controller General of India (DCGI) earlier this month.
According to the registry of clinical trials – India (CTRI), the clinical study is based on two criteria – inclusion and exclusion.
The inclusion criteria are divided into two phases.
In phase 1, the company selected healthy males and females (non-pregnant and non-lactating) between 18 and 55 years of age.
Volunteers must follow test procedures and must remain available for the duration of the follow-up. Participants should be able and willing to complete an informed consent process with an understanding of the purpose and procedures of the study, he said.
For phase 2, healthy volunteers 12 years of age or older will be selected.
The company must obtain the informed consent of adult subjects or parents of pediatric subjects.
The next is the exclusion criterion which is also divided into phases 1 and 2, respectively.
In the exclusion criteria – subjects are not allowed to have – a febrile illness (temperature> = 38 ° C or 100.4 ° F) or any acute illness or infection within four weeks of registration, having history of confirmed case of coronavirus or history of contact with a COVID – 19 patient confirmed within 14 days or history of infection with SARS / MERS, individual positive for the antibody and antigen against the coronavirus, person having already participated in a clinical trial of a COVID candidate vaccine, history of hepatitis C, infection B or human immunodeficiency virus I or II, history or presence of significant smoking (> 10 cigarettes per day), history of reaction hypersensitivity or any serious adverse event after any vaccination and subjects with thrombocytopenia or any bleeding disorder, or subjects on anticoagulant therapy, he said.
Phase 1 trials, from day 0 to day 84, will be conducted to assess the safety of the candidate COVID-19 vaccine intradermally in healthy subjects. In phase 2, which will last from 0 to 224 days, the immunogenicity of COVID-19 vaccine candidates intradermally in healthy subjects compared to placebo will be assessed.
The World Health Organization (WHO) said that the coronavirus epidemic was first reported in China in late December 2019. Being a highly transmissible virus between humans, it has taken the form of a pandemic. As of July 15, there were 13,119,239 confirmed cases of COVID-19 worldwide, including 573,752 deaths reported to the global health agency.
In the absence of effective prevention measures, the current management of the fight against the epidemic is the application of quarantine, isolation and physical distance. Effective vaccines against COVID-19 are urgently needed to reduce the huge burden of mortality and morbidity associated with infection.
The number of deaths from COVID-19 rose to 24,309 and the total number of cases rose to 9,366,181 in India, after recording 582 deaths and a one-day record peak of 29,429 cases until Wednesday 8 a.m., according to Union Health. Ministry.
(With the exception of the title, this story was not edited by GalacticGaming staff and is published from a syndicated feed.)
