Coronavirus Vaccine Latest Updates: Early-stage trial data of AstraZeneca to be out by July 20, second Indian vaccine enters human trial phase
New Delhi | Jagran Lifestyle Desk: Early-stage human trial data on a COVID-19 vaccine being developed by AstraZeneca and Oxford University will be published by July 20, the Lancet mediacal journal has said.
The vaccine candidate is already in large-scale Phase III human trials to assess whether it can protect against COVID-19, but its developers have yet to report Phase I results which would show whether it is safe and whether or not it induces an immune response.
The statement by Lancet came after several reports said that that Phase I data could be released as soon as Thursday.
Developers of the vaccine, known as known as AZD1222, said earlier this month they were encouraged by the immune response they had seen in trials so far and were expecting to publish Phase 1 data by the end of July.
A preclinical trial of the shot in pigs showed that two doses produced a greater antibody response than a single dose.
Meanwhile, in India, 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 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.
More than 100 vaccines are being developed and tested around the world to try to stop the COVID-19 pandemic, which has killed hundreds of thousands and ravaged the global economy.
(With inputs from Reuters and ANI)
Posted By: Abhinav Gupta