Nagpurians line up for vaccine trials

Nagpur: Many enthusiastic and young Nagpurians have eagerly volunteered for the human trials of Covid-19, which are to be held at a private hospital in city. Dr Chandrashekhar Gillurkar, director of Gillurkar Multispecialty Hospital and Research Institute, told TOI since the news of his institute being one of the 12 trial sites in India was published, he has been inundated with calls from people willing to be a part of this trial.
“Good to see that people are willing to be a part of this trial and volunteering to join the research. It’s completely safe and no patient will suffer from any serious consequences. We welcome healthy people from 18 to 55 years of age, but, they must fit in the national-level criteria,” said Dr Gillurkar. Registration for volunteers will start from Monday.
“We have already got 25 volunteers but looking for a few more. For first phase, only 50 volunteers will be enrolled. Out of these, only those who pass physical tests will be included in the trials. All blood tests and vital parameter medical tests will be conducted in New Delhi,” Dr Gillurkar said.
The inclusion and exclusion criteria for the phase I trials are very strict. People may clear the age and fitness tests, but clearing other vital health parameters is tough. In all, there are 8 inclusion criteria and 29 exclusion criteria by ICMR for this test.
After enrollment of participants based on the basic tests, further tests will be conducted. Subjects will be informed if their results are positive for hepatitis C, HIV 1 and 2 antibody or hepatitis B surface antigen (HBsAg), and will be referred to a primary care provider for follow up of these abnormal laboratory tests. Even those living in the same household as any Covid-19 positive person will be disqualified.
For women, additional tests regarding pregnancy will be done. Obese or underweight people, those who use steroids, those having chronic heart disease, kidney or liver disease will also not qualify.
Any other condition that, in the opinion of the investigator, would jeopardize the safety or rights of a volunteer participating in the trial or would render the subject unable to comply with the protocol, will also lead to disqualification.
“We understand the enthusiasm of people who are willing to join this mission for the nation. But, as we have to expedite the trials, only those who fulfill these basic criteria should contact us,” said Dr Gillurkar. The hospital is at Plot No 20, Reshimbagh, Umred Road.
Inclusion Criteria for Phase I trial
- Ability to provide written, informed consent
- Gender no bar, age between ≥18 to ≤55 years
- Good general health as determined by discretion of investigator
- Heart rate ≥60 to≤100 bpm
- Blood pressure systolic ≥90 mm Hg and <140 mm Hg
- Oral temperature <100.4ºF
- Interest and availability to fulfill study requirements
Exclusion criteria for Phase I trial
- History of any other Covid-19 investigational vaccination
- Abnormal Complete Blood Count (CBC), random blood sugar level
- Renal function test, liver function tests, urine analysis report
- Medical problems as a result of alcohol or illicit drug use during past 12 months
- Morbidly obese (BMI≥35 kg/m2) or underweight (BMI ≤18 kg/m2)
- Living in same household as any Covid-19 positive person
- History of any cancer