How To Take Part in Coronavirus Vaccine Trials? Will I Get Paid?
At least 250 volunteers have registered with PGIMS and nearly 3500 have registered with AIIMS, Delhi.
Vaccine maker Bharat Biotech and Indian Council of Medical Research (ICMR)'s coronavirus vaccine candidate Covaxin is undergoing Phase-1 human trials across 12 cities. Patna AIIMS, Delhi AIIMS, PGIMS Rohtak are among the 14 research institutes that have been chosen as trial sites.
FIT reached out to Patna AIIMS and PGIMS, Rohtak to understand who can take part in the trials, how many volunteers have registered so far and how does one participate in the trials.
According to reports, 250 volunteers have registered with PGIMS and nearly 3500 have registered with AIIMS, Delhi.
Dr Savita Verma, head of the department of pharmacology at PGIMS, and principal investigator on the trials, says that usually 50 people are selected for phase 1 human trials. Phase 2 involves 200 to 300 volunteers and phase 3 will need 1000 to 2000 volunteers.
When it comes to vaccines, there isn't much difference between phase 2 and 3 trials. So far, Drug Controller General of India has given permission only for Phase 1 and 2 trials of Covaxin. They've also increased the number of volunteers required for these trials, however there is no specific number decided for each trial site. In a way, this is a competitive trail, explains Dr Verma.
In phase 1, a total of 325 volunteers will be taken in, followed by 750 volunteers in phase 2.
What’s the first step to enrol in vaccine trials?
Helpline numbers have been issued on hospital websites. The numbers are also shared via papers and other media. Volunteers can make the first contact on phone, and they are called in to the hospital if they meet all criteria.
Who all can participate in the trials?
Each study has its unique inclusion and exclusion criteria, a protocol is issued to decide who should participate. For Covaxin, the sites are looking at healthy volunteers in the age group of 18 to 55. Volunteers should not have diabetes, hypertension, heart disease, lung disease, asthma, cancer, or any kind of allergies. They should not be on any medication or steroids. Pregnant women cannot volunteer.
What documents do I need to volunteer?
You will be given a written 'informed consent form' by the hospital. The form contains all information related to the trial, for eg, what responsibility lies with the hospital, how often is the volunteer expected to visit the site for follow ups, what steps will be followed while administrating the vaccine etc. Volunteers are then counselled.
If they wish to take the form home and study it more, they are given 1 to 3 days to consider their decision. Once this form is signed, along with the Adhaar card, the volunteer is registered for the trial. The identity of the volunteer is kept a secret.
Can people living in different cities and states volunteer?
People who live near the trial site are preferred. This is because the volunteers are expected to visit the site some 5-6 times during the trial period. It's easier to trace and monitor candidates who live nearby. But, others are not excluded. If you agree to make yourself available for site visits, you may be considered.
How are volunteers screened?
FIT has previously written in detail on how volunteers are screened, they undergo physical screening, blood test, urine test and a coronavirus test, before being finalised. Once the reports give an all-clear, the volunteer is called for vaccination.
Are people given the virus during clinical trials?
It's a misconception that volunteers are given a virus during trials. Trials in which volunteers are 'infected' with the virus are called 'challenge study.' Where as, ICMR has designed Covaxin trial as randomised, double blind, placebo controlled clinical trial. Those volunteers are registered who are likely to be exposed to the SARS-CoV-2 virus or like to get the COVID-19 disease.
Dr Verma tells us that Covaxin is a 'killed virus vaccine' and not a live virus vaccine. This vaccine acts as an antigen, as it enters the body, it generates an immune and antibody response. This vaccine cannot give you coronavirus disease.
It’s a misconception that volunteers are given a virus during trials. Trials in which volunteers are ‘infected’ with the virus are called ‘challenge study.’ Where as, ICMR has designed Covaxin trial as randomised, double blind, placebo controlled clinical trial.
Those volunteers are registered who are likely to be exposed to the SARS-CoV-2 virus or like to get the COVID-19 disease.Dr Verma tells us that Covaxin is a ‘killed virus vaccine’ and not a live virus vaccine. This vaccine acts as an antigen, as it enters the body, it generates an immune and antibody response. This vaccine cannot give you coronavirus disease.
Are those participating in the trials paid for their services?
According to rules set up for trials, the volunteers get transportation costs. The vaccine company sets a certain amount and that is ratified by the DGCI. But volunteers are not paid for participation.
Patna AIIMs told FIT that a volunteer gets Rs 1000 per visit.
Are volunteers expected to commit to a time period?
Volunteers have been asked to commit 7 months for the trial. This information is included in the consent form. During this time, they are monitored, their health updates are taken on phone, and when needed they will be called to the site.
Are there any side-effects?
Pain, skin redness at the site of the injection and fever are common side effects of vaccine. A more serious side effect is anaphylactic reaction. It is an allergic reaction and that's why it is essential that the site have an ICU attached to it. This is a rare side effect and all this is shared with the volunteer in the consent form and during counselling.
If you wish to participate in the trials, these are the numbers you can contact. Patna AIIMS: 9471408832, PGIMS Rohtak: +91-1262281417, Delhi AIIMS: Ctaiims.email@example.com / 7428847499.
Other hospitals selected for the trials are: King George Hospital, Visakhapatnam; Jeevan Rekha Hospital, Belgaum; Gillurkar Multi speciality hospital, Nagpur; Rana Hospital, Gorakhpur; SRM Hospital, Chennai; Nizam Institute of Medical Sciences, Hyderabad; Kalinga Hospital, Bhubaneshwar; Prakhar Hospital, Kanpur and one hospital in Goa.
(This article was first published on FIT and has been republished with permission.)
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