Human trials for Covid-19 vaccines by Bharat Biotech, Zydus underway in 6 cities
Volunteers across the country are being administered the indigenous vaccine candidates against the coronavirus disease (Covid-19) developed by Bharat Biotech International Limited (BBIL) and Zydus Cadila.
Bharat Biotech and Zydus were granted permission for Phase I and II clinical trials of Covaxin and ZyCoV-D respectively and the pharmaceutical companies have said the first doses of their vaccine candidates were administered to volunteers on July 15.
A third vaccine candidate developed by Oxford University and backed by AstraZeneca Plc will soon be tested in India. Serum Institute of India is in a manufacturing partnership with the UK’s AstraZeneca.
The Pune-based Serum Institute has said it will be starting trials of the Oxford University’s Covid-19 vaccine candidate by the end of August on up to 5,000 Indian volunteers after getting the necessary nods and launch it by June next year if all goes well.
Covaxin, which has been developed in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV), will be tested at 12 institutes, including All India Institute of Medical Science (AIIMS) in Delhi and Patna, and PGI Rohtak.
Testing of Zydus’ ZyCoV-D is limited to its research centre in Gujarat’s Ahmedabad right now and will be extended to multiple cities across the country.
Zydus is looking to complete clinical trials of ZyCoV-D in seven months, the company’s chairperson said on Friday. The firm is looking to complete phase I and phase II clinical trials in the next three months and submit the data to the regulator, Zydus Cadila Chairman Pankaj R Patel said in a statement.
It could take a total of seven months for the trials to be completed and for the vaccine to be launched, depending on the study outcomes and if the data is encouraging and the vaccine is found to be effective during the trials, he added.
Covaxin trials have already begun in All India Institute of Medical Sciences (AIIMS) Delhi, AIIMS Patna, Post Graduate Institute of Medical Sciences (PGIMS) in Haryana’s Rohtak, SRM Medical College Hospital and Research Centre in Kanchipuram and Nizam Institute of Medical Sciences in Hyderabad.
The centres are conducting simultaneous phase 1 and phase 2 clinical trials to study the safety and immunogenicity of different doses and adjuvant combinations of the vaccine developed by the biotechnology company, in collaboration with ICMR’s National Institute of Virology. An adjuvant is a compound that helps increase the effectiveness of a vaccine.
Vaccine trials are yet to start at King George Hospital in Visakhapatnam, Jeevan Rekha Hospital in Belgaum, Gillurkar Multispeciality Hospital in Nagpur, Rana Hospital in Gorakhpur, Kalinga Hospital in Bhubaneswar, Prakhar Hospital in Kanpur and CROM Clinical Research Private Ltd and Medical Tourism in Goa.
AIIMS Delhi administered its first dose of Bharat Biotech’s vaccine candidate to a 30-year-old healthy man on Friday as part of its combined phase 1 and 2 trials for the drug.
“The vaccine candidate was administered to the first trial participant — a healthy 30-year-old man — around noon on Friday. He was monitored for two hours to check for any adverse reactions. All trial participants will be monitored every day for the first seven days. They will then be followed-up on day 14 and day 28. They will be tracked for up to a year to observe any long-term impacts,” said Dr Puneet Misra, one of the investigators of the trial and a professor of community medicine at AIIMS.
The centre has received nearly 3,500 applications for the trials so far, and 100 healthy participants will be enrolled from among them. Participants have to be between the ages of 18 and 55 years and have no comorbidities like diabetes, hypertension, heart or kidney disease.
“Our priority is safety and hence we need healthy participants. Those who are called in for the trial have to undergo a battery of tests to determine their general health. They are tested for a current infection using RT-PCR test and for past infections using an antibody test. Participants are given the vaccine only if they are free of Covid-19. For now, we are also selecting participants only from Delhi and the National Capital Region for the ease of follow-ups,” said Dr Misra.
The vaccine is currently being administered in two doses — 0.3 and 0.5 microgram. In the 0.5 microgram dosage, the vaccine is being given with two different adjuvants. Of the 100 who will be enrolled, 80 will get different dosages and combination of the vaccine, and 20 participants will receive placebos.
PGIMS became the second facility in India after AIIMS Patna, to begin the human trials. Dr Savita Verma, the principal investigator of the trial, said they had administered the first dose of vaccine (0.5ml) to three volunteers on July 17.
“These volunteers were kept under observation for three hours. They tolerated the vaccine very well. Later, the volunteers were sent back home and a team of doctors will now examine their health every day. PGIMS, along with three other medical institutes, will conduct human trials on 50 volunteers in the first phase. The second phase will commence 14 days later after seeing the result of the vaccine in these volunteers,” she added.
Dr Verma said 17 individuals have undergone rigorous medical scrutiny so far to check whether they have been previously infected with the virus or suffered from any liver, lungs or kidney ailments and any other infectious diseases.
“Three of these volunteers, who were found eligible, were administered the vaccine today and the report of 13 is awaited,” she added.
Clinical trials for Covaxin began at the Nizam’s Institute of Medical Sciences (NIMS) in Hyderabad on July 20 with hospital authorities administering the first vaccine dose to two volunteers. In Hyderabad, as many as 30 volunteers have registered with the NIMS for the clinical trials.
“Of them, seven more subjects are available and they would be administered the vaccine in the next few days,” NIMS director Dr K Manohar said.
According to an official familiar with the development, the volunteers are being drawn from different parts of the state. These subjects would be administered two doses of the vaccine. There will be three types of vaccines — three micrograms, six micrograms and placebo. Each subject would be given the second dose of the same vaccine after 14 days.
For two days after administering the vaccine, the subjects would be monitored by a team of doctors in the Intensive Critical Care Unit (ICCU) before being discharged.
“Their health condition will be monitored from time to time. The doctors would also look into the interaction with the vaccine digitally as well as through frequent physical check-ups,” the official said.
Human trials at SRM Medical College Hospital and Research Centre began on Thursday with two volunteers being administered 0.05 ml of the vaccine each. They will get the next dose on day 14.
King George Hospital (KGH) in Andhra Pradesh’s Visakhapatnam, which was also selected by the ICMR for clinical trials for Covid-19 vaccine, is yet to commence the exercise.
“We have got the approval from the ICMR, but are yet to get the clearance from the state government. We have written to the Director of Medical Education to give the nod for clinical trials and once we get it, we shall start,” Dr K Indira Devi, in-charge superintendent of the KGH, told Hindustan Times.
Institute of Medical Sciences and Sum Hospital, a privately-run medical college in Bhubaneswar, started screening prospective candidates on July 20.
Reports said Nagpur’s Gillurkar Multispecialty Hospital and Research Centre, the only site for human trials of Covaxin in Maharashtra, is expected to start Phase 1 by end of July or the first week of August.
Two private hospitals in Uttar Pradesh will also soon begin human trials of Covaxin, the Covid-19 vaccine developed by Bharat Biotech.
The two hospitals—Prakhar Hospital in Kanpur and Rana Hospital and Trauma Centre in Gorakhpur—are also among the 12 institutes across the country where the human trial of the vaccine candidate will be conducted.
Prakhar Hospital is looking at a sample size of 50 people in the first phase and another 150 in the second phase of the human trial. The Rana Hospital, meanwhile, is awaiting a safety certificate before the trials can begin.