VINS Bioproducts on April 26 said that it has commenced clinical trials of purified horse antisera rich in polyclonal antibodies for the treatment of COVID-19 patients.
The therapeutic product called VINCOV-19 is obtained after immunisation of horses with spike glycoprotein of the inactivated COVID virus.
This results in the development of antibodies in horses and the resultant antisera — the blood serum containing antibodies — were synthesised from the horse and can be injected into humans infected with COVID-19 to neutralise the virus.
The Clinical Trials of VINCOV-19 will involve over 300 subjects spread across the country. The safety and efficacy of the antibodies will be examined in a group of around 300 patients, with COVID-19. The clinical plan is to administer the hyperimmune serum to patients with moderate to severe disease.
The antisera, which are rich in antibodies against specific antigens, are injected into humans to help kickstart the immune system to fight specific infections.
Frequently Asked Questions
A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.
There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.
Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.
The antisera were developed in partnership with the Centre for Cellular and Molecular Biology (CCMB) and the University of Hyderabad.
At the moment patients are struggling to get plasma donors of recovered COVID-19 positive people. Even if available, the profile of antibodies, their efficacy and concentration keep varying from one patient to another, making it an unreliable clinical tool for patient management.
It is pertinent to note that, along with VINS Bioproducts, other companies such as Biological E and Bharat Serums and Vaccines are also working on equine antisera products.
Encouraging results in pre-clinical trials
The pre-clinical trials for VINCOV-19, which began in October 2020, were "very successful" and the F(ab´)2 polyclonal antibodies proved to have high neutralising capacity.
"The results indicated that the product has a high neutralising capacity against SARS-CoV-2. Since neutralising antibodies could block the internalisation of SARS-CoV-2 to lung cells, it was postulated that their passive administration should render maximal clinical benefits if they are applied at the early stages of the disease," the company said.
“The development of VINCOV-19, in partnership with the Centre for CCMB and the University of Hyderabad and under the aegis of the Indian Council of Medical Research (ICMR), is a significant breakthrough in the fight against COVID-19," said Siddharth Daga, Chief Executive Officer, VINS Bioproducts.Hyderabad-based CCMB, which is part of the CSIR lab, helped develop the viral antigen; the University of Hyderabad (UoH) helped with product characterisation; and VINS Bioproducts managed the equine immunisation and clinical development in their state-of-art manufacturing plant in Telangana.