Antisera gets DCGI nod for phase-1 human trials: May be more effective than plasma therapy for COVID-19 treatment

An "antisera" developed by injecting inactivated SARS-CoV-2 in horses may be a potential treatment for COVID-19. DCGI gives nod for human trials.

The Drugs Controller General of India has given permission for conducting Phase-1 human clinical trial for an "antisera" that was developed by injecting inactivated SARS-CoV-2 in horses and can be a potential treatment for COVID-19, ICMR officials said on Tuesday. The 'antisera' has been developed by the Indian Council of Medical Research (ICMR) in collaboration with a Hyderabad-based bio-pharmaceutical firm. The pre-print version of the study regarding the development of the equine antisera has been posted on the Research Square platform. As part of the study, 10 healthy horses were immunised with inactivated SARS-CoV-2 and after 21 days of immunisation, plasma samples were tested. The results of the plasma samples indicated presence of SARS-CoV-2 specific IgG antibodies as detected in ELISA with neutralising capacity.

The 'antisera' has been developed by the Indian Council of Medical Research (ICMR) in collaboration with a Hyderabad-based bio-pharmaceutical firm. "With Biological E Limited we have developed a horse 'antisera' and we have just got clearance for conducting clinical trials for that," ICMR Director General Dr Balram Bhargava said at press briefing on Tuesday. The 'antisera' is yet to undergo human clinical trials to establish safety and efficacy.

Antisera can kickstart the immune system

ICMR had earlier said in a tweet that antisera are blood serum high in antibodies against specific antigens and are injected in humans to help kickstart the immune system to fight specific infections. The ICMR and Biological E Limited, Hyderabad, have developed highly purified antisera (raised in animals) for prophylaxis and treatment of COVID-19. The study provides evidence of the potential of generating highly purified F(ab')2 from equines against SARS-CoV-2 that can demonstrate consistent and high neutralisation activity. Further, in-vivo testing for efficacy of this indigenously developed, cost effective product will pave the way to clinical evaluation. Additionally, being a donor independent method, this may prove as an efficient alternative to convalescent plasma for treatment of COVID-19 patients. Earlier such measures were used for controlling several viral and bacterial infections.

Antisera may be more effective than antibodies, say experts

Antisera is basically a serum that contains antibodies. These antibodies are obtained by inoculating animals and used to provide immunity to a specific disease. According to ICMR, although, plasma recovered from patients experiencing COVID-19 could serve similar purpose, the profile of antibodies, their efficacy and concentration keep varying from one patient to another and therefore, make it an unreliable clinical tool for patient management. Standardisation achievable through equine sera-based treatment modality thus stands out as yet another remarkable public health initiative supported by ICMR in the time of COVID-19.

What exactly are antisera?

Antisera are native sera that contains specific immunoglobulin, which have prophylactic or therapeutic action when administered to people suffering from a viral or bacterial disease. This are prepared by injecting antigens or venoms into healthy animals like horses. Once injected, the animals produce antibodies which are normally associated with a globulin fraction serum. Once a certain degree of antibodies is produced, blood is taken from the animal and plasma is processed to produce specific antisera.

(With inputs from Agencies)