Starts human trial of zika vaccine

Starts human trial of zika vaccine

4 years, 3 months ago

Sinergium Biotech has been investigating a safe immunization against zika virus. It is expected that this year will begin tests in humans, after obtaining good results in mice in the preclinical stage. The zika virus expands throughout the region, and in the summer the countries seek to limit the circulation of the disease, transmitted by the same mosquito as dengue.

The difference with the ills that Aedes brings is that the complications of zika are much more serious, such as neural problems in babies, or the possibility of suffering Guillain Barré syndrome. Even now a study says it could affect the male reproductive system. For that reason, to obtain a vaccine would be a great achievement for the continent, that works in several projects of this type. One of them, with Argentine participation, announced that it will start testing the drug in humans in April of this year, after the first encouraging results. The vaccine to be created is recombinant type, and gave good indications in mice.

The project of this vaccine against zika is headed by an international consortium, composed of laboratories and firms from several countries, including Argentina. National firm Sinergium Biotech is part of this ambitious project, which includes Protein Sciences Corporation of the United States, Liomont Laboratory of Mexico, UMN Pharma of Japan and Fiocruz, one of the main health institutions in Brazil. In addition, the NGO Mundo Sano is added to the work.

According to the national firm said in a statement, in April will begin testing in humans this vaccine, after the good results generated in mice. "According to the good results obtained in pre-clinical studies with mice, it is expected that by April of this year clinical trials of Phase I in humans," said the investigators. So far, the Sinergium Biotech vaccine showed "a good safety profile and the generation of neutralizing antibodies against the virus".

The start of phase I clinical trials in humans is expected in the coming months of the year. "Although the research protocol is not yet defined, it will undoubtedly be of great importance the incorporation of people from Latin America given the high incidence of the disease in this population," said the laboratory, which leaves the door open to the participation of Patients and Argentinean volunteers.

This vaccine is composed of a purified protein called "protein E" that matches a protein that is naturally found on the surface of the zika virus. According to early results in preclinical studies with mice, the purified protein formulated in the laboratory causes strong levels of neutralizing antibodies, which is a positive indicator that the vaccine will protect against virus infection. In addition, the investigational vaccine demonstrated good safety results in a toxicological study sponsored by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health through its program Of preclinical support.

It is worth mentioning that the vaccine in development is of the recombinant type. For their production insect cells infected with a baculovirus (virus that infects insect cells, not pathogenic to humans) containing the genetic information of the zika virus E protein will be used. This development mode provides a fast and safe production method (since it does not use pathogenic virus for its production). It is also a technology with a long and proven track record in the production of complex proteins and is currently used in the production of other veterinary and human vaccines approved in several countries of the world.

Once installed in the country, this technology will allow not only the development of the zika vaccine but also the development of new vaccines for the prevention or treatment of other diseases. According to the terms of the agreement, the Argentinean laboratory Sinergium Biotech finances the development and manufacture of the vaccine using the technology registered by Protein Sciences.

Every day, new complications appear that generates the virus, for that reason the importance of this advance in the matter of prevention. One of the most recent is a study published last year conducted at the University of Washington, Missouri, which found that zika could affect the reproductive system of males. The study, tested in mice, found that zika affected the production of sperm and testosterone among these animals.

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