Based on an international collaboration approach, Sinergium Biotech, Mundo Sano, and Protein Sciences promoted an international Consortium to develop an innovative vaccine against ZIKV. The initiative found support of companies such as Liomont and UMN Pharma. The objective is to develop and obtain regulatory approval of the vaccine which uses the recombinant protein bacillus / recombinant protein (BEVS) platform, with a clinical trial approach.
Participants and contributions:
The project includes the following stages
The results of pre-clinical studies carried out in mice showed profilaxis and the generation of neutralizing antibodies against the virus. Researchers estimate to begin clinical trials in humans in April 2017. This stage in development is called “Phase I”. It consists of the first introduction of an experimental vaccine into a human population. It aims to determine its safety and biological effects, including immunogenicity.
This phase may include dose studies and administration possibilities and generally involves fewer than 100 volunteers. “Phase II” involves initial studies to determine the efficacy of the vaccine in a limited number of volunteers (generally between 200 and 500); This phase focuses on immunogenicity. “Phase III” studies aim to thoroughly assess safety and efficacy in preventing disease and involve more volunteers participating in a properly controlled multicenter study.
Although the research protocol is not yet defined, the incorporation of people from Latin America will undoubtedly be of great importance, given its high degree of disease incidence.
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 infection of the zika virus.
In addition, research demonstrated good safety results in a toxicological study sponsored by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health.
The vaccine in development is of the recombinant type. The production of the vaccine relies in thel use insect cells infected with a baculovirus containing the genetic information of the Zika virus E protein. Baculoviruses are not pathogenic to humans The approach provides a fast and safe production method (since it does not use pathogenic viruses 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. The technology may enable future developments in other areas of disease prevention and treatment.