Peter Ilicciev / Fiocruz The candidate for a vaccine that can protect humans from schistosomiasis has passed the initial phase of clinical trials. These trials are necessary to establish the safety of the future vaccine. Developed entirely in Brazil, it targets the worm Schistosoma mansoni, which causes the disease. Transmission occurs through the consumption of water contaminated with larvae of the parasite. Fever, headache, loss of appetite, chills, cough and diarrhea are some of the symptoms of the disease, also called water belly because it causes abdominal swelling, if not treated with medication. Schistosomiasis affects about 7 million Brazilians and 200 million people worldwide, especially in Africa. Another 800 million worldwide are at risk of contracting the disease.
The vaccine was developed at the Oswaldo Cruz Foundation (Fiocruz) in Rio de Janeiro, under the coordination of physician and researcher Miriam Tendler, who has been studying the disease for 30 years. The immunizing agent uses an antigen—a substance that stimulates the production of antibodies—to neutralize the parasite’s attack on the human body. The antigen is a protein called Sm14 and was chosen in 2014 by the World Health Organization (WHO) as one of the priority projects in the world for diseases affecting the poorest populations.
Gutemberg Brito / FiocruzProduct made at Fiocruz, in Rio de Janeiro. If approved, it will be manufactured by the Brazilian company OrygenGutemberg Brito / Fiocruz
In Phase 1 clinical trials the vaccine was administered to humans to determine its degree of safety. “We tested 20 healthy men and 10 healthy women in the state of Rio de Janeiro; the results were very good and indicated we could move on to the next phase, testing with more people,” says Tendler. Phase one of the study was conducted in partnership with the University of Washington and the Infectious Disease Research Institute (IDRI), in the United States. “We analyzed 486 parameters relating to the safety of the vaccine.” Part of the study was published in January 2016 in the journal Vaccine.
Phase 2 is expected to begin in 2016 and will be done with volunteers in Brazil and Africa. Phase 1 tests cost R$5 million, financed through a public-private partnership (PPP) with Ourofino, a Brazilian company located in the state of Minas Gerais that specializes in veterinary medicine. Beginning in 2016, Ourofino gave up the rights it held on the human vaccine, having licensed the immunizing agent from Fiocruz, and retained only the veterinary version. Orygen, a joint venture formed by Biolab and Eurofarma, which are also Brazilian companies, took over the human vaccine. Phase 2 will have investments from the companies, Fiocruz and the Brazilian Innovation Agency (FINEP), which amount to a total of $4.5 million.
Scientific article
Santini-Oliveira, M. et al. Schistosomiasis vaccine candidate Sm14/GLA-SE: Phase 1 safety and immunogenicity clinical trial in healthy, male adults. Vaccine. V. 34, pp. 586-94. January 20, 2016.
