Brazil: Clinical trial for LepVax, leprosy vaccine, to be led by Fiocruz
The Oswaldo Cruz Institute (IOC), part of the Oswaldo Cruz Foundation (Fiocruz), will be responsible for leading a historic clinical trial for global public health: a stage in the development of a vaccine against leprosy.
A candidate to be the first vaccine against leprosy, LepVax was developed by the Access to Advanced Health Institute (AAHI), an American non-profit biotechnology research institute. Using modern protein subunit technology, the vaccine has had promising preclinical tests against the bacterium Mycobacterium leprae, which causes the disease.
fore reaching the human studies stage in Brazil, which will involve 54 volunteers, the vaccine's safety has already been demonstrated in tests on 24 healthy people in the United States. The study showed the vaccine's safety, with no serious adverse events recorded. It also indicated immunogenicity, that is, the ability to stimulate the immune response.
Brazil accounts for 90% of cases of the disease in the Americas and is also the second country in the world in terms of the number of reports of the disease, behind only India. In the ten years from 2014 to 2023, there were almost 245,000 new infections, according to the Ministry of Health. In 2023 alone, 22,773 new cases were recorded.
The head of the IOC/Fiocruz Leprosy Laboratory, Roberta Olmo, highlights that the LepVax clinical trial at the Fiocruz institute reflects the level of maturity achieved over years of pioneering work by the laboratory, which has allowed it to gain recognition from the national and international scientific community.
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"The sustained elimination of leprosy as a public health problem requires a vaccine. In this scenario, LepVax emerges as a prophylactic and therapeutic vaccine, which could contribute to the goals of controlling the disease", she says.
For leprosy, the goals include interrupting transmission in 99% of municipalities, eliminating the disease in 75% of municipalities and reducing the absolute number of new cases with apparent physical disability at the time of diagnosis by 30% by 2030.
The Oswaldo Cruz Institute will evaluate the safety and immunogenicity of the vaccine, in addition to investigating the use of two different formulations of the vaccine, with low and high doses of antigen. To do this, participants will be randomly divided into three groups: two will receive the vaccine, one with a low dose and the other with a high dose; and the third group will receive the placebo, which is a saline solution with no biological effect.
Each participant will receive three doses of the vaccine corresponding to their group, 28 days apart. After that, they will be monitored for one year. To participate, participants must be between 18 and 55 years old, in good health and not pregnant. In addition, volunteers cannot be people who have already had the disease or have close contact with leprosy patients.
Dermatologist and researcher at Ambulatório Souza Araújo, Cássio Ferreira, explains in a text released by the Oswaldo Cruz Institute that the safety of the vaccine will be assessed through clinical monitoring and laboratory tests. “In the United States, the result was very positive, with no major adverse events. The reactions recorded, such as pain at the injection site, fatigue and headache, are common in immunizations. This first demonstration of safety was essential for the research to advance.”
The Oswaldo Cruz Institute was chosen as the clinical center responsible for the tests, and the Institute of Immunobiological Technology (Bio-Manguinhos/Fiocruz) is the sponsor of the clinical trial. The LepVax project is funded by the American Leprosy Missions (ALM) philanthropic organization in the United States, which has been leading the development of the vaccine since 2002. The study in Brazil is also funded by the Ministry of Health and the Japanese Global Health Innovative Technology Fund (GHIT Fund). The Sasakawa Health Foundation in Japan is a partner in the research.
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According to the World Health Organization (WHO), the infection occurs in 120 countries, with around 200,000 new cases each year. The disease mainly affects vulnerable populations and receives little investment. Although it is one of the oldest diseases in the world, with cases reported more than four thousand years ago, there is still no vaccine. Immunization with the BCG vaccine is recommended to prevent infection in people at higher risk, but protection is partial.