A new vaccine for leprosy will be tested in Brazil by the Oswaldo Cruz Institute (IOC/Fiocruz). Called LepVax, the vaccine will be the first for the disease evaluated in the country during clinical trials. Authorization to begin testing was granted by the National Health Surveillance Agency (Anvisa) this Monday, October 14.
IOC will lead the first clinical trial of a leprosy vaccine in Brazil. Photo: Gutemberg Brito
The Institute was chosen as the clinical center responsible for the tests due to its extensive scientific contribution to leprosy studies. Leprosy Laboratory do IOC works in research and patient care within the scope of the National Reference Service for Leprosy with the Ministry of Health. With a high capacity to carry out clinical studies, the Laboratory has a multidisciplinary team and structure for immunological and molecular analyses.
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) charity 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 of Japan is a partner in the research.
If the results of the studies are positive, the leprosy vaccine could, in the future, be part of the national immunization schedule. Brazil is the country with the second highest number of cases of the disease in the world, behind only India. In ten years, from 2014 to 2023, there were almost 245 thousand new infections, according to the Ministry of Health. In 2023 alone, there were 22.773 new cases.
Surrounded by prejudice, leprosy is a neglected disease that can cause serious skin and nerve damage. With treatment available through the Unified Health System (SUS), the disease can be cured. However, many cases are identified late, when there is already damage that impairs the quality of life and ability to work of patients.
Vaccination room recently opened at Souza Araújo Outpatient Clinic will be the stage for the research. Photo: Gutemberg Brito
The deputy head of the Hansen's Disease Laboratory at the Oswaldo Cruz Institute (IOC/Fiocruz) and scientific leader of the LepVax clinical trial, Verônica Schmitz, considers the study being carried out in the country to be historic.
“Brazil accounts for 90% of leprosy cases in the Americas. Every four minutes, a new case of leprosy is recorded in the world. The WHO has already pointed out that we need new tools to control leprosy and that people affected by leprosy deserve a vaccine,” says the immunologist.
According to the World Health Organization (WHO), the infection occurs in 120 countries, with around 200 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.
"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", assesses the head of the Leprosy Laboratory of IOC, Roberta Olmo.
Part of the team that will work on the research alongside the scientific leader of the study, Verônica Schmitz (center, in black), and the medical leader, Cássio Ferreira (left, in blue shirt). Photo: Gutemberg Brito
LepVax was developed by the Access to Advanced Health Institute (AAHI), an American non-profit biotechnology research institute.
This is the first specific vaccine against the bacteria Mycobacterium leprae, which causes leprosy. The formulation was developed with one of the most modern technologies for the production of immunizers, called protein subunit.
Preclinical trials have yielded promising results. In mice vaccinated with LepVax, the infection rate was significantly reduced, even when exposed to large numbers of bacteria. When the vaccine was administered after infection, motor and sensory nerve damage was delayed in armadillos, which are considered a model for studies of the neurological form of leprosy. These results signal the potential for the vaccine to be used in the prevention and treatment of the disease.
The first stage of the trial with human beings, called phase 1a, was carried out in the United States, with the immunization of 24 healthy volunteers. The study demonstrated the safety of the vaccine, with no serious adverse events recorded. It also indicated immunogenicity, that is, the ability to stimulate the immune response.
The trial in Brazil will be LepVax's first in a territory with leprosy transmission. Classified as a phase 1b clinical trial, the study will aim to confirm the safety and immunogenicity of the vaccine.
According to Verônica, this assessment is important because, considering the country's epidemiological scenario, the immune system of a large part of Brazilians may have had previous contact with mycobacteria, which may influence the response to the vaccine. The scenario is the same in other countries endemic for leprosy, where the vaccine may be adopted.
“In Brazil, even people who have never had leprosy may have come into contact with it. M. leprosy and we have circulation of other mycobacteria, such as the one that causes tuberculosis. Brazilians are also vaccinated with BCG at birth. This is a different reality from the United States, where there is no transmission of the disease”, explains the immunologist.
The volunteers' immune response will be analyzed by the Hansneiasis Laboratory of IOC. Photo: Gutenberg Brito
The study will have the participation of 54 healthy volunteers. In addition to evaluating the safety and immunogenicity of the vaccine, the research will investigate the safety of two 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. The third group will receive the placebo – a saline solution that has no biological effect.
Following global protocols for this type of research, during the study, participants and researchers will not know which group each individual is included in.
“In phase 1a, in the United States, all participants were vaccinated for an initial assessment of the vaccine’s safety. Now, in phase 1b, we will have the opportunity to conduct a randomized, double-blind, placebo-controlled trial. This is the gold standard research method, which allows us to compare the vaccinated groups with the control group,” Verônica points out.
Regardless of the low or high dosage, the vaccination will be carried out in three applications, with an interval of 28 days between them, as occurred in the American trial. After that, the participants will be monitored for one year, totaling 421 days of clinical trial.
With Anvisa's authorization, the import of the vaccine from the United States to Brazil will begin. The study has already been approved by the Ethics Committee for Research with Human Beings of the IOC (CEP Fiocruz/IOC). The recruitment of volunteers to begin testing will be carried out after approval by the National Research Ethics Committee (Conep).
Importation of the vaccine and recruitment of volunteers will begin after authorization from Anvisa. Photo: Gutemberg Brito
To participate, you must be between 18 and 55 years old and in good health. At this stage of the study, volunteers cannot be people who have already had the disease or have had close contact with leprosy patients. The experimental immunization also cannot be administered to pregnant women.
Participation in the research will last approximately 14 months. During this period, volunteers must attend eleven appointments, three for vaccination and the rest for follow-up. During the visits, participants will undergo clinical evaluation and blood and urine tests.
In accordance with legal requirements, volunteers cannot be paid for participating in the research. Reimbursement for costs such as travel and food is provided. Participants will also have access to medical assistance, with 24-hour telephone contact, should they require assistance related to immunization.
Vaccination and monitoring of participants will be carried out at Souza Araújo Outpatient Clinic, maintained by the Leprosy Laboratory of IOC, on the campus of F.iocruz, in Manguinhos, North Zone of Rio de Janeiro (Av. Brasil, 4.365).
In addition to having a specialized team, the unit is certified by the National Accreditation Organization (ONA), which attests to the application of organizational guidelines and policies for safe and quality care. A recently opened vaccination room in the space will be used during the research.
Those interested in participating in the study can contact us by email vaccine.lepvax@ioc.fiocruz.br or by phone/WhatsApp (21) 93618-5232.
The study's medical leader, dermatologist and researcher at Ambulatório Souza Araújo, Cássio Ferreira, explains that the vaccine's safety will be assessed through clinical monitoring and laboratory tests.
“In the United States, the results were very positive, with no serious 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 to phase 1b in Brazil,” highlighted Cássio.
Clinical research room was prepared to carry out analyses on the vaccine. Photo: Gutemberg Brito
The blood samples collected will also be used to analyze the immune response triggered by the vaccine. These analyses will be carried out at the Hansen's Disease Laboratory of IOC, who prepared a clinical research room to carry out the tests.
To ensure the quality of the results, the equipment used for the analyses was certified by specialized companies. The procedures were validated using samples from the clinical trial conducted in the United States. The team follows good laboratory practice procedures, which are required by Anvisa.
To analyze the immunogenicity of the vaccine, researchers will measure the amount of antibodies present in the volunteers' serum (the liquid part of the blood without the coagulation molecules). They will also investigate the activation of defense cells, especially the so-called T cells.
“In leprosy, T cells are more important than antibodies in controlling the growth of the bacteria. Therefore, the factor that will preliminarily signal the vaccine’s potential for protection – called the correlate of protection – will be the dosage of molecules produced by active T cells,” explains the immunologist.
Samples from the clinical trial conducted in the United States were used to validate procedures. Photo: Gutemberg Brito
The study has an independent monitoring committee, which includes experts with no connection to Fiocroz.
If the phase 1b trial confirms the good performance of LepVax, researchers are already planning the next stage of the research, which will also be carried out by Fiocruz in Brazil.
In the phase 2a clinical trial, the plan is to vaccinate 582 patients with leprosy to evaluate the safety of immunization in individuals infected with M. leprosy and the therapeutic action of the immunizer.
“The request for authorization for phase 2a of the study will be submitted to Anvisa after the completion of the first safety analyses of the vaccine in trial 1b. The data will be evaluated by the study’s independent monitoring committee and then sent to the regulatory agency,” says Verônica.
The Leprosy Laboratory of the IOC has a history of relevant actions to combat the disease. The unit was a pioneer in the administration of polychemotherapy in Brazil. It was also the first to adopt the 12-dose treatment, having carried out studies that contributed to the recommendation of this regimen, currently recommended by the WHO.
“The LepVax clinical trial at our center is a good reflection of the level of maturity we have achieved over the years, which has allowed us to be recognized by the national and international scientific community today. It is also a reflection of our commitment to policies focused on quality care, as attested by the Souza Araújo Outpatient Clinic certification,” emphasizes Roberta.
One of the group's most recent contributions was the development of the NAT-HANS diagnostic kit, based on the detection of DNA from M. leprosy. The product was adopted by the Unified Health System (SUS) and began to be distributed to the Central Public Health Laboratories (Lacens) last year.
The innovation was developed by the Laboratory of IOC in partnership with the Carlos Chagas Institute (Fiocruz-PR) and the Institute of Molecular Biology of Paraná (IBMP).
The development of the NAT-HANS Kit was led by the researcher Milton Osorio Moraes, former head of the Leprosy Laboratory, who passed away in 2022.
The LepVax study in Brazil was also one of the scientist's projects. Internationally recognized as a reference in leprosy research, he was approached by the vaccine developers to conduct the product's clinical trial.
Between 2019 and 2022, Milton participated in organizing the research in Brazil and submitting the authorization request to Anvisa.
“During this period, Milton was diagnosed with cancer and we had the Covid-19 pandemic. Even so, he continued with the vaccine project. His death was a great loss for us and for science, but he prepared us to take this research forward,” Verônica emphasizes.
Leprosy affects the skin and nerves. The disease usually initially causes spots or lumps on the skin, with changes in sensitivity.
Without treatment, neurological damage can progress, impairing the ability to move, especially in the hands and feet, which affects the quality of life and ability to work of patients. The lesions can also affect the face, reinforcing the stigma, which is another of the major problems of the condition.
The BCG vaccine, produced with an attenuated version of the bacteria Mycobacterium bovis, offers partial protection against leprosy and tuberculosis. The WHO recommends immunization at birth in countries with a high burden of these diseases, as is the case in Brazil.
Since 1981, leprosy treatment has been based on a combination of antibiotics. So-called polychemotherapy has cured the infection and changed the outlook for the disease. Globally, cases have fallen by 95%.
However, in recent years, experts have drawn attention to the stagnation in the fight against the disease. Leprosy continues to cause new cases and permanent deformities.
To change this scenario, in 2021, the WHO published a new strategy against the disease, which seeks to interrupt the transmission of the infection by 2030.
In Brazil, the disease is still considered a public health problem, due to the high number of cases.
Tackling this problem is the target of the Interministerial Committee for the Elimination of Tuberculosis and Other Socially Determined Diseases (CIEDS), established in June.
Led by the Ministry of Health, the group has representatives from nine departments to combat neglected problems, often associated with poverty and other social determinants.
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.
According to experts, to combat leprosy, it is necessary to commit to applying available strategies, overcoming negligence, and at the same time, seeking innovations against this ancient infection.
“An effective vaccine is one of the tools capable of accelerating progress towards a future without leprosy,” highlights Verônica.
Led by American Leprosy Missions (ALM), the development of LepVax has involved collaboration with nearly 30 institutions from several countries since 2002. In addition to the IOC/Fiocruz, Bio-Manguinhos-Fiocruz and Fiotec, cooperate with the project: Access to Advanced Health Institute (AAHI), Aeras, Anesvad, Covance, Damien Foundation, DFnet, Effect Hope, FairMed, German Leprosy and Tuberculosis Relief Association (DAHW), Global Health Innovative Technology Fund ( GHIT), HL Snyder Medical Foundation, ILEP Federation, Leonard Wood Memorial, Leprosy Relief - Canada, Leprosy Research Initiative, National Hansen's Disease Program, National Institute of Allergy and Infectious Diseases (NIH), PS and Ouida Bailey Foundation, Raoul Follereau Foundation, St. Francis Leprosy Guild, Sasakawa Health Foundation, The Leprosy Mission - International, Turing Foundation and Until No Leprosy Remains (NLR). Donors who support ALM also contributed to the research.
A new vaccine for leprosy will be tested in Brazil by the Oswaldo Cruz Institute (IOC/Fiocruz). Called LepVax, the vaccine will be the first for the disease evaluated in the country during clinical trials. Authorization to begin testing was granted by the National Health Surveillance Agency (Anvisa) this Monday, October 14.
IOC will lead the first clinical trial of a leprosy vaccine in Brazil. Photo: Gutemberg Brito
The Institute was chosen as the clinical center responsible for the tests due to its extensive scientific contribution to leprosy studies. Leprosy Laboratory do IOC works in research and patient care within the scope of the National Reference Service for Leprosy with the Ministry of Health. With a high capacity to carry out clinical studies, the Laboratory has a multidisciplinary team and structure for immunological and molecular analyses.
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) charity 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 of Japan is a partner in the research.
If the results of the studies are positive, the leprosy vaccine could, in the future, be part of the national immunization schedule. Brazil is the country with the second highest number of cases of the disease in the world, behind only India. In ten years, from 2014 to 2023, there were almost 245 thousand new infections, according to the Ministry of Health. In 2023 alone, there were 22.773 new cases.
Surrounded by prejudice, leprosy is a neglected disease that can cause serious skin and nerve damage. With treatment available through the Unified Health System (SUS), the disease can be cured. However, many cases are identified late, when there is already damage that impairs the quality of life and ability to work of patients.
Vaccination room recently opened at Souza Araújo Outpatient Clinic will be the stage for the research. Photo: Gutemberg Brito
The deputy head of the Hansen's Disease Laboratory at the Oswaldo Cruz Institute (IOC/Fiocruz) and scientific leader of the LepVax clinical trial, Verônica Schmitz, considers the study being carried out in the country to be historic.
“Brazil accounts for 90% of leprosy cases in the Americas. Every four minutes, a new case of leprosy is recorded in the world. The WHO has already pointed out that we need new tools to control leprosy and that people affected by leprosy deserve a vaccine,” says the immunologist.
According to the World Health Organization (WHO), the infection occurs in 120 countries, with around 200 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.
"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", assesses the head of the Leprosy Laboratory of IOC, Roberta Olmo.
Part of the team that will work on the research alongside the scientific leader of the study, Verônica Schmitz (center, in black), and the medical leader, Cássio Ferreira (left, in blue shirt). Photo: Gutemberg Brito
LepVax was developed by the Access to Advanced Health Institute (AAHI), an American non-profit biotechnology research institute.
This is the first specific vaccine against the bacteria Mycobacterium leprae, which causes leprosy. The formulation was developed with one of the most modern technologies for the production of immunizers, called protein subunit.
Preclinical trials have yielded promising results. In mice vaccinated with LepVax, the infection rate was significantly reduced, even when exposed to large numbers of bacteria. When the vaccine was administered after infection, motor and sensory nerve damage was delayed in armadillos, which are considered a model for studies of the neurological form of leprosy. These results signal the potential for the vaccine to be used in the prevention and treatment of the disease.
The first stage of the trial with human beings, called phase 1a, was carried out in the United States, with the immunization of 24 healthy volunteers. The study demonstrated the safety of the vaccine, with no serious adverse events recorded. It also indicated immunogenicity, that is, the ability to stimulate the immune response.
The trial in Brazil will be LepVax's first in a territory with leprosy transmission. Classified as a phase 1b clinical trial, the study will aim to confirm the safety and immunogenicity of the vaccine.
According to Verônica, this assessment is important because, considering the country's epidemiological scenario, the immune system of a large part of Brazilians may have had previous contact with mycobacteria, which may influence the response to the vaccine. The scenario is the same in other countries endemic for leprosy, where the vaccine may be adopted.
“In Brazil, even people who have never had leprosy may have come into contact with it. M. leprosy and we have circulation of other mycobacteria, such as the one that causes tuberculosis. Brazilians are also vaccinated with BCG at birth. This is a different reality from the United States, where there is no transmission of the disease”, explains the immunologist.
The volunteers' immune response will be analyzed by the Hansneiasis Laboratory of IOC. Photo: Gutenberg Brito
The study will have the participation of 54 healthy volunteers. In addition to evaluating the safety and immunogenicity of the vaccine, the research will investigate the safety of two 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. The third group will receive the placebo – a saline solution that has no biological effect.
Following global protocols for this type of research, during the study, participants and researchers will not know which group each individual is included in.
“In phase 1a, in the United States, all participants were vaccinated for an initial assessment of the vaccine’s safety. Now, in phase 1b, we will have the opportunity to conduct a randomized, double-blind, placebo-controlled trial. This is the gold standard research method, which allows us to compare the vaccinated groups with the control group,” Verônica points out.
Regardless of the low or high dosage, the vaccination will be carried out in three applications, with an interval of 28 days between them, as occurred in the American trial. After that, the participants will be monitored for one year, totaling 421 days of clinical trial.
With Anvisa's authorization, the import of the vaccine from the United States to Brazil will begin. The study has already been approved by the Ethics Committee for Research with Human Beings of the IOC (CEP Fiocruz/IOC). The recruitment of volunteers to begin testing will be carried out after approval by the National Research Ethics Committee (Conep).
Importation of the vaccine and recruitment of volunteers will begin after authorization from Anvisa. Photo: Gutemberg Brito
To participate, you must be between 18 and 55 years old and in good health. At this stage of the study, volunteers cannot be people who have already had the disease or have had close contact with leprosy patients. The experimental immunization also cannot be administered to pregnant women.
Participation in the research will last approximately 14 months. During this period, volunteers must attend eleven appointments, three for vaccination and the rest for follow-up. During the visits, participants will undergo clinical evaluation and blood and urine tests.
In accordance with legal requirements, volunteers cannot be paid for participating in the research. Reimbursement for costs such as travel and food is provided. Participants will also have access to medical assistance, with 24-hour telephone contact, should they require assistance related to immunization.
Vaccination and monitoring of participants will be carried out at Souza Araújo Outpatient Clinic, maintained by the Leprosy Laboratory of IOC, on the campus of F.iocruz, in Manguinhos, North Zone of Rio de Janeiro (Av. Brasil, 4.365).
In addition to having a specialized team, the unit is certified by the National Accreditation Organization (ONA), which attests to the application of organizational guidelines and policies for safe and quality care. A recently opened vaccination room in the space will be used during the research.
Those interested in participating in the study can contact us by email vaccine.lepvax@ioc.fiocruz.br or by phone/WhatsApp (21) 93618-5232.
The study's medical leader, dermatologist and researcher at Ambulatório Souza Araújo, Cássio Ferreira, explains that the vaccine's safety will be assessed through clinical monitoring and laboratory tests.
“In the United States, the results were very positive, with no serious 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 to phase 1b in Brazil,” highlighted Cássio.
Clinical research room was prepared to carry out analyses on the vaccine. Photo: Gutemberg Brito
The blood samples collected will also be used to analyze the immune response triggered by the vaccine. These analyses will be carried out at the Hansen's Disease Laboratory of IOC, who prepared a clinical research room to carry out the tests.
To ensure the quality of the results, the equipment used for the analyses was certified by specialized companies. The procedures were validated using samples from the clinical trial conducted in the United States. The team follows good laboratory practice procedures, which are required by Anvisa.
To analyze the immunogenicity of the vaccine, researchers will measure the amount of antibodies present in the volunteers' serum (the liquid part of the blood without the coagulation molecules). They will also investigate the activation of defense cells, especially the so-called T cells.
“In leprosy, T cells are more important than antibodies in controlling the growth of the bacteria. Therefore, the factor that will preliminarily signal the vaccine’s potential for protection – called the correlate of protection – will be the dosage of molecules produced by active T cells,” explains the immunologist.
Samples from the clinical trial conducted in the United States were used to validate procedures. Photo: Gutemberg Brito
The study has an independent monitoring committee, which includes experts with no connection to Fiocroz.
If the phase 1b trial confirms the good performance of LepVax, researchers are already planning the next stage of the research, which will also be carried out by Fiocruz in Brazil.
In the phase 2a clinical trial, the plan is to vaccinate 582 patients with leprosy to evaluate the safety of immunization in individuals infected with M. leprosy and the therapeutic action of the immunizer.
“The request for authorization for phase 2a of the study will be submitted to Anvisa after the completion of the first safety analyses of the vaccine in trial 1b. The data will be evaluated by the study’s independent monitoring committee and then sent to the regulatory agency,” says Verônica.
The Leprosy Laboratory of the IOC has a history of relevant actions to combat the disease. The unit was a pioneer in the administration of polychemotherapy in Brazil. It was also the first to adopt the 12-dose treatment, having carried out studies that contributed to the recommendation of this regimen, currently recommended by the WHO.
“The LepVax clinical trial at our center is a good reflection of the level of maturity we have achieved over the years, which has allowed us to be recognized by the national and international scientific community today. It is also a reflection of our commitment to policies focused on quality care, as attested by the Souza Araújo Outpatient Clinic certification,” emphasizes Roberta.
One of the group's most recent contributions was the development of the NAT-HANS diagnostic kit, based on the detection of DNA from M. leprosy. The product was adopted by the Unified Health System (SUS) and began to be distributed to the Central Public Health Laboratories (Lacens) last year.
The innovation was developed by the Laboratory of IOC in partnership with the Carlos Chagas Institute (Fiocruz-PR) and the Institute of Molecular Biology of Paraná (IBMP).
The development of the NAT-HANS Kit was led by the researcher Milton Osorio Moraes, former head of the Leprosy Laboratory, who passed away in 2022.
The LepVax study in Brazil was also one of the scientist's projects. Internationally recognized as a reference in leprosy research, he was approached by the vaccine developers to conduct the product's clinical trial.
Between 2019 and 2022, Milton participated in organizing the research in Brazil and submitting the authorization request to Anvisa.
“During this period, Milton was diagnosed with cancer and we had the Covid-19 pandemic. Even so, he continued with the vaccine project. His death was a great loss for us and for science, but he prepared us to take this research forward,” Verônica emphasizes.
Leprosy affects the skin and nerves. The disease usually initially causes spots or lumps on the skin, with changes in sensitivity.
Without treatment, neurological damage can progress, impairing the ability to move, especially in the hands and feet, which affects the quality of life and ability to work of patients. The lesions can also affect the face, reinforcing the stigma, which is another of the major problems of the condition.
The BCG vaccine, produced with an attenuated version of the bacteria Mycobacterium bovis, offers partial protection against leprosy and tuberculosis. The WHO recommends immunization at birth in countries with a high burden of these diseases, as is the case in Brazil.
Since 1981, leprosy treatment has been based on a combination of antibiotics. So-called polychemotherapy has cured the infection and changed the outlook for the disease. Globally, cases have fallen by 95%.
However, in recent years, experts have drawn attention to the stagnation in the fight against the disease. Leprosy continues to cause new cases and permanent deformities.
To change this scenario, in 2021, the WHO published a new strategy against the disease, which seeks to interrupt the transmission of the infection by 2030.
In Brazil, the disease is still considered a public health problem, due to the high number of cases.
Tackling this problem is the target of the Interministerial Committee for the Elimination of Tuberculosis and Other Socially Determined Diseases (CIEDS), established in June.
Led by the Ministry of Health, the group has representatives from nine departments to combat neglected problems, often associated with poverty and other social determinants.
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.
According to experts, to combat leprosy, it is necessary to commit to applying available strategies, overcoming negligence, and at the same time, seeking innovations against this ancient infection.
“An effective vaccine is one of the tools capable of accelerating progress towards a future without leprosy,” highlights Verônica.
Led by American Leprosy Missions (ALM), the development of LepVax has involved collaboration with nearly 30 institutions from several countries since 2002. In addition to the IOC/Fiocruz, Bio-Manguinhos-Fiocruz and Fiotec, cooperate with the project: Access to Advanced Health Institute (AAHI), Aeras, Anesvad, Covance, Damien Foundation, DFnet, Effect Hope, FairMed, German Leprosy and Tuberculosis Relief Association (DAHW), Global Health Innovative Technology Fund ( GHIT), HL Snyder Medical Foundation, ILEP Federation, Leonard Wood Memorial, Leprosy Relief - Canada, Leprosy Research Initiative, National Hansen's Disease Program, National Institute of Allergy and Infectious Diseases (NIH), PS and Ouida Bailey Foundation, Raoul Follereau Foundation, St. Francis Leprosy Guild, Sasakawa Health Foundation, The Leprosy Mission - International, Turing Foundation and Until No Leprosy Remains (NLR). Donors who support ALM also contributed to the research.
The non-profit reproduction of the text is allowed as long as the source is cited (Comunicação / Instituto Oswaldo Cruz)
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