World’s First Leprosy-Specific Vaccine Progresses to Human Trials in Brazil: American Leprosy Missions Champions Development of New Tool for Prevention and Treatment of Ancient Disease
Oct 21, 2024
(Greenville, S.C., October 21, 2024) ⸺ Today marks a significant step forward in the prevention and treatment of leprosy as American Leprosy Missions announces the start of a Phase 1b clinical trial for LepVax, a promising leprosy vaccine candidate – the first vaccine developed specifically for leprosy. The goal of the Phase 1b trial is to show vaccine safety and an immune response in healthy people in a leprosy-endemic area of Brazil.
Characterized by the World Health Organization as a “neglected tropical disease,” leprosy (also known as Hansen’s disease) is caused by the bacteria Mycobacterium leprae. Nearly a quarter of a million people worldwide have leprosy, which causes progressive and incurable nerve damage. While multi-drug therapy (MDT) exists for leprosy, it must be taken for many months, has many side effects and often is given too late to reverse the permanent damage caused by the bacterial infection. Existing tools are insufficient to stop leprosy transmission, so the World Health Organization (WHO) calls for scaling up leprosy prevention with a vaccine. The WHO’s Global Leprosy Strategy 2030 recognizes that “Passive case detection and treatment with MDT alone have proven insufficient to interrupt transmission. … Trials of … new vaccines, including LepVax … , may result in an important new tool for leprosy prevention … .”
A viable vaccine to prevent and/or treat leprosy is the next step in the effort to bring this disease to an end. “We are excited to continue the journey toward a lasting solution that prevents leprosy transmission and consequent nerve damage and disabilities,” says Bill Simmons, President and CEO of American Leprosy Missions. “People affected and their families deserve innovative solutions to prevent and cure this disease. The Phase 1b clinical trial is the next step toward a world without leprosy.”
In 2002, ALM began the search for the world’s first leprosy-specific vaccine. Scientists at the Infectious Disease Research Institute, now The Access to Advanced Health Institute, along with national and international collaborators including the National Hansen’s Disease Program and the National Institute of Allergy and Infectious Diseases, with financial support from American Leprosy Missions and many partners, developed LepVax, a promising leprosy vaccine candidate designed to help treat leprosy and prevent exposed individuals from developing the disease and resulting disabilities.
In early animal studies, a good immune response and bacilli reduction were observed. Results indicated that LepVax had the potential to prevent, and even treat, leprosy. With these exciting results, the U.S. Food and Drug Administration approved LepVax for a first-in-human clinical trial in the U.S. By 2019, the Phase 1a clinical trial with healthy adults had been successfully completed. The study showed that the vaccine was safe and elicited strong immune responses.
The next step is to study LepVax in people living in a leprosy-endemic area. The Phase 1b clinical trial will be conducted by the Oswaldo Cruz Institute of the Oswaldo Cruz Foundation (IOC/Fiocruz), the most prominent institution of science and technology in health in Latin America, attached to the Brazilian Ministry of Health. This trial, made possible with the generous support of the Global Health Innovative Technology Fund (GHIT), Sasakawa Health Foundation and Leprosy Research Initiative, will evaluate LepVax safety and immunity and it may address the vaccine’s preliminary effectiveness as a therapeutic vaccine for treating leprosy. The double-blind, randomized, placebo-controlled, antigen dose-escalation trial will enroll 54 healthy participants followed by a Phase 2 study with pauci-bacillary and multi-bacillary leprosy patients.
In October 2024, ANVISA, the Brazilian National Health Surveillance Agency, issued an opinion to authorize the Phase 1b trial. Trial participants will be enrolled and vaccinated in early 2025, and the Phase 2 study could begin as soon as 9 months later. Results from the combined two-and-a-half-year study are anticipated in 2027, and are expected to show that LepVax is safe, produces an immune response, and reduces nerve damage if present in leprosy patients.
Recent epidemiological modeling indicates that if LepVax is rolled out between 2028 and 2040, 823,000 new cases of leprosy-related disability could be prevented and transmission intercepted.
About American Leprosy Missions
American Leprosy Missions is dedicated to breaking barriers to health and renewing hope for people suffering from the pain and stigma of neglected tropical diseases like leprosy. For more than a century, the organization has been training, supporting and equipping Christian partners around the world to meet the physical and spiritual needs of afflicted people and help them integrate into their communities. American Leprosy Missions also works to increase the effectiveness of early detection and treatments, bridge the gap in research and invest in tools and technologies that expand access to healing – all while living and proclaiming the gospel.
For Additional Information
Jessica Mussro, Communications Manager
[email protected]
LepVax Partners
American Leprosy Missions initiated leprosy vaccine research and development in 2002, and has guided its progression through clinical trials with the support of our generous donors and:
- Access to Advanced Health Institute (AAHI)
- Aeras
- Anesvad
- Covance
- Damien Foundation
- DFnet
- Effect Hope
- FairMed
- Fiocruz Bio-Manguinhos
- Foundation for Scientific and Technological Development in Health (Fiotec)
- German Leprosy and Tuberculosis Relief Association (DAHW)
- Global Health Innovative Technology Fund (GHIT)
- H.L. 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)
- Oswaldo Cruz Foundation (Fiocruz)
- P.S. and Ouida Bailey Foundation
- Raoul Follereau Foundation
- St. Francis Leprosy Guild
- Sasakawa Health Foundation
- The Leprosy Mission – International
- Turing Foundation
- Until No Leprosy Remains (NLR)