An investment of 17 years and more than $6 million has resulted in LepVax: a vaccine that finished Phase Ia clinical safety trials in healthy human volunteers and is headed into Phase Ib among people most at risk.
Phase Ia results
In the summer of 2019, the 18-month Phase Ia clinical trial for LepVax was completed. This study was the first step in testing LepVax for clinical use. Phase Ia was designed to demonstrate the vaccine’s safety and to evaluate the immune response to the vaccine.
The study showed that the vaccine was extremely safe and resulted in no serious adverse events. The FDA recommended that the LepVax candidate proceed to the next phase of clinical trials.
LepVax is the first leprosy-specific vaccine to go through Phase I clinical trials. ALM believes this vaccine will be an exciting new way to stop the transmission of leprosy and the only way to protect people from the disease long-term. What’s more, the vaccine may protect against nerve damage, the most serious complication of leprosy.
The Phase Ib clinical trial preparations have begun, and participant enrolment is expected to begin in the next few months. The trial will run for two years. Thirty healthy participants and 24 patients with pauci-bacillary (PB) leprosy will be enrolled. After showing the safety of the vaccine in the Phase Ib study, Phase II clinical trials of LepVax will begin.
Progress and next steps
- August 2017: Approved by Food and Drug Administration
- October 2017: Started Phase Ia clinical trial
- November 2017: Interim safety review successfully completed
- January-March 2018: Complete injections of second cohort; perform last blood draw; begin one-year follow-up period
- June-December 2018: Complete clinical sample processing; analyse data and clinical immunology
- January-March 2019: Analyse data and clinical immunology; write clinical study report
- August 2019: Completed Phase Ia clinical trial
- July 2019 – July 2021: Two-year Phase Ib clinical trial in Brazil
- 2021: Phase II clinical trials
Read more about the clinical trials and the results from Phase Ia here.
Reposted with permission from the ALM – originally published in November 2019 here.