Malaria vaccine
- Generic Name
- Malaria vaccine
MTBVAC TB Vaccine Enters Landmark Phase 2b Trial Across Three African Countries
• The IMAGINE trial has commenced with first vaccinations of MTBVAC, a novel tuberculosis vaccine candidate, administered in South Africa on February 19, 2025, marking a significant step in combating the world's deadliest infectious disease.
• The large-scale safety and efficacy trial will enroll approximately 4,300 participants with latent TB infection across 15 sites in South Africa, Kenya, and Tanzania, evaluating MTBVAC's effectiveness in preventing active TB lung disease.
• MTBVAC, developed by Spanish researchers and Biofabri/Zendal, is the only live-attenuated TB vaccine candidate derived from Mycobacterium tuberculosis in current trials, offering potential advantages over the century-old BCG vaccine.
FDA Lifts Clinical Hold on Novavax's COVID-19-Influenza Combination Vaccine
• The FDA has removed the clinical hold on Novavax's Investigational New Drug (IND) application for its COVID-19-Influenza Combination (CIC) and stand-alone influenza vaccine candidates.
• Novavax is now cleared to begin enrolling participants in the planned Phase 3 trial for the combination vaccine and stand-alone influenza vaccine.
• The clinical hold was initiated due to a serious adverse event reported in a Phase 2 trial participant, which was later determined to be unrelated to the vaccine.
• Novavax plans to collaborate with clinical trial investigators and partners to resume trial activities for the Phase 3 trial as quickly as possible.
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.
© Copyright 2025. All Rights Reserved by MedPath