Clinical Trials
31
2 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
N/A
Completed
23
74.2%
Not yet recruiting
2
6.5%
Recruiting
2
6.5%
Unknown
3
9.7%
Withdrawn
1
3.2%
No approval data available
- Brazil's Butantan Institute developed a single-dose tetravalent dengue vaccine that demonstrated 80.5% efficacy against hospitalization for dengue over five years in a phase 3 clinical trial. - The vaccine showed 65.0% overall efficacy against symptomatic dengue, with higher protection in previously infected participants (77.1%) compared to dengue-naive individuals (58.9%). - The Brazilian Health Regulatory Agency approved Butantan-DV in November 2025 for use in people aged 12 to 59 years, marking a significant milestone in dengue prevention. - No vaccinated participants were hospitalized during the five-year follow-up period, and the vaccine demonstrated strong safety profile with headache being the most common adverse event.
- Brazil's national drug regulator approved the world's first single-dose dengue vaccine, Butantan-DV, for use in people aged 12 to 59, marking a significant breakthrough in dengue prevention. - The vaccine demonstrated 74.7% overall efficacy and 91.6% efficacy against severe forms of dengue in late-stage trials involving 16,000 volunteers across Brazil. - The single-dose format will particularly benefit remote communities in hard-to-reach regions like the Amazon, eliminating the need for multiple clinic visits required by existing two-dose vaccines. - Brazil plans to incorporate the vaccine into its national immunization program by early 2026, with over 1 million doses ready for distribution following the country's worst dengue epidemic with 6.4 million cases and 5,972 deaths in 2024.
- Several dengue vaccine candidates are progressing through clinical trials, offering potential solutions for this widespread disease. - Butantan-DV showed 67-79% efficacy in preventing dengue in a Phase 3 trial in Brazil and is awaiting regulatory approval. - Panacea Biotech, in collaboration with ICMR, initiated a Phase 3 trial for their DengiAll vaccine in India after promising early-stage results. - Codagenix Inc. received $5.88 million from the U.S. Department of Defense to advance its CodaVax-DENV tetravalent vaccine candidate.
- The Butantan Institute has applied for regulatory approval in Brazil for its single-dose dengue vaccine, Butantan-DV. - Clinical trials showed the vaccine to have 79.6% overall efficacy in preventing symptomatic dengue and 89% protection against severe dengue. - The tetravalent vaccine targets all four dengue virus serotypes and could significantly reduce hospitalizations. - If approved, the institute can produce 100 million doses over three years, potentially boosting immunization efforts.
