The global effort to combat dengue fever is gaining momentum with several vaccine candidates showing promise in ongoing clinical trials. These developments signal a potential shift in how dengue is prevented and managed, addressing a significant public health need.
Butantan-DV Shows Efficacy in Phase 3 Trial
The Butantan Institute's Butantan-DV tetravalent dengue vaccine candidate demonstrated a 67-79% efficacy in preventing the disease in Brazil, according to results from a Phase 3 clinical study. The study is ongoing through 2024, and the company submitted a proposal to Anvisa for approval on December 16, 2024. The institute anticipates the capacity to produce 100 million doses over the next three years if approved. A Phase 3 clinical study found that a single dose of Butantan-DV prevented symptomatic DENV-1 and DENV-2, regardless of dengue serostatus at baseline, through 2 years of follow-up.
Panacea Biotec's DengiAll Enters Phase 3
Panacea Biotech, in collaboration with the Indian Council of Medical Research (ICMR), is advancing its DengiAll dengue vaccine. In August 2024, ICMR and Panacea announced the launch of a Phase 3 clinical trial in India. The tetravalent dengue vaccine strain (TV003/TV005), initially developed by the U.S. National Institutes of Health, has shown promising results in preclinical and clinical trials worldwide. Phase 1 and 2 clinical trials of the Indian vaccine formulation were completed in 2018-19, yielding promising results. With 3 years of follow-up, the single-dose tetravalent dengue vaccine, TV005, was well tolerated and immunogenic for all four serotypes in young children to adults, including individuals with no previous dengue exposure.
Codagenix's CodaVax-DENV Receives Funding
Codagenix Inc. is developing CodaVax-DENV, a next-generation tetravalent live-attenuated dengue vaccine candidate. On October 24, 2023, Codagenix announced that the U.S. Department of Defense awarded the Company $5.88 million to advance the development of its CodaVax-DENV program. The funding supports good manufacturing practices of drug substances and tetravalent drug products for a Phase 1 study and a first-in-human Phase 1 safety and immunogenicity trial. This award complements a $4.4 million DoD award granted in 2022.
Other Notable Dengue Vaccine Developments
Several other organizations are also making strides in dengue vaccine development:
- Serum Institute of India: Conducting Phase 2 clinical research for its tetravalent dengue vaccine live candidate, Dengusiil.
- Indian Immunologicals Limited (IIL): Expects to launch its dengue fever vaccine commercially by 2026. Early-stage trials of their vaccine did not demonstrate any adverse effects.
- Emergex: Developing PepGNP-Dengue DengueTcP™, a novel T cell-priming immune set-point candidate that uses synthetic vaccines to generate virus-specific CTLs.
These ongoing efforts highlight the commitment to developing effective dengue vaccines and addressing the global burden of this disease.
