Dengue Vaccines

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Last reviewed

December 17, 2024

Fact checked by Robert Carlson, MD
Fact checked by Holly Lutmer PharmD

Content Overview

Dengue vaccines are approved by various countries.

Dengue Vaccines 2024

According to the World Health Organization (WHO) in 2024, Dengue is a vaccine-preventable disease, with approved vaccines available. As of November 2024, the U.S. Food and Drug Administration (FDA), the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA), the Pan American Health Organization (PAHO), the European Medicine Agency (EMA), Australia's Technical Advisory Group on Immunisation, and Brazil's National Health Surveillance Agency (ANVISA) recommend dengue vaccination for certain persons living or visiting dengue-risk areas. The U.K. Health Security Agency published new guidance on dengue vaccination in the 'Green Book' (Chapter 15a) in October 2024.

Dengvaxia® is a live attenuated tetravalent chimeric vaccine approved by the U.S. FDA and various countries. Dengvaxia is no longer offered in the U.S.

QDENGA® dengue vaccine is approved or authorized in various countries and does not require pre-admission testing. However, as of December 2024, the U.S. FDA has not approved it.

Dengue Vaccine Candidates 2024

Panacea Biotech, in collaboration with the Indian Council of Medical Research (ICMR), is developing the DengiAll dengue vaccine. 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. Panacea Biotec has worked extensively on these strains to create a full-fledged vaccine formulation and holds a process patent. In August 2024, ICMR and Panacea announced the launch of a Phase 3 clinical trial in India.

Butantan Institute Butantan-DV tetravalent dengue vaccine candidate showed 67-79% efficacy in preventing the disease in Brazil, according to a phase 3 clinical study, which continues through 2024. On December 16, 2024, the Company submitted the proposal to Anvisa for approval. The institute can produce 100 million doses if approved over the next three years. On February 1, 2024, an Original Article concluded a phase 3 clinical study found 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. Butantan-DV is derived from a technology from the U.S. NIH licensed in 2009. Under the collaboration agreement announced in December 2018, Merck and Instituto Butantan are sharing clinical study data.

Serum Institute of India tetravalent dengue vaccine live candidate Dengusiil is conducting phase 2 clinical research in 2024. A previous phase 1 study concluded that a single dose of Dengusiil was safe and well tolerated in adults and was highly immunogenic with trivalent or tetravalent (69%) seroconversion and seropositivity in most participants.

National Institute of Allergy and Infectious Diseases - TetraVax-DV T005 (rDEN3Δ30/31-7164) is a live attenuated tetravalent vaccine. A phase 2 clinical trial revealed that, with three years of follow-up, a single dose of TV005 was well tolerated and immunogenic for all four serotypes in young children and adults, including individuals with no previous dengue exposure. Results of a phase 2 study of TV005 in Bangladesh published in 2024 reported the waning of antibody titers in children aged 1–4 years who were seronegative at the time of vaccination. Only 22–28% of children in this age group remained seropositive for DENV-1, DENV-3, and DENV-4 after three years of follow-up, compared with 69% seropositivity for DENV-2.

TetraVax-DV-TV003 (V180) is a live attenuated recombinant tetravalent investigational dengue vaccine conducting a phase 3 clinical trial in Brazil. Dr. Stephen Whitehead's laboratory developed the vaccine. Merck recently completed a phase 1 study (V180-001).

The DV1-DV4 vaccine candidate is transitioning into a human clinical study. This new vaccine construct, which comprises Nature's gene-chip peptides bound to a quantum cluster gold nanoparticle delivery system, was shown to have an excellent safety profile in a repeat dose Good Laboratory Practice grade toxicology study using a standard industry model.

Àvida Biotech's novel oral vaccine candidate for Dengue does not require cold transport or storage and has completed proof of concept in a mouse model. In addition, the University of Buffalo's Center for Integrated Global Biomedical Sciences will provide preclinical drug development expertise.

K.M. Biologics KD-382 vaccine is a live attenuated tetravalent dengue candidate in phase 1 clinical t. It is expected to be effective against all four serotypes with a single dose. In addition, this live attenuated virus vaccine is expected to induce neutralizing antibodies and cellular immunity, similar to natural infection.

Emergex PepGNP-Dengue DengueTcP™, Its Novel T Cell-Priming Immune Set-Point Candidate, uses 100% synthetic vaccines to 'prime' naive CD8+ T-Cells to generate virus-specific CTL (CD8+ Cytotoxic T Lymphocyte cells) to kill infected cells before productive viral infection, thus preventing viral replication and disease in the vaccinated person. naNO-DENGUE: A Phase-I study of a nanoparticle-based peptide vaccine against Dengue virus.

CodaVax-DENV is a next-generation tetravalent live-attenuated dengue vaccine candidate under development by Codagenix Inc., whose vaccine design platform has enabled precise and rational attenuation of contemporary serotypes of all four strains of dengue virus through selective codon deoptimization. With this approach, Codagenix can rationally balance all four virus serotypes to produce a safe and highly immunogenic vaccine. On October 24, 2023, Codagenic 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.

Indian Immunologicals Limited (IIL) expects to launch its dengue fever vaccine commercially by 2026. IIL's managing director, K. Anand Kumar, said on August 20, 2024, that the vaccine's early-stage trials of about 90 individuals aged 18-50 did not demonstrate any adverse effects. The U.S. National Institute of Health provided IIL with the dengue virus required to develop the vaccine. ILI is a subsidiary of the National Dairy Development Board.

Dengushield (VIS513) Monoclonal Antibody Therapy

Dengushield (VIS513) is a humanized monoclonal antibody (mAb), not a vaccine, that delivers passive immunization and is evaluated in phase 2 clinical trials to treat Dengue. VIS513 is a highly potent inhibitor of all four types of dengue viruses, both in vitro and in preclinical animal models. VIS513 was licensed to the Serum Institute of India Pvt. Ltd (SIIPL) for development and commercialization may cost 5,000 to 10,000 rupees per dose. SIIPL funded a phase 1 study announced in February 2024, and the VIS513 mAb was safe and well tolerated. It showed a dose-proportionate increase in pharmacokinetic exposure.