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ACTIVE NOT RECRUITING
NCT05229354
PHASE2

Dengue Controlled Human Infection Model in Dhaka, Bangladesh

Sponsor: Beth Kirkpatrick

View on ClinicalTrials.gov

Summary

The primary objective is to determine, among dengue-naïve adults in an endemic population, the protective efficacy of TetraVax-DV TV005 vaccine against dengue infection induced by a live recombinant attenuated rDEN2∆30-7169 attenuated virus strain administered 6, 12, or 24 months after vaccination. Secondary objectives are: 1. Determine the durability of protection of TetraVax-DV TV005. 2. Evaluate the safety of TetraVax-DV TV005 in dengue-naïve volunteers in a dengue endemic population. 3. Evaluate the safety of the rDEN2∆30-7169 attenuated virus strain in a dengue endemic population.

Official title: Phase II Evaluation of the Safety and Protective Efficacy of a Single Dose of the Live Attenuated Tetravalent Dengue Vaccine TetraVax-DV TV005 to Protect Against Infection With Live, Recombinant DENV-2 (rDEN2∆30-7169) Attenuated Strain in a Dengue Endemic Population in South Asia

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

192

Start Date

2021-12-11

Completion Date

2025-07

Last Updated

2024-07-17

Healthy Volunteers

Yes

Conditions

Interventions

BIOLOGICAL

TV005

The TV005 admixture is comprised of four monovalent dengue vaccine candidates representing each of the four DENV serotypes: rDEN1Δ30, rDEN2/4Δ30(ME), rDEN3Δ30/31, and rDEN4Δ30.

BIOLOGICAL

rDEN2Δ30-7169 attenuated virus strain

based on a cDNA derived DENV-2 virus (strain Tonga/74) in which the 3´ UTR of DENV-2 contains a 30 (nt) deletion (nt 173 - 143) homologous to the ∆30 deletion in the 3´ UTR of rDEN4Δ30 (named Δ30 for consistency). A plasmid was constructed to encode the entire genome of DENV-2 Tonga/74. The cDNA of the 3´ UTR of DENV-2 Tonga/74 was then modified to introduce a 31-nucleotide deletion homologous to the DEN4Δ30 deletion (∆30). Genome-length, capped, RNA transcripts were synthesized from the plasmid p2Δ30-7169 and purified

Locations (1)

Icddr,B

Dhaka, Bangladesh