MedTrace Logo

Dengue Controlled Human Infection Model in Dhaka, Bangladesh

NCT05229354 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 192

Last updated 2024-07-17

No results posted yet for this study

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.

Conditions

  • Dengue

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

Sponsors & Collaborators

  • International Centre for Diarrhoeal Disease Research, Bangladesh

    collaborator OTHER

  • Beth Kirkpatrick

    lead OTHER

Principal Investigators

  • Beth Kirkpatrick, MD · University of Vermont

  • Rashidul Haque, MD · International Centre for Diarrhoeal Disease Research

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-11
Primary Completion
2023-11-20
Completion
2025-07-31
FDA Drug
Yes

Countries

  • Bangladesh

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05229354 on ClinicalTrials.gov