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Comparison of Tetravalent Dengue Virus Purified Inactivated Vaccine and Tetravalent Dengue Virus Live Attenuated Vaccine

NCT03141138 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-03-26

No results posted yet for this study

Summary

This study is a Phase 1, randomized, open-label study of the prime-boost vaccine candidates given in the prime-boost regimen previously demonstrated to have a high level of immunogenicity and immune durability: Day 0 prime (PIV) and Day 180 boost (LAV), and compare it with a previously untested schedule: Day 0 prime (PIV) and Day 90 boost (LAV) in order to define the potential tradeoff between potential immunogenicity, including cell-mediated immunity, and a more practical dosing schedule.

Conditions

  • Dengue Virus

Interventions

BIOLOGICAL

TDENV-PIV

Dosage: 0.5 mL of DENV serotypes 1-4 (4 µg / serotype) in alum adjuvant Mode of administration: intramuscular (IM) into the subject's upper arm, deltoid area of the subject's arm; vaccination will be given in the non-dominant arm whenever possible

BIOLOGICAL

TDENV-LAV F17

Dosage: 0.5 mL of the post-transfection LAV F17 vaccine Mode of administration: subcutaneously into the upper-outer triceps/deltoid area of the subject's arm; vaccination will be given in the non-dominant arm whenever possible.

Sponsors & Collaborators

  • U.S. Army Medical Research and Development Command

    lead FED

Principal Investigators

  • Simon D Pollett · Walter Reed Army Institute of Research (WRAIR)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-11-08
Primary Completion
2019-10-31
Completion
2021-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT03141138 on ClinicalTrials.gov