Phase I Study of VLPDEN-02 Dengue Vaccine in Healthy Adults

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
VLP Therapeutics
Study ID
NCT07831473
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Challenge Test
  • Dengue
  • Dose Escalation and Safety
  • Double Blind
  • Randomised Clinical Trial

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • VLPDEN-02 1.0 µg (0.25 µg of each VLP) + ALFQ adjuvant — BIOLOGICAL
    VLPDEN-02 is comprised of 4 virus-like particles (VLPs) each containing the Pre-membrane (prM), and envelope (E) of either DENV-1, DENV-2, DENV-3 or DENV-4. Mixed 1:1 with Army Liposome Formulation containing QS21 saponin (ALFQ).
  • VLPDEN-02 10 µg (2.5 µg of each VLP) + ALFQ adjuvant — BIOLOGICAL
    VLPDEN-02 is comprised of 4 virus-like particles (VLPs) each containing the Pre-membrane (prM), and envelope (E) of either DENV-1, DENV-2, DENV-3 or DENV-4. Mixed 1:1 with Army Liposome Formulation containing QS21 saponin (ALFQ).
  • VLPDEN-02 100 µg (25 µg of each VLP) + ALFQ adjuvant — BIOLOGICAL
    VLPDEN-02 is comprised of 4 virus-like particles (VLPs) each containing the Pre-membrane (prM), and envelope (E) of either DENV-1, DENV-2, DENV-3 or DENV-4. Mixed 1:1 with Army Liposome Formulation containing QS21 saponin (ALFQ).
  • ALFQ adjuvant + Saline — BIOLOGICAL
    Army Liposome Formulation containing QS21 saponin (ALFQ) adjuvant mixed 1:1 with saline
  • rDEN3Delta30 — BIOLOGICAL
    rDEN3Delta30 is an under-attenuated DENV-3 derived from the naturally attenuated DENV-3 Sleman/78 strain. It will be administered subcutaneously (SC) at a dose of 1,000 plaque-forming units (PFU).

Study Details

This is a Phase 1, randomized, double-blind, placebo-controlled, dose escalation study. Forty-two flavivirus-naïve adults will be enrolled and will receive 3 administrations of VLPDEN-02 or control at days 0, 28, and 56. Three dose-cohorts of VLPDEN-02 will be evaluated (1 µg, 10 µg, and 100 µg) in a dose-escalation strategy. Each dose cohort will enroll 14 participants (10 VLPDEN-02 recipients and 4 control recipients).

Key Dates

First listed
Sep 21, 2026
Start date
Jan 4, 2027
Status verified
Sep 2026
Primary completion
Mar 15, 2028
Completion
May 15, 2028

Study Design

Enrollment
42 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION

Arms

  • Experimental: Cohort A
    VLPDEN-02 1.0 µg + ALFQ adjuvant vs. Control ALFQ adjuvant alone - 3 doses 28 days apart
  • Experimental: Cohort B
    VLPDEN-02 10 µg + ALFQ adjuvant vs. Control ALFQ adjuvant alone - 3 doses 28 days apart
  • Experimental: Cohort C
    VLPDEN-02 100.0 µg + ALFQ adjuvant vs. Control ALFQ adjuvant alone - 3 doses 28 days apart

Primary Outcome Measure

Safety and Reactogenicity Assessment [ Time Frame: Injection to 7 days post vaccination ]

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins UniversityBaltimoreMaryland21218-

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By research site
Johns Hopkins University· Baltimore, MD

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