Phase I Study of VLPDEN-02 Dengue Vaccine in Healthy Adults
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This page only displays public information reproduced from the official ClinicalTrials.gov record NCT07831473. It adds no medical advice, opinions, or eligibility judgments. The official record remains the source of truth for eligibility criteria, enrollment, and contact information.
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Official title
A Phase I Study of the Safety, Immunogenicity and Efficacy of a Tetravalent Dengue VLP Vaccine (VLPDEN-02) Against DENV-3 Challenge in Healthy Adults
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT07831473
- Recruitment status
- Not yet recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 42 participants
Conditions and interventions
Interventions
- VLPDEN-02 1.0 µg (0.25 µg of each VLP) + ALFQ adjuvant Biological
- VLPDEN-02 10 µg (2.5 µg of each VLP) + ALFQ adjuvant Biological
- VLPDEN-02 100 µg (25 µg of each VLP) + ALFQ adjuvant Biological
- ALFQ adjuvant + Saline Biological
- rDEN3Delta30 Biological
Biological
Eligibility (public fields only)
- Age range
- 18 Years to 55 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 4, 2027 (Estimated)
- Primary completion
- Mar 15, 2028 (Estimated)
- Completion
- May 15, 2028 (Estimated)
- Last update posted
- Sep 21, 2026
2027 – 2028
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Johns Hopkins University | Baltimore | Maryland | 21218 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07831473, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 21, 2026 · Synced Nov 15, 2026
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