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VLPDEN-02 Vaccine for Dengue Fever

Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: VLP Therapeutics
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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).

Are You a Good Fit for This Trial?

This trial is for healthy adults who have never been infected with flaviviruses like dengue. Participants should not have any major health issues and must be able to attend all study visits.

Inclusion Criteria

Willingness to participate as evidenced by signing the informed consent document
Available for the duration of the study, approximately 50 weeks
Able and willing to comply with all research requirements, in the opinion of the investigator
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Exclusion Criteria

Positive urine drug toxicology at screening for drugs of abuse without medical need confirmation
History of significant alcoholism or drug/chemical abuse within 12 months prior to enrollment causing medical, occupational, or family problems
Confirmed screening laboratory value of Grade 1 or above for ANC, ALT, or serum creatinine unless repeated and deemed clinically insignificant
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What Are the Treatments Tested in This Trial?

Interventions

  • VLPDEN-02 Dengue Vaccine

Trial Overview

Researchers are testing different doses of a new dengue vaccine called VLPDEN-02, given three times, compared to a placebo. The study is randomized and double-blind, meaning neither participants nor doctors know who gets the vaccine or placebo.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Group I: Cohort CExperimental Treatment3 Interventions
Group II: Cohort BExperimental Treatment3 Interventions
Group III: Cohort AExperimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

VLP Therapeutics

Lead Sponsor

Trials
2
Recruited
80+

Global Health Innovative Technology Fund

Collaborator

Trials
4
Recruited
320+

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