VLP Therapeutics
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).
VLPDEN-02 is a non-infectious vaccine candidate comprised of four VLPs, each corresponding to a different dengue serotype (DENV-1-4), mixed in equal quantities.
Inclusion Criteria: 1. Male or female between 18 and 55 years of age, inclusive, at the time of screening. 2. Able and willing to comply with all research requirements, in the opinion of the investigator. 3. Good general health as determined by physical examination, laboratory screening, and review of medical history. 4. Available for the duration of the study, which is approximately 50 weeks. 5. Willingness to participate in the study as evidenced by signing the informed consent document. 6. Participant has 12-lead electrocardiogram (ECG\*) and clinical laboratory evaluations at screening wi…
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 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 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).
Army Liposome Formulation containing QS21 saponin (ALFQ) adjuvant mixed 1:1 with saline
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).
Arctuva estimate
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