Phase I Study of VLPDEN-02 Dengue Vaccine in Healthy Adults
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorVLP Therapeutics
About 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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Male or female between 18 and 55 years of age, inclusive, at the time of screening.
Able and willing to comply with all research requirements, in the opinion of the investigator.
Good general health as determined by physical examination, laboratory screening, and review of medical history.
Available for the duration of the study, which is approximately 50 weeks.
Disqualifiers
Females only: Currently pregnant, as determined by positive beta-human choriogonadotropin (beta-HCG) test, or breast-feeding.
The participant has a history of significant alcoholism or drug/chemical abuse within 12 months prior to enrollment that has caused medical, occupational, or family problems as indicated by participant history.
Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a participant's ability to give informed consent.
A participant with a confirmed screening laboratory value of Grade 1 or above for absolute neutrophil count (ANC), alanine aminotransferase (ALT), or serum creatinine. Values of Grade 1 or above for these tests may be repeated to confirm a Grade 1 or above value. Abnormal laboratory values other than those specified will not be exclusionary if the clinician deems them not clinically significant.
Trial design
Design model
Sequential
Treatments tested in this trial
VLPDEN-02 1.0 µg (0.25 µg of each VLP) + ALFQ adjuvant
Biological/VaccineVLPDEN-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/VaccineVLPDEN-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/VaccineVLPDEN-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/VaccineArmy Liposome Formulation containing QS21 saponin (ALFQ) adjuvant mixed 1:1 with saline
rDEN3Delta30
Biological/VaccinerDEN3Delta30 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).
Treatment groups
42 Participants
are divided into 3 treatment groupsGroup A: Cohort AExperimental treatment 3 interventions
Group B: Cohort BExperimental treatment 3 interventions
Group C: Cohort CExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Safety and Reactogenicity Assessment
The primary objective of this Phase 1 clinical trial is to assess the safety and reactogenicity of three doses of VLPDEN-02 for 7 days post vaccination compared with placebo control as determined by solicited local and systemic reactogenicity.
Time frame
Injection to 7 days post vaccinationSecondary outcomes
1
Immunogenicity Assessment
To assess the immunogenicity of VLPDEN-02 vaccine after each vaccination.
Time frame
Initial injection to day 1682
Protective Efficacy to Dengue 3 Challenge
To assess the protective efficacy of VLPDEN-02 vaccine against viremia induced by 10\^3 PFU of the DENV-3 challenge strain rDEN3Delta30 administered approximately 4 months post-third vaccination.
Time frame
Day 168 to Day 3483
Protective efficacy against rash induction
To assess the protective efficacy of VLPDEN-02 against rash induced by 10\^3 PFU of the DENV-3 challenge strain rDEN3Delta30 administered approximately 4 months post-third vaccination.
Time frame
Day 168 to Day 348Sponsors and contacts
Click on the lead sponsor to view all of their trials.
VLP Therapeutics
Lead sponsor
Global Health Innovative Technology Fund
Collaborator
Source ClinicalTrials.gov
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