A Phase-I Study of a Nanoparticle-based Peptide Vaccine Against Dengue Virus
NCT04935801 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26
Last updated 2022-12-05
Summary
This trial aims to test the safety of 2 doses of a T-cell priming specific cocktail of Dengue viruses peptides representing all 4 DENV serotypes and mounted on a gold nanoparticle.
NOTE: This is the master protocol of a prospective 2-stage adaptive trial, which aims to add and test a Coronavirus vaccine candidate as well, in an identical trial design.
Conditions
- Dengue
Interventions
- BIOLOGICAL
-
LD vehicle-GNP
Two intradermal injections in the upper arm spaced 21 days apart
- BIOLOGICAL
-
LD PepGNP-Dengue
Two intradermal injections in the upper arm spaced 21 days apart
- BIOLOGICAL
-
HD vehicle-GNP
Two intradermal injections in the upper arm spaced 21 days apart
- BIOLOGICAL
-
HD PepGNP-Dengue
Two intradermal injections in the upper arm spaced 21 days apart
Sponsors & Collaborators
-
Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
collaborator OTHER -
University of Lausanne Hospitals
collaborator OTHER -
Gylden Pharma Ltd
lead INDUSTRY
Principal Investigators
-
Blaise Genton, Prof · Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-08-02
- Primary Completion
- 2022-03-11
- Completion
- 2022-09-15
Countries
- Switzerland
Study Locations
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