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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04935801 on ClinicalTrials.gov