Next Generation T-cell Vaccine Against Coronavirus Disease (COVID-19)
NCT05633446 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 110
Last updated 2025-02-24
Summary
The study aims to investigate the safety and immunogenicity of one dose vs two doses of a T-cell priming next-generation vaccine against Coronavirus disease.
Conditions
- Coronavirus
- SARS-CoV-2 Infection
- COVID-19
Interventions
- BIOLOGICAL
-
PepGNP-COVID19 (One vaccination)
One dose with 7.5 nmol total peptide/dose with 47.8ug gold base particle in 50 µl WFI
- OTHER
-
Water for injection (One vaccination)
Water For Injection (WFI): (sodium chloride, a 0.9% solution for the preparation of dosage forms for injections) 50 µl per dose
- BIOLOGICAL
-
PepGNP-COVID19 (Two vaccinations)
Two vaccinations with 7.5 nmol total peptide/dose with 47.8ug gold base particle in 50 µl WFI
- OTHER
-
Water for injection (Two vaccinations)
Water For Injection (WFI): (sodium chloride, a 0.9% solution for the preparation of dosage forms for injections) 50 µl per dose
Sponsors & Collaborators
-
Gylden Pharma Ltd
lead INDUSTRY
Principal Investigators
-
Alberto R Edison, MD · Research Institute for Tropical Medicine
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-09-01
- Primary Completion
- 2026-06-01
- Completion
- 2026-12-01
Countries
- Philippines
Study Locations
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