Next Generation T-cell Vaccine Against Coronavirus Disease (COVID-19)

Sponsor
Gylden Pharma Ltd
Study ID
NCT05633446
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • PepGNP-COVID19 (One vaccination) — BIOLOGICAL
    One dose with 7.5 nmol total peptide/dose with 47.8ug gold base particle in 50 µl WFI
  • Water for injection (One vaccination) — OTHER
    Water For Injection (WFI): (sodium chloride, a 0.9% solution for the preparation of dosage forms for injections) 50 µl per dose
  • PepGNP-COVID19 (Two vaccinations) — BIOLOGICAL
    Two vaccinations with 7.5 nmol total peptide/dose with 47.8ug gold base particle in 50 µl WFI
  • Water for injection (Two vaccinations) — OTHER
    Water For Injection (WFI): (sodium chloride, a 0.9% solution for the preparation of dosage forms for injections) 50 µl per dose

Study Details

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.

Key Dates

First listed
Dec 1, 2022
Start date
Sep 1, 2025
Status verified
Feb 2025
Primary completion
Jun 1, 2026
Completion
Dec 1, 2026

Study Design

Enrollment
110 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: PepGNP-COVID19 (One vaccination)
    One vaccination of PepGNP-COVID19 vaccine candidate administered on Day 0 (50 µl per dose)
  • Placebo Comparator: Placebo (One vaccination)
    One vaccination of WFI administered on Day 0 (50 µl per dose)
  • Experimental: PepGNP-COVID19 (Two vaccinations)
    Two vaccinations of PepGNP-COVID19 vaccine candidate administered on Day 0 and Day 21 (50 µl per dose)
  • Placebo Comparator: Placebo (Two vaccinations)
    Two vaccinations of WFI administered with on Day 0 \& Day 21 (50 µl per dose)

Primary Outcome Measure

To assess the safety, tolerability and reactogenicity of the vaccine [ Time Frame: 6 months following first vaccination or End Of Study (EOS), whichever is later ]

Central Contacts

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