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

No results posted yet for this study

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

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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Entities

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 NCT05633446 on ClinicalTrials.gov