NCT05633446

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

A Phase I-II, Blinded, Randomized, Placebo-controlled Study of a T Cell Priming Next-generation Vaccine Against Coronavirus Disease in Healthy Adults

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Gylden Pharma Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Detailed description

The scale of the COVID-19 pandemic requires multiple vaccine candidates to ensure equitable and rapid access to protection by: * Providing a range of vaccine choices tailored to variations in immunological profiles across demographics as well as suited to environments with various levels of resources (cold chain etc). * Distributing and parallelizing manufacture, to speed up scale, avoid reagent stockouts and dilute monopolies * The ability for SARS -CoV-2 (Severe Acute Respiratory Syndrome Coronavirus-2) to mutate, requires multiple vaccine candidates to ensure robust and sustainable protection. Vaccines with a range of epitopes and immune targets provide immunological diversity and reduce vulnerability to mutant escape. * Nanotechnology fulfils the needs of a Universal Coronaviruses vaccine by being a rapidly scalable and modular platform * Humoral immunity may be transient and insufficient against emerging variants of SARS-CoV-2 * Cellular immunity against SARS-CoV-2 is lasting and associated with recovery in COVID-19. A vaccine (prime or booster) inducing the right T cell response can be the solution against the need to develop new vaccines every time the virus mutates or a new variant persists. This is a Phase I-II, double-blind, randomized, placebo-controlled study investigating the safety and immunogenicity of a T cell priming next-generation vaccine against Coronavirus disease in healthy adults. The clinical study will enrol 110 participants (88 vaccine vera and 22 placebo, \[split 50:50 between two groups one receiving one vaccination and the other two vaccinations\]). Therefore, 110 eligible participants will be randomized in the following groups: * Group 1 One Vaccination (Day 0) (n=55): 44 PepGNP-COVID19 (7.5 nmol peptide + 47.8ug GNP) + 11 placebo (WFI) * Group 2 Two Vaccinations (Day 0 \& Day 21) (n=55): 44 PepGNP-COVID19 (7.5 nmol peptide + 47.8ug GNP) + 11 placebo (WFI) Allocations of vaccine vera vs placebo for each group are single blinded."

Conditions

• Coronavirus
• SARS-CoV-2 Infection
• COVID-19

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-09-01
• Primary completion: 2026-06-01
• Completion: 2026-12-01
• First posted: 2022-12-01
• Last updated: 2025-02-24

Locations

2 sites across 1 country: Philippines