Next Generation T-cell Vaccine Against Coronavirus Disease (COVID-19)
NCT ID: NCT05633446
Last Updated: 2025-02-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1/PHASE2
110 participants
INTERVENTIONAL
2025-09-01
2026-12-01
Brief Summary
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Detailed Description
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* 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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
* Blinding will be maintained for the duration of the study.
Study Groups
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PepGNP-COVID19 (One vaccination)
One vaccination of PepGNP-COVID19 vaccine candidate administered on Day 0 (50 µl per dose)
PepGNP-COVID19 (One vaccination)
One dose with 7.5 nmol total peptide/dose with 47.8ug gold base particle in 50 µl WFI
Placebo (One vaccination)
One vaccination of WFI administered on Day 0 (50 µl per dose)
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
PepGNP-COVID19 (Two vaccinations)
Two vaccinations of PepGNP-COVID19 vaccine candidate administered on Day 0 and Day 21 (50 µl per dose)
PepGNP-COVID19 (Two vaccinations)
Two vaccinations with 7.5 nmol total peptide/dose with 47.8ug gold base particle in 50 µl WFI
Placebo (Two vaccinations)
Two vaccinations of WFI administered with on Day 0 \& Day 21 (50 µl per dose)
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
Interventions
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PepGNP-COVID19 (One vaccination)
One dose with 7.5 nmol total peptide/dose with 47.8ug gold base particle in 50 µl WFI
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
PepGNP-COVID19 (Two vaccinations)
Two vaccinations with 7.5 nmol total peptide/dose with 47.8ug gold base particle in 50 µl WFI
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Participant signed informed consent
3. Residing in Philippines.
4. A participant can be included providing COVID-19 polymerase chain reaction (PCR) test is negative at screening.
5. A participant can be included providing, the participant haven't received any vaccination against COVID-19 in the past, or if the participant had already received any of the following licensed vaccines against COVID-19: Oxford/AstraZeneca; Pfizer/BioNTech; Moderna; or J\&J/Janssen, with the participants last dose received at least 6 months prior the inclusion in this trial.
Exclusion Criteria
2. Participation in the 6 months preceding the first trial vaccination or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
3. Receipt of any vaccination against COVID-19 less than 6 months prior to participation in study.
4. Receipt of any vaccine in the three months preceding the first trial vaccination or planned receipt of any vaccine in the 6 months following last trial vaccination.
5. Positive SARS-CoV-2 test in the 4 weeks preceding the first trial vaccination
6. Receipt of immunoglobulins, blood, or blood-derived products in the past 3 months
7. Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy
8. Self-reported or documented seropositivity for human immunodeficiency virus (HIV), hepatitis B natural infection (HBcAb positive serology), or hepatitis C
9. Known systemic hypersensitivity to any of the vaccine components (e.g. gold), or history of a life-threatening reaction to vaccines or to a vaccine containing any of the same substances
10. Current alcohol abuse or drug addiction (reported or suspected)
11. Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
12. Thrombocytopenia or any coagulation disorder
13. Identified as an Investigator or employee of the Investigator or study centre with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study (i.e. in the employment of the clinical trial sites).
14. Refusal to be informed if relevant results concerning the participant's health are revealed
18 Years
75 Years
ALL
Yes
Sponsors
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Gylden Pharma Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Alberto R Edison, MD
Role: PRINCIPAL_INVESTIGATOR
Research Institute for Tropical Medicine
Locations
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Health Index Multispecialty Clinic, Barangay Toclong 2B
Imus, Cavite, Philippines
Tropical Disease Foundation
Makati City, National Capital Region, Philippines
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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naNO-COVID 2
Identifier Type: -
Identifier Source: org_study_id
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