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

February 21, 2025 updated by: Gylden Pharma Ltd

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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."

Study Type

Interventional

Enrollment (Estimated)

110

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Philippines
    • Cavite
      • Imus, Cavite, Philippines, 4104
        • Health Index Multispecialty Clinic, Barangay Toclong 2B
        • Contact:
        • Contact:
    • National Capital Region
      • Makati City, National Capital Region, Philippines, 1229
        • Tropical Disease Foundation
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Healthy volunteers aged 18 to 75 years on the day of inclusion
  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:

  1. Participant is pregnant, lactating, or of childbearing potential
  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PepGNP-COVID19 (One vaccination)
One vaccination of PepGNP-COVID19 vaccine candidate administered on Day 0 (50 µl per dose)
Biological: PepGNP-COVID19 (One vaccination)
One dose with 7.5 nmol total peptide/dose with 47.8ug gold base particle in 50 µl WFI
Placebo Comparator: Placebo (One vaccination)
One vaccination of WFI administered on Day 0 (50 µl per dose)
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
Other Names:
  • WFI
Experimental: PepGNP-COVID19 (Two vaccinations)
Two vaccinations of PepGNP-COVID19 vaccine candidate administered on Day 0 and Day 21 (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
Placebo Comparator: Placebo (Two vaccinations)
Two vaccinations of WFI administered with on Day 0 & Day 21 (50 µl per dose)
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
Other Names:
  • WFI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Occurrence of solicited local reactogenicity signs and symptoms up to 7 days after each injection. Occurrence of solicited systemic reactogenicity signs and symptoms up to 14 days after each injection. Occurrence of unsolicited adverse events, serious adverse events (SAEs), and adverse events of special interest (AESI) up to 6 months following first vaccination or End Of Study (EOS), whichever is later.
6 months following first vaccination or End Of Study (EOS), whichever is later

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess the cellular immunogenicity of the vaccine candidate
Time Frame: 180 days following first vaccination
Proportion of participants with T cells specific to PepGNP-COVID19 vaccine, and Proportion of subjects with activated cellular immunity cells via assessment of peptide-specific T cell response performed by cytometry, using dextramer staining and, by measuring activation markers upon stimulation with peptides
180 days following first vaccination
Assess the humoral immunogenicity of the vaccine candidate
Time Frame: 180 days following first vaccination
For individuals seronegative at enrolment - Proportion of participants becoming seropositive (antibodies against SARS-CoV-2 as determined by Enzyme-linked Immunosorbent Assay (ELISA)), and For individuals seropositive at enrolment - Fold change in anti-SARS-CoV-2 antibodies as determined by Enzyme-linked Immunosorbent Assay (ELISA)
180 days following first vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gylden Pharma Ltd

Investigators

  • Principal Investigator: Alberto R Edison, MD, Research Institute For Tropical Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

November 30, 2022

First Submitted That Met QC Criteria

November 30, 2022

First Posted (Actual)

December 1, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 21, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • naNO-COVID 2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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