CoronavirusPhase 1/2NCT05633446
Next Generation T-cell Vaccine Against Coronavirus Disease (COVID-19)
A Phase 1/2 study testing PepGNP-COVID19 (One vaccination), Water for injection (One vaccination) and PepGNP-COVID19 (Two vaccinations) in people with Coronavirus and SARS-CoV-2 Infection, run by Gylden Pharma Ltd at 2 sites in Philippines.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronavirus, SARS-CoV-2 Infection, COVID-19
- What is being tested?
- PepGNP-COVID19 (One vaccination), Water for injection (One vaccination) and PepGNP-COVID19 (Two vaccinations)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 2 sitesPhilippines
- Study dates
- 1 Sep 2025to 1 Dec 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers aged 18 to 75 years on the day of inclusion
- Participant signed informed consent
- Residing in Philippines.
- A participant can be included providing COVID-19 polymerase chain reaction (PCR) test is negative at screening.
- 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.
Who cannot join
- Participant is pregnant, lactating, or of childbearing potential
- 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
- Receipt of any vaccination against COVID-19 less than 6 months prior to participation in study.
- 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.
- Positive SARS-CoV-2 test in the 4 weeks preceding the first trial vaccination
- Receipt of immunoglobulins, blood, or blood-derived products in the past 3 months
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- Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy
- Self-reported or documented seropositivity for human immunodeficiency virus (HIV), hepatitis B natural infection (HBcAb positive serology), or hepatitis C
- 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
- Current alcohol abuse or drug addiction (reported or suspected)
- Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
- Thrombocytopenia or any coagulation disorder
- 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).
- Refusal to be informed if relevant results concerning the participant's health are revealed
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Philippines2 sites
Health Index Multispecialty Clinic, Barangay Toclong 2B
Imus, Cavite, 4104
Kassandra G Navea, BS, +639454099847, navea.kassandra@gmail.com
Coreign A Domingo, AB Psy, +63468877356, coreign17@gmail.com
Tropical Disease Foundation
Makati City, National Capital Region, 1229
Charissa Fay Corazon B Tabora, BS, +639178294349, cbtabora@gmail.com
Sarah Jane T Lo, BS, +639393090547, losarahjane20@gmail.com
About this study
Official title: 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.
Read the 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
- Being tested
- PepGNP-COVID19 (One vaccination), Water for injection (One vaccination), PepGNP-COVID19 (Two vaccinations), Water for injection (Two vaccinations)
- Keywords
- Coronavirus, SARS-CoV-2, COVID-19, T-cell priming, COVID vaccine, Nanoparticle, T cell, Cellular immunity, T-cell vaccine
- Medical subject headings
- Coronavirus Infections, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Also called WFI
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
Also called WFI
Water For Injection (WFI): (sodium chloride, a 0.9% solution for the preparation of dosage forms for injections) 50 µl per dose
| Study group | Role | What they receive |
|---|---|---|
| PepGNP-COVID19 (One vaccination) | Experimental | One vaccination of PepGNP-COVID19 vaccine candidate administered on Day 0 (50 µl per dose) Receives: Biological: PepGNP-COVID19 (One vaccination) |
| Placebo (One vaccination) | Placebo comparator | One vaccination of WFI administered on Day 0 (50 µl per dose) Receives: Other: Water for injection (One vaccination) |
| PepGNP-COVID19 (Two vaccinations) | Experimental | Two vaccinations of PepGNP-COVID19 vaccine candidate administered on Day 0 and Day 21 (50 µl per dose) Receives: Biological: PepGNP-COVID19 (Two vaccinations) |
| Placebo (Two vaccinations) | Placebo comparator | Two vaccinations of WFI administered with on Day 0 \& Day 21 (50 µl per dose) Receives: Other: Water for injection (Two vaccinations) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety, tolerability and reactogenicity of the vaccine
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.
Measured: 6 months following first vaccination or End Of Study (EOS), whichever is later
Secondary outcomes (2)
Assess the cellular immunogenicity of the vaccine candidate
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
Measured: 180 days following first vaccination
Assess the humoral immunogenicity of the vaccine candidate
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)
Measured: 180 days following first vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2022
- Study start1 Sep 2025 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoronavirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gylden Pharma Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alberto R Edison, MD, Principal investigator, Research Institute for Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05633446
- Sponsor's protocol ID
- naNO-COVID 2
- Status last verified
- Feb 2025
- First submitted
- 30 Nov 2022
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I-II, Blinded, Randomized, Placebo-controlled Study of a T Cell Priming Next-generation Vaccine Against Coronavirus Disease in Healthy Adults
- ClinicalTrials.gov ID
- NCT05633446
- Acronym / sponsor ID
- naNO-COVID 2
- Conditions
- Coronavirus, SARS-CoV-2 Infection, COVID-19
- Keywords
- Coronavirus, SARS-CoV-2, COVID-19, T-cell priming, COVID vaccine, Nanoparticle, T cell, Cellular immunity
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Gylden Pharma LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 1 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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."
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PepGNP-COVID19 (One vaccination) | Experimental | Biological: PepGNP-COVID19 (One vaccination)One vaccination of PepGNP-COVID19 vaccine candidate administered on Day 0 (50 µl per dose) |
| Placebo (One vaccination) | Placebo comparator | Other: Water for injection (One vaccination)One vaccination of WFI administered on Day 0 (50 µl per dose) |
| PepGNP-COVID19 (Two vaccinations) | Experimental | Biological: PepGNP-COVID19 (Two vaccinations)Two vaccinations of PepGNP-COVID19 vaccine candidate administered on Day 0 and Day 21 (50 µl per dose) |
| Placebo (Two vaccinations) | Placebo comparator | Other: Water for injection (Two vaccinations)Two vaccinations of WFI administered with on Day 0 \& Day 21 (50 µl per dose) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy volunteers aged 18 to 75 years on the day of inclusion
- Participant signed informed consent
- Residing in Philippines.
- A participant can be included providing COVID-19 polymerase chain reaction (PCR) test is negative at screening.
- 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.
Key exclusion criteria (14 listed)
- Participant is pregnant, lactating, or of childbearing potential
- 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
- Receipt of any vaccination against COVID-19 less than 6 months prior to participation in study.
- 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.
- Positive SARS-CoV-2 test in the 4 weeks preceding the first trial vaccination
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PepGNP-COVID19 (One vaccination)One dose with 7.5 nmol total peptide/dose with 47.8ug gold base particle in 50 µl WFI | Biological | PepGNP-COVID19 (One vaccination) |
| Water for injection (One vaccination)Also: WFIWater For Injection (WFI): (sodium chloride, a 0.9% solution for the preparation of dosage forms for injections) 50 µl per dose | Other | Placebo (One vaccination) |
| PepGNP-COVID19 (Two vaccinations)Two vaccinations with 7.5 nmol total peptide/dose with 47.8ug gold base particle in 50 µl WFI | Biological | PepGNP-COVID19 (Two vaccinations) |
| Water for injection (Two vaccinations)Also: WFIWater For Injection (WFI): (sodium chloride, a 0.9% solution for the preparation of dosage forms for injections) 50 µl per dose | Other | Placebo (Two vaccinations) |
Primary outcome
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.
2 secondary outcomes
Assess the cellular immunogenicity of the vaccine candidate
Time frame: 180 days following first vaccination
Assess the humoral immunogenicity of the vaccine candidate
Time frame: 180 days following first vaccination
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alberto R Edison, MD principal investigator
Research Institute for Tropical Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing PepGNP-COVID19 (One vaccination), Water for injection (One vaccination) and PepGNP-COVID19 (Two vaccinations) in people with Coronavirus and SARS-CoV-2 Infection, run by Gylden Pharma Ltd at 2 sites in Philippines.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alberto R Edison, MD (+63 (040) 471-0996, edisonalberto@rocketmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2025.