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
1 other identifier
interventional
110
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Sep 2025
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 30, 2022
CompletedFirst Posted
Study publicly available on registry
December 1, 2022
CompletedStudy Start
First participant enrolled
September 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
February 24, 2025
February 1, 2025
9 months
November 30, 2022
February 21, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
6 months following first vaccination or End Of Study (EOS), whichever is later
Secondary Outcomes (2)
Assess the cellular immunogenicity of the vaccine candidate
180 days following first vaccination
Assess the humoral immunogenicity of the vaccine candidate
180 days following first vaccination
Study Arms (4)
PepGNP-COVID19 (One vaccination)
EXPERIMENTALOne vaccination of PepGNP-COVID19 vaccine candidate administered on Day 0 (50 µl per dose)
Placebo (One vaccination)
PLACEBO COMPARATOROne vaccination of WFI administered on Day 0 (50 µl per dose)
PepGNP-COVID19 (Two vaccinations)
EXPERIMENTALTwo vaccinations of PepGNP-COVID19 vaccine candidate administered on Day 0 and Day 21 (50 µl per dose)
Placebo (Two vaccinations)
PLACEBO COMPARATORTwo vaccinations of WFI administered with on Day 0 \& Day 21 (50 µl per dose)
Interventions
One dose with 7.5 nmol total peptide/dose with 47.8ug gold base particle in 50 µl WFI
Water For Injection (WFI): (sodium chloride, a 0.9% solution for the preparation of dosage forms for injections) 50 µl per dose
Two vaccinations with 7.5 nmol total peptide/dose with 47.8ug gold base particle in 50 µl WFI
Water For Injection (WFI): (sodium chloride, a 0.9% solution for the preparation of dosage forms for injections) 50 µl per dose
Eligibility Criteria
You may qualify if:
- Participant signed informed consent
- Residing in Philippines.
- A participant can be included providing COVID-19 polymerase chain reaction (PCR) test is negative at screening.
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Health Index Multispecialty Clinic, Barangay Toclong 2B
Imus, Cavite, 4104, Philippines
Tropical Disease Foundation
Makati City, National Capital Region, 1229, Philippines
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alberto R Edison, MD
Research Institute for Tropical Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- * This trial is double-blinded (blinded to investigators and participants) * Blinding will be maintained for the duration of the study.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 30, 2022
First Posted
December 1, 2022
Study Start
September 1, 2025
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
February 24, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share