Next Generation T-cell Vaccine Against Coronavirus Disease (COVID-19)
Coronavirus, SARS-CoV-2 Infection, COVID-19
About this trial
This is an interventional prevention trial for Coronavirus focused on measuring Coronavirus, SARS-CoV-2, COVID-19, T-cell priming, COVID vaccine, Nanoparticle, T-cell vaccine, T cell, T-cell, Cellular immunity
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Sites / Locations
- Health Index Multispecialty Clinic, Barangay Toclong 2B
- Tropical Disease Foundation
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Placebo Comparator
Experimental
Placebo Comparator
PepGNP-COVID19 (One vaccination)
Placebo (One vaccination)
PepGNP-COVID19 (Two vaccinations)
Placebo (Two vaccinations)
One vaccination of PepGNP-COVID19 vaccine candidate administered on Day 0 (50 µl per dose)
One vaccination of WFI administered on Day 0 (50 µl per dose)
Two vaccinations of PepGNP-COVID19 vaccine candidate administered on Day 0 and Day 21 (50 µl per dose)
Two vaccinations of WFI administered with on Day 0 & Day 21 (50 µl per dose)