A Phase I-II Study of a T-cell Next-generation Vaccine Against Coronavirus Disease

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.

Inclusion Criteria:Healthy volunteers aged 18 to 75 years on the day of inclusionParticipant signed informed consentResiding in Philippines.An individual can be included providing their COVID-19 polymerase chain reaction (PCR) test is negative at screening.An individual can be included providing: they haven't received any vaccination against COVID-19 in the past, or if they had already received any of the following licensed vaccines against COVID-19: Oxford/AstraZeneca; Pfizer/BioNTech; Moderna; or J&J/Janssen, with their last dose received at least 6 months prior the inclusion in this trial.Exclusion Criteria:Participant is pregnant, lactating, or of childbearing potentialaParticipation 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 procedureReceipt 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 6 months preceding the trial vaccinationReceipt of immunoglobulins, blood, or blood-derived products in the past 3 monthsKnown or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapySelf-reported or documented seropositivity for human immunodeficiency virus (HIV), hepatitis B natural infection (HBcAb positive serology), or hepatitis CKnown 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 substancesCurrent 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 completionThrombocytopenia or any coagulation disorderIdentified 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