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

Launched by GYLDEN PHARMA LTD · Nov 30, 2022

Keywords

ClinConnect Summary

This clinical trial is testing a new type of vaccine aimed at protecting against COVID-19. The researchers want to find out how safe it is and how well it helps the body develop an immune response when given in one dose compared to two doses. The study is not yet recruiting participants, but when it starts, it will include healthy adults aged 18 to 75 who live in the Philippines and have not been vaccinated against COVID-19 in the past six months.

To participate, individuals will need to confirm they are healthy and have a negative COVID-19 test result before joining. There are certain groups of people who cannot participate, such as those who are pregnant or have recently received other vaccines. Participants can expect to receive the vaccine and be monitored for any side effects or reactions. This trial is important because it may help develop better vaccines that can protect against COVID-19 in the future.

Gender

ALL

Eligibility criteria

• 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