Coronavirus, COVID-19, SARS-CoV-2 Infection
Conditions
Keywords
Coronavirus, SARS-CoV-2, COVID-19, T-cell priming, COVID vaccine, Nanoparticle, T cell, Cellular immunity, T-cell vaccine
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.
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.
Interventions
BIOLOGICALPepGNP-COVID19 (One vaccination)
One dose with 7.5 nmol total peptide/dose with 47.8ug gold base particle in 50 µl WFI
OTHERWater for injection (One vaccination)
Water For Injection (WFI): (sodium chloride, a 0.9% solution for the preparation of dosage forms for injections) 50 µl per dose
BIOLOGICALPepGNP-COVID19 (Two vaccinations)
Two vaccinations with 7.5 nmol total peptide/dose with 47.8ug gold base particle in 50 µl WFI
OTHERWater for injection (Two vaccinations)
Water For Injection (WFI): (sodium chloride, a 0.9% solution for the preparation of dosage forms for injections) 50 µl per dose
Sponsors
Gylden Pharma Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Masking description
* This trial is double-blinded (blinded to investigators and participants) * Blinding will be maintained for the duration of the study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess the safety, tolerability and reactogenicity of the vaccine | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assess the cellular immunogenicity of the vaccine candidate | 180 days following first vaccination | 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 |
| Assess the humoral immunogenicity of the vaccine candidate | 180 days following first vaccination | 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) |
Countries
Philippines
Contacts
Primary ContactAlberto R Edison, MD
Backup ContactKassandra G Navea, BS
Outcome results
None listed