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.
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."
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
110
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
Health Index Multispecialty Clinic, Barangay Toclong 2B
Imus, Cavite, Philippines
Tropical Disease Foundation
Makati City, National Capital Region, Philippines
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.
Time frame: 6 months following first vaccination or End Of Study (EOS), whichever is later
Assess the cellular immunogenicity of the vaccine candidate
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
Time frame: 180 days following first vaccination
Assess the humoral immunogenicity of the vaccine candidate
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)
Time frame: 180 days following first vaccination
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Water For Injection (WFI): (sodium chloride, a 0.9% solution for the preparation of dosage forms for injections) 50 µl per dose