Next Generation T-cell Vaccine Against Coronavirus Disease (COVID-19)
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorGylden Pharma Ltd
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
PepGNP-COVID19 (One vaccination)
Biological/VaccineOne dose with 7.5 nmol total peptide/dose with 47.8ug gold base particle in 50 µl WFI
Water for injection (One vaccination)
Other interventionWater For Injection (WFI): (sodium chloride, a 0.9% solution for the preparation of dosage forms for injections) 50 µl per dose
PepGNP-COVID19 (Two vaccinations)
Biological/VaccineTwo vaccinations with 7.5 nmol total peptide/dose with 47.8ug gold base particle in 50 µl WFI
Water for injection (Two vaccinations)
Other interventionWater For Injection (WFI): (sodium chloride, a 0.9% solution for the preparation of dosage forms for injections) 50 µl per dose
Treatment groups
110 Participants
are divided into 4 treatment groupsGroup A: PepGNP-COVID19 (One vaccination)Experimental treatment 1 intervention
Group B: Placebo (One vaccination)Placebo comparator 1 intervention
Group C: PepGNP-COVID19 (Two vaccinations)Experimental treatment 1 intervention
Group D: Placebo (Two vaccinations)Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 laterSecondary outcomes
1
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 vaccination2
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 vaccinationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: