The study aims to investigate the safety and immunogenicity of one dose vs two doses of aT-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."
Biological: PepGNP-COVID19 (One vaccination)
One dose with 7.5 nmol total peptide/dose with 47.8ug gold base particle in 50 µl WFI
Other: Water 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
Other Name: WFI
Biological: PepGNP-COVID19 (Two vaccinations)
Two vaccinations with 7.5 nmol total peptide/dose with 47.8ug gold base particle in 50 µl
WFI
Other: Water 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
Other Name: WFI
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
Health Index Multispecialty Clinic, Barangay Toclong 2B
Imus, Cavite, Philippines
Tropical Disease Foundation
Makati City, National Capital Region, Philippines
Alberto R Edison, MD
+63 (040) 471-0996
edisonalberto@rocketmail.com
Kassandra G Navea, BS
+63 9454099847
navea.kassandra@gmail.com
Alberto R Edison, MD, Principal Investigator
Research Institute for Tropical Medicine