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

Gylden Pharma Ltd

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: COVID-19; SARS-CoV-2 Infection; Coronavirus

Treatments: Biological: PepGNP-COVID19 (One vaccination); Other: Water for injection (One vaccination); Biological: PepGNP-COVID19 (Two vaccinations); Other: Water for injection (Two vaccinations)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05633446

naNO-COVID 2

Details and patient eligibility

About

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.

Full 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."

Enrollment: 110 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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110 participants in 4 patient groups, including a placebo group

PepGNP-COVID19 (One vaccination)

Experimental group

Description:

One vaccination of PepGNP-COVID19 vaccine candidate administered on Day 0 (50 µl per dose)

Treatment:

Biological: PepGNP-COVID19 (One vaccination)

Placebo (One vaccination)

Placebo Comparator group

Description:

One vaccination of WFI administered on Day 0 (50 µl per dose)

Treatment:

Other: Water for injection (One vaccination)

PepGNP-COVID19 (Two vaccinations)

Experimental group

Description:

Two vaccinations of PepGNP-COVID19 vaccine candidate administered on Day 0 and Day 21 (50 µl per dose)

Treatment:

Biological: PepGNP-COVID19 (Two vaccinations)

Placebo (Two vaccinations)

Placebo Comparator group

Description:

Two vaccinations of WFI administered with on Day 0 \& Day 21 (50 µl per dose)

Treatment:

Other: Water for injection (Two vaccinations)