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

COVID-19 Clinical Trial

Official title:

A Phase I-II, Double-blind, Randomized, Placebo-controlled Study of a T Cell Priming Next-generation Vaccine Against Coronavirus Disease in Healthy Adults

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05633446
• Other study ID #: naNO-COVID 2
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: May 23, 2023
• Est. completion date: October 23, 2024

Study information

• Verified date: April 2023
• Source: Emergex Vaccines Holding Ltd.
• Contact: Alberto R Edison, MD
• Phone: +63 (040) 471-0996
• Email: edisonalberto[@]rocketmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 + 38.3ug GNP) + 11 placebo (WFI)

• Group 2 Two Vaccinations (Day 0 & Day 21) (n=55): 44 PepGNP-COVID19 (7.5 nmol peptide + 38.3ug GNP) + 11 placebo (WFI) Allocations of vaccine vera vs placebo for each group are double blinded."

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 110
• Est. completion date: October 23, 2024
• Est. primary completion date: March 23, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronavirus
• Coronavirus Infections
• COVID-19
• SARS-CoV-2 Infection

Intervention

Biological:
• PepGNP-COVID19 (One vaccination)
One dose with 7.5 nmol total peptide/dose with 38.3ug 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

Biological:
• PepGNP-COVID19 (Two vaccinations)
Two vaccinations with 7.5 nmol total peptide/dose with 38.3ug 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

Locations

Country	Name	City	State
Philippines	Health Index Multispecialty Clinic, Barangay Toclong 2B	Imus	Cavite
Philippines	Tropical Disease Foundation	Makati City	National Capital Region

Sponsors (1)

Lead Sponsor	Collaborator
Emergex Vaccines Holding Ltd.

Country where clinical trial is conducted

Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months following first vaccination or End Of Study (EOS), whichever is later
Secondary	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	180 days following first vaccination
Secondary	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)	180 days following first vaccination