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

Primary Purpose

Coronavirus, SARS-CoV-2 Infection, COVID-19

Status
Not yet recruiting
Phase
Phase 1
Locations
Philippines
Study Type
Interventional
Intervention
PepGNP-COVID19 (One vaccination)
Water for injection (One vaccination)
PepGNP-COVID19 (Two vaccinations)
Water for injection (Two vaccinations)
Sponsored by
Emergex Vaccines Holding Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coronavirus focused on measuring Coronavirus, SARS-CoV-2, COVID-19, T-cell priming, COVID vaccine, Nanoparticle, T-cell vaccine, T cell, T-cell, Cellular immunity

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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. 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: 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. Positive SARS-CoV-2 test in the 4 weeks preceding the first trial vaccination Receipt of immunoglobulins, blood, or blood-derived products in the past 3 months Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy Self-reported or documented seropositivity for human immunodeficiency virus (HIV), hepatitis B natural infection (HBcAb positive serology), or hepatitis C 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 Current alcohol abuse or drug addiction (reported or suspected) Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion Thrombocytopenia or any coagulation disorder 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). Refusal to be informed if relevant results concerning the participant's health are revealed

Sites / Locations

  • Health Index Multispecialty Clinic, Barangay Toclong 2B
  • Tropical Disease Foundation

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

PepGNP-COVID19 (One vaccination)

Placebo (One vaccination)

PepGNP-COVID19 (Two vaccinations)

Placebo (Two vaccinations)

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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)

Full Information

First Posted
November 30, 2022
Last Updated
April 18, 2023
Sponsor
Emergex Vaccines Holding Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05633446
Brief Title
Next Generation T-cell Vaccine Against Coronavirus Disease (COVID-19)
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 23, 2023 (Anticipated)
Primary Completion Date
March 23, 2024 (Anticipated)
Study Completion Date
October 23, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Emergex Vaccines Holding Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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."

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronavirus, SARS-CoV-2 Infection, COVID-19
Keywords
Coronavirus, SARS-CoV-2, COVID-19, T-cell priming, COVID vaccine, Nanoparticle, T-cell vaccine, T cell, T-cell, Cellular immunity

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
This trial is double-blinded (blinded to investigators and participants) Blinding will be maintained for the duration of the study.
Allocation
Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PepGNP-COVID19 (One vaccination)
Arm Type
Experimental
Arm Description
One vaccination of PepGNP-COVID19 vaccine candidate administered on Day 0 (50 µl per dose)
Arm Title
Placebo (One vaccination)
Arm Type
Placebo Comparator
Arm Description
One vaccination of WFI administered on Day 0 (50 µl per dose)
Arm Title
PepGNP-COVID19 (Two vaccinations)
Arm Type
Experimental
Arm Description
Two vaccinations of PepGNP-COVID19 vaccine candidate administered on Day 0 and Day 21 (50 µl per dose)
Arm Title
Placebo (Two vaccinations)
Arm Type
Placebo Comparator
Arm Description
Two vaccinations of WFI administered with on Day 0 & Day 21 (50 µl per dose)
Intervention Type
Biological
Intervention Name(s)
PepGNP-COVID19 (One vaccination)
Intervention Description
One dose with 7.5 nmol total peptide/dose with 38.3ug gold base particle in 50 µl WFI
Intervention Type
Other
Intervention Name(s)
Water for injection (One vaccination)
Other Intervention Name(s)
WFI
Intervention Description
Water For Injection (WFI): (sodium chloride, a 0.9% solution for the preparation of dosage forms for injections) 50 µl per dose
Intervention Type
Biological
Intervention Name(s)
PepGNP-COVID19 (Two vaccinations)
Intervention Description
Two vaccinations with 7.5 nmol total peptide/dose with 38.3ug gold base particle in 50 µl WFI
Intervention Type
Other
Intervention Name(s)
Water for injection (Two vaccinations)
Other Intervention Name(s)
WFI
Intervention Description
Water For Injection (WFI): (sodium chloride, a 0.9% solution for the preparation of dosage forms for injections) 50 µl per dose
Primary Outcome Measure Information:
Title
To assess the safety, tolerability and reactogenicity of the vaccine
Description
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
Secondary Outcome Measure Information:
Title
Assess the cellular immunogenicity of the vaccine candidate
Description
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
Title
Assess the humoral immunogenicity of the vaccine candidate
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. 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: 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. Positive SARS-CoV-2 test in the 4 weeks preceding the first trial vaccination Receipt of immunoglobulins, blood, or blood-derived products in the past 3 months Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy Self-reported or documented seropositivity for human immunodeficiency virus (HIV), hepatitis B natural infection (HBcAb positive serology), or hepatitis C 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 Current alcohol abuse or drug addiction (reported or suspected) Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion Thrombocytopenia or any coagulation disorder 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). Refusal to be informed if relevant results concerning the participant's health are revealed
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alberto R Edison, MD
Phone
+63 (040) 471-0996
Email
edisonalberto@rocketmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Kassandra G Navea, BS
Phone
+63 9454099847
Email
navea.kassandra@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alberto R Edison, MD
Organizational Affiliation
Research Institute for Tropical Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Health Index Multispecialty Clinic, Barangay Toclong 2B
City
Imus
State/Province
Cavite
ZIP/Postal Code
4104
Country
Philippines
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kassandra G Navea, BS
Phone
+639454099847
Email
navea.kassandra@gmail.com
First Name & Middle Initial & Last Name & Degree
Coreign A Domingo, AB Psy
Phone
+63468877356
Email
coreign17@gmail.com
Facility Name
Tropical Disease Foundation
City
Makati City
State/Province
National Capital Region
ZIP/Postal Code
1229
Country
Philippines
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charissa Fay Corazon B Tabora, BS
Phone
+639178294349
Email
cbtabora@gmail.com
First Name & Middle Initial & Last Name & Degree
Sarah Jane T Lo, BS
Phone
+639393090547
Email
losarahjane20@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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