A Phase I-II Study of a T-cell Next-generation Vaccine Against Coronavirus Disease

Sponsor
Emergex Vaccines Holding Ltd. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05633446
Collaborator
(none)
110
2
4
17.1
55
3.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: PepGNP-COVID19 (One vaccination)
  • Other: Water for injection (One vaccination)
  • Biological: PepGNP-COVID19 (Two vaccinations)
  • Other: Water for injection (Two vaccinations)
Phase 1/Phase 2

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 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."

Study Design

Study Type:
Interventional
Anticipated Enrollment :
110 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Masking Description:
This trial is double-blinded (blinded to investigators and participants) Blinding will be maintained for the duration of the study.
Primary Purpose:
Prevention
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
Anticipated Study Start Date :
May 23, 2023
Anticipated Primary Completion Date :
Mar 23, 2024
Anticipated Study Completion Date :
Oct 23, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: PepGNP-COVID19 (One vaccination)

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

Biological: PepGNP-COVID19 (One vaccination)
One dose with 7.5 nmol total peptide/dose with 38.3ug gold base particle in 50 µl WFI

Placebo Comparator: Placebo (One vaccination)

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

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 Names:
  • WFI
  • Experimental: PepGNP-COVID19 (Two vaccinations)

    Two vaccinations of PepGNP-COVID19 vaccine candidate administered on Day 0 and Day 21 (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

    Placebo Comparator: Placebo (Two vaccinations)

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

    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 Names:
  • WFI
  • Outcome Measures

    Primary Outcome Measures

    1. To assess the safety, tolerability and reactogenicity of the vaccine [6 months following first vaccination or End Of Study (EOS), whichever is later]

      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

    1. Assess the cellular immunogenicity of the vaccine candidate [180 days following first vaccination]

      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

    2. Assess the humoral immunogenicity of the vaccine candidate [180 days following first vaccination]

      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)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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. An individual can be included providing their COVID-19 polymerase chain reaction (PCR) test is negative at screening.

    5. An individual can be included providing: they haven't received any vaccination against COVID-19 in the past, or if they had already received any of the following licensed vaccines against COVID-19: Oxford/AstraZeneca; Pfizer/BioNTech; Moderna; or J&J/Janssen, with their last dose received at least 6 months prior the inclusion in this trial.

    Exclusion Criteria:
    1. Participant is pregnant, lactating, or of childbearing potentiala

    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 6 months preceding the 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Health Index Multispecialty Clinic, Barangay Toclong 2B Imus Cavite Philippines 4104
    2 Tropical Disease Foundation Makati City National Capital Region Philippines 1229

    Sponsors and Collaborators

    • Emergex Vaccines Holding Ltd.

    Investigators

    • Principal Investigator: Alberto R Edison, MD, Research Institute for Tropical Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Emergex Vaccines Holding Ltd.
    ClinicalTrials.gov Identifier:
    NCT05633446
    Other Study ID Numbers:
    • naNO-COVID 2
    First Posted:
    Dec 1, 2022
    Last Update Posted:
    Dec 1, 2022
    Last Verified:
    Nov 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Emergex Vaccines Holding Ltd.
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 1, 2022