Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06381739
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-25
First Post:
2024-04-23
Brief Title:
A Trial of a Next Generation COVID-19 Vaccine Delivered by Inhaled Aerosol
Sponsor:
McMaster University
Organization:
McMaster University
Study Overview
Official Title:
A Phase 2 Trial to Evaluate Safety and Immunogenicity of a Next-generation COVID-19 Vaccine Delivered by Inhaled Aerosol to Humans
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AeroVax
Brief Summary:
The goal of this clinical trial is to study the safety of a new inhaled vaccine to prevent COVID infection and learn about the immune responses that are made in the lungs and the blood after vaccination Participants will be randomized like the toss of a coin to receive the experimental vaccine or a placebo a look-alike solution that contains no vaccine
To be in the study participants will have to have already had three doses of a messenger ribonucleic acid mRNA COVID vaccine and be generally healthy Participants are given a single dose of the vaccine by breathing in a fine mist that goes directly into the lungs
During follow-up participants will
visit the clinic for checkups and blood tests at 2 4 and 8 weeks after vaccination
report their symptoms for 24 weeks after getting the vaccine
In some participants the researchers will collect cells from the lung 4 weeks after vaccination a test known as a bronchoscopy
To be in the study participants will have to have already had three doses of a messenger ribonucleic acid mRNA COVID vaccine and be generally healthy Participants are given a single dose of the vaccine by breathing in a fine mist that goes directly into the lungs
During follow-up participants will
visit the clinic for checkups and blood tests at 2 4 and 8 weeks after vaccination
report their symptoms for 24 weeks after getting the vaccine
In some participants the researchers will collect cells from the lung 4 weeks after vaccination a test known as a bronchoscopy
Detailed Description:
The global impact of the coronavirus disease 2019 COVID-19 pandemic remains profound COVID-19 continues to be one of the leading causes of death and hospitalization due to infectious disease disproportionately affecting the elderly and immunocompromised The continuous evolution of the virus has significantly challenged the effectiveness of first-generation and updated vaccination strategies These variants of concern VOCs can evade neutralizing antibodies
Adequate and early lung mucosal immunity is critical for control of infection but current vaccines fail to induce robust mucosal immunity in the lungs a major reason for the high rates of break-through infections The respiratory mucosal route of immunization however can induce protective respiratory mucosal immunity consisting of trained innate immunity via memory airway macrophages mucosal antibodies and tissue-resident memory CD4CD8 T cells
A phase 1 study has been completed using a recombinant chimpanzee adenovirus ChAd vector ChAd-CoV3Mac in 23 healthy volunteers and has shown that the vaccine can be safely administered by aerosol and that immune responses against COVID-19 develop in the lung and T-cells and neutralizing antibodies are generated in the blood
The purpose of this placebo-controlled Phase 2 trial is to determine if this new COVID-19 vaccine ChAd-triCoVMac is safe to give by aerosol to people who have been vaccinated with at least three doses of a COVID mRNA vaccine and evaluate the immune responses generated Specifically the researchers want to see if T cell responses and antibody responses to the COVID virus proteins develop in the blood after receiving the vaccine
There is a lack of surrogate immune markers for vaccine-induced protection against antibody-evading VOCs of SARS-CoV-2 However given the now recognized importance of respiratory mucosal T cell immunity in anti-SARS-CoV-2 host defense this study will allow for a correlation of mucosal T cell immunity with the T cells in blood to help predict vaccine efficacy and inform the design of phase 3 efficacy studies
Adequate and early lung mucosal immunity is critical for control of infection but current vaccines fail to induce robust mucosal immunity in the lungs a major reason for the high rates of break-through infections The respiratory mucosal route of immunization however can induce protective respiratory mucosal immunity consisting of trained innate immunity via memory airway macrophages mucosal antibodies and tissue-resident memory CD4CD8 T cells
A phase 1 study has been completed using a recombinant chimpanzee adenovirus ChAd vector ChAd-CoV3Mac in 23 healthy volunteers and has shown that the vaccine can be safely administered by aerosol and that immune responses against COVID-19 develop in the lung and T-cells and neutralizing antibodies are generated in the blood
The purpose of this placebo-controlled Phase 2 trial is to determine if this new COVID-19 vaccine ChAd-triCoVMac is safe to give by aerosol to people who have been vaccinated with at least three doses of a COVID mRNA vaccine and evaluate the immune responses generated Specifically the researchers want to see if T cell responses and antibody responses to the COVID virus proteins develop in the blood after receiving the vaccine
There is a lack of surrogate immune markers for vaccine-induced protection against antibody-evading VOCs of SARS-CoV-2 However given the now recognized importance of respiratory mucosal T cell immunity in anti-SARS-CoV-2 host defense this study will allow for a correlation of mucosal T cell immunity with the T cells in blood to help predict vaccine efficacy and inform the design of phase 3 efficacy studies
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None