Ignite Creation Date:
2024-05-06 @ 4:10 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04896086
Status:
COMPLETED
Last Update Posted:
2024-03-06
First Post:
2021-05-20
Brief Title:
First-in-Human Clinical Trial of a Mosaic Quadrivalent Influenza Vaccine Compared With a Licensed Inactivated Seasonal QIV in Healthy Adults
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
VRC 325 000410 A Phase I Open-Label Clinical Trial to Evaluate the Dose Safety Tolerability and Immunogenicity of Mosaic Quadrivalent Influenza Vaccine With and Without Adjuplex Compared With a Licensed Inactivated Seasonal QIV In Healthy Adults
Status:
COMPLETED
Status Verified Date:
2024-09
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:
None
Brief Summary:
Background
Influenza flu is a contagious respiratory illness It is caused by influenza viruses that infect the nose throat and sometimes the lungs Vaccines are given to teach the body to prevent or fight infection Researchers want to study a new vaccine to prevent the seasonal flu
Objective
To see if the FluMos-v1 vaccine is safe and how the body responds to it
Eligibility
Healthy adults ages 18-50 who received at least one licensed flu vaccine from 2016 through the 2019-2020 influenza season
Design
Participants will be screened through a separate protocol
Participants will be tested for COVID-19 They may have a pregnancy test
Participants will receive the FluMos-v1 vaccine or the Flucelvax vaccine It will be injected in the upper arm
Participants will complete a diary card for 7 days They will record any symptoms they have They will be given a thermometer to check their temperature They will also be given a ruler to measure any skin changes at the injection site
Participants will have about 10 study visits They will be asked how they are feeling and if they have taken any medications They will have blood drawn
Participants will have oral mucosal samples collected using a thin swab They may have nose and throat secretions collected using a thin swab
Some participants will have optional apheresis Blood will be removed through a needle in a vein in one arm A machine will separate the white blood cells The rest of the blood will be returned through a needle in a vein in the other arm
Participation will last for 40 weeks
Influenza flu is a contagious respiratory illness It is caused by influenza viruses that infect the nose throat and sometimes the lungs Vaccines are given to teach the body to prevent or fight infection Researchers want to study a new vaccine to prevent the seasonal flu
Objective
To see if the FluMos-v1 vaccine is safe and how the body responds to it
Eligibility
Healthy adults ages 18-50 who received at least one licensed flu vaccine from 2016 through the 2019-2020 influenza season
Design
Participants will be screened through a separate protocol
Participants will be tested for COVID-19 They may have a pregnancy test
Participants will receive the FluMos-v1 vaccine or the Flucelvax vaccine It will be injected in the upper arm
Participants will complete a diary card for 7 days They will record any symptoms they have They will be given a thermometer to check their temperature They will also be given a ruler to measure any skin changes at the injection site
Participants will have about 10 study visits They will be asked how they are feeling and if they have taken any medications They will have blood drawn
Participants will have oral mucosal samples collected using a thin swab They may have nose and throat secretions collected using a thin swab
Some participants will have optional apheresis Blood will be removed through a needle in a vein in one arm A machine will separate the white blood cells The rest of the blood will be returned through a needle in a vein in the other arm
Participation will last for 40 weeks
Detailed Description:
Design
This is a Phase I open-label dose escalation study to evaluate the dose safety tolerability and immunogenicity of the mosaic quadrivalent influenza vaccine VRC-FLUMOS0111-00-VP FluMos-v1 The hypotheses are that the FluMos-v1 vaccine is safe and tolerable and will elicit an immune response The primary objective is to evaluate the safety and tolerability of the investigational vaccine alone or with adjuvant in healthy adults Secondary objectives relate to immunogenicity of the investigational vaccine and dosing regimen compared with the licensed inactivated seasonal Flucelvax Registered Trademark quadrivalent influenza vaccine QIV in healthy adults
Study Products
The investigational vaccine FluMos-v1 was developed by the Vaccine Research Center VRC National Institute of Allergy and Infectious Diseases NIAID and is composed of the following 4 influenza strains Influenza A H1 AIdaho072018 and H3 APerth10082019 and Influenza B Victoria lineage BColorado062017 and Yamagata lineage BPhuket30732013 FluMos-v1 is supplied in a single-use vial at a concentration of 180 mcgmL
In Part A FluMos-v1 was compared to licensed 2020-2021 QIV Flucelvax Registered Trademark developed by Seqirus Inc and composed of the following 4 influenza strains Influenza A H1 AHawaii702019 H1N1 pdm09- like virus and H3 AHong Kong452019 H3N2-like virus and Influenza B Victoria lineage BWashington022019-like virus and Yamagata lineage BPhuket30732013-like virus
In Part B a higher dose of FluMos-v1 was tested that more closely matches the amount of each HA antigen in Flucelvax The adjuvant Adjuplex Registered Trademark was added to FluMos-v1 to evaluate the potential for increased immunogenicity All study enrollments and injections have been completed and no further enrollments are planned in this study
Adjuplex is provided as a sterile pyrogen-free homogeneous solution filled to 07 mL in 3-mL glass vials Adjuplex is mixed with study products in the pharmacy during preparation prior to vaccination at a 20 dose by volume
FluMos-v1 FluMos-V1 plus Adjuplex and Flucelvax Registered Trademark are administered intramuscularly IM in the deltoid muscle via needle and syringe
Subjects
Healthy adults between the ages of 18-50 years inclusive will be enrolled
Study Plan
In Part A the study evaluated the safety tolerability and immunogenicity of a single dose of FluMos-v1 vaccine alone in a dose-escalation design
In Part B the study evaluated the safety tolerability and immunogenicity of a single dose of FluMos-v1 vaccine with or without Adjuplex
Group 6 and Part C are optional and a decision was made not to enroll the optional groups 6-8 in the study All study enrollments and injections have been completed for groups 1-5 and no further enrollments are planned in this study
The protocol requires 1 vaccination visit about 8 follow-up visits and a telephone contact on the day after vaccination Solicited reactogenicity will be evaluated using a 7-day diary card Assessment of vaccine safety will include clinical observation and monitoring of hematological and chemical parameters at clinical visits throughout the study
Study Duration
Subjects will be evaluated for 40 weeks following vaccine administration and through an influenza season
This is a Phase I open-label dose escalation study to evaluate the dose safety tolerability and immunogenicity of the mosaic quadrivalent influenza vaccine VRC-FLUMOS0111-00-VP FluMos-v1 The hypotheses are that the FluMos-v1 vaccine is safe and tolerable and will elicit an immune response The primary objective is to evaluate the safety and tolerability of the investigational vaccine alone or with adjuvant in healthy adults Secondary objectives relate to immunogenicity of the investigational vaccine and dosing regimen compared with the licensed inactivated seasonal Flucelvax Registered Trademark quadrivalent influenza vaccine QIV in healthy adults
Study Products
The investigational vaccine FluMos-v1 was developed by the Vaccine Research Center VRC National Institute of Allergy and Infectious Diseases NIAID and is composed of the following 4 influenza strains Influenza A H1 AIdaho072018 and H3 APerth10082019 and Influenza B Victoria lineage BColorado062017 and Yamagata lineage BPhuket30732013 FluMos-v1 is supplied in a single-use vial at a concentration of 180 mcgmL
In Part A FluMos-v1 was compared to licensed 2020-2021 QIV Flucelvax Registered Trademark developed by Seqirus Inc and composed of the following 4 influenza strains Influenza A H1 AHawaii702019 H1N1 pdm09- like virus and H3 AHong Kong452019 H3N2-like virus and Influenza B Victoria lineage BWashington022019-like virus and Yamagata lineage BPhuket30732013-like virus
In Part B a higher dose of FluMos-v1 was tested that more closely matches the amount of each HA antigen in Flucelvax The adjuvant Adjuplex Registered Trademark was added to FluMos-v1 to evaluate the potential for increased immunogenicity All study enrollments and injections have been completed and no further enrollments are planned in this study
Adjuplex is provided as a sterile pyrogen-free homogeneous solution filled to 07 mL in 3-mL glass vials Adjuplex is mixed with study products in the pharmacy during preparation prior to vaccination at a 20 dose by volume
FluMos-v1 FluMos-V1 plus Adjuplex and Flucelvax Registered Trademark are administered intramuscularly IM in the deltoid muscle via needle and syringe
Subjects
Healthy adults between the ages of 18-50 years inclusive will be enrolled
Study Plan
In Part A the study evaluated the safety tolerability and immunogenicity of a single dose of FluMos-v1 vaccine alone in a dose-escalation design
In Part B the study evaluated the safety tolerability and immunogenicity of a single dose of FluMos-v1 vaccine with or without Adjuplex
Group 6 and Part C are optional and a decision was made not to enroll the optional groups 6-8 in the study All study enrollments and injections have been completed for groups 1-5 and no further enrollments are planned in this study
The protocol requires 1 vaccination visit about 8 follow-up visits and a telephone contact on the day after vaccination Solicited reactogenicity will be evaluated using a 7-day diary card Assessment of vaccine safety will include clinical observation and monitoring of hematological and chemical parameters at clinical visits throughout the study
Study Duration
Subjects will be evaluated for 40 weeks following vaccine administration and through an influenza season
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 000410-I | None | None | None |