Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06602531
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-16
Brief Title:
Safety and Immunogenicity Study of Self-Amplifying RNA Pandemic Influenza Vaccine in Adults
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 1 First-in-human Randomized Observer-blind Parallel Design Controlled Dose Level and Schedule-finding Study to Evaluate the Safety Reactogenicity and Immunogenicity of a Self-Amplifying MRNA Pandemic Influenza Vaccine ARCT-2304 When Administered to Healthy Adults
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to evaluate the safety and immune responses of three different dose levels a self-amplifying RNA pandemic influenza vaccine ARCT-2304 in adults The key objectives of the study are
To evaluate safety and reactogenicity of different dose levels of the ARCT-2304 vaccine
To describe the Immune responses of different dose levels of the ARCT-2304 vaccine as measured by hemagglutination inhibition HAI and neuraminidase enzyme-linked lectin ELLA antibody responses
Researchers will compare the results with licensed influenza vaccines to select the most optimal dose level and schedule for vaccine administration in terms of safety and immunogenicity for further development of the vaccine
Participants will receive 2 doses of the ARCT-2304 vaccine or 1 dose of licensed influenza vaccine and 1 dose of placebo
They will be asked
to complete a daily diary for 7 days after each vaccination answering questions how they have been feeling on that day
to provide blood samples at each visit in the clinic
to comply with all study visits and procedures eg be available for planned telephone contacts and unscheduled clinic visits if required
To evaluate safety and reactogenicity of different dose levels of the ARCT-2304 vaccine
To describe the Immune responses of different dose levels of the ARCT-2304 vaccine as measured by hemagglutination inhibition HAI and neuraminidase enzyme-linked lectin ELLA antibody responses
Researchers will compare the results with licensed influenza vaccines to select the most optimal dose level and schedule for vaccine administration in terms of safety and immunogenicity for further development of the vaccine
Participants will receive 2 doses of the ARCT-2304 vaccine or 1 dose of licensed influenza vaccine and 1 dose of placebo
They will be asked
to complete a daily diary for 7 days after each vaccination answering questions how they have been feeling on that day
to provide blood samples at each visit in the clinic
to comply with all study visits and procedures eg be available for planned telephone contacts and unscheduled clinic visits if required
Detailed Description:
Phase 1 first-in-human randomized controlled observer blind dose level and schedule-finding study to evaluate the safety reactogenicity and immunogenicity of a self-amplifying mRNA pandemic influenza H5N1 vaccine ARCT-2304 when administered as a 2-dose vaccination series to healthy adults in comparison with an inactivated influenza vaccine
Study drug ARCT-2304 or control will be administered as a 2-dose vaccination series as an intramuscular IM injection The study comprises two parts
In Part 1 120 participants young adults will be randomized to one of the three dose levels of the ARCT-2304 vaccine or control vaccine Participants will be further randomized to one of the two different vaccination schedules
In Part 2 80 participants older adults will be randomized to one of the three dose levels of the ARCT-2304 vaccine or control vaccine Participants will be further randomized to one of the two different vaccination schedules
Investigational Vaccine ARCT-2304
Control Vaccines licensed influenza vaccines
Study drug ARCT-2304 or control will be administered as a 2-dose vaccination series as an intramuscular IM injection The study comprises two parts
In Part 1 120 participants young adults will be randomized to one of the three dose levels of the ARCT-2304 vaccine or control vaccine Participants will be further randomized to one of the two different vaccination schedules
In Part 2 80 participants older adults will be randomized to one of the three dose levels of the ARCT-2304 vaccine or control vaccine Participants will be further randomized to one of the two different vaccination schedules
Investigational Vaccine ARCT-2304
Control Vaccines licensed influenza vaccines
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None