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Vaccine
Mosaic Quadrivalent Influenza Vaccine for Flu
Phase 1
Waitlist Available
Led By Lesia Dropulic, M.D.
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 0 through day 280
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing if a new vaccine, FluMos-v1, is safe and effective in preventing the seasonal flu. Healthy adults ages 18-50 who have received a flu vaccine in the past 4 years are eligible to participate. The trial will last 40 weeks.
Who is the study for?
Healthy adults aged 18-50 who've had at least one flu shot between 2016 and the 2019-2020 season can join. They must be HIV negative, not pregnant or breastfeeding, have a BMI <=35, and cannot plan to become pregnant during the study. No history of certain flu vaccines or significant health conditions is allowed.
What is being tested?
This trial tests a new seasonal flu vaccine called FluMos-v1 against an approved vaccine, Flucelvax. Participants will get one shot in the arm and track their symptoms for a week using diary cards. The study involves about ten visits over 40 weeks with blood draws and other sample collections.
What are the potential side effects?
Possible side effects are not detailed but may include reactions at the injection site like redness or swelling, general symptoms such as fever or fatigue following vaccination, which are common with many vaccines.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 0 through day 280
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 0 through day 280
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Laboratory measures
Local Reactogenicity
New chronic medical conditions
+3 moreSecondary study objectives
Vaccines
Part A: Group 2A-2B: vaccine-induced antibodies
Vaccines
+4 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
8Treatment groups
Experimental Treatment
Active Control
Group I: Group 8A-8BExperimental Treatment2 Interventions
Optional: TBD of FluMos-v1 plus Adjuplex
Group II: Group 7A-7BExperimental Treatment1 Intervention
Optional: TBD mcg of FluMos-v1
Group III: Group 6A-6BExperimental Treatment2 Interventions
Optional: 60 mcg of FluMos-v1 plus Adjuplex
Group IV: Group 5A-5BExperimental Treatment2 Interventions
100 mcg of FluMos-v1 plus Adjuplex
Group V: Group 4A-4BExperimental Treatment1 Intervention
100 mcg of FluMos-v1
Group VI: Group 2A-2BExperimental Treatment1 Intervention
60 mcg of FluMos-v1
Group VII: Group 1A-1BExperimental Treatment1 Intervention
20 mcg of FluMos-v1
Group VIII: Group 3A-3BActive Control1 Intervention
standard dose of 60 mcg of the licensed QIV Flucelvax
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VRC-FLUMOS0111-00-VP (FluMos-v1)
2021
Completed Phase 1
~40
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Who is running the clinical trial?
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,319 Previous Clinical Trials
5,548,125 Total Patients Enrolled
Lesia Dropulic, M.D.Principal InvestigatorNational Institute of Allergy and Infectious Diseases (NIAID)
Alicia T Widge, M.D.Principal InvestigatorNational Institute of Allergy and Infectious Diseases (NIAID)
3 Previous Clinical Trials
102 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have received experimental H1, H2, or H10 influenza vaccines in the past.People who are healthy and between 18 and 50 years old can participate.You do not have HIV, as confirmed by an approved test.You have received a flu vaccine from certain seasons.You are currently taking medication to prevent or treat tuberculosis.You need to have specific lab tests done within 56 days before joining the study.You are currently receiving allergy shots, unless you are on a regular schedule for them.You must test negative for COVID-19 before joining the study.
Research Study Groups:
This trial has the following groups:- Group 1: Group 1A-1B
- Group 2: Group 2A-2B
- Group 3: Group 3A-3B
- Group 4: Group 4A-4B
- Group 5: Group 5A-5B
- Group 6: Group 6A-6B
- Group 7: Group 7A-7B
- Group 8: Group 8A-8B
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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