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Vaccine

Mosaic Quadrivalent Influenza Vaccine for Flu

Q: Is eligibility for this medical study restricted to individuals aged sixty or younger?

This trial is restricted to patients aged 18-50. Alternatively, there are 44 trials for people younger than 18 and 80 for those older than 65 years of age.

Q: Are there any openings available for participants in this experiment?

Affirmative. Clinicaltrials.gov hosts data which reveals that this medical trial, initially posted on May 24th 2021, is in the process of seeking participants. 40 patients must be enrolled at a single site for the study to continue.

Q: Is this research novel in its methodology?

VRC-FLUMOS0111-00-VP (FluMos-v1) has been the focus of various studies since it was first trialled in 2019, backed by Seqirus. After a successful Phase 3 drug trial involving 3830 patients, VRC-FLUMOS0111-00-VP (FluMos-v1) is currently being evaluated over 4 live trials across 14 countries and 9 cities.

Q: What prior research has been conducted using VRC-FLUMOS0111-00-VP (FluMos-v1)?

Currently, there are 4 trials being conducted on VRC-FLUMOS0111-00-VP (FluMos-v1), one of which is Phase 3. Trials for this procedure have been set up in 59 sites across Lahore and Bangkok.

Q: What is the ceiling for this trial's participant count?

Affirmative. According to clinicaltrials.gov, this medical trial is currently recruiting patients from a single location. It was originally published on May 24th 2021 and last amended on November 10th 2022 with the goal of admitting 40 participants in total.

Q: What aims is this medical research attempting to accomplish?

This medical trial seeks to assess any adverse effects of the product over a one-week period. Additionally, scientists will be measuring antibody responses at 20 and 60 mcg single doses of FluMos-v1, as well as 60mcg plus Adjuplex in Group 6A-6B participants.

Q: Has the FluMos-v1 vaccine obtained FDA authorization?

Our team at Power has rated the safety of VRC-FLUMOS0111-00-VP (FluMos-v1) as a 1, given that this is an initial Phase 1 trial and there exists limited proof for both its efficacy and security.

Q: Is there an opportunity to join in this medical experiment?

This clinical trial requires 40 subjects suffering from <a href="https://www.withpower.com/clinical-trials/influenza">influenza</a>, with ages falling between 18-50. Applicants must also meet the criteria of being generally healthy and free of any conditions listed in the study's exclusionary documents.

Phase 1

Waitlist Available

Led By Alicia T Widge, 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

Study 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.Check my eligibility

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.See study design

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 0 through day 280 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Laboratory measures

Local Reactogenicity

New chronic medical conditions

+3 more

Secondary outcome measures

Vaccines

Part A: Group 2A-2B: vaccine-induced antibodies

Vaccines

+4 more

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor

3,269 Previous Clinical Trials

5,481,434 Total Patients Enrolled

Alicia T Widge, M.D.Principal InvestigatorNational Institute of Allergy and Infectious Diseases (NIAID)

3 Previous Clinical Trials

112 Total Patients Enrolled

Maxwell R Norris, M.D.Principal InvestigatorNational Institute of Allergy and Infectious Diseases (NIAID)

1 Previous Clinical Trials

40 Total Patients Enrolled

Media Library

Flucelvax (Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT04896086 — Phase 1

Flu Research Study Groups: Group 1A-1B, Group 2A-2B, Group 3A-3B, Group 4A-4B, Group 5A-5B, Group 6A-6B, Group 7A-7B, Group 8A-8B

Flu Clinical Trial 2023: Flucelvax Highlights & Side Effects. Trial Name: NCT04896086 — Phase 1

Flucelvax (Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04896086 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is eligibility for this medical study restricted to individuals aged sixty or younger?

"This trial is restricted to patients aged 18-50. Alternatively, there are 44 trials for people younger than 18 and 80 for those older than 65 years of age."

Answered by AI

Are there any openings available for participants in this experiment?

"Affirmative. Clinicaltrials.gov hosts data which reveals that this medical trial, initially posted on May 24th 2021, is in the process of seeking participants. 40 patients must be enrolled at a single site for the study to continue."

Answered by AI

Is this research novel in its methodology?

"VRC-FLUMOS0111-00-VP (FluMos-v1) has been the focus of various studies since it was first trialled in 2019, backed by Seqirus. After a successful Phase 3 drug trial involving 3830 patients, VRC-FLUMOS0111-00-VP (FluMos-v1) is currently being evaluated over 4 live trials across 14 countries and 9 cities."

Answered by AI

What prior research has been conducted using VRC-FLUMOS0111-00-VP (FluMos-v1)?

"Currently, there are 4 trials being conducted on VRC-FLUMOS0111-00-VP (FluMos-v1), one of which is Phase 3. Trials for this procedure have been set up in 59 sites across Lahore and Bangkok."

Answered by AI

What is the ceiling for this trial's participant count?

"Affirmative. According to clinicaltrials.gov, this medical trial is currently recruiting patients from a single location. It was originally published on May 24th 2021 and last amended on November 10th 2022 with the goal of admitting 40 participants in total."

Answered by AI

What aims is this medical research attempting to accomplish?

"This medical trial seeks to assess any adverse effects of the product over a one-week period. Additionally, scientists will be measuring antibody responses at 20 and 60 mcg single doses of FluMos-v1, as well as 60mcg plus Adjuplex in Group 6A-6B participants."

Answered by AI

Has the FluMos-v1 vaccine obtained FDA authorization?

"Our team at Power has rated the safety of VRC-FLUMOS0111-00-VP (FluMos-v1) as a 1, given that this is an initial Phase 1 trial and there exists limited proof for both its efficacy and security."

Answered by AI

Is there an opportunity to join in this medical experiment?

"This clinical trial requires 40 subjects suffering from influenza, with ages falling between 18-50. Applicants must also meet the criteria of being generally healthy and free of any conditions listed in the study's exclusionary documents."

Answered by AI

Recent research and studies

Nature ImmunologyJournal

Mosaic Nanoparticle Display of Diverse Influenza Virus Hemagglutinins Elicits Broad B Cell Responses

Kanekiyo, Masaru, M. Gordon Joyce, Rebecca A. Gillespie, John R. Gallagher, Sarah F. Andrews, Hadi M. Yassine, Adam K. Wheatley, et al.. 2019. “Mosaic Nanoparticle Display of Diverse Influenza Virus Hemagglutinins Elicits Broad B Cell Responses”. Nature Immunology. Springer Science and Business Media LLC. doi:10.1038/s41590-018-0305-x.

New England Journal of MedicineJournal

Influenza Vaccines for the Future

Lambert, Linda C., and Anthony S. Fauci. 2010. “Influenza Vaccines for the Future”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmra1002842.

clinicaltrials.govStudy

First-in-Human Clinical Trial of a Mosaic Quadrivalent Influenza Vaccine Compared With a Licensed Inactivated Seasonal QIV, in Healthy Adults

2021. "First-in-Human Clinical Trial of a Mosaic Quadrivalent Influenza Vaccine Compared With a Licensed Inactivated Seasonal QIV, in Healthy Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04896086.