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Virus Therapy
Flu Vaccine for Influenza
Phase 1
Recruiting
Led By Maxwell R Norris, 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
Physical examination and laboratory results without clinically significant findings and a Body Mass Index (BMI) <= 35 within the 56 days before enrollment
Healthy adults between the ages of 18-50 years, inclusive
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at two weeks after each injection at week 2 and week 18
Awards & highlights
Study Summary
This trial tests a new flu vaccine in healthy adults aged 18-50. 11 clinic visits & follow-up phone calls, plus monitoring temp & skin changes. 2nd shot after 4 months & 9 more clinic visits. Option to do apheresis 2 weeks after each shot.
Who is the study for?
Healthy adults aged 18-50 who've had a flu shot since 2018 can join this trial. They must be in good health, not pregnant or breastfeeding, and agree to avoid the standard flu vaccine for the study duration. People with poorly controlled thyroid disease, hypertension, autoimmune diseases, bleeding disorders, recent receipt of other vaccines or blood products are excluded.Check my eligibility
What is being tested?
The trial is testing FluMos-v2, an experimental hexavalent influenza vaccine designed to protect against multiple strains of flu. Participants will receive two shots four months apart and have follow-up visits including temperature monitoring and blood draws over ten months.See study design
What are the potential side effects?
Potential side effects may include reactions at the injection site like redness or swelling, fever after vaccination, fatigue or headaches. More serious side effects could occur but are less common.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My recent health checks are normal and my BMI is 35 or less.
Select...
I am a healthy adult aged between 18 and 50.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at two weeks after each injection at week 2 and week 18
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at two weeks after each injection at week 2 and week 18
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To evaluate the safety and tolerability
Secondary outcome measures
To evaluate the antibody responses to FluMos-v2 vaccine
Trial Design
3Treatment groups
Experimental Treatment
Group I: Group 3Experimental Treatment1 Intervention
180 mcg of FluMos-v2 on Day 0 and Week16
Group II: Group 2Experimental Treatment1 Intervention
180 mcg of FluMos-v2 on Day 0 and Week16
Group III: Group 1Experimental Treatment1 Intervention
60 mcg of FluMos-v2 on Day 0 and Week 16
Find a Location
Who is running the clinical trial?
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,270 Previous Clinical Trials
5,485,197 Total Patients Enrolled
Maxwell R Norris, M.D.Principal InvestigatorNational Institute of Allergy and Infectious Diseases (NIAID)
1 Previous Clinical Trials
35 Total Patients Enrolled
Richard L Wu, M.D.Principal InvestigatorNational Institute of Allergy and Infectious Diseases (NIAID)
4 Previous Clinical Trials
110 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a bleeding disorder or often have issues with bleeding or bruising.I have received specific experimental flu vaccines, except if I was in certain groups of the VRC 316 study.I do not have a spleen or my spleen does not work properly.I have received a flu shot at least once between 2018 and the 2022-2023 season.My recent health checks are normal and my BMI is 35 or less.My asthma is not well controlled.I haven't needed treatment for seizures in the last 3 years, except for specific exceptions.Your blood test results need to be within the normal range for white blood cells, platelets, hemoglobin, liver enzymes, and kidney function. You should also test negative for HIV.My thyroid condition is not well managed.You have a history of autoimmune disease or problems with your immune system.I haven't taken strong immune system or cancer drugs in the last 2 weeks.I am a healthy adult aged between 18 and 50.I received the FluMos-v1 flu vaccine.I am currently receiving allergy shots, but not on a maintenance schedule.I am currently on medication to prevent or treat tuberculosis.I have a history of swelling attacks due to angioedema.I have diabetes (not including gestational diabetes).I have had Guillain-Barre Syndrome in the past.I agree not to get the flu shot for 2023-2024 during the study.I have received a blood transfusion in the last 16 weeks.I have not received any live vaccines in the last 4 weeks.I agree to give blood samples for indefinite research use.I haven't taken any experimental drugs in the last 4 weeks and won't while in the study, except for COVID-19 vaccines.I am in good health with no major illnesses as per the trial's exclusion list.I have received a vaccine not containing live virus within the last 2 weeks.My high blood pressure is not well managed.I have received an mRNA vaccine in the last 4 weeks.You have had unexplained hives in the past year.I have received a flu shot in the last 6 months.I have received this season's flu vaccine.I have a history of cancer that might come back during the study.
Research Study Groups:
This trial has the following groups:- Group 1: Group 2
- Group 2: Group 3
- Group 3: Group 1
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the criteria for individuals to become part of this experimental research?
"In order to qualify for this study, individuals must have contracted influenza and be between 18-50 years old. Currently the trial is aiming to recruit 24 participants."
Answered by AI
Does this clinical trial admit individuals of advanced age?
"This trial calls for candidates aged 18 to 50. Alternatively, there are 38 trials for minors and 75 studies catered specifically towards elderly individuals who meet the criteria."
Answered by AI
Has Group 1 obtained regulatory approval from the FDA?
"Due to the limited evidence available, Group 1's safety was rated a 1 on our scale. This is because it is still in its initial phase of clinical trials and there have yet to be any reports about effectiveness or safety."
Answered by AI
Do any vacancies currently exist for participants in this research trial?
"According to clinicaltrials.gov, recruitment for this trial has ended after being published on August 7th 2023 and last edited on August 1st of the same year. However, 131 other trials are actively looking for volunteers at the moment."
Answered by AI
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