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Virus Therapy
Flu Vaccine for Influenza
Phase 1
Recruiting
Led By Tejaswi S Dittakavi, D.O.
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
Must not have
History of bleeding disorder diagnosed by a doctor (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws
History of asplenia, functional asplenia or any condition resulting in the absence or removal of the spleen
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at two weeks after each injection at week 2 and week 18
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a new flu vaccine, FluMos-v2, in healthy adults aged 18 to 50. The vaccine aims to protect against multiple flu strains by teaching the immune system to recognize and combat them. Participants will receive two shots and have follow-up visits over a period of time to monitor their health and immune response.
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.
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.
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.
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I am a healthy adult aged between 18 and 50.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a bleeding disorder or often have issues with bleeding or bruising.
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I do not have a spleen or my spleen does not work properly.
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My asthma is not well controlled.
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My thyroid condition is not well managed.
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I haven't taken strong immune system or cancer drugs in the last 2 weeks.
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I received the FluMos-v1 flu vaccine.
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I am currently on medication to prevent or treat tuberculosis.
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I have a history of swelling attacks due to angioedema.
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I have had Guillain-Barre Syndrome in the past.
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I have received a blood transfusion in the last 16 weeks.
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I have not received any live vaccines in the last 4 weeks.
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I have received a vaccine not containing live virus within the last 2 weeks.
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My high blood pressure is not well managed.
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I have received an mRNA vaccine in the last 4 weeks.
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I have received a flu shot in the last 6 months.
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I have received this season's flu vaccine.
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I have a history of cancer that might come back during the study.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
To evaluate the safety and tolerability
Secondary study objectives
To evaluate the antibody responses to FluMos-v2 vaccine
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for influenza include antiviral medications and vaccines. Antiviral medications like oseltamivir and zanamivir work by inhibiting the neuraminidase enzyme, which prevents the release of new viral particles from infected cells, thereby limiting the spread of the virus.
Vaccines, such as the experimental FluMos-v2, stimulate the immune system to recognize and fight against various strains of the influenza virus by introducing inactivated or attenuated virus particles or specific viral proteins. This immune response helps the body quickly identify and neutralize the virus upon future exposures.
These mechanisms are crucial for influenza patients as they reduce the severity and duration of illness, prevent complications, and limit the spread of the virus.
Clinical presentation, microbiological aetiology and disease course in patients with flu-like illness: a post hoc analysis of randomised controlled trial data.Oseltamivir PK/PD Modeling and Simulation to Evaluate Treatment Strategies against Influenza-Pneumococcus Coinfection.Outcomes and Prognostic Features of Patients With Influenza Requiring Hospitalization and Receiving Early Antiviral Therapy: A Prospective Multicenter Cohort Study.
Clinical presentation, microbiological aetiology and disease course in patients with flu-like illness: a post hoc analysis of randomised controlled trial data.Oseltamivir PK/PD Modeling and Simulation to Evaluate Treatment Strategies against Influenza-Pneumococcus Coinfection.Outcomes and Prognostic Features of Patients With Influenza Requiring Hospitalization and Receiving Early Antiviral Therapy: A Prospective Multicenter Cohort Study.
Find a Location
Who is running the clinical trial?
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,312 Previous Clinical Trials
5,546,676 Total Patients Enrolled
Tejaswi S Dittakavi, D.O.Principal InvestigatorNational Institute of Allergy and Infectious Diseases (NIAID)
Maxwell R Norris, M.D.Principal InvestigatorNational Institute of Allergy and Infectious Diseases (NIAID)
1 Previous Clinical Trials
35 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 1
- Group 3: Group 3
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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