What side effects are associated with this type of intervention?

Common treatments for influenza, such as antiviral medications and vaccines, have several known side effects. Antiviral drugs like oseltamivir can cause nausea, vomiting, and headache, while zanamivir may lead to bronchospasm, especially in patients with respiratory conditions. Laninamivir is generally well-tolerated but can cause gastrointestinal issues. Influenza vaccines, which stimulate the immune system to recognize and fight the virus, may cause mild side effects such as soreness at the injection site, low-grade fever, and muscle aches. Serious side effects are rare but can include allergic reactions.

What prior FDA approvals exist?

The FDA has approved several antiviral drugs for the treatment of influenza, including oseltamivir (Tamiflu), zanamivir (Relenza), laninamivir, and baloxavir (Xofluza). These drugs primarily function by inhibiting viral replication. Oseltamivir and zanamivir are neuraminidase inhibitors, while baloxavir is a cap-dependent endonuclease inhibitor. Additionally, experimental vaccines like FluMos-v2 are being studied to stimulate the immune system to recognize and fight against various strains of the influenza virus, aiming to provide broader protection compared to current vaccines.

What other types of research exist?

Promising novel alternatives to FluMos-v2 for influenza treatment in 2024 include: 1) mRNA-based influenza vaccines, which have shown potential for rapid development and high efficacy. 2) Universal influenza vaccines targeting conserved viral components to provide broader protection. 3) New antiviral drugs such as baloxavir marboxil, which inhibits viral replication. 4) Combination therapies that enhance immune response and reduce viral load.

← Back to Search

Virus Therapy

Flu Vaccine for Influenza

Q: What is the mechanism of action of this treatment?

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.

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 below

Select...

My recent health checks are normal and my BMI is 35 or less.

Select...

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.

Select...

I do not have a spleen or my spleen does not work properly.

Select...

My asthma is not well controlled.

Select...

My thyroid condition is not well managed.

Select...

I haven't taken strong immune system or cancer drugs in the last 2 weeks.

Select...

I received the FluMos-v1 flu vaccine.

Select...

I am currently on medication to prevent or treat tuberculosis.

Select...

I have a history of swelling attacks due to angioedema.

Select...

I have had Guillain-Barre Syndrome in the past.

Select...

I have received a blood transfusion in the last 16 weeks.

Select...

I have not received any live vaccines in the last 4 weeks.

Select...

I have received a vaccine not containing live virus within the last 2 weeks.

Select...

My high blood pressure is not well managed.

Select...

I have received an mRNA vaccine in the last 4 weeks.

Select...

I have received a flu shot in the last 6 months.

Select...

I have received this season's flu vaccine.

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and at two weeks after each injection at week 2 and week 18 for reporting.

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

0 / 19Eligibility criteria met

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.