What side effects are associated with this type of intervention?

Common treatments for influenza include antiviral medications such as oseltamivir, baloxavir, and zanamivir, as well as various flu vaccines. Oseltamivir can cause gastrointestinal issues like nausea and vomiting, and in rare cases, neuropsychiatric effects such as delirium and hallucinations. Baloxavir is generally well-tolerated but can cause diarrhea and vomiting, particularly in children. Zanamivir may lead to bronchospasm, especially in individuals with respiratory conditions. Flu vaccines, while generally safe, can cause mild side effects such as soreness at the injection site, fever, and muscle aches. Severe reactions are rare but can include allergic responses.

What prior FDA approvals exist?

The FDA has approved several antiviral drugs for the treatment of influenza, including oseltamivir (Tamiflu) and zanamivir (Relenza). These drugs are neuraminidase inhibitors that help reduce the severity and duration of flu symptoms. Additionally, baloxavir marboxil (Xofluza) is another antiviral that has been approved for treating influenza. These treatments are similar to the new flu vaccine being studied, which aims to stimulate an immune response to the influenza virus. The focus on enhancing the immune response is a common strategy in both antiviral treatments and vaccine development.

What other types of research exist?

Promising novel alternatives to the new flu vaccine for influenza patients in 2024 include: 1) Universal influenza vaccines, which aim to provide broader protection against multiple flu strains. 2) Antiviral medications like baloxavir marboxil, which can reduce the duration and severity of flu symptoms. 3) Monoclonal antibody therapies that target specific influenza proteins to neutralize the virus. 4) Adjuvanted and recombinant vaccines that enhance immune response and provide better protection, especially in high-risk populations.

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Virus Vaccine

BPL-1357 Vaccine for Flu

Phase 1

Waitlist Available

Led By Matthew J Memoli, 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

18 and <= 55 years of age.

Non-smoker (tobacco and cannabis) and does not use vape or e-cigarette products.

Must not have

Presence of significant medical conditions including chronic pulmonary disease, chronic cardiovascular disease, chronic medical conditions requiring close medical follow-up or hospitalization during the past 5 years, immunosuppression, immune deficiency, ongoing malignancy, neurological and neurodevelopmental conditions, postinfectious or postvaccine neurological sequelae, BMI <= 18 and >= 35, acute illness within 7 days prior to enrollment, grade 2 or above clinically significant laboratory values outside the limits specified by normal laboratory parameters

Receipt of any unlicensed drug within 3 months or 5.5 half-lives (whichever is greater) prior to enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up v2d182 (day 210)

Summary

This trial is testing a new flu vaccine called BPL-1357, which can be given as a shot or a nasal spray. It aims to see if the vaccine is safe and effective in healthy adults aged 18-55 who haven't had other vaccines in the near past. The vaccine uses inactivated flu viruses to help the body build immunity against various flu strains.

Who is the study for?

Healthy adults aged 18-55 who don't smoke, haven't had a flu shot in the last 8 weeks or a COVID-19 vaccine in the last 4 weeks. Women must be infertile or practicing abstinence and not pregnant or breastfeeding. Participants should have no significant health issues, not use certain medications, and agree to avoid donating blood during the study.

What is being tested?

The trial is testing BPL-1357, a new universal influenza vaccine designed to protect against various flu strains. Participants will receive either this vaccine or placebos through injections and nasal sprays over several visits while their immune response is monitored.

What are the potential side effects?

Potential side effects are likely similar to other flu vaccines which can include soreness at injection site, headache, fever, nausea, and fatigue. Since it's an investigational vaccine, there may be unknown risks that will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 55 years old.

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I do not smoke or use vape/e-cigarette products.

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I am infertile due to menopause, hysterectomy, or oophorectomy.

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I agree to not have sexual intercourse.

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I am between 18 and 55 years old.

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I haven't had a COVID-19 vaccine in the last 4 weeks and won't get one until after V2D28.

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I do not smoke or use vape/e-cigarette products.

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I am not pregnant or breastfeeding and follow specific guidelines regarding not becoming pregnant.

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I haven't had a flu shot in the last 8 weeks and won't get one until after the V2D56 visit.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have serious health issues or a very high or low body weight.

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I haven't taken any experimental drugs recently.

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I have had COVID-19 and still experience symptoms.

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I have not received any blood or blood products in the last 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ v2d182 (day 210)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~v2d182 (day 210)

This trial's timeline: 3 weeks for screening, Varies for treatment, and v2d182 (day 210) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Immunogenicity - Systemic and Mucosal Immune Responses against Hemagglutinin

Immunogenicity - Systemic and Mucosal Immune Responses against Neuraminidase

Safety - Adverse Events

+1 more

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Group BExperimental Treatment2 Interventions

15 participants receiving IN BPL1357 \& IM Placebo

Group II: Group AExperimental Treatment2 Interventions

15 participants receiving IM BPL1357 \& IN Placebo

Group III: Group CPlacebo Group2 Interventions

15 participants receiving IM and IN placebo

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

BPL-1357

2022

Completed Phase 1

~50

0 / 13Eligibility 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 such as oseltamivir and zanamivir inhibit the neuraminidase enzyme, preventing the release of new viral particles from infected cells, while baloxavir inhibits viral RNA transcription. Vaccines stimulate the immune system to produce antibodies against specific influenza strains, providing immunity. The new flu vaccine under study aims to elicit a broader immune response, potentially offering protection against multiple strains. These treatments are vital for reducing illness severity, preventing complications, and limiting virus spread.

Influenza Vaccination in Older Adults: Recent Innovations and Practical Applications.Influenza in solid organ transplant recipients: epidemiology, management, and outcomes.Influenza vaccines for preventing cardiovascular disease.