BPL-1357 for Influenza, Human

Phase-Based Estimates
1
Effectiveness
1
Safety
National Institutes of Health Clinical Center, Bethesda, MD
Influenza, Human+1 More
BPL-1357 - Biological
Eligibility
18 - 65
All Sexes
Eligible conditions
Influenza, Human

Study Summary

This study is evaluating whether a new flu vaccine is safe and if it creates an immune response.

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Eligible Conditions

  • Influenza, Human
  • Flu caused by Influenza

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether BPL-1357 will improve 2 primary outcomes and 7 secondary outcomes in patients with Influenza, Human. Measurement will happen over the course of V2D28 (Day 56).

V2D182 (Day 210)
Safety - Adverse Events
Safety - Serious Adverse Event
Safety: Serious Adverse events
V2D182 (Day 210) ]
Safety: Adverse events
V2D28 (Day 56)
Adverse events
Immunogenicity - Systemic and Mucosal Immune Responses against Hemagglutinin
Immunogenicity - Systemic and Mucosal Immune Responses against Neuraminidase
Serious adverse event
Systemic and mucosal immune responses

Trial Safety

Safety Estimate

1 of 3

Trial Design

3 Treatment Groups

Group C
Group B
Placebo group

This trial requires 45 total participants across 3 different treatment groups

This trial involves 3 different treatments. BPL-1357 is the primary treatment being studied. Participants will be divided into 2 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Group B15 participants receiving IN BPL1357 & IM Placebo
Group A15 participants receiving IM BPL1357 & IN Placebo
Group C15 participants receiving IM and IN placebo

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: v2d182 (day 210)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly v2d182 (day 210) for reporting.

Closest Location

National Institutes of Health Clinical Center - Bethesda, MD

Eligibility Criteria

This trial is for patients born any sex between 18 and 65 years old. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
18 and <= 55 years of age.
Non-smoker (tobacco and cannabis) and does not use vape or e-cigarette products.
Has not received influenza vaccination of any type in the 8 weeks prior to enrollment and willing to not receive influenza vaccination of any type until after the V2D56 visit. Participants who enroll in our study will be informed of the Centers for Disease Control and Prevention (CDC) recommendation to receive seasonal influenza vaccination annually.
Has not received Coronavirus Disease 19 (COVID-19) vaccination of any type in the 4 weeks prior to enrollment and willing to not receive COVID-19 vaccination of any type after the V2D28 visit. Participants who enroll in our study who are interested in getting a COVID-19 vaccination will be counselled to receive it prior to enrolling into our study.
Is infertile, including postmenopausal status (as defined by no menses for >= 1 year) or history of hysterectomy or bilateral oophorectomy.
Agrees to practice abstinence.
Agrees that, with heterosexual intercourse with a fertile male partner, she will use an acceptable form of contraception and her male partner will use a condom with spermicide. Acceptable effective methods of female contraception include the following: bilateral tubal ligation, implant of levonorgestrel, injectable progestogen, intrauterine device, oral contraceptive pills, and diaphragm with spermicide.
Able to provide informed consent.
Able to speak English.
Human immunodeficiency virus (HIV) uninfected with a negative test within 60 days of enrollment.

Patient Q&A Section

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

How many people get influenza, human a year in the United States?

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[An annual [influenza](https://www.withpower.com/clinical-trials/influenza) vaccination rate of 47.7% was estimated] [and the annual influenza infection rate in the United States is 2.3%]. The incidence of seasonal influenza is thought to decline as the flu season ends. Flu season typically lasts from late autumn to early spring in the Northern hemisphere and from early to late autumn in the Southern hemisphere. The U.S. National Institutes of Health (NIH) and the Advisory Committee on Immunization Practices (ACIP) recommend that all people should get an annual flu vaccine during the peak influenza season. The timing of flu vaccination is based on strain predictions at several weeks in advance.

Unverified Answer

What are the signs of influenza, human?

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Symptoms include headache, muscle and joint aches and pains, cough, sore throat and watery eyes. These symptoms usually resolve 2 days after infection, although some people may experience the flu for an extended period.

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What causes influenza, human?

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Influenza is a common viral infection which is most contagious within a family. Since the main cause of influenza is viral, it is also a prime example of a pandemic disease. To help reduce the spread of influenza, vaccinations should be made available to the public for everyone. Furthermore, since humans are the only host for influenza, prevention through vaccination is highly recommended.

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Can influenza, human be cured?

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The present data indicate a role of both the innate and adaptive host immune response in suppressing influenza infection, and there is evidence that both the innate and adaptive immune response to influenza infection are inhibited by the innate antiviral response of the host.

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What is influenza, human?

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Influenza is a contagious, highly contagious, and potentially fatal viral infection that spreads by direct or close contact with an infected person. It is spread mainly by respiratory droplet excretion and has three main subtypes: A, B and C.

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What are common treatments for influenza, human?

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The most effective method to prevent serious medical and neurological complications caused by influenza is vaccination, which provides lifelong protection. If vaccination is contraindicated, treatment with antivirals such as oseltamivir is recommended. The effectiveness of these methods has been established in clinical trials in adults and children. In individuals with special considerations, such as those who are immunocompromised, it is recommended treatment should be considered, provided it was not done for reasons of personal and/or community or staff safety. Vaccinated individuals should not receive antivirals.

Unverified Answer

How does bpl-1357 work?

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Bpl-1357 appears to act through the PI3K/AKT pathway, possibly interfering at the transcriptional level with the expression of several pro-inflammatory and anti-inflammation genes. This anti-inflammatory activity, coupled with the potent anti-IL-17 activity, suggests that Bpl-1357 may be a promising therapy to be further evaluated in clinical trials for a variety of inflammatory and autoimmune diseases.

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Does influenza, human run in families?

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We found that the epidemiology of HIB as a disease is not independent of the epidemiology of influenza. Results from a recent clinical trial support the hypothesis that influenza (and HIB) and related illnesses affect infants during the first few months of life, possibly with a genetic factor; thus transmission of the influenza virus may have an effect on HIB susceptibility.

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What are the latest developments in bpl-1357 for therapeutic use?

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Treatment with bpl-1357 for 6 weeks has shown promise in mouse models of L-DOPA induced Parkinson's disease. Although bpl-1357 did not show any significant effects in its tolerability and safety study in humans, we are interested in further research into the safety and efficacy in humans following treatment with bpl-1357.

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Is bpl-1357 safe for people?

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Results from a recent clinical trial indicate that Bpl-1357 was well tolerated and could be considered safe in patients requiring BXD2P, and was generally well tolerated in combination with other anti-influenza agents in this clinical trial. For future studies, further dose escalation will be necessary to study the risk of pulmonary complications, and if further safety studies confirm these results then Bpl-1357 could be used more widely in flu pandemics.

Unverified Answer

Have there been any new discoveries for treating influenza, human?

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Most [influenza](https://www.withpower.com/clinical-trials/influenza) A (I) vaccines are ineffective in humans and ineffective against I. In the past decades, vaccines have been widely used for preventing epidemics of flu, but these vaccines have been shown to be ineffective against I for over 20 years. I vaccines have not been modified to generate cross-protective antibodies against I which can protect against I of various flu strains and which has been the standard of care since 1979 in children, adults, and animals. The main question is, 'Why hasn't I vaccine been modified to generate cross-protective antibodies against I that can protect against I of various flu strains?' There are a number of explanations, including poor immune memory maintenance, antigenic shift, poor vaccine candidate selection, and vaccine mismatch.

Unverified Answer

How serious can influenza, human be?

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Serious influenza cases occur more commonly among people with HIV than those without HIV, whereas influenza in children is less severe than in adults. Thus, public health efforts targeting HIV patients are especially critical during outbreaks of influenza virus.

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