InfluenzaPhase 1NCT05027932
Safety and Immunogenicity of BPL-1357, A BPL-Inactivated, Whole-Virus, Universal Influenza Vaccine
A Phase 1 study testing BPL-1357 in people with Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
Background: Influenza (flu) is a virus that infects people of all ages. Some people may have mild flu symptoms. Others may get very sick and even die from the flu. Flu vaccines help protect people against the flu, but if the flu strains in the vaccine are not a good match with the strains circulating in the community… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- BPL-1357
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jun 2022to 25 Feb 2025
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Individuals must meet all of the following criteria to be eligible for study participation:
- 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 until 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.
- A female participant is eligible for this study if she is not pregnant or breastfeeding and meets one of the following criteria, beginning at least 4 weeks prior to enrollment through the end of the study period (V2D182):
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- 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.
- Does not use IN medications (including but not limited to nasal sprays, sinus rinses), over-the-counter medications (including but not limited to aspirin, decongestants, antihistamines, and other nonsteroidal anti-inflammatory drugs), and herbal medications (including but not limited to herbal tea or St. John s Wort) within 14 days prior to study enrollment, and agrees not to use these mediations through the final study visit, unless approved by the investigator.
- Agrees not to donate blood or blood products from 3 months prior to enrollment through the final study visit.
Who cannot join
- Individuals meeting any of the following criteria will be excluded from study participation:
- Presence of self-reported or medically documented significant medical condition including but not limited to:
- Chronic pulmonary disease (e.g., asthma, emphysema).
- Chronic cardiovascular disease (e.g., cardiomyopathy, congestive heart failure, cardiac surgery, ischemic heart disease, known anatomic defects).
- Chronic medical conditions requiring close medical follow-up or hospitalization during the past 5 years (e.g., insulin-dependent diabetes mellitus, renal dysfunction, hemoglobinopathies).
- Immunosuppression, immune deficiency, or ongoing malignancy.
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- Neurological and neurodevelopmental conditions (e.g., Bell s palsy, cerebral palsy, epilepsy, stroke, seizures).
- Postinfectious or postvaccine neurological sequelae including GBS.
- Body mass index (BMI) <= 18 and >= 35.
- Acute illness within 7 days prior to enrollment.
- Individuals who have grade 2 or above clinically significant laboratory values outside the limits thus specified by normal laboratory parameters.
- Known allergy to influenza vaccination or excipients contained in the influenza vaccine used.
- Known allergy to lidocaine or phenylephrine.
- Receipt of blood or blood products (including immunoglobulins) within 3 months prior to enrollment.
- Receipt of any unlicensed drug within 3 months or 5.5 half-lives (whichever is greater) prior to enrollment.
- Receipt of any unlicensed vaccine within 6 months prior to enrollment, not including COVID-19 vaccines under Emergency Use Authorization.
- Self-reported or known history of alcoholism or drug abuse within 6 months prior to enrollment, or positive urine test for drugs of abuse (i.e., amphetamines, cocaine metabolites, benzodiazepines, opiates, or tetrahydrocannabinol) prior to vaccination on V1D0.
- Self-reported or known history of psychiatric or psychological issues that require treatment and are deemed by the principal investigator (PI) to be a contraindication to protocol participation.
- History of angioedema or anaphylaxis.
- History of SARS-COV-2 infection with residual or ongoing symptoms.
- Any condition or event that, in the judgment of the PI, is a contraindication to protocol participation or impairs the participant s ability to give informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Randomized, Double-Blinded, Placebo-Controlled, Phase 1 Study of the Safety and Immunogenicity of BPL-1357, A BPL-Inactivated, Whole-Virus, Universal Influenza Vaccine
Background:
Influenza (flu) is a virus that infects people of all ages. Some people may have mild flu symptoms. Others may get very sick and even die from the flu. Flu vaccines help protect people against the flu, but if the flu strains in the vaccine are not a good match with the strains circulating in the community, the vaccine is not as effective. Researchers want to make flu vaccines that protect against changing flu strains.
Read more
Objective:
To test if a new flu vaccine is safe and if it creates an immune response.
Eligibility:
Healthy adults ages 18-55 who do not smoke and have not received a flu vaccine in the 8 weeks prior or a COVID-19 vaccine in the 4 weeks prior to enrollment.
Design:
Participants will be screened on a separate protocol.
Participants will have 9 visits over 7 months. They will get a combination of study vaccine and/or placebo, both as a shot in the arm and as a spray into the nose, at 2 visits. For 7 days after getting the vaccines, they will take their temperature and complete online surveys at home to record any symptoms.
At each visit, participants will have a physical exam and medical history. They will give blood and urine samples. They will have nasal testing. For this, a thin absorptive strip will be inserted into their nostril for 1 minute to collect mucus. At some visits, the inside of their nose will be wiped with a small brush to collect cells. For this, their nostril will be numbed to make it more comfortable. Some blood and nasal samples will be used for genetic testing. Participants who get flu-like symptoms during the study will be asked to collect nasal samples at home and send these samples back to NIH to test if they actually have the flu.
Read the detailed description
Study Description: This is a randomized, double-blinded, placebo-controlled, single-center, phase 1 clinical trial of beta-propiolactone (BPL)- inactivated quadruple influenza virus cocktail vaccine (BPL-1357) administered intramuscularly (IM) or intranasally (IN) in 2 doses 28 days apart. Participants will be randomized to one of three groups for treatment assignment. The primary hypothesis is that IN and IM BPL-1357 will be well tolerated.
Objectives:
Primary Objective:
- To assess the safety of BPL-1357 given IM or IN, compared to placebo.
Secondary Objective:
- To further assess the safety of BPL-1357 given IM or IN, compared to placebo.
- To assess the immunogenicity of BPL-1357 given IM or IN, compared to placebo.
Tertiary Objective:
- To characterize the systemic and mucosal humoral immune responses induced by BPL-1357 given IM or IN, compared to placebo.
- To further characterize the immune response induced by BPL-1357 given IM or IN through variable, diversity, and joining (VDJ) gene repertoire analysis, cytokine analysis, cytometry, transcriptomics, and assessment of T-cell responses.
- To assess the rates of influenza disease among groups given IM or IN BPL-1357 compared to placebo.
Endpoints:
Primary Endpoints:
- Type and severity (by grading) of adverse events (AEs) through vaccine 2 (V2) day 28 (D28) [28 days after vaccine dose 2].
- Type of serious adverse events (SAEs) through V2D28 [28 days after vaccine dose 2].
Secondary Endpoints:
- Safety
- Type and severity (by grading) of AEs through V2D182 [182 days after vaccine dose 2].
- Type of SAEs through V2D182 [182 days after vaccine dose 2].
- Immunogenicity
- Antibodies against H1, H3, H5, and H7 head and stalk as measured by hemagglutination inhibition (HAI) or enzyme-linked immunosorbent assay (ELISA) from blood and mucosal samples at V2D28.
- Antibodies against N1, N3, N8, and N9 as measured by neuraminidase inhibition (NAI) or ELISA from blood and mucosal samples at V2D28.
Tertiary Endpoints:
- Additional antibody titer characterization via:
- Antibodies against H1, H3, H5, and H7 head and stalk as measured by HAI or ELISA from blood and mucosal samples at V1D7, V1D14, V1D28, V2D7, V2D14, V2D56, and V2D182.
- Antibodies against N1, N3, N8, and N9 as measured by NAI or ELISA from blood and mucosal samples at V1D7, V1D14, V1D28, V2D7, V2D14, V2D56, and V2D182.
- Additional immune response characterization via:
- VDJ gene repertoire analysis.
- Cytokine analysis.
- Flow cytometric phenotyping of lymphocytes.
- Transcriptomic gene expression.
- T-cell responses.
- Influenza disease
- Conditions
- Influenza
- Being tested
- IN Placebo, IM Placebo, BPL-1357
- Keywords
- Flu, Immunity, Virology, Investigational, Healthy Volunteer
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IN PlaceboOther
The placebo is normal saline in two syringes administered IN.
IM PlaceboOther
The placebo is normal saline in a syringe administered IM.
BPL-1357Drug
BPL-1357 contains 4 whole inactivated avian influenza viruses: A /Environment /Maryland/261/2006 H7N3, A/Mallard /Maryland/802/2007 H5N1, A/Pintail/Ohio /339/1987 H3N8, and A/Mallard/Ohio /265/1987 H1N9. It is administered either IM or IN depending on the assigned treatment group.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | 15 participants receiving IM BPL1357 \& IN Placebo Receives: Other: IN Placebo; Drug: BPL-1357 |
| Group B | Experimental | 15 participants receiving IN BPL1357 \& IM Placebo Receives: Other: IM Placebo; Drug: BPL-1357 |
| Group C | Sham comparator | 15 participants receiving IM and IN placebo Receives: Other: IN Placebo; Other: IM Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety - Serious Adverse Event
Type of SAEs through day V2D28.
Measured: V2D28 (Day 56)
Safety - Adverse Events
Type and severity (by grading) of intervention-related AEs through day V2D28.
Measured: V2D28 (Day 56)
Secondary outcomes (4)
Safety - Serious Adverse Event
Type of SAEs through day V2D182
Measured: V2D182 (Day 210)
Safety - Adverse Events
Type and severity (by grading) of AEs through day V2D182
Measured: V2D182 (Day 210)
Immunogenicity - Systemic and Mucosal Immune Responses Against Hemagglutinin
Antibodies against H1, H3, H5, and H7 head and stalk as measured by HAI or ELISA from blood and mucosal samples at V2D28
Measured: V2D28 (Day 56)
Immunogenicity - Systemic and Mucosal Immune Responses Against Neuraminidase
Antibodies against N1, N3, N8, and N9 as measured by NAI or ELISA from blood and mucosal samples at V2D28
Measured: V2D28 (Day 56)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2021
- Study start27 Jun 2022
- Primary completion13 Jun 2023
- Study completion25 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Matthew J Memoli, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05027932
- Sponsor's protocol ID
- 10000320
- Other IDs
- 000320-I
- Status last verified
- Feb 2025
- First submitted
- 28 Aug 2021
- Last updated
- 8 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: .We are not working with any outside collaborators that require this information.
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blinded, Placebo-Controlled, Phase 1 Study of the Safety and Immunogenicity of BPL-1357, A BPL-Inactivated, Whole-Virus, Universal Influenza Vaccine
- ClinicalTrials.gov ID
- NCT05027932
- Acronym / sponsor ID
- 10000320
- Conditions
- Influenza
- Keywords
- Flu, Immunity, Virology, Investigational, Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 27 Jun 2022 (actual)
- Primary completion
- 13 Jun 2023 (actual)
- Study completion
- 25 Feb 2025 (actual)
- First posted
- 31 Aug 2021 (actual)
- Results
- Posted 8 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
Influenza (flu) is a virus that infects people of all ages. Some people may have mild flu symptoms. Others may get very sick and even die from the flu. Flu vaccines help protect people against the flu, but if the flu strains in the vaccine are not a good match with the strains circulating in the community, the vaccine is not as effective. Researchers want to make flu vaccines that protect against changing flu strains.
Objective:
To test if a new flu vaccine is safe and if it creates an immune response.
Eligibility:
Healthy adults ages 18-55 who do not smoke and have not received a flu vaccine in the 8 weeks prior or a COVID-19 vaccine in the 4 weeks prior to enrollment.
Design:
Participants will be screened on a separate protocol.
Participants will have 9 visits over 7 months. They will get a combination of study vaccine and/or placebo, both as a shot in the arm and as a spray into the nose, at 2 visits. For 7 days after getting the vaccines, they will take their temperature and complete online surveys at home to record any symptoms.
At each visit, participants will have a physical exam and medical history. They will give blood and urine samples. They will have nasal testing. For this, a thin absorptive strip will be inserted into their nostril for 1 minute to collect mucus. At some visits, the inside of their nose will be wiped with a small brush to collect cells. For this, their nostril will be numbed to make it more comfortable. Some blood and nasal samples will be used for genetic testing. Participants who get flu-like symptoms during the study will be asked to collect nasal samples at home and send these samples back to NIH to test if they actually have the flu.
Detailed description
Study Description: This is a randomized, double-blinded, placebo-controlled, single-center, phase 1 clinical trial of beta-propiolactone (BPL)- inactivated quadruple influenza virus cocktail vaccine (BPL-1357) administered intramuscularly (IM) or intranasally (IN) in 2 doses 28 days apart. Participants will be randomized to one of three groups for treatment assignment. The primary hypothesis is that IN and IM BPL-1357 will be well tolerated.
Objectives:
Primary Objective:
- To assess the safety of BPL-1357 given IM or IN, compared to placebo.
Secondary Objective:
- To further assess the safety of BPL-1357 given IM or IN, compared to placebo.
- To assess the immunogenicity of BPL-1357 given IM or IN, compared to placebo.
Tertiary Objective:
- To characterize the systemic and mucosal humoral immune responses induced by BPL-1357 given IM or IN, compared to placebo.
- To further characterize the immune response induced by BPL-1357 given IM or IN through variable, diversity, and joining (VDJ) gene repertoire analysis, cytokine analysis, cytometry, transcriptomics, and assessment of T-cell responses.
- To assess the rates of influenza disease among groups given IM or IN BPL-1357 compared to placebo.
Endpoints:
Primary Endpoints:
- Type and severity (by grading) of adverse events (AEs) through vaccine 2 (V2) day 28 (D28) [28 days after vaccine dose 2].
- Type of serious adverse events (SAEs) through V2D28 [28 days after vaccine dose 2].
Secondary Endpoints:
- Safety
- Type and severity (by grading) of AEs through V2D182 [182 days after vaccine dose 2].
- Type of SAEs through V2D182 [182 days after vaccine dose 2].
- Immunogenicity
- Antibodies against H1, H3, H5, and H7 head and stalk as measured by hemagglutination inhibition (HAI) or enzyme-linked immunosorbent assay (ELISA) from blood and mucosal samples at V2D28.
- Antibodies against N1, N3, N8, and N9 as measured by neuraminidase inhibition (NAI) or ELISA from blood and mucosal samples at V2D28.
Tertiary Endpoints:
- Additional antibody titer characterization via:
- Antibodies against H1, H3, H5, and H7 head and stalk as measured by HAI or ELISA from blood and mucosal samples at V1D7, V1D14, V1D28, V2D7, V2D14, V2D56, and V2D182.
- Antibodies against N1, N3, N8, and N9 as measured by NAI or ELISA from blood and mucosal samples at V1D7, V1D14, V1D28, V2D7, V2D14, V2D56, and V2D182.
- Additional immune response characterization via:
- VDJ gene repertoire analysis.
- Cytokine analysis.
- Flow cytometric phenotyping of lymphocytes.
- Transcriptomic gene expression.
- T-cell responses.
- Influenza disease
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: IN Placebo, Drug: BPL-135715 participants receiving IM BPL1357 \& IN Placebo |
| Group B | Experimental | Other: IM Placebo, Drug: BPL-135715 participants receiving IN BPL1357 \& IM Placebo |
| Group C | Sham comparator | Other: IN Placebo, Other: IM Placebo15 participants receiving IM and IN placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Individuals must meet all of the following criteria to be eligible for study participation:
- 18 and <= 55 years of age.
Key exclusion criteria (21 listed)
- Individuals meeting any of the following criteria will be excluded from study participation:
- Presence of self-reported or medically documented significant medical condition including but not limited to:
- Acute illness within 7 days prior to enrollment.
- Individuals who have grade 2 or above clinically significant laboratory values outside the limits thus specified by normal laboratory parameters.
- Known allergy to influenza vaccination or excipients contained in the influenza vaccine used.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IN PlaceboThe placebo is normal saline in two syringes administered IN. | Other | Group A, Group C |
| IM PlaceboThe placebo is normal saline in a syringe administered IM. | Other | Group B, Group C |
| BPL-1357BPL-1357 contains 4 whole inactivated avian influenza viruses: A /Environment /Maryland/261/2006 H7N3, A/Mallard /Maryland/802/2007 H5N1, A/Pintail/Ohio /339/1987 H3N8, and A/Mallard/Ohio /265/1987 H1N9. It is administered either IM or IN depending on the assigned treatment group. | Drug | Group A, Group B |
Primary outcome
Safety - Serious Adverse Event
Time frame: V2D28 (Day 56)
Type of SAEs through day V2D28.
Safety - Adverse Events
Time frame: V2D28 (Day 56)
Type and severity (by grading) of intervention-related AEs through day V2D28.
4 secondary outcomes
Safety - Serious Adverse Event
Time frame: V2D182 (Day 210)
Safety - Adverse Events
Time frame: V2D182 (Day 210)
Immunogenicity - Systemic and Mucosal Immune Responses Against Hemagglutinin
Time frame: V2D28 (Day 56)
Immunogenicity - Systemic and Mucosal Immune Responses Against Neuraminidase
Time frame: V2D28 (Day 56)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: No. .We are not working with any outside collaborators that require this information.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew J Memoli, M.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BPL-1357 in people with Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety - Serious Adverse Event (time frame: V2D28 (Day 56)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.