NCT05027932

Safety and Immunogenicity of BPL-1357, A BPL-Inactivated, Whole-Virus, Universal Influenza Vaccine

Completed Phase 1 Results posted Last updated 8 April 2025

What this trial tests

Phase 1 trial testing IN Placebo in Influenza in 45 participants. Completed in 25 February 2025.

Timeline

27 June 2022

Primary endpoint
13 June 2023

25 February 2025

Quick facts

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	45
Start date	27 June 2022
Primary completion	13 June 2023
Estimated completion	25 February 2025
Sites	1 location across United States

Drugs / interventions tested

• IN Placebo
• IM Placebo
• BPL-1357 — full drug profile →

Conditions studied

• Influenza — all drugs for Influenza →

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

Adults 18 to 55, any sex, with Influenza. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Safety - Serious Adverse Event Primary · V2D28 (Day 56)

Type of SAEs through day V2D28.

Group	Value	95% CI
Group A	0
Group B	0
Group C	0

Safety - Adverse Events Primary · V2D28 (Day 56)

Type and severity (by grading) of intervention-related AEs through day V2D28.

Fatigue

Group	Value	95% CI
Group A	10
Group B	8
Group C	9

Injection Site Pain

Group	Value	95% CI
Group A	14
Group B	6
Group C	0

Headache

Group	Value	95% CI
Group A	8
Group B	3
Group C	6

Myalgia

Group	Value	95% CI
Group A	4
Group B	3
Group C	2

Sore Throat

Group	Value	95% CI
Group A	3
Group B	2
Group C	4

Sneezing

Group	Value	95% CI
Group A	1
Group B	1
Group C	4

Arthralgia

Group	Value	95% CI
Group A	1
Group B	3
Group C	1

Hoarseness

Group	Value	95% CI
Group A	1
Group B	3
Group C	1

Safety - Serious Adverse Event Secondary · V2D182 (Day 210)

Type of SAEs through day V2D182

Group	Value	95% CI
Group A	0
Group B	0
Group C	0

Safety - Adverse Events Secondary · V2D182 (Day 210)

Type and severity (by grading) of AEs through day V2D182

Fatigue

Group	Value	95% CI
Group A	10
Group B	8
Group C	9

Injection site pain

Group	Value	95% CI
Group A	14
Group B	6
Group C	0

Headache

Group	Value	95% CI
Group A	8
Group B	3
Group C	6

Myalgia

Group	Value	95% CI
Group A	4
Group B	3
Group C	2

Sore throat

Group	Value	95% CI
Group A	3
Group B	2
Group C	4

Sneezing

Group	Value	95% CI
Group A	1
Group B	1
Group C	4

Arthralgia

Group	Value	95% CI
Group A	1
Group B	3
Group C	1

Hoarseness

Group	Value	95% CI
Group A	1
Group B	3
Group C	1

Immunogenicity - Systemic and Mucosal Immune Responses Against Hemagglutinin Secondary · V2D28 (Day 56)

Antibodies against H1, H3, H5, and H7 head and stalk as measured by HAI or ELISA from blood and mucosal samples at V2D28

Serum Anti-H1 IgG

Group	Value	95% CI
Group A	2765	1580 – 4839
Group B	2093	1309 – 3345
Group C	1776	1223 – 2580

Serum Anti-H3 IgG

Group	Value	95% CI
Group A	1104	737 – 1653
Group B	379	202 – 710
Group C	333	219 – 505

Serum Anti-H5 IgG

Group	Value	95% CI
Group A	1010	632 – 1615
Group B	365	234 – 569
Group C	284	210 – 386

Serum Anti-H7 IgG

Group	Value	95% CI
Group A	638	452 – 902
Group B	169	92 – 311
Group C	141	86 – 231

Nasal Anti-H1 IgA

Group	Value	95% CI
Group A	0.446	0.288 – 0.690
Group B	0.556	0.411 – 0.754
Group C	0.504	0.375 – 0.676

Nasal Anti-H3 IgA

Group	Value	95% CI
Group A	0.525	0.420 – 0.655
Group B	0.564	0.438 – 0.726
Group C	0.543	0.418 – 0.706

Nasal Anti-H5 IgA

Group	Value	95% CI
Group A	0.213	0.132 – 0.343
Group B	0.377	0.242 – 0.589
Group C	0.264	0.168 – 0.415

Nasal Anti-H7 IgA

Group	Value	95% CI
Group A	0.279	0.185 – 0.421
Group B	0.357	0.285 – 0.446
Group C	0.329	0.236 – 0.460

Immunogenicity - Systemic and Mucosal Immune Responses Against Neuraminidase Secondary · V2D28 (Day 56)

Antibodies against N1, N3, N8, and N9 as measured by NAI or ELISA from blood and mucosal samples at V2D28

Serum Anti-N1 IgG

Group	Value	95% CI
Group A	222	119 – 415
Group B	266	138 – 513
Group C	282	184 – 432

Serum Anti-N3 IgG

Group	Value	95% CI
Group A	43	19 – 100
Group B	30	17 – 52
Group C	20	13 – 29

Serum Anti-N8 IgG

Group	Value	95% CI
Group A	25	15 – 44
Group B	15	10 – 22
Group C	23	13 – 41

Serum Anti-N9 IgG

Group	Value	95% CI
Group A	25	13 – 46
Group B	12	10 – 16
Group C	13	10 – 17

Nasal Anti-N1 IgA

Group	Value	95% CI
Group A	0.171	0.111 – 0.264
Group B	0.405	0.264 – 0.622
Group C	0.308	0.169 – 0.561

Nasal Anti-N3 IgA

Group	Value	95% CI
Group A	0.091	0.076 – 0.110
Group B	0.132	0.091 – 0.190
Group C	0.142	0.089 – 0.226

Nasal Anti-N8 IgA

Group	Value	95% CI
Group A	0.139	0.102 – 0.190
Group B	0.238	0.165 – 0.343
Group C	0.288	0.178 – 0.464

Nasal Anti-N9 IgA

Group	Value	95% CI
Group A	0.124	0.095 – 0.162
Group B	0.164	0.164 – 0.252
Group C	0.240	0.152 – 0.379

Adverse events — posted to ClinicalTrials.gov

Time frame: 7 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Group A

Serious: 0/15 (0%)

Deaths: 0/15

Group B

Serious: 0/15 (0%)

Deaths: 0/15

Group C

Serious: 0/15 (0%)

Deaths: 0/15

Other adverse events (92 terms — click to expand)

Reaction	System	Group A	Group B	Group C
Injection site pain	General disorders	—	—	—
Fatigue	General disorders	—	—	—
Headache	Nervous system disorders	—	—	—
Nasal congestion	Respiratory, thoracic and mediastinal disorders	—	—	—
Respiratory rate	Investigations	—	—	—
Sore throat	Respiratory, thoracic and mediastinal disorders	—	—	—
Hyperglycemia	Metabolism and nutrition disorders	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—	—
Hypokalemia	Metabolism and nutrition disorders	—	—	—
Hemoglobin decreased	Investigations	—	—	—
Neutrophil count decreased	Investigations	—	—	—
Sneezing	Respiratory, thoracic and mediastinal disorders	—	—	—
Bradycardia	Investigations	—	—	—
CPK increased	Investigations	—	—	—
Rhinorrhea	Respiratory, thoracic and mediastinal disorders	—	—	—
COVID-19	Infections and infestations	—	—	—
Hoarseness	Respiratory, thoracic and mediastinal disorders	—	—	—
Chills	General disorders	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—
Upper respiratory infection	Infections and infestations	—	—	—
Hypophosphatemia	Investigations	—	—	—
Lymphocyte count decreased	Investigations	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—
Fever	General disorders	—	—	—
Hyponatremia	Investigations	—	—	—
Abdominal cramps	Gastrointestinal disorders	—	—	—
WBC decreased	Investigations	—	—	—
Nausea	Gastrointestinal disorders	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—
Diarrhea	Gastrointestinal disorders	—	—	—
Eye discomfort	Eye disorders	—	—	—
Feverish	General disorders	—	—	—
Hypoglycemia	Metabolism and nutrition disorders	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—
WBC increased	Investigations	—	—	—
Platelet count decreased	Investigations	—	—	—
Shortness of breath	Respiratory, thoracic and mediastinal disorders	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—

Data from ClinicalTrials.gov NCT05027932 adverse events section.

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Progress towards the Development of a Universal Influenza Vaccine.
   Wang WC, Sayedahmed EE, Sambhara S, Mittal SK. · · 2022 · cited 49× · PMID 36016306 · DOI 10.3390/v14081684
2. Development of Nasal Vaccines and the Associated Challenges.
   Nian X, Zhang J, Zhang J, Huang S, et al · · 2022 · cited 33× · PMID 36297419 · DOI 10.3390/pharmaceutics14101983
3. Nanoplatform Based Intranasal Vaccines: Current Progress and Clinical Challenges.
   Bai Z, Wan D, Lan T, Hong W, et al · · 2024 · cited 14× · PMID 39185745 · DOI 10.1021/acsnano.3c10797
4. Harnessing the potential of the NALT and BALT as targets for immunomodulation using engineering strategies to enhance mucosal uptake.
   Seefeld ML, Templeton EL, Lehtinen JM, Sinclair N, et al · · 2024 · cited 9× · PMID 39286244 · DOI 10.3389/fimmu.2024.1419527
5. Waning immunity and the future of booster vaccination strategies in global vaccine programs post COVID-19.
   Biswas R, Roy A, Kayal T, Basu S, et al · · 2026 · cited 4× · PMID 41656902 · DOI 10.1080/21645515.2026.2626088
6. Influenza Virus: Global Health Impact, Strategies, Challenges, Role of Nanotechnolgy in Influenza Vaccine Development.
   Parvez S, Pathrathota A, Uppar AL, Yadagiri G, et al · · 2025 · cited 3× · PMID 41012096 · DOI 10.3390/vaccines13090890
7. Research Progress of Universal Influenza Vaccine.
   Wang L, Xie Q, Yu P, Zhang J, et al · · 2025 · cited 3× · PMID 40872948 · DOI 10.3390/vaccines13080863