Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:36 PM
Ignite Modification Date:
2025-12-24 @ 9:36 PM
NCT ID:
NCT05027932
Brief 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, 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:
1\. To assess the safety of BPL-1357 given IM or IN, compared to placebo.
Secondary Objective:
1. To further assess the safety of BPL-1357 given IM or IN, compared to placebo.
2. To assess the immunogenicity of BPL-1357 given IM or IN, compared to placebo.
Tertiary Objective:
1. To characterize the systemic and mucosal humoral immune responses induced by BPL-1357 given IM or IN, compared to placebo.
2. 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.
3. To assess the rates of influenza disease among groups given IM or IN BPL-1357 compared to placebo.
Endpoints:
Primary Endpoints:
1. Type and severity (by grading) of adverse events (AEs) through vaccine 2 (V2) day 28 (D28) \[28 days after vaccine dose 2\].
2. Type of serious adverse events (SAEs) through V2D28 \[28 days after vaccine dose 2\].
Secondary Endpoints:
1. Safety
1. Type and severity (by grading) of AEs through V2D182 \[182 days after vaccine dose 2\].
2. Type of SAEs through V2D182 \[182 days after vaccine dose 2\].
2. Immunogenicity
1. 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.
2. Antibodies against N1, N3, N8, and N9 as measured by neuraminidase inhibition (NAI) or ELISA from blood and mucosal samples at V2D28.
Tertiary Endpoints:
1. Additional antibody titer characterization via:
1. 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.
2. 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.
2. Additional immune response characterization via:
1. VDJ gene repertoire analysis.
2. Cytokine analysis.
3. Flow cytometric phenotyping of lymphocytes.
4. Transcriptomic gene expression.
5. T-cell responses.
3. Influenza disease
Study:
NCT05027932
Study Brief:
Protocol Section:
NCT05027932