About this trial
Background:
Influenza (flu) infections are a serious global health threat. Each year, between 3 and 5 million people get the flu, and up to 500,000 die from it. Current vaccines protect against seasonal flus, but broader vaccines are needed to protect against potential flu pandemics.
Objective:
To test an experimental flu vaccine.
Eligibility:
Healthy people aged 18 to 55 years.
Design:
The study will last 5 to 8 months and has 2 phases, A and B.
The study vaccine will be given either as a shot in the arm or as a nasal spray. Participants will receive 1 of 3 combinations: (1) study vaccine in the nose and placebo in the arm; (2) placebo in the nose and study vaccine in the arm; or (3) placebo in the nose and placebo in the arm. A placebo is just like the real vaccine but contains no active ingredients.
Phase A: Participants will have 5 clinic visits over 56 days. They will receive a shot and a nasal spray at 2 of the visits, 28 days apart. At each visit, they will have a physical exam, with tests of their blood, urine, and nasal secretions. They will check their temperature at home and record any symptoms for 7 days after each vaccine.
Phase B: Participants will stay in the hospital for at least 9 days. They will be infected with a flu virus. They will provide blood, urine, and nasal fluid samples. They will have tests of their heart function. They will remain in the hospital until they test negative for the flu 2 days in a row.
They will have 2 follow-up visits, 4 and 8 weeks after leaving the hospital.
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Eligibility criteria
This trial accepts healthy volunteersQualifiers
Adults >=18 and <= 55 years of age at the time of consent.
Able to provide written informed consent.
Non-smoker (i.e., tobacco and cannabis) and does not use vape or e-cigarette products currently. Also, must not have used any of these products extensively in the past (regular use more than 5 times per week, more than 6 months lifetime total).
Has not received influenza vaccination of any type within 6 months prior to enrollment and consents to not receive influenza vaccination of any type until after the end of study participation (PBD63).
Disqualifiers
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 (e.g., insulin-dependent diabetes mellitus, renal dysfunction, hemoglobinopathies).
Immunosuppression, immune deficiency, or ongoing malignancy.
Trial design
Parallel
Treatments tested in this trial
BPL-1357 IM
Biological/VaccineQuadrivalent, inactivated, whole-virus vaccine containing 4 different wild-type avian viruses given intramuscularly.
BPL-1357 IN
Biological/VaccineQuadrivalent, inactivated, whole-virus vaccine containing 4 different wild-type avian viruses given intranasally.
Placebo IM
Other interventionPlacebo given intramuscularly.
Placebo IN
Other interventionPlacebo given intranasally.
Treatment groups
Trial outcomes
Primary outcomes
Safety (solicited AEs 7 days after vaccination, unsolicited adverse events (AEs) within 28 days post-vaccination, serious AEs (SAEs)
Safety of the vaccine will be assessed, including standardized measurement of immediate reactogenicity by symptom survey, as well as long-term follow-up for any SAEs, including after challenge, will be performed.
Rate of mild-to-moderate influenza disease (MMID), defined as a positive US FDA-approved clinical test for influenza plus one or more influenza symptoms
Rate of MMID will be compared across groups to estimate vaccine efficacy.
Secondary outcomes
Immunogenicity at 28 days after vaccine dose 2 (PAD56):
Antibodies against N1, N3, N8, and N9 and H1, H3, H5, H7 head and stalk as measured by NAI, HAI and/or ELISA from blood and mucosal samples to assess immunogenicity.
Mean duration (days) of shedding as measured by rtPCR.
Vaccine, IM or IN, may affect the duration of shedding.
Proportion of patients who shed virus after influenza challenge as measured by rtPCR.
Vaccine, IM or IN, may affect the rate of infection (whether symptomatic or asymptomatic).
Total FLU-PRO questionnaire scores after influenza challenge.
Vaccine, IM or IN, may affect duration and severity of symptoms as measured by FLU-PRO, a validated survey tool for measuring severity of symptoms with influenza.
Sponsors and contacts
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