Randomized, Double-Blinded, Placebo-Controlled, Phase 2 Study of the Safety and Efficacy of BPL-1357 Against H1N1 Influenza Virus Challenge
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. ...
• Individuals must meet all of the following criteria to be eligible for study participation:
• 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).
• Has not received any other vaccination of any type within 4 weeks prior to enrollment and consents to not receive any unlicensed vaccine until after the end of the study (PBD63).
• Has not received any broadly protective influenza vaccine in the past.
• Participants of childbearing potential must meet one of the following criteria through the end of study participation (PBD63):
∙ Is infertile, including postmenopausal status (as defined by age .45 years plus no menses for \>= 1 year without an alternative medical cause) or history of hysterectomy or bilateral oophorectomy.
‣ Agrees that, when engaging in intercourse that can result in pregnancy, they will use an acceptable or highly effective form of contraception, and their male partner will use a condom with spermicide. Acceptable methods of female contraception include
• the following:
⁃ Bilateral tubal ligation
⁃ Implant of levonorgestrel
⁃ Injectable progestogen
⁃ Oral contraceptive pills
⁃ Diaphragm with spermicide
⁃ Intrauterine device (IUD)
⁃ Sexual abstinence
⁃ Vasectomized partner
• Able to speak and understand English (NIH).
• Able to speak and understand English and/or Spanish (UTMB).
⁃ A negative HIV test within 6 months before enrollment.
⁃ Has not used IN medications (including but not limited to nasal sprays, sinus rinses), and has not routinely used 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 (about 2 weeks) prior to study enrollment and agrees not to use these medications until after the end of study participation (PBD63), unless approved by the investigator.
⁃ Agrees not to donate blood or blood products from enrollment through the final study visit (PBD63).
⁃ Not planning on cohabitating with any high-risk individuals (e.g., infants, elderly, those with high-risk conditions (e.g., pregnancy, medical conditions such as those outlined in exclusion criterion 1) for at least 2 weeks after discharge from the inpatient portion of this study.
⁃ Participant is willing and able to comply with all trial procedures.