A Safety and Immunogenicity of Intranasal Nanoemulsion Adjuvanted Recombinant Pandemic Flu Vaccin… (NCT05397119) | Clinical Trial Compass
CompletedPhase 1
A Safety and Immunogenicity of Intranasal Nanoemulsion Adjuvanted Recombinant Pandemic Flu Vaccine in Healthy Adults
United States40 participantsStarted 2022-07-07
Plain-language summary
The purpose of this clinical trial is to evaluate the safety and immunogenicity of BW-1014.
BW-1014 is a nanoemulsion (NE) adjuvanted recombinant Hemagglutinin 5 (rH5) that would protect against pandemic flu.
The study will be conducted in 40 healthy adults volunteers, age 18 - 45, in one center in the United States.
The study will compare 3 different dose levels of rH5 (25µg, 50µg and 100µg rH5 in 20% NE adjuvant using a pipette dropper with rH5 control (100µg without NE adjuvant) and placebo control (saline). The investigational product will be administered in 2 doses intranasally (IN). This will be followed 6 months later with a licensed H5N1 IIV IM vaccine.
In addition to safety outcome, homologous and heterologous immunological outcomes will be tested in nasal wash, serum, and blood cells.
Who can participate
Age range18 Years – 45 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Healthy men or women aged 18 through 45 years of age, inclusive.
✓. Women must not be pregnant or nursing. If premenopausal, absence of pregnancy must be confirmed by a negative serum pregnancy test conducted at screening and a negative urine pregnancy test conducted at the site within 24 hours preceding receipt of vaccine.
✓. Women who are not surgically sterile or at least one year post-menopausal must agree to use acceptable birth control. Acceptable birth control methods include oral, implantable, transdermal or injectable contraceptive; barrier methods such as condoms, cervical caps, or diaphragms with spermicide; abstinence from sexual relationships with a male partner, non-male sexual relationships, monogamous relationship with vasectomized partner who has been vasectomized for 180 days or more prior to the subject receiving the first study vaccination, and other reliable forms of contraception approved by the Investigator. Acceptable birth control must be used for a minimum of 30 days prior to vaccination and for 3 months following final study vaccination.
Exclusion criteria
✕. Subjects must be able to comprehend the study requirements as evidenced by a score of ≥ 70% on the comprehension assessment (two attempts permitted), be available for the required study period, and have the ability to attend scheduled visits.
✕
What they're measuring
1
Safety Outcome: Number of participants reporting local or systemic reactions
Timeframe: Up to Day 29
2
Safety Outcome: Number of participants reporting solicited reactions and general AEs
Timeframe: Up to Day 36
3
Safety Objective: Number of participants reporting unsolicited AEs
Timeframe: Up to Day 57
4
Safety Outcome: Number of participants reporting any hematological and biochemical laboratory abnormality (Class 1 of higher)
Timeframe: Up to Day 43
5
Safety Outcome: Number of participants reporting medically attended AEs (MAAEs)
Timeframe: Up to Day 57
6
Safety Outcome: Number of participants reporting serious adverse events (SAEs)
Timeframe: Up to Day 393
7
Safety Outcome: Number of participants reporting potential immune-mediated medical conditions (PIMMCs)
Timeframe: Up to Day 393
8
Safety Outcome: Number of participants reporting new onset chronic medical conditions (NOCMCs)
. Subjects must be able to provide written informed consent to participate in the study.
✕. Subject agrees to future use of left-over specimens and to the collection of additional specimens for potential future use research.
✕. Receipt of the CDC-recommended number of doses of an EUA authorized or licensed COVID-19 vaccine product ≥ four weeks prior to first study vaccination.
✕. Presence of significant acute or chronic, uncontrolled medical or psychiatric illness (institution of new medical or surgical treatment, or a significant dose alteration for uncontrolled symptoms or drug toxicity within 3 months). This includes signs or symptoms consistent with upper or lower respiratory tract infections.
✕. Participants with symptoms of COVID-19 and/or who are positive for SARS-CoV-2 by molecular testing conducted within 2 days prevaccination.
✕. Have known hypersensitivity or allergy to eggs, egg or chicken protein, or other components of the Influenza Virus Vaccine, H5N1 (Sanofi Pasteur).
✕. Receipt of licensed or experimental H5N1 influenza vaccine ever.