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 range

18 Years – 45 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Safety Outcome: Number of participants reporting local or systemic reactions

Timeframe: Up to Day 29

Safety Outcome: Number of participants reporting solicited reactions and general AEs

Timeframe: Up to Day 36

Safety Objective: Number of participants reporting unsolicited AEs

Timeframe: Up to Day 57

Safety Outcome: Number of participants reporting any hematological and biochemical laboratory abnormality (Class 1 of higher)

Timeframe: Up to Day 43

Safety Outcome: Number of participants reporting medically attended AEs (MAAEs)

Timeframe: Up to Day 57

Safety Outcome: Number of participants reporting serious adverse events (SAEs)

Timeframe: Up to Day 393

Safety Outcome: Number of participants reporting potential immune-mediated medical conditions (PIMMCs)

Timeframe: Up to Day 393

Trial details

NCT IDNCT05397119

SponsorBlueWillow Biologics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-10-12

View on ClinicalTrials.gov More Influenza, Pandemic trials

Plain-language summary

Who can participate

Age range

18 Years – 45 Years

Sex

ALL

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

What they're measuring

Safety Outcome: Number of participants reporting local or systemic reactions

Timeframe: Up to Day 29

Safety Outcome: Number of participants reporting solicited reactions and general AEs

Timeframe: Up to Day 36

Safety Objective: Number of participants reporting unsolicited AEs

Timeframe: Up to Day 57

Safety Outcome: Number of participants reporting any hematological and biochemical laboratory abnormality (Class 1 of higher)

Timeframe: Up to Day 43

Safety Outcome: Number of participants reporting medically attended AEs (MAAEs)

Timeframe: Up to Day 57

Safety Outcome: Number of participants reporting serious adverse events (SAEs)

Timeframe: Up to Day 393

Safety Outcome: Number of participants reporting potential immune-mediated medical conditions (PIMMCs)

Timeframe: Up to Day 393