Anthrax AV7909 Boost Evaluation Study (NCT05997264) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Anthrax AV7909 Boost Evaluation Study
United States220 participantsStarted 2023-12-05
Plain-language summary
This randomized, phase 2, double-blinded, multicenter study is designed to assess the safety and immune response kinetics of CYFENDUS™ (henceforth AV7909) administered on 2 primary series vaccination schedules followed by 6- and 12-month boosters.
Who can participate
Age range
18 Years – 65 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
. Male or non-pregnant females, 18 through 65 years of age, inclusive.
. Willing and able to provide written informed consent prior to initiation of study procedures.
. In relatively stable health, as determined by medical history and physical examination. Any chronic medical diagnoses or conditions should be stable and well managed, with no significant changes expected during the study period, and in the opinion of the site investigator, will not impact the ability to assess safety and/or immunogenicity per the study design.
. If a female of childbearing potential who is sexually active, agrees to use an acceptable method of birth control from Screening to Day 396 and has used a reliable birth control method for at least 2 months prior to Screening.
. Female of childbearing potential is defined as post onset menarche and pre-menopausal person capable of becoming pregnant. This does not include females who meet any of the following conditions: a) menopausal \>2 years; b) tubal ligation \>1 year; c) bilateral salpingo-oophorectomy; or d) hysterectomy.
. Adequate contraception is defined as a contraceptive method with a failure rate of less than 1% per year when used consistently and correctly and when applicable, in accordance with the product label, for example: oral contraceptives, either combined or progestogen alone; injectable progestogen; implants of etenogestrel or levonorgestrel; estrogenic vaginal ring; percutaneous contraceptive patches; intrauterine device or intrauterine system; the female subject has exclusively female sexual partners; partner is sterile or otherwise unable to produce sperm (information on the person's sterility can come from the site personnel's review of the subject's medical records or interview with the subject regarding her medical history); male condom combined with a vaginal spermicide (foam, gel, film, cream, or suppository); or male condom combined with a female diaphragm, either with or without a vaginal spermicide (foam, gel, film, cream, or suppository).
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
1
All solicited local and systemic reactogenicity symptoms with onset within 7 days after each investigational product (IP) administration day.
Timeframe: Within 7 days after each IP administration.
2
Geometric mean titer (GMT) as measured by toxin-neutralizing antibody (TNA) 50% neutralization
Timeframe: Day 64
Trial details
NCT IDNCT05997264
SponsorBiomedical Advanced Research and Development Authority
. Available for all study visits, willing to participate in all study procedures, and not planning to relocate from the area for the duration of the study.
. Has a body mass index (BMI) greater than 18.0 and less than 35.0 kg/m2, inclusive
Exclusion criteria
. Has an acute illness, as determined by the site investigator, within 72 hours prior to study IP administration.
. Has a history of severe reactions to components of AV7909.
. Has a history of anthrax disease, suspected exposure to anthrax, or previous vaccination with any anthrax vaccine.
. Has recently diagnosed or poorly controlled human immunodeficiency virus (HIV).
. Has an acute or chronic hepatitis B or hepatitis C infection, as identified through laboratory testing.
. Is suffering from or has a history of neuralgia, paresthesia, neuritis, convulsions, or encephalomyelitis within 90 days prior to Screening, or a family history of Guillain-Barré syndrome.
. Has a history of alcohol or drug abuse within 5 years prior to Screening.
. Has any diagnosis, current or past, of schizophrenia, bipolar disease, or any other psychiatric diagnosis that may, in the opinion of the site investigator, interfere with subject compliance or safety evaluations.