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 CYFENDUSâ„¢ (henceforth AV7909) administered on 2 primary series vaccination schedules followed by 6- and 12-month boosters.
Who can participate
Age range18 Years – 65 Years
SexALL
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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).
✓. 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.
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
✕. 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.