Anthrax AV7909 Boost Evaluation Study

Last updated: August 28, 2024
Sponsor: Biomedical Advanced Research and Development Authority
Overall Status: Active - Not Recruiting

Phase

2

Condition

N/A

Treatment

AV7909 Half Dose (0.25 mL)

AV7909 Full Dose (0.5 mL)

Clinical Study ID

NCT05997264
ABST001
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male or non-pregnant females, 18 through 65 years of age, inclusive.

  2. Willing and able to provide written informed consent prior to initiation of studyprocedures.

  3. In relatively stable health, as determined by medical history and physicalexamination. Any chronic medical diagnoses or conditions should be stable and wellmanaged, with no significant changes expected during the study period, and in theopinion of the site investigator, will not impact the ability to assess safetyand/or immunogenicity per the study design.

  4. If a female of childbearing potential who is sexually active, agrees to use anacceptable method of birth control from Screening to Day 396 and has used a reliablebirth control method for at least 2 months prior to Screening.

  5. Female of childbearing potential is defined as post onset menarche andpre-menopausal person capable of becoming pregnant. This does not includefemales who meet any of the following conditions: a) menopausal >2 years; b)tubal ligation >1 year; c) bilateral salpingo-oophorectomy; or d) hysterectomy.

  6. Adequate contraception is defined as a contraceptive method with a failure rateof less than 1% per year when used consistently and correctly and whenapplicable, in accordance with the product label, for example: oralcontraceptives, 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 sterileor otherwise unable to produce sperm (information on the person's sterility cancome from the site personnel's review of the subject's medical records orinterview with the subject regarding her medical history); male condom combinedwith a vaginal spermicide (foam, gel, film, cream, or suppository); or malecondom combined with a female diaphragm, either with or without a vaginalspermicide (foam, gel, film, cream, or suppository).

  7. Available for all study visits, willing to participate in all study procedures, andnot planning to relocate from the area for the duration of the study.

  8. Has a body mass index (BMI) greater than 18.0 and less than 35.0 kg/m2, inclusive

Exclusion

Exclusion Criteria:

  1. Has an acute illness, as determined by the site investigator, within 72 hours priorto study IP administration.
  • An acute illness that is nearly resolved, with only minor residual symptomsremaining, is allowable if, in the opinion of the site investigator, theresidual symptoms will not interfere with the ability of study staff to assesssafety parameters as required by the protocol.

  • If the subject's temperature is above 100.4°F, indicating illness, the subjectmay be re-assessed for eligibility a minimum of 24 hours later.

  1. Has a history of severe reactions to components of AV7909.

  2. Has a history of anthrax disease, suspected exposure to anthrax, or previousvaccination with any anthrax vaccine.

  3. Has recently diagnosed or poorly controlled human immunodeficiency virus (HIV).

  4. Has an acute or chronic hepatitis B or hepatitis C infection, as identified throughlaboratory testing.

  • A subject who has been effectively treated for hepatitis C, as evidenced by anegative hepatitis C ribonucleic acid (RNA) confirmation test, and who nolonger requires antiviral therapy is not excluded.
  1. Is suffering from or has a history of neuralgia, paresthesia, neuritis, convulsions,or encephalomyelitis within 90 days prior to Screening, or a family history ofGuillain-Barré syndrome.

  2. Has a history of alcohol or drug abuse within 5 years prior to Screening.

  3. Has any diagnosis, current or past, of schizophrenia, bipolar disease, or any otherpsychiatric diagnosis that may, in the opinion of the site investigator, interferewith subject compliance or safety evaluations.

  4. Is taking herbal medicines/preparations that are known to have a direct or indirecteffect on the immune system.

  5. Presence of tattoos on both upper arms that would cover or partially cover allpotential vaccination sites.

  6. Clinically relevant signs of pathology or conduction disturbances documented byelectrocardiogram (EKG).

  7. Has taken corticosteroids as follows within 30 days prior to Screening.

  • Oral or parenteral corticosteroids at a dose of ≥20 mg daily and/or

  • High-dose (>800 mcg/day of beclomethasone di-iso-propionate chlorofluorocarbon [CFC] or equivalent) inhaled corticosteroids.

  1. Female of childbearing potential who has a positive urine pregnancy test or who iscurrently breastfeeding.

  2. Has had any vaccination (licensed or under Emergency Use Authorization [EUA]; anytype) within the 30 days prior to the planned first study IP administration.

  3. Is immunosuppressed due to an underlying disease or medication, use of anticancerchemotherapy (cytotoxic), or radiation therapy.

  4. With the exception of basal or squamous cell skin cancer, has known activeneoplastic disease, including hematologic malignancy.

  5. Has received an investigational agent within 30 days prior to the planned firststudy IP administration.

  6. Has any laboratory test result or clinical findings (including vital signs) thatsingly or in combination are likely to unfavorably alter the risks of subjectparticipation or to confound study safety or immunogenicity results, in the opinionof the site investigator. Additionally, the following are exclusionary:

  7. Has any clinically significant Grade 3 laboratory or vital sign result, or anyGrade 4 laboratory or vital sign result (regardless of assessed significance)at Screening.

  8. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2 times theupper limit of normal (ULN), or bilirubin >1.5 times the ULN unless isolatedGilbert's syndrome.

  9. Creatinine >1.5 times ULN for age and sex.

  10. White blood cell count <3,000/µL or >12,500/µL; absolute neutrophil count <1,200/µL; absolute lymphocyte count <750/µL; hemoglobin <10 g/dL females, or <11.5 g/dL males; platelet count <75,000/µL.

  11. Hemoglobin A1c (HbA1c) >7.0% at Screening.

  12. Has any disease or medical condition that, in the opinion of the site investigator,might confound interpretation of safety or immunogenicity.

Study Design

Total Participants: 220
Treatment Group(s): 2
Primary Treatment: AV7909 Half Dose (0.25 mL)
Phase: 2
Study Start date:
December 05, 2023
Estimated Completion Date:
August 31, 2026

Study Description

This trial is a randomized, double-blinded, multicenter study designed to evaluate safety and immune response kinetics of full and half doses of AV7909 administered on 2 primary series vaccination schedules followed by 6- and 12-month boosters. Healthy adult male and female subjects aged 18 through 65 years, inclusive, will be screened for baseline health status to ensure trial eligibility. Subjects meeting all the inclusion and none of the exclusion criteria will be randomized to receive either half or full doses of AV7909 on 1 of 2 vaccination schedules. Randomization will be stratified by sex. Subjects will be randomized 1:1:1:1 within stratum across 4 treatment groups (approximately 55 subjects per group). Subjects will receive a total of 5 intramuscular (IM) injections. Primary series IP doses will be administered on Days 1, 15, and 29, and booster IP doses will be administered on Days 181 and 366. On each IP administration day, each subject will receive an IM injection of full-dose AV7909 (0.5 mL), half-dose AV7909 (0.25 mL), or placebo (0.5 mL or 0.25 mL sodium chloride for injection), based on their assigned treatment group.

Update: The 2 treatment groups (Study Groups 1 and 2) in which subjects are to receive full doses of AV7909 were closed to enrollment on 13 May 2024 to preserve resources for the groups that BARDA considers the highest priority and reflects no concerns due to a safety signal or request of the Data Safety Monitoring Board (DSMB). Subjects randomized prior to this date will continue in the study in their assigned treatment group as described in the protocol. Subjects randomized on or after 13 May 2024 will be randomized 1:1 within stratum across the 2 remaining treatment groups (Study Groups 3 and 4), and on each IP administration day will receive an IM injection of half-dose AV7909 (0.25 mL) or placebo (0.25 mL sodium chloride for injection), based on their assigned treatment group. There are no other changes to the study protocol.

Safety assessments will be based on solicited adverse events (AEs; local and systemic reactogenicity symptoms) with onset within 7 days after each IP administration; unsolicited treatment-emergent adverse events (TEAEs) with onset within 30 days after each IP administration; and treatment-emergent serious adverse events (SAEs), potentially immune-mediated medical conditions (PIMMCs), and medically attended adverse events (MAAEs) occurring during study participation (ie, up to 1 year after the last IP administration). For this study, a PIMMC is considered to be unexpected and will be treated as a serious and unexpected suspected adverse reaction (SUSAR) per 21 CFR 312.32.

Immunogenicity assessments will include geometric mean titer (GMT), seroprotection rate, and seroconversion rate by toxin-neutralizing antibody (TNA) 50% neutralization factor (NF50) and enzyme-linked immunosorbent assay (ELISA) anti-protective antigen (PA) Immunoglobulin G (IgG).

Connect with a study center

  • Accellacare of Hickory

    Hickory, North Carolina 28601
    United States

    Site Not Available

  • Accellacare of Salisbury

    Salisbury, North Carolina 28144
    United States

    Site Not Available

  • Accellacare of Piedmont

    Statesville, North Carolina 28625
    United States

    Site Not Available

  • Accellacare of Piredmont

    Statesville, North Carolina 28625
    United States

    Site Not Available

  • Accellacare of Winston-Salem

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • Accellacare Knoxville

    Jefferson City, Tennessee 37760
    United States

    Site Not Available

  • Accellacare Knoxville

    Knoxville, Tennessee 37912
    United States

    Site Not Available

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