Anthrax AV7909 Boost Evaluation Study

NCT05997264 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: ABST001
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Anthrax

Outcome Measures

Primary Outcomes (2)

• All solicited local and systemic reactogenicity symptoms with onset within 7 days after each investigational product (IP) administration day.

  Within 7 days after each IP administration.

• Geometric mean titer (GMT) as measured by toxin-neutralizing antibody (TNA) 50% neutralization

  Day 64

Secondary Outcomes (7)

• Unsolicited treatment-emergent adverse events (TEAEs) with onset within 30 days after each IP administration day.

  Within 30 days after each IP administration.

• Treatment-emergent serious adverse events (SAEs) up to 1 year after the last IP administration day.

  Within 1 year after the last IP administration.

• Treatment-emergent potentially immune-mediated medical conditions (PIMMCs) up to 1 year after the last IP administration day.

  Within 1 year after the last IP administration.

• Treatment-emergent medically attended adverse events (MAAEs) up to 1 year after the last IP administration day.

  Within 1 year after the last IP administration.

• Geometric mean titer (GMT) as measured by toxin-neutralizing antibody (TNA) 50% neutralization factor (NF50) at Day 15, Day 29, Day 36, Day 43, Day 50, Day 85, Day 181, Day 211, Day 366, Day 396, Day 546, and Day 731.

  Day 15 through 731.

Study Arms (4)

Full Dose Schedule 1

EXPERIMENTAL

This study group will receive full dose AV7909 (0.5mL) at study days 1, 15, 181 and 366. A placebo full dose (0.5 mL) will be administered between the second and third dose of AV7909 at study day 29. Update: Enrollment to this treatment arm was closed on 13 May 2024.

Biological: AV7909 Full Dose (0.5 mL); Biological: Placebo: Sodium Chloride Injection, USP 0.9% (0.5 mL)

Full Dose Schedule 2

EXPERIMENTAL

This study group will receive of AV7909 full dose (0.5 mL) at study days 1, 29, 181 and 366. A placebo full dose (0.5 mL) will be administered between the first and second dose of AV7909 at study day 15. Update: Enrollment to this treatment arm was closed on 13 May 2024.

Biological: AV7909 Full Dose (0.5 mL); Biological: Placebo: Sodium Chloride Injection, USP 0.9% (0.5 mL)

Half Dose Schedule 1

EXPERIMENTAL

This study group will receive of AV7909 half dose (0.25 mL) at study days 1, 15, 181 and 366. A placebo half dose (0.25 mL) will be administered between the second and third dose of AV7909 at study day 29.

Biological: AV7909 Half Dose (0.25 mL); Biological: Placebo: Sodium Chloride Injection, USP 0.9% (0.25 mL)

Half Dose Schedule 2

EXPERIMENTAL

This study group will receive of AV7909 half dose (0.25 mL) at study days 1, 29, 181 and 366. A placebo full dose (0.25 mL) will be administered between the first and second dose of AV7909 at study day 15.

Biological: AV7909 Half Dose (0.25 mL); Biological: Placebo: Sodium Chloride Injection, USP 0.9% (0.25 mL)

Interventions

AV7909 Full Dose (0.5 mL) BIOLOGICAL

AV7909 Anthrax Vaccine is being developed by Emergent Product Development Gaithersburg Inc. (Emergent) for post-exposure prophylaxis (PEP) of disease in persons 18 through 65 years of age following suspected or confirmed B. anthracis exposure when administered in conjunction with the recommended antibacterial regimen. AV7909 is a combination product containing BioThrax and CPG 7909, a synthetic immunostimulatory oligodeoxynucleotide that has been shown to be a potent vaccine adjuvant. CPG 7909 is a Toll-like receptor 9 agonist designed to induce both an enhanced antigen-specific antibody response and a natural killer T-cell immune response when used in combination with prophylactic (preventative) or therapeutic vaccines.

Full Dose Schedule 1; Full Dose Schedule 2

AV7909 Half Dose (0.25 mL) BIOLOGICAL

AV7909 Anthrax Vaccine is being developed by Emergent Product Development Gaithersburg Inc. (Emergent) for PEP of disease in persons 18 through 65 years of age following suspected or confirmed B. anthracis exposure when administered in conjunction with the recommended antibacterial regimen. AV7909 is a combination product containing BioThrax and CPG 7909, a synthetic immunostimulatory oligodeoxynucleotide that has been shown to be a potent vaccine adjuvant. CPG 7909 is a Toll-like receptor 9 agonist designed to induce both an enhanced antigen-specific antibody response and a natural killer T-cell immune response when used in combination with prophylactic (preventative) or therapeutic vaccines.

Half Dose Schedule 1; Half Dose Schedule 2

Placebo: Sodium Chloride Injection, USP 0.9% (0.5 mL) BIOLOGICAL

Sodium chloride 9 mg water for injection Quantum satis (q.s.). It contains no bacteriostat, antimicrobial agent, or added buffer. The solution may contain hydrochloric acid and/or sodium hydroxide for pH adjustment (pH 4.5-7.0).

Full Dose Schedule 1; Full Dose Schedule 2

Placebo: Sodium Chloride Injection, USP 0.9% (0.25 mL) BIOLOGICAL

Sodium chloride 9 mg water for injection Quantum satis (q.s.). It contains no bacteriostat, antimicrobial agent, or added buffer. The solution may contain hydrochloric acid and/or sodium hydroxide for pH adjustment (pH 4.5-7.0).

Half Dose Schedule 1; Half Dose Schedule 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Has an acute illness, as determined by the site investigator, within 72 hours prior to study IP administration.
• An acute illness that is nearly resolved, with only minor residual symptoms remaining, is allowable if, in the opinion of the site investigator, the residual symptoms will not interfere with the ability of study staff to assess safety parameters as required by the protocol.
• If the subject's temperature is above 100.4°F, indicating illness, the subject may be re-assessed for eligibility a minimum of 24 hours later.
• 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.
• \- A subject who has been effectively treated for hepatitis C, as evidenced by a negative hepatitis C ribonucleic acid (RNA) confirmation test, and who no longer requires antiviral therapy is not excluded.
• 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.
• Is taking herbal medicines/preparations that are known to have a direct or indirect effect on the immune system.
• Presence of tattoos on both upper arms that would cover or partially cover all potential vaccination sites.
• Clinically relevant signs of pathology or conduction disturbances documented by electrocardiogram (EKG).
• Has taken corticosteroids as follows within 30 days prior to Screening.

Sponsors & Collaborators

• Rho Federal Systems Division, Inc.: collaborator
• Biomedical Advanced Research and Development Authority: lead
• ICON plc: collaborator

Study Sites (7)

Accellacare of Hickory

Hickory, North Carolina, 28601, United States

Location

Accellacare of Salisbury

Salisbury, North Carolina, 28144, United States

Location

Accellacare of Piedmont

Statesville, North Carolina, 28625, United States

Location

Accellacare of Winston-Salem

Winston-Salem, North Carolina, 27103, United States

Location

Accellacare Knoxville

Jefferson City, Tennessee, 37760, United States

Location

Accellacare Knoxville

Knoxville, Tennessee, 37912, United States

Location

Accellacare Knoxville

Knoxville, Tennessee, 37938, United States

Location

MeSH Terms

Conditions

Anthrax

Condition Hierarchy (Ancestors)

Bacillaceae Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Derek Eisnor, MD

  Biomedical Advanced Research and Development Authority

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2023
• First Posted: August 18, 2023
• Study Start: December 5, 2023
• Primary Completion: August 28, 2025
• Study Completion (Estimated): August 1, 2026
• Last Updated: February 24, 2026

Record last verified: 2026-02

Locations

US (7)