AV7909 Vaccine Booster for Anthrax

(ABESt Trial)

Recruiting at 5 trial locations

Overseen By Brian Pyers

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Biomedical Advanced Research and Development Authority

Must not be taking: Herbal medicines, Corticosteroids

Disqualifiers: HIV, Hepatitis B/C, Schizophrenia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

220 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests the AV7909 vaccine on healthy adults aged 18-65 to see if it is safe and effective. The vaccine helps the body produce antibodies that can neutralize harmful substances. The AV7909 vaccine has shown to elicit a more robust immune response in older adults.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are taking herbal medicines that affect the immune system or certain corticosteroids, you may need to stop those before joining.

What data supports the effectiveness of the AV7909 treatment for anthrax?

Research shows that the AV7909 vaccine, which combines an existing anthrax vaccine with an immune-boosting component, produces a strong immune response in animals and humans. It has been shown to protect guinea pigs and nonhuman primates from lethal anthrax exposure, and it generates higher levels of protective antibodies faster than the currently approved anthrax vaccine. ^{1 2 3 4 5}

Is the AV7909 anthrax vaccine booster generally safe for humans?

The AV7909 anthrax vaccine has been tested in both animals and humans, showing a favorable safety profile. In studies with rats, it did not cause serious health issues, and in human trials, it was well tolerated with common side effects being mild reactions at the injection site. No serious adverse events related to the vaccine were reported. ^{1 3 5 6 7}

How does the AV7909 vaccine differ from other anthrax treatments?

The AV7909 vaccine is unique because it combines the existing Anthrax Vaccine Adsorbed (AVA) with an adjuvant (a substance that enhances the body's immune response) called CPG 7909, which accelerates the immune response and may reduce the number of injections needed compared to the standard BioThrax vaccine. This combination aims to provide faster protection in post-exposure scenarios. ^{1 3 4 5 6}

Research Team

Derek Eisnor, MD

Principal Investigator

Biomedical Advanced Research and Development Authority

Eligibility Criteria

Adults aged 18-65 in stable health, with well-managed chronic conditions, if any. Women of childbearing potential must use effective birth control and not be pregnant or breastfeeding. Participants should have a BMI between 18.0 and 35.0 kg/m2, no recent vaccinations or investigational agents, no severe psychiatric disorders or uncontrolled diseases like HIV or hepatitis C.

Inclusion Criteria

Are you between the ages of 18-65?

Is your BMI between 18-35?

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

Exclusion Criteria

Do you identify as white/caucasian?

Have you ever received an anthrax vaccine?

Has an acute illness, as determined by the site investigator, within 72 hours prior to study IP administration

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Primary Series Vaccination

Participants receive AV7909 or placebo on Days 1, 15, and 29

4 weeks

3 visits (in-person)

Booster Doses

Participants receive booster doses of AV7909 or placebo on Days 181 and 366

12 months

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Treatment Details

Interventions

• AV7909

Trial Overview The study is testing two dosages of the anthrax vaccine AV7909: a full dose (0.5 mL) and a half dose (0.25 mL). It's to see how safe they are and how the body responds over time including after booster shots at 6 and 12 months.

Participant Groups

Group I: Half Dose Schedule 2 Experimental Treatment 1 Intervention

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.

Group II: Half Dose Schedule 1 Experimental Treatment 1 Intervention

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.

Group III: Full Dose Schedule 2 Experimental Treatment 1 Intervention

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.

Group IV: Full Dose Schedule 1 Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Biomedical Advanced Research and Development Authority

Lead Sponsor

Trials

108

Recruited

574,000+

Rho Federal Systems Division, Inc.

Industry Sponsor

Trials

44

Recruited

15,000+

ICON plc

Industry Sponsor

Trials

88

Recruited

28,900+

Dr. Steve Cutler

ICON plc

Chief Executive Officer since 2017

PhD from the University of Sydney, MBA from the University of Birmingham

Dr. Greg Licholai

ICON plc

Chief Medical Officer since 2023

Degrees from Harvard Business School, Yale School of Medicine, Columbia University, and Boston College

References

1. United States pubmed.ncbi.nlm.nih.gov

Repeat Dose Toxicity Study of the AV7909 Anthrax Vaccine Candidate in Juvenile Rats. [2020]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Correlation between anthrax lethal toxin neutralizing antibody levels and survival in guinea pigs and nonhuman primates vaccinated with the AV7909 anthrax vaccine candidate. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Evaluation of the AV7909 Anthrax Vaccine Toxicity in Sprague Dawley Rats Following Three Intramuscular Administrations. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Efficacy of the AV7909 anthrax vaccine candidate in guinea pigs and nonhuman primates following two immunizations two weeks apart. [2021]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Randomized, double-blind, placebo-controlled, safety and immunogenicity study of 4 formulations of Anthrax Vaccine Adsorbed plus CPG 7909 (AV7909) in healthy adult volunteers. [2021]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Randomized, double-blind, active-controlled study evaluating the safety and immunogenicity of three vaccination schedules and two dose levels of AV7909 vaccine for anthrax post-exposure prophylaxis in healthy adults. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Developmental and reproductive safety evaluation of AV7909 anthrax vaccine candidate in rats. [2021]