AV7909 Vaccine Booster for Anthrax

(ABESt Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates the safety and immune response of the AV7909 vaccine booster for anthrax. Participants receive different doses of the vaccine on various schedules to determine the most effective and safe option. The trial seeks individuals who are generally healthy and have not previously had anthrax or its vaccine. It may suit those without severe vaccine reactions and without tattoos covering both upper arms. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that AV7909, a booster vaccine for anthrax, is safe for people. Studies have found it well-tolerated, with no major safety concerns. For example, one study found that AV7909 has a good safety record with no serious side effects. Another study noted that AV7909 seems safe, with benefits outweighing any risks. Administered as an injection, safety data suggests it is tolerated without significant issues. Overall, these findings support the safety of AV7909 for use in clinical trials. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Researchers are excited about the AV7909 vaccine booster for anthrax because it introduces a novel approach to enhancing immunity. Unlike traditional anthrax vaccines, AV7909 includes an adjuvant that boosts the body's immune response more effectively, potentially offering stronger and longer-lasting protection. This vaccine also provides flexibility in dosing schedules, with both half-dose and full-dose options being explored, which could make it more adaptable for different populations and situations. By potentially reducing the number of doses needed, AV7909 could simplify the vaccination process and improve compliance compared to existing vaccines.

What evidence suggests that this trial's treatments could be effective for anthrax?

Research has shown that the AV7909 vaccine effectively prevents anthrax infections. One study found the vaccine to be 92.5% effective, with no cases of inhalation anthrax among those who completed the vaccination series. The body's defense system, which protects against disease, strengthened after the second dose and peaked at 36 weeks. Previous patients demonstrated that two doses of AV7909 work better than one. In this trial, participants will receive either a half dose or a full dose of AV7909 on different schedules to evaluate its safety and effectiveness. Current evidence suggests that AV7909 is both safe and effective. ^{2 3 6 7 8}

Who Is on the Research Team?

Derek Eisnor, MD

Principal Investigator

Biomedical Advanced Research and Development Authority

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10760354/

Efficacy of different AV7909 dose regimens in a nonclinical ... In this study, our results indicate that a single dose of AV7909 is less effective compared to the two-dose regimen in the guinea pig anthrax ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05997264

NCT05997264 | Anthrax AV7909 Boost Evaluation Study This trial is a randomized, double-blinded, multicenter study designed to evaluate safety and immune response kinetics of full and half doses of AV7909 ...

3. cdc.gov cdc.gov/mmwr/volumes/68/rr/rr6804a1.htm

Use of Anthrax Vaccine in the United States However, the limited amount of phase 2 safety and immunogenicity data indicate that AV7909 appears to be safe and effective. The benefits of an ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0264410X25005092

Serological correlates of protection and long-term efficacy ... Immune responses began to increase after the second dose of GC1109, peaked at 36 weeks, and subsequently declined over the following weeks.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9041331/

Recent developments in the understanding and use of ... The study demonstrated vaccine effectiveness of 92.5% in those environments, with no reported cases of inhalation anthrax in any participants who completed the ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7821328/

Developmental and reproductive safety evaluation of ... Anthrax lethal toxin‐neutralizing antibodies were detected in AV7909‐vaccinated F0 females. The antibodies were also detected in the sera of fetuses and F1 pups ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0264410X20313621

Evaluation of BioThrax® and AV7909 anthrax vaccines in ... We conducted a Phase 2 clinical study to evaluate safety and immunogenicity of three vaccination schedules of the AV7909 vaccine candidate and ...

8. fda.gov fda.gov/media/171140/download

CYFENDUS Adequate data are presented to demonstrate safety and tolerability of the vaccine when administered IM. Overall, no findings of concern ...