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Virus Therapy

AV7909 Vaccine Booster for Anthrax (ABESt Trial)

Verified Trial
Phase 2
Recruiting
Research Sponsored by Biomedical Advanced Research and Development Authority
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Are you between the ages of 18-65?
Is your BMI between 18-35?
Must not have
Do you identify as white/caucasian?
Have you ever received an anthrax vaccine?
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 1 year after the last ip administration.
Awards & highlights

Summary

This trial tests a new vaccine to see how safe & effective it is after booster shots 6 & 12 months later.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects for AV7909 aren't listed here, vaccines typically can cause reactions at the injection site like pain or swelling, temporary muscle aches, fatigue, headache, mild fever or chills.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 1 year after the last ip administration.
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 1 year after the last ip administration. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
All solicited local and systemic reactogenicity symptoms with onset within 7 days after each IP administration day.
Geometric mean titer (GMT) as measured by toxin-neutralizing antibody (TNA) 50% neutralization
Secondary outcome measures
Geometric mean titer (GMT) as measured by ELISA anti-PA IgG at Day 15, Day 29, Day 36, Day 43, Day 50, Day 64, Day 85, Day 181, Day 211, Day 366, Day 396, Day 546, and Day 731.
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.
Seroprotection rate as measured by toxin-neutralizing antibody (TNA) 50% neutralization factor (NF50) at Day 15, Day 29, Day 36, Day 43, Day 50, Day 64, Day 85, Day 181, Day 211, Day 366, Day 396, Day 546, and Day 731.
+4 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Half Dose Schedule 2Experimental Treatment1 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 1Experimental Treatment1 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 2Experimental Treatment1 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.
Group IV: Full Dose Schedule 1Experimental Treatment1 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.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Anthrax, particularly vaccines like CYFENDUS™ (AV7909), work by stimulating the immune system to recognize and combat Bacillus anthracis, the bacteria responsible for Anthrax. These vaccines introduce antigens that mimic the bacteria, prompting the body to produce specific antibodies and memory cells. This immune response is crucial for Anthrax patients as it provides long-term protection and helps prevent severe complications associated with the infection. Effective vaccination schedules and booster doses are essential to maintain this immunity over time.

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Who is running the clinical trial?

Biomedical Advanced Research and Development AuthorityLead Sponsor
85 Previous Clinical Trials
540,356 Total Patients Enrolled
4 Trials studying Anthrax
4,827 Patients Enrolled for Anthrax
Rho Federal Systems Division, Inc.Industry Sponsor
41 Previous Clinical Trials
13,401 Total Patients Enrolled
ICON plcIndustry Sponsor
83 Previous Clinical Trials
26,654 Total Patients Enrolled

Media Library

AV7909 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05997264 — Phase 2
Anthrax Research Study Groups: Half Dose Schedule 1, Full Dose Schedule 1, Full Dose Schedule 2, Half Dose Schedule 2
Anthrax Clinical Trial 2023: AV7909 Highlights & Side Effects. Trial Name: NCT05997264 — Phase 2
AV7909 (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05997264 — Phase 2
~139 spots leftby Jul 2025