What side effects are associated with this type of intervention?

The most common side effects of anthrax vaccines, such as CYFENDUS™ (AV7909), include injection site reactions like pain, redness, and swelling. Systemic side effects may include mild fever, fatigue, headache, and muscle aches. These side effects are generally mild and temporary. Serious adverse events are rare but can include severe allergic reactions.

What prior FDA approvals exist?

The FDA has approved several vaccines for the prevention of Anthrax, primarily focusing on stimulating an immune response. The most notable is the Anthrax Vaccine Adsorbed (AVA), marketed as BioThrax, which has been used for pre-exposure prophylaxis in individuals at high risk of exposure. BioThrax works by stimulating the immune system to produce antibodies against the protective antigen component of Bacillus anthracis. Similar to CYFENDUS™ (AV7909), these vaccines aim to enhance the body's immune response to prevent infection.

What other types of research exist?

Currently, there are no specific alternatives to CYFENDUS™ (AV7909) mentioned in the provided context for Anthrax treatment. Patients should consult with their healthcare provider to discuss the latest available treatments and ongoing clinical trials for Anthrax.

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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

No Placebo-Only Group

Summary

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.

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 1 year after the last ip administration.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 4Eligibility criteria met

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.