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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 belowExclusion 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.
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 moreAwards & 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.
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
92 Previous Clinical Trials
553,432 Total Patients Enrolled
4 Trials studying Anthrax
4,827 Patients Enrolled for Anthrax
Rho Federal Systems Division, Inc.Industry Sponsor
43 Previous Clinical Trials
14,749 Total Patients Enrolled
ICON plcIndustry Sponsor
85 Previous Clinical Trials
28,256 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had nerve pain, tingling, seizures, or brain inflammation recently or a family history of Guillain-Barré syndrome.I am taking herbal medicines that affect my immune system.I am between 18 and 65 years old and not pregnant.My EKG shows signs of heart issues.I have had anthrax, been exposed to it, or been vaccinated against it.I have not received any vaccines in the last 30 days.I do not have any active cancer except for skin cancer.I am pregnant or breastfeeding.I have recently been diagnosed with or have poorly controlled HIV.I have been diagnosed with hepatitis B or C.I have used corticosteroids in the last 30 days.I am immunosuppressed due to a condition, medication, chemotherapy, or radiation.
Research Study Groups:
This trial has the following groups:- Group 1: Half Dose Schedule 1
- Group 2: Full Dose Schedule 1
- Group 3: Full Dose Schedule 2
- Group 4: Half Dose Schedule 2
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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