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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 7 days after each ip administration.
Awards & highlights
ABESt Trial 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.
ABESt Trial 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:ABESt Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 7 days after each ip administration.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 7 days after each ip administration.
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 moreABESt 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.
Find a Location
Who is running the clinical trial?
Biomedical Advanced Research and Development AuthorityLead Sponsor
82 Previous Clinical Trials
909,537 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
81 Previous Clinical Trials
24,994 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: Full Dose Schedule 2
- Group 2: Full Dose Schedule 1
- Group 3: Half Dose Schedule 1
- 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the age limit of this clinical trial greater than 80 years?
"This trial will consider patients aged 18 and above, but not those over 65."
Answered by AI
Am I eligible to participate in this experiment?
"Qualified applicants for this trial must be afflicted with anthrax and aged between 18-65. It is expected that a total of 220 participants will be recruited."
Answered by AI
Has the FDA sanctioned Full Dose Schedule 1?
"Due to the Phase 2 status, our team has assigned Full Dose Schedule 1 a safety rating of 2 out of 3. This means there is existing data that attests to its security, yet efficacy remains untested at this stage."
Answered by AI
Are there any vacancies available to join this clinical trial?
"According to clinicaltrials.gov, the trial that was initially posted on September 1st 2023 is no longer actively recruiting patients and has not been updated since August 10th 2023. Nonetheless, there are 3 other active studies currently open for enrollment."
Answered by AI
How many locations are hosting this investigation?
"Accellacare of Salisbury, Statesville, and Winston-Salem are 3 of 6 available clinical sites, with the remaining three being situated in different cities."
Answered by AI
Who else is applying?
What site did they apply to?
Accellacare of Salisbury
Other
Accellacare of Winston-Salem
Accellacare Knoxville
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Why did patients apply to this trial?
I saw it online. Make extra money. I need the money. Saw it on Facebook. For the greater good.
PatientReceived 2+ prior treatments
How responsive is this trial?
Most responsive sites:
- Accellacare Knoxville: < 24 hours
- Accellacare of Piedmont: < 24 hours
- Accellacare of Hickory: < 24 hours
Typically responds via
Phone Call
Average response time
- < 2 Days
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