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Vaccine
Anthrax Vaccine for Anthrax Prevention
Phase 1
Waitlist Available
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be a male or non-pregnant female, 18 to 45 years of age, inclusive, at the time of enrollment.
Be a male or non-pregnant female, 18 to 45 years of age, inclusive, at the time of enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 through day 380
Awards & highlights
Study Summary
This trial is testing a new anthrax vaccine to see if it is safe and effective. The vaccine will be given to 40 healthy adults in 2 doses. Safety will be assessed by monitoring for side effects. The vaccine's effectiveness will be measured by how well it produces antibodies to the anthrax bacteria.
Who is the study for?
Healthy adults aged 18-45 with stable blood pressure, BMI ≤35.0 kg/m2, and normal lab results can join this anthrax vaccine trial. Women must use contraception and have negative pregnancy tests before vaccinations. Participants cannot have acute illnesses or conditions that the study doctor thinks are unsuitable for the trial.Check my eligibility
What is being tested?
The study is testing two forms of an anthrax vaccine (AV7909): a lyophilized (freeze-dried) version versus a liquid form. Forty participants will be randomly assigned to receive one of these vaccines in a double-blind setup, meaning neither they nor the researchers know who gets which form.See study design
What are the potential side effects?
Possible side effects include reactions at the injection site, general body reactions like fever or fatigue within a week after vaccination, and potentially immune-mediated medical conditions. Safety is monitored through reports of adverse events and laboratory evaluations.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 45 years old and not pregnant.
Select...
I am between 18 and 45 years old and not pregnant.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 through day 380
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 through day 380
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Occurrence of all Adverse Events of Special Interest (AESIs)
Occurrence of all Medically-Attended Adverse Events (MAAEs)
Occurrence of all Serious Adverse Events (SAEs)
+4 moreSecondary outcome measures
Geometric mean titer (with 95% confidence interval) of anti-protective antigen (PA) immunoglobulin G (IgG) antibodies
Geometric mean titer (with 95% confidence interval) of toxin neutralizing antibodies
Proportion (with 95% confidence interval) of participants with putative seroprotection
+2 moreSide effects data
From 2020 Phase 3 trial • 3862 Patients • NCT038779263%
Injection site pain
2%
Urinary tract infection
2%
Vaccination complication
2%
Upper respiratory tract infection
2%
Procedural headache
2%
Back pain
1%
Diarrhoea
1%
Injection site induration
1%
Influenza
1%
Nasopharyngitis
1%
Headache
1%
Musculoskeletal procedural complication
100%
80%
60%
40%
20%
0%
Study treatment Arm
AV7909 Lot 1
BioThrax
AV7909 Lot 2
AV7909 Lot 3
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Group 1Experimental Treatment1 Intervention
AV7909 liquid formulation will be administered 0.5mL intramuscularly in a 2-dose schedule, 2 weeks apart (on Day 1 and Day 15). N=20
Group II: Group 2Active Control1 Intervention
AV7909 lyophilized formulation will be administered 0.5mL intramuscularly in a 2-dose schedule, 2 weeks apart (on Day 1 and Day 15). N=20
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AV7909
2019
Completed Phase 3
~4590
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,268 Previous Clinical Trials
5,481,091 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can have blood drawn without difficulty.I have not been sterilized and am still having periods or am less than a year into menopause.I am breastfeeding or plan to breastfeed during the study vaccination period and up to 30 days after.I am between 18 and 45 years old and not pregnant.I have not been hospitalized for psychiatric reasons or posed a danger to myself or others in the last 5 years.I can follow the study plan and attend all visits.I am using birth control and will continue for 60 days after my last study vaccine.I have or recently had cancer or a blood-related cancer.I am currently immunosuppressed due to illness or treatment.I haven't had chemotherapy or radiation in the last 3 years.I have HIV, chronic hepatitis B, or hepatitis C.I have received or plan to receive an anthrax vaccine during this study.I have received or will receive a standard vaccine within 2 weeks of the study vaccine.I have not and will not get a live vaccine around the time of the study vaccination.I have not received blood products, except for Rho(D) immunoglobulin, in the last 90 days.I plan to donate blood within 4 months after my second vaccine dose.I am planning to have surgery while participating in the study.I can have blood drawn without difficulty.I am between 18 and 45 years old and not pregnant.I am in good health overall.I am using birth control and will continue for 60 days after my second study vaccine.I am using effective birth control or am not sexually active with a male partner.I have been diagnosed with or exposed to anthrax.I can follow the study's procedures and attend all visits.I have taken a pregnancy test and it was negative before receiving the study vaccine.You need to be in overall good health.
Research Study Groups:
This trial has the following groups:- Group 1: Group 2
- Group 2: Group 1
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.
Who can enroll in this clinical research endeavor?
"Candidates for this medical trial must have a confirmed diagnosis of anthrax and be 18 to 45 years old. Currently, the study is searching for 41 enrollees in total."
Answered by AI
Is the age limit for participation in this clinical trial above thirty years?
"The criteria for participation in this clinical trial requires applicants to be aged between 18 and 45. There are additional trials available for those under 18, and over 65 respectively."
Answered by AI
To what outcome is this exploration aspiring?
"This trial, to be monitored over the course of 29 days, aims to measure the prevalence of injection-site reactogenicity events. Secondary goals involve assessing seroconversion with ELISA and TNA assays as well as calculating geometric mean titer for toxin neutralizing antibodies relative to baseline levels before vaccination."
Answered by AI
What potential risks does AV7909 pose to individuals?
"The safety of AV7909 has been determined to be a 1 due to Phase 1 trial data which suggests that the efficacy and safety of this drug is still under evaluation."
Answered by AI
Are enrollments still open for this clinical study?
"According to clinicaltrials.gov, recruitment for this study has been suspended since December 1st 2022. The initial posting date was May 25th 2022. Although this trial is not accepting patients at the moment, 3 other research projects are actively seeking participants."
Answered by AI
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