New anthrax vaccine shows promise in large trial

NCT ID NCT03877926

Vaccine Sponsor: Emergent BioSolutions Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial tested a new anthrax vaccine called AV7909 in nearly 3,700 healthy adults. The vaccine aims to protect people after they have been exposed to anthrax bacteria. Results showed that AV7909 produced a strong immune response and was safe, similar to the current licensed vaccine BioThrax.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: AV7909 (anthrax vaccine with adjuvant)
What this could lead to: If successful, this could provide a more effective vaccine to protect people after exposure to anthrax bacteria.
What could go wrong: This is a completed Phase 3 trial, but real-world effectiveness and long-term safety are still being studied. The vaccine is tested in healthy adults, not in people actually exposed to anthrax.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

3,689 people

The number who actually took part.

Started

Mar 2019

Finished

Aug 2020

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Written informed consent obtained from the participant (dated and signed). 2. Healthy condition as established by medical history and clinical examination before entering into the study. 3. A male or female aged 18 to 65 years, inclusive, at the time of informed consent. 4. Body mass index (BMI) ≤35.0 kg/m\^2 at Screening visit. 5. Have adequate venous access for phlebotomies. 6. For a woman of childbearing potential (WOCBP), negative serum pregnancy test at Screening and negative urine pregnancy test prevaccination on Day 1, not currently breastfeeding, and no intention to become pregnant during the study through Month 13. Every female participant is considered to be a WOCBP unless surgically sterile (bilateral oophorectomy or bilateral salpingectomy or hysterectomy) OR postmenopausal (defined as \>12 consecutive months without menses and screening follicle-stimulating hormone \>30 mIU/mL). Women who are not of childbearing potential are allowed to enroll if they are surgically sterile or postmenopausal as defined above. Exclusion Criteria: 1. Use of any investigational or nonregistered product (drug, vaccine, device, or combination product) within 30 days preceding the dose of study vaccine, or planned use during the study through Month 13. 2. Positive test result on urine drug screen, any evidence of ongoing drug abuse or dependence (including alcohol), or recent history (over the past five years) of treatment for alcohol or drug abuse. 3. Chronic administration (defined as \>14 days) of immunosuppressants or other immune-modifying drugs (includes oral or parenteral corticosteroids, for example, a glucocorticoid dose exceeding 10 mg/day prednisone or equivalent) within six months prior to the vaccine dose; inhalation use (for example, for seasonal allergies) is permitted. 4. Planned administration of any commercially-available vaccine from seven days prior to the first study vaccination through two weeks after the last vaccination. 5. Previous anaphylactic reaction, severe systemic response, or serious hypersensitivity to a prior immunization or a known allergy to synthetic Oligodeoxynucleotides, aluminum, formaldehyde, benzethonium chloride (phemerol), or latex. 6. History of anthrax disease, suspected exposure to anthrax, or previous vaccination with any anthrax vaccine. 7. Have a tattoo/scar/birthmark or any other skin condition affecting the deltoid area that may interfere with injection site assessments. 8. A positive blood test for hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus (HIV) HIV-1 or HIV-2 antibodies. 9. Any confirmed or suspected immunodeficiency condition (congenital or secondary) or autoimmune disease based on medical history and Physical Exam, for example, Guillain-Barré. 10. A family history of congenital or hereditary immunodeficiency. 11. Major congenital defects or serious chronic illness, including any cancer other than the following: a) any non-metastatic cancer (excluding hematologic malignancies) or melanoma of which the participant has been disease-free for at least five years and b) localized skin cancer, resected (including squamous cell and basal cell carcinomas). 12. Acute disease at the time of enrollment. Note that screening lab tests may be delayed to allow the resolution of a transient acute condition or the subject may be rescreened. 13. Any medical condition that, in the opinion of the investigator, could adversely impact the participant's participation or the conduct of the study. 14. Any planned elective surgery during the study through 12 months after the last vaccination. 15. Planned receipt of immunoglobulins and/or any blood products within the three months preceding study enrollment or at any point during the study period until after the final safety phone contact. 16. Woman of childbearing potential refusing to practice an adequate method of contraception from at least one month before Day 1 and continuing through Month 13. An adequate method of contraception is defined as abstinence from sexual intercourse; prior bilateral tubal ligation; monogamous relationship with a vasectomized partner (vasectomy performed at least six months prior to the participant's screening visit); or any of these forms of birth control: pill, intrauterine device (IUD), implantable or injectable contraceptive (for example, Norplant® or Depo-Provera®), removable device (for example, NuvaRing® or Evra® patch), or double-barrier method (condom with spermicide, diaphragm with spermicide). The Principal Investigator and/or designee will discuss with the participant the need to use adequate contraception consistently and correctly and document such conversation in the participant's chart. In addition, the Principal Investigator and/or designee will instruct the participant to call immediately if the selected contraception method is discontinued or if pregnancy is known or suspected. 17. Member or family member of the investigator site team. 18. Previously served in the military any time after 1990 and/or plan to enlist in the military at any time from screening through the final telephone contact.

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Conditions

The condition(s) this trial relates to.

anthrax infection prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anthrax

Contacts and locations

Locations

Achieve Clinical Research, LLC

Birmingham, Alabama, 35216, United States
Advanced Clinical Research

Boise, Idaho, 83642, United States
Advanced Clinical Research

West Jordan, Utah, 84088, United States
Aventiv Research Inc.

Grove City, Ohio, 43123, United States
Benchmark Research

Fort Worth, Texas, 76135, United States
Benchmark Research New Orleans

Metairie, Louisiana, 70006, United States
Benchmark Research San Angelo

San Angelo, Texas, 76904, United States
California Research Foundation

San Diego, California, 92103, United States
Central Phoenix Medical Clinic, LLC

Phoenix, Arizona, 85020, United States
Christie Clinic, LLC

Champaign, Illinois, 61820, United States
Clinical Research Associates, Inc.

Nashville, Tennessee, 37203, United States
Clinical Research Center of Nevada LLC

Las Vegas, Nevada, 89104, United States
Clinical Research Consortium, an AMR company

Tempe, Arizona, 85283, United States
Coastal Carolina Research Center, Inc

Mt. Pleasant, South Carolina, 29464, United States
Coastal Clinical Research, an AMR company

Mobile, Alabama, 36608, United States
Heartland Research Associates, LLC

Augusta, Kansas, 67010, United States
Heartland Research Associates, LLC

Wichita, Kansas, 67205, United States
Hutchinson Clinic

Hutchinson, Kansas, 67502, United States
Johnson County Clin-Trials, LLC

Lenexa, Kansas, 66219, United States
Lynn Institute of Norman

Norman, Oklahoma, 73072, United States
Martin Diagnostic Clinic

Tomball, Texas, 77375, United States
Meridian Clinical Research, LLC

Savannah, Georgia, 31406, United States
Meridian Clinical Research, LLC

Omaha, Nebraska, 68134, United States
New Horizon Research Center, Inc

Miami, Florida, 33175, United States
Optimal Research, LLC

Huntsville, Alabama, 35802, United States
Optimal Research, LLC

San Diego, California, 92108, United States
Optimal Research, LLC

Melbourne, Florida, 32934, United States
Optimal Research, LLC

Peoria, Illinois, 61614, United States
Optimal Research, LLC

Rockville, Maryland, 20850, United States
Rapid Medical Research, Inc.

Cleveland, Ohio, 44122, United States
Research Centers of America

Hollywood, Florida, 33024, United States
Spartanburg Medical Research

Spartanburg, South Carolina, 29303, United States
Tekton Research

Austin, Texas, 78745, United States
The Center for Pharmaceutical Research, an AMR company

Kansas City, Missouri, 64114, United States
The Iowa Clinic, PC

West Des Moines, Iowa, 50266, United States

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