VELOCITY: An Anthrax Vaccine Clinical Study

NCT03877926 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: EBS.AVA.212
• Study Type: interventional
• Target: 3,689
• Locations: 1 country
• Sites: 35

Brief Summary

This study is designed to evaluate the lot consistency (using three consecutively manufactured lots), safety, and ability of the AV7909 anthrax vaccine to generate an immune response in healthy adults and compare the response to that induced by the currently licensed vaccine, BioThrax®, (Anthrax Vaccine Adsorbed; AVA) for post-exposure of anthrax disease.

Conditions

Anthrax

Keywords

Anthrax; AV7909; BioThrax; Bacillus anthracis; Anthrax Vaccine Adsorbed; Post-exposure Prophylaxis; Vaccine; CPG 7909; Adjuvant

Outcome Measures

Primary Outcomes (5)

• Geometric Mean Titer (GMT) of Toxin Neutralizing Antibody (TNA) 50% Neutralization Factor (NF50) at Day 64

  GMT of TNA NF50 at Day 64 in AV7909 study groups (Lots 1, 2 and 3) and BioThrax group. The outcome measure in AV7909 study groups was assessed for AV7909 lot-to-lot consistency, which was based on GMT TNA NF50 response at Day 64, wherein the 95% confidence interval (CI) for ratios of geometric mean titer (GMT) of TNA NF50 at Day 64 (seven weeks after second AV7909 vaccination) for each of the three AV7909 lot-to-lot comparisons had to be within equivalence margin of 0.5 and 2.0.

  Day 64 (seven weeks after second AV7909 vaccination)

• Percentage of Participants in AV7909 Lot 1, Lot 2 and Lot 3 Groups Achieving a TNA NF50 ≥0.56 on Day 64

  Proportion of participants with TNA NF50 ≥0.56 at Day 64 in each AV7909 study groups (Lot 1, Lot 2, Lot 3). The assessment of the immune response in each study group was pre-defined as the lower bound of the two-sided 95% CI to be ≥40% for the percentage of AV7909 participants in each of the three lots achieving a TNA NF50 ≥0.56 at seven weeks after second AV7909 vaccination (Day 64).

  Day 64 (seven weeks after second AV7909 vaccination)

• Percentage of AV7909 Participants Achieving a TNA NF50 ≥0.56 on Day 64

  Percentage of AV7909 participants (from all three AV7909 study groups pooled) achieving a TNA NF50 ≥0.56 on Day 64 (seven weeks after second AV7909 vaccination). The assessment of the immune response in AV7909 participants was pre-defined as the lower bound of the two-sided 95% CI for proportion of AV7909 participants with TNA NF50 ≥0.56 at Day 64 ≥40%.

  Day 64 (seven weeks after second AV7909 vaccination)

• Percentage of AV7909 Participants and BioThrax Participants With TNA NF50 ≥0.29 at Day 64

  Proportion of AV7909 participants (in each AV7909 study groups) and BioThrax participants who achieved TNA NF50 ≥0.29 at Day 64. Non-inferiority of AV7909 vaccine to BioThrax vaccine at Day 64 was assessed as determined by the two-sided lower bound for the 95% CI of the difference in the percentage of AV7909 participants (three lots pooled) with a TNA NF50 ≥0.29 and the percentage of BioThrax participants with a TNA NF50 ≥0.29 being greater than -15%.

  Day 64 (seven weeks after second AV7909 vaccination; five weeks after third BioThrax vaccination)

• Incidence of Serious Adverse Events

  Number of AV7909 participants or BioThrax participants who received at least one vaccination and reported serious adverse event(s) (SAEs) from the time of the first vaccination on Day 1 through Day 394.

  Day 1 though Day 394

Secondary Outcomes (5)

• Percentage of AV7909 Participants Achieving a TNA NF50 ≥0.15 on Day 29.

  Day 29 (two weeks after second AV7909 vaccination)

• Incidence of Adverse Events

  Day 1 through Day 64

• Incidence of Adverse Events of Special Interest (Events of Autoimmune Etiology)

  Day 1 through Day 394

• Incidence of Solicited Systemic Reactogenicity Events

  Day 1-7, Day 15-21, Day 29-35 (within 7 days after each vaccination, inclusive of the vaccination day)

• Incidences of Solicited Injection Site Reactogenicity Events

  Day 1-7, Day 15-21, Day 29-35 (within 7 days after each vaccination, inclusive of the vaccination day)

Study Arms (4)

AV7909 Lot 1

EXPERIMENTAL

Participants meeting the entry criteria will be randomized 2:2:2:1 to one of four study groups. Groups 1 to 3 will each receive one of the three consecutively manufactured lots of AV7909, per the study visit schedule.

Biological: AV7909

AV7909 Lot 2

EXPERIMENTAL

Participants meeting the entry criteria will be randomized 2:2:2:1 to one of four study groups. Groups 1 to 3 will each receive one of the three consecutively manufactured lots of AV7909, per the study visit schedule.

Biological: AV7909

AV7909 Lot 3

EXPERIMENTAL

Participants meeting the entry criteria will be randomized 2:2:2:1 to one of four study groups. Groups 1 to 3 will each receive one of the three consecutively manufactured lots of AV7909, per the study visit schedule.

Biological: AV7909

BioThrax

ACTIVE COMPARATOR

Participants meeting the entry criteria will be randomized 2:2:2:1 to one of four study groups. In Group 4, one lot of BioThrax® vaccine will be administered, per the study visit schedule.

Biological: BioThrax

Interventions

AV7909 BIOLOGICAL

AV7909 consists of Anthrax Vaccine Adsorbed (AVA) drug substance and CPG 7909 adjuvant. AVA drug substance in AV7909 is similar in composition and manufactured using the same process as commercial BioThrax® vaccine. BioThrax is licensed for post-exposure prophylaxis of anthrax disease. CPG 7909 is an immunostimulatory synthetic oligodeoxynucleotide that functions as an adjuvant. It is designed to induce an enhanced immune response.

AV7909 Lot 1; AV7909 Lot 2; AV7909 Lot 3

BioThrax BIOLOGICAL

BioThrax vaccine (Anthrax Vaccine Adsorbed; AVA) is licensed for post-exposure prophylaxis of anthrax disease.

BioThrax

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent obtained from the participant (dated and signed).
• Healthy condition as established by medical history and clinical examination before entering into the study.
• A male or female aged 18 to 65 years, inclusive, at the time of informed consent.
• Body mass index (BMI) ≤35.0 kg/m\^2 at Screening visit.
• Have adequate venous access for phlebotomies.
• 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.

You may not qualify if:

• 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.
• 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.
• 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.
• Planned administration of any commercially-available vaccine from seven days prior to the first study vaccination through two weeks after the last vaccination.
• 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.
• History of anthrax disease, suspected exposure to anthrax, or previous vaccination with any anthrax vaccine.
• Have a tattoo/scar/birthmark or any other skin condition affecting the deltoid area that may interfere with injection site assessments.
• A positive blood test for hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus (HIV) HIV-1 or HIV-2 antibodies.
• Any confirmed or suspected immunodeficiency condition (congenital or secondary) or autoimmune disease based on medical history and Physical Exam, for example, Guillain-Barré.
• A family history of congenital or hereditary immunodeficiency.
• 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).
• 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.
• Any medical condition that, in the opinion of the investigator, could adversely impact the participant's participation or the conduct of the study.
• Any planned elective surgery during the study through 12 months after the last vaccination.
• 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.

Sponsors & Collaborators

• Emergent BioSolutions: lead
• Biomedical Advanced Research and Development Authority: collaborator

Study Sites (35)

Achieve Clinical Research, LLC

Birmingham, Alabama, 35216, United States

Location

Optimal Research, LLC

Huntsville, Alabama, 35802, United States

Location

Coastal Clinical Research, an AMR company

Mobile, Alabama, 36608, United States

Location

Central Phoenix Medical Clinic, LLC

Phoenix, Arizona, 85020, United States

Location

Clinical Research Consortium, an AMR company

Tempe, Arizona, 85283, United States

Location

California Research Foundation

San Diego, California, 92103, United States

Location

Optimal Research, LLC

San Diego, California, 92108, United States

Location

Research Centers of America

Hollywood, Florida, 33024, United States

Location

Optimal Research, LLC

Melbourne, Florida, 32934, United States

Location

New Horizon Research Center, Inc

Miami, Florida, 33175, United States

Location

Meridian Clinical Research, LLC

Savannah, Georgia, 31406, United States

Location

Advanced Clinical Research

Boise, Idaho, 83642, United States

Location

Christie Clinic, LLC

Champaign, Illinois, 61820, United States

Location

Optimal Research, LLC

Peoria, Illinois, 61614, United States

Location

The Iowa Clinic, PC

West Des Moines, Iowa, 50266, United States

Location

Heartland Research Associates, LLC

Augusta, Kansas, 67010, United States

Location

Hutchinson Clinic

Hutchinson, Kansas, 67502, United States

Location

Johnson County Clin-Trials, LLC

Lenexa, Kansas, 66219, United States

Location

Heartland Research Associates, LLC

Wichita, Kansas, 67205, United States

Location

Benchmark Research New Orleans

Metairie, Louisiana, 70006, United States

Location

Optimal Research, LLC

Rockville, Maryland, 20850, United States

Location

The Center for Pharmaceutical Research, an AMR company

Kansas City, Missouri, 64114, United States

Location

Meridian Clinical Research, LLC

Omaha, Nebraska, 68134, United States

Location

Clinical Research Center of Nevada LLC

Las Vegas, Nevada, 89104, United States

Location

Rapid Medical Research, Inc.

Cleveland, Ohio, 44122, United States

Location

Aventiv Research Inc.

Grove City, Ohio, 43123, United States

Location

Lynn Institute of Norman

Norman, Oklahoma, 73072, United States

Location

Coastal Carolina Research Center, Inc

Mt. Pleasant, South Carolina, 29464, United States

Location

Spartanburg Medical Research

Spartanburg, South Carolina, 29303, United States

Location

Clinical Research Associates, Inc.

Nashville, Tennessee, 37203, United States

Location

Tekton Research

Austin, Texas, 78745, United States

Location

Benchmark Research

Fort Worth, Texas, 76135, United States

Location

Benchmark Research San Angelo

San Angelo, Texas, 76904, United States

Location

Martin Diagnostic Clinic

Tomball, Texas, 77375, United States

Location

Advanced Clinical Research

West Jordan, Utah, 84088, United States

Location

Related Publications (1)

• Drobic B, Akintunde G, Kim J, Mirceta M, Beach M, Komlenovic V. Immunogenicity, safety, and lot consistency of the anthrax vaccine adsorbed, adjuvanted for post-exposure prophylaxis of anthrax in healthy adults: A phase 3, randomized, double-blind trial. Vaccine. 2026 Feb 6;72:128068. doi: 10.1016/j.vaccine.2025.128068. Epub 2025 Dec 15.

  PMID: 41401704 DERIVED

MeSH Terms

Conditions

Anthrax

Interventions

Biothrax

Condition Hierarchy (Ancestors)

Bacillaceae Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: Bojan Drobic, Director, Clinical Research
• Organization: Emergent BioSolutions Inc.

bdrobic@ebsi.com

204 275 4196

Study Officials

• Gideon Akintunde, MD

  Emergent BioSolutions

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2019
• First Posted: March 18, 2019
• Study Start: March 11, 2019
• Primary Completion: August 6, 2020
• Study Completion: August 6, 2020
• Last Updated: May 6, 2026
• Results First Posted: December 21, 2021

Record last verified: 2026-04

Locations

US (35)