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VELOCITY: An Anthrax Vaccine Clinical Study

Primary Purpose

Anthrax

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
AV7909
BioThrax
Sponsored by
Emergent BioSolutions
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anthrax focused on measuring Anthrax, AV7909, BioThrax, Bacillus anthracis, Anthrax Vaccine Adsorbed, Post-exposure Prophylaxis, Vaccine, CPG 7909, Adjuvant

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Achieve Clinical Research, LLC
  • Optimal Research, LLC
  • Coastal Clinical Research, an AMR company
  • Central Phoenix Medical Clinic, LLC
  • Clinical Research Consortium, an AMR company
  • California Research Foundation
  • Optimal Research, LLC
  • Research Centers of America
  • Optimal Research, LLC
  • New Horizon Research Center, Inc
  • Meridian Clinical Research, LLC
  • Advanced Clinical Research
  • Christie Clinic, LLC
  • Optimal Research, LLC
  • The Iowa Clinic, PC
  • Heartland Research Associates, LLC
  • Hutchinson Clinic
  • Johnson County Clin-Trials, LLC
  • Heartland Research Associates, LLC
  • Benchmark Research New Orleans
  • Optimal Research, LLC
  • The Center for Pharmaceutical Research, an AMR company
  • Meridian Clinical Research, LLC
  • Clinical Research Center of Nevada LLC
  • Rapid Medical Research, Inc.
  • Aventiv Research Inc.
  • Lynn Institute of Norman
  • Coastal Carolina Research Center, Inc
  • Spartanburg Medical Research
  • Clinical Research Associates, Inc.
  • Tekton Research
  • Benchmark Research
  • Benchmark Research San Angelo
  • Martin Diagnostic Clinic
  • Advanced Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

AV7909 Lot 1

AV7909 Lot 2

AV7909 Lot 3

BioThrax

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
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).
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%.
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%.
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.

Secondary Outcome Measures

Percentage of AV7909 Participants Achieving a TNA NF50 ≥0.15 on Day 29.
Proportion of AV7909 participants (in each AV7909 study group) who achieved TNA NF50 ≥0.15 at Day 29 (two weeks after second AV7909 vaccination). Assessment of the lower bound of the two-sided 95% CI to be ≥67% for the percentage of AV7909 participants in AV7909 study groups 1-3 (Pooled AV7909) achieving a TNA NF50 ≥0.15 on Day 29 was performed.
Incidence of Adverse Events
Number of AV7909 or BioThrax participants who received at least one vaccination and had at least one adverse event reported from the time of the first vaccination on Day 1 through Day 64.
Incidence of Adverse Events of Special Interest (Events of Autoimmune Etiology)
Incidence of adverse events of special interest (AESIs; events of autoimmune etiology) from the time of the first vaccination on Day 1 through Day 394 in participants who received at least one dose of AV7909 (Lot 1, Lot 2 or Lot 3) or BioThrax vaccines.
Incidence of Solicited Systemic Reactogenicity Events
Incidence of any solicited systemic reactogenicity reaction after any AV7909 or BioThrax vaccination.
Incidences of Solicited Injection Site Reactogenicity Events
Incidence of any solicited injection site reactogenicity reaction after any AV7909 (Lots 1, 2 or 3) or BioThrax vaccination.

Full Information

First Posted
March 14, 2019
Last Updated
November 21, 2021
Sponsor
Emergent BioSolutions
Collaborators
Biomedical Advanced Research and Development Authority
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1. Study Identification

Unique Protocol Identification Number
NCT03877926
Brief Title
VELOCITY: An Anthrax Vaccine Clinical Study
Official Title
A Phase 3, Randomized, Double-blind, Parallel-group Trial to Evaluate the Lot Consistency, Immunogenicity, and Safety of AV7909 for Postexposure Prophylaxis of Anthrax in Healthy Adults
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
March 11, 2019 (Actual)
Primary Completion Date
August 6, 2020 (Actual)
Study Completion Date
August 6, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Emergent BioSolutions
Collaborators
Biomedical Advanced Research and Development Authority

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
This is a Phase 3, multicenter, randomized, double-blind, parallel-group trial designed to evaluate the lot consistency (using three consecutively manufactured lots), immunogenicity, and safety of AV7909 administered in healthy adults for an indication of postexposure prophylaxis (PEP) of anthrax. Healthy adults between 18 and 65 years of age (inclusive) will sign and date an informed consent form and then be screened for eligibility for participation in the study 2 to 28 days prior to randomization. Participants meeting the entry criteria will be randomized 2:2:2:1 to one of four study groups on Day 1. Randomization will be stratified by site. Participants will be evaluated for safety through Day 64 [or the early withdrawal visit (EWV)], as assessed by clinical laboratory tests (hematology, serum chemistry, and urinalysis), monitoring of Adverse Events (AE) including Serious Adverse Events (SAE) and Adverse Events of Special Interest (AESI), vital signs, and physical examinations. Adverse Events of Special Interest are adverse events associated with autoimmune disease as defined by the Center for Biologics Evaluation and Research, and might represent a safety signal for vaccine-associated autoimmunity. Reactogenicity (solicited systemic and injection site reactions) will be assessed daily by the participants using electronic diaries (e-diaries) after each vaccination. Information on the use of medications will be collected at each study visit. In addition, blood samples for auto-antibody assessment will be taken at Day 1 predose and Day 64 (or Early Withdrawal Visit). Participants who receive at least one dose of vaccine but who for any reason discontinue vaccinations prematurely will be asked to participate in the further planned study visits up to Day 64 for safety assessment only. Participants who receive at least one dose of vaccine will also be asked to participate in safety follow-up phone calls occurring on Day 43, Month 4, Month 7, Month 10, and Month 13 (nominally 0.5, 3, 6, 9, and 12 months after the last vaccination) to collect information on AEs, SAEs and any potential AESIs. Based on responses at these phone contacts, participants may be asked to return to the clinic for an unscheduled visit to provide blood samples for auto-antibody testing to investigate reports of potential AESIs. Independent safety oversight will be provided by a Data Safety Monitoring Board, which will be notified of significant AEs as determined by the Medical Monitor on an ongoing basis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anthrax
Keywords
Anthrax, AV7909, BioThrax, Bacillus anthracis, Anthrax Vaccine Adsorbed, Post-exposure Prophylaxis, Vaccine, CPG 7909, Adjuvant

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
3862 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AV7909 Lot 1
Arm Type
Experimental
Arm Description
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.
Arm Title
AV7909 Lot 2
Arm Type
Experimental
Arm Description
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.
Arm Title
AV7909 Lot 3
Arm Type
Experimental
Arm Description
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.
Arm Title
BioThrax
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
AV7909
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
BioThrax
Intervention Description
BioThrax vaccine (Anthrax Vaccine Adsorbed; AVA) is licensed for post-exposure prophylaxis of anthrax disease.
Primary Outcome Measure Information:
Title
Geometric Mean Titer (GMT) of Toxin Neutralizing Antibody (TNA) 50% Neutralization Factor (NF50) at Day 64
Description
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.
Time Frame
Day 64 (seven weeks after second AV7909 vaccination)
Title
Percentage of Participants in AV7909 Lot 1, Lot 2 and Lot 3 Groups Achieving a TNA NF50 ≥0.56 on Day 64
Description
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).
Time Frame
Day 64 (seven weeks after second AV7909 vaccination)
Title
Percentage of AV7909 Participants Achieving a TNA NF50 ≥0.56 on Day 64
Description
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%.
Time Frame
Day 64 (seven weeks after second AV7909 vaccination)
Title
Percentage of AV7909 Participants and BioThrax Participants With TNA NF50 ≥0.29 at Day 64
Description
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%.
Time Frame
Day 64 (seven weeks after second AV7909 vaccination; five weeks after third BioThrax vaccination)
Title
Incidence of Serious Adverse Events
Description
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.
Time Frame
Day 1 though Day 394
Secondary Outcome Measure Information:
Title
Percentage of AV7909 Participants Achieving a TNA NF50 ≥0.15 on Day 29.
Description
Proportion of AV7909 participants (in each AV7909 study group) who achieved TNA NF50 ≥0.15 at Day 29 (two weeks after second AV7909 vaccination). Assessment of the lower bound of the two-sided 95% CI to be ≥67% for the percentage of AV7909 participants in AV7909 study groups 1-3 (Pooled AV7909) achieving a TNA NF50 ≥0.15 on Day 29 was performed.
Time Frame
Day 29 (two weeks after second AV7909 vaccination)
Title
Incidence of Adverse Events
Description
Number of AV7909 or BioThrax participants who received at least one vaccination and had at least one adverse event reported from the time of the first vaccination on Day 1 through Day 64.
Time Frame
Day 1 through Day 64
Title
Incidence of Adverse Events of Special Interest (Events of Autoimmune Etiology)
Description
Incidence of adverse events of special interest (AESIs; events of autoimmune etiology) from the time of the first vaccination on Day 1 through Day 394 in participants who received at least one dose of AV7909 (Lot 1, Lot 2 or Lot 3) or BioThrax vaccines.
Time Frame
Day 1 through Day 394
Title
Incidence of Solicited Systemic Reactogenicity Events
Description
Incidence of any solicited systemic reactogenicity reaction after any AV7909 or BioThrax vaccination.
Time Frame
Day 1-7, Day 15-21, Day 29-35 (within 7 days after each vaccination, inclusive of the vaccination day)
Title
Incidences of Solicited Injection Site Reactogenicity Events
Description
Incidence of any solicited injection site reactogenicity reaction after any AV7909 (Lots 1, 2 or 3) or BioThrax vaccination.
Time Frame
Day 1-7, Day 15-21, Day 29-35 (within 7 days after each vaccination, inclusive of the vaccination day)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. 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. Member or family member of the investigator site team. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gideon Akintunde, MD
Organizational Affiliation
Emergent BioSolutions
Official's Role
Study Director
Facility Information:
Facility Name
Achieve Clinical Research, LLC
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
Facility Name
Optimal Research, LLC
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35802
Country
United States
Facility Name
Coastal Clinical Research, an AMR company
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Central Phoenix Medical Clinic, LLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85020
Country
United States
Facility Name
Clinical Research Consortium, an AMR company
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85283
Country
United States
Facility Name
California Research Foundation
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Optimal Research, LLC
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Research Centers of America
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Optimal Research, LLC
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32934
Country
United States
Facility Name
New Horizon Research Center, Inc
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
Meridian Clinical Research, LLC
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
Advanced Clinical Research
City
Boise
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Christie Clinic, LLC
City
Champaign
State/Province
Illinois
ZIP/Postal Code
61820
Country
United States
Facility Name
Optimal Research, LLC
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61614
Country
United States
Facility Name
The Iowa Clinic, PC
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Facility Name
Heartland Research Associates, LLC
City
Augusta
State/Province
Kansas
ZIP/Postal Code
67010
Country
United States
Facility Name
Hutchinson Clinic
City
Hutchinson
State/Province
Kansas
ZIP/Postal Code
67502
Country
United States
Facility Name
Johnson County Clin-Trials, LLC
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66219
Country
United States
Facility Name
Heartland Research Associates, LLC
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67205
Country
United States
Facility Name
Benchmark Research New Orleans
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Optimal Research, LLC
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
The Center for Pharmaceutical Research, an AMR company
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
Facility Name
Meridian Clinical Research, LLC
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
Clinical Research Center of Nevada LLC
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89104
Country
United States
Facility Name
Rapid Medical Research, Inc.
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Aventiv Research Inc.
City
Grove City
State/Province
Ohio
ZIP/Postal Code
43123
Country
United States
Facility Name
Lynn Institute of Norman
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73072
Country
United States
Facility Name
Coastal Carolina Research Center, Inc
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Spartanburg Medical Research
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Clinical Research Associates, Inc.
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Tekton Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
Benchmark Research
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76135
Country
United States
Facility Name
Benchmark Research San Angelo
City
San Angelo
State/Province
Texas
ZIP/Postal Code
76904
Country
United States
Facility Name
Martin Diagnostic Clinic
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375
Country
United States
Facility Name
Advanced Clinical Research
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States

12. IPD Sharing Statement

Learn more about this trial

VELOCITY: An Anthrax Vaccine Clinical Study

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