CompletedPhase 3

VELOCITY: An Anthrax Vaccine Clinical Study

United States3,689 participantsStarted 2019-03-11

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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

Timeframe: 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

Timeframe: Day 64 (seven weeks after second AV7909 vaccination)

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

Timeframe: Day 64 (seven weeks after second AV7909 vaccination)

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

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

Incidence of Serious Adverse Events

Timeframe: Day 1 though Day 394

Trial details

NCT IDNCT03877926

SponsorEmergent BioSolutions

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-08-06

Results submitted2021-07-08

View on ClinicalTrials.gov More Anthrax trials

Plain-language summary

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.