A Phase 2 Safety and Immunogenicity Study for an Anthrax Vaccine Using 3 Schedules and Two Dose Levels

NCT01770743 | Completed Phase 2 Results DMC

• 2 other identifiers: EBS.AVA.208 / DMID 11-0055HHSN272201000035C
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this study is to assess the safety and immunogenicity of an anthrax vaccine. The vaccine schedule and dose will also be assessed.

Conditions

Anthrax

Keywords

post-exposure prophylaxis; toxin neutralization assay

Outcome Measures

Primary Outcomes (6)

• Toxin Neutralizing Antibody (TNA) Level at Day 63

  Immunogenicity measured by the lower bound (LB) of the 95% confidence intervals (CIs) for the proportion of subjects in each study arm with Day 63 TNA 50% neutralization factor (NF50) values greater than or equal to threshold

  Day 63

• Incidence of Adverse Events

  Incidence of adverse events (including assessment of symptoms, physical exam findings, clinical laboratory tests, and vital signs) from the time of the first immunization on Day 0 through Day 84

  From the time of the first immunization on Day 0 through Day 84

• Incidence of Serious Adverse Events

  Incidence of serious adverse events, from the time of the first immunization on Day 0 through the 12-month safety follow-up telephone call following the last scheduled vaccination

  From the time of the first immunization on Day 0 through the 12-month safety follow-up telephone call following the last scheduled vaccination

• Incidence of Reactogenicity By Severity

  Incidence of solicited systemic reactions and solicited injection site reactions each day for 7 days following each vaccination using subject e-diaries by severity. Reactions were graded using the following scale (note, for redness and swelling, the diameter \[greater of two perpendicular measurements\] was assessed by the subject using an injection site measurement tool): Grade 0 (Absent): Symptom not present; Grade 1 (Mild): Symptom present but does not interfere with activities of daily living, or affected area (redness, swelling) measures \<3 cm; Grade 2 (Moderate): Symptom causes some interference with activities of daily living, or affected area (redness, swelling) measures 3 - 10 cm; Grade 3 (Severe): Symptom prevents activities of daily living or requires treatment, or affected area (redness, swelling) measures \> 10 cm. For each reaction, subjects are counted once across all vaccinations at the highest reported level of severity.

  For 7 days following each vaccination on Days 0, 14, 28

• Incidence of Clinical Laborabory Abnormalities

  Incidence of clinical laboratory abnormalities throughout the study (up to Day 84). Clinical laboratory abnormalities are presented as the total of Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), and Grade 4 (potentially life-threatening) abnormalities according to criteria adapted from the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research: Guidance for Industry. Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (September 2007). Within each laboratory parameter, subjects are counted once for their most severe occurrence of clinical laboratory abnormality.

  From the time of first immunization on Day 0 to Day 84

• Incidence of Immunologically Significant Adverse Events of Special Interest

  Incidence of immunologically significant adverse events of special interest as defined by the Center for Biologics Evaluation and Research from the time of the first immunization on Day 0 through the 12-month safety follow-up telephone call following the last scheduled vaccination

  From the time of the first immunization on Day 0 through the 12-month safety follow-up telephone call following the last scheduled vaccination

Secondary Outcomes (3)

• TNA Level at Day 42

  Day 42

• TNA Level at Day 28

  Day 28

• TNA Seroconversion Rate

  Up to Day 84

Study Arms (5)

AV7909 (Day 0 and 14)

EXPERIMENTAL

Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 14

Biological: AV7909

AV7909 (Day 0 and 28)

EXPERIMENTAL

Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 28

Biological: AV7909

AV7909 (Day 0, 14, and 28)

EXPERIMENTAL

Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28

Biological: AV7909

AV7909 Reduced Dose

EXPERIMENTAL

Route of administration: Intramuscular Dose: 0.25 mL Schedule: Day 0, Day 14,and Day 28

Biological: AV7909

BioThrax

ACTIVE COMPARATOR

Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28

Biological: BioThrax

Interventions

AV7909 BIOLOGICAL

Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant

Also known as: AV7909 Anthrax Vaccine, NuThrax

AV7909 (Day 0 and 14); AV7909 (Day 0 and 28); AV7909 (Day 0, 14, and 28); AV7909 Reduced Dose

BioThrax BIOLOGICAL

Also known as: Anthrax Vaccine Adsorbed (AVA)

BioThrax

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Be 18-50 years old
• Be in good health
• Have access to a computer and the internet so you can complete a diary
• Agree to abstain from sex the first 84 days of the study or practice birth control if you are a woman who is able to get pregnant
• Have not donated blood for the previous 8 weeks

You may not qualify if:

• A known anaphylactic response, severe systemic response, or serious hypersensitivity reaction to a prior immunization.
• A history of latex allergy.
• Have received a shot (vaccine), including flu shots, in the past 6 weeks or plan to get a shot for 4 weeks after the last study shot is given.
• Have previously served in the military any time after 1990 or plan to enlist in the military from Screening through Day 84.
• Prior immunization with anthrax vaccine, recombinant protective antigen (rPA) vaccine, or known exposure to anthrax organisms.
• Have participated in anthrax therapeutic or vaccine studies (monoclonal anti-PA or anthrax immune globulins or anthrax vaccines).
• Participation in any investigational study involving use of a pharmacological intervention within 30 days before the Screening visit or planning to participate in a study requiring dosing through the 12-month safety follow-up telephone call.
• Have a known diagnosis of any immunodeficiency disease including but not limited to: acquired immune deficiency syndrome (AIDS), common variable immunodeficiency disease, immunoglobulin A (IgA) deficiency, or hypogammaglobulinemia.
• Past history of significant autoimmune disease such as rheumatoid arthritis, lupus erythematous, psoriasis in the area of vaccinations, or requires immunotherapy, glomerulonephritis, or autoimmune thyroiditis.
• Have received immunosuppressive therapy with cytotoxic drugs or Rituximab within the past 2 years.
• A history of cytotoxic chemotherapy or radiation therapy.
• Chronic (\>10 days) daily oral or parenteral corticosteroid therapy in the past 12 months.
• Any lung disease, including reactive airway disease, which requires the daily use of medications.
• A female currently breastfeeding or with a positive pregnancy test.
• A history of drug or alcohol abuse within 12 months prior to Screening, or a positive result on a urine drug screen for cocaine, marijuana, opiates, methamphetamines, benzodiazepines, or oxycodone.

Sponsors & Collaborators

• Emergent BioSolutions: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (4)

Miami Research Associates

Miami, Florida, 33143, United States

Location

Costal Carolina Research

Mt. Pleasant, South Carolina, 29464, United States

Location

Central Texas Allergy and Asthma

New Braunfels, Texas, 78130, United States

Location

Jean Brown Research

Salt Lake City, Utah, 84124, United States

Location

MeSH Terms

Conditions

Anthrax

Interventions

Biothrax; Anthrax Vaccines

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures

Limitations and Caveats

A few events collected in e-diary were downgraded (severe to moderate) on verification by the PI but were unable to be corrected in subjects' e-diary data: headache \& fatigue/tenderness in 2 subjects each; muscle ache \& pain \& AML in 1 subject each.

Results Point of Contact

• Title: Dr. Gurdyal Kalsi
• Organization: Emergent BioSolutions

kalsig@ebsi.com

301-216-9927

Study Officials

• Gurdyal Kalsi, MD, MTOPRA

  Emergent BioSolutions

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2013
• First Posted: January 18, 2013
• Study Start: January 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: December 1, 2014
• Last Updated: March 18, 2024
• Results First Posted: February 24, 2015

Record last verified: 2024-03

Locations

US (4)