This study is designed to assess the safety and ability of BioThrax and AV7909 anthrax vaccines to generate an immune response in adults ≥ 66 years of age in stable health in comparison to adults 18-50 years of age in stable health.
This is a phase 2, randomized, active-controlled, double-blinded, multi-site study to assess the safety and immunogenicity of BioThrax (Anthrax Vaccine Adsorbed) and AV7909 (Anthrax Vaccine Adsorbed plus CPG 7909 adjuvant) using a post-exposure prophylaxis dosing regimen in adults ≥ 66 years of age in stable health. The safety and immunogenicity profile of BioThrax and AV7909 in adults ≥ 66 years of age will also be compared to the safety and immunogenicity profile of subjects 18-50 years of age in stable health. The main study goal is to determine optimal dosing for AV7909 in the elderly population. Subjects will receive either 3 doses of BioThrax, 3 doses of AV7909, or 2 doses of AV7909 and 1 dose of placebo. Doses will be administered approximately 14 days apart. Subjects will be followed for safety assessment for 12 months following the last dose. The expected study duration is approximately 14 months per subject.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
305
Johnson County Clin-Trials
Lenexa, Kansas, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, United States
Clinical Research Associates, Inc.
Nashville, Tennessee, United States
JBR Clinical Research
Salt Lake City, Utah, United States
Solicited Local Reactogenicity Symptoms
Count of participants who experienced at least one of the following during the time frame specified on the arm which received the vaccination: injection site warmth, tenderness, itching, pain, restriction of range of arm motion, erythema/redness, palpable or observable lump, induration/swelling, or bruising.
Time frame: Day 1-8, Day 15-22, Day 29-36 (within 8 days of each vaccination, inclusive of the vaccination day)
Solicited Systemic Reactogenicity Symptoms
Count of participants who experienced at least one of the following during the time frame specified on the arm which received the vaccination: fatigue, myalgia/muscle ache, headache, and fever.
Time frame: Day 1-8, Day 15-22, Day 29-36 (within 8 days of each vaccination, inclusive of the vaccination day)
Seroprotection Based on Toxin Neutralization Antibody (TNA) 50% Neutralization Factor (NF50) Antibody Level, Defined as a TNA NF50 Antibody Level ≥0.56
The percentage of participants achieving seroprotection based on TNA NF50. A 70% probability of survival was associated with a TNA NF50 level of 0.56 in rabbits exposed to Bacillus anthracis, the bacteria that causes anthrax.
Time frame: Day 64
Treatment-emergent Unsolicited Adverse Events (AEs)
The count of participants who experienced at least one post-vaccination unsolicited AE (i.e. AEs not included in the solicited local and systemic adverse event list through Day 50 and those reported as a serious AE, medically attended adverse event (MAAE), or potentially immune-mediated medical condition (PIMMC) after Day 50).
Time frame: Day 1 through Day 394
Treatment-emergent Serious Adverse Events (SAEs)
The count of participants who experienced at least one post-vaccination SAE
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Time frame: Day 1 through Day 394
Treatment-emergent Medically Attended Adverse Events (MAAEs)
Count of participants who experienced at least one adverse event that requires a visit to medical personnel, including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason occurring post-vaccination.
Time frame: Day 1 through Day 394
Treatment-emergent Potentially Immune Mediated Medical Conditions (PIMMCs)
Count of participants who experienced at least one medical condition that was potentially immune mediated occurring post-vaccination
Time frame: Day 1 through Day 394
Solicited Local Reactogenicity Symptoms on the Contralateral Arm
Count of participants who experienced at least one of the following during the time frame specified on the arm which did not receive the vaccination: injection site warmth, tenderness, itching, pain, restriction of range of arm motion, erythema/redness, palpable or observable lump, induration/swelling, or bruising.
Time frame: Day 1-8, Day 15-22, Day 29-36 (within 8 days of each vaccination, inclusive of the vaccination day)
TNA NF50 Antibody Levels
A higher TNA NF50 antibody level means a better immune response to the vaccine.
Time frame: Days 1, 8, 22, 29, 36, 43, 50, 64, 85, 181, and 394
TNA Effective Dilution Resulting in 50% Neutralization (ED50) Antibody Levels
A higher TNA ED50 antibody level means a better immune response to the vaccine.
Time frame: Days 1, 8, 22, 29, 36, 43, 50, 64, 85, 181, and 394
Enzyme-linked Immunosorbent Assay (ELISA) Anti-protective Antigen (Anti-PA) Immunoglobulin G (IgG) Antibody Levels
A higher ELISA anti-PA IgG antibody level means a better immune response to the vaccine.
Time frame: Days 1, 8, 22, 29, 36, 43, 50, 64, 85, 181, and 394
Seroprotection Based on TNA NF50, Defined as a TNA NF50 Antibody Level ≥0.56
The percentage of participants achieving seroprotection based on TNA NF50 antibody level. A 70% probability of survival was associated with a TNA NF50 level of 0.56 in rabbits exposed to Bacillus anthracis, the bacteria that causes anthrax.
Time frame: Days 1, 8, 22, 29, 36, 43, 50, 85, 181, and 394
Seroconversion Based on TNA NF50, Defined as a ≥4-fold Increase Over Pre-vaccination Levels, or a ≥4-fold Increase Over the Lower Limit of Quantification (LLOQ) if the Pre-vaccination Value is Below the LLOQ
The percentage of subjects obtaining seroconversion based on TNA NF50 antibody levels. Seroconversion represents the minimum intended effect of vaccination.
Time frame: Days 8, 22, 29, 36, 43, 50, 64, 85, 181, and 394
Seroconversion Based on TNA ED50, Defined as a ≥4-fold Increase Over Pre-vaccination Levels, or a ≥4-fold Increase Over the Lower Limit of Quantification (LLOQ) if the Pre-vaccination Value is Below the LLOQ
The percentage of subjects obtaining seroconversion based on TNA ED50 antibody levels. Seroconversion represents the minimum intended effect of vaccination.
Time frame: Days 8, 22, 29, 36, 43, 50, 64, 85, 181, and 394
Seroconversion Based on ELISA Anti-PA IgG, Defined as a ≥4-fold Increase Over Pre-vaccination Levels, or a ≥4-fold Increase Over the Lower Limit of Quantification (LLOQ) if the Pre-vaccination Value is Below the LLOQ
The percentage of subjects obtaining seroconversion based on ELISA anti-PA IgG antibody levels. Seroconversion represents the minimum intended effect of vaccination.
Time frame: Days 8, 22, 29, 36, 43, 50, 64, 85, 181, and 394