Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03877926
Study type Interventional
Source Emergent BioSolutions
Contact
Status Completed
Phase Phase 3
Start date March 11, 2019
Completion date August 6, 2020

See also
  Status Clinical Trial Phase
Completed NCT00114621 - Anthrax Vaccine Clinical Trials Phase 1
Recruiting NCT00050310 - Natural History of Anthrax: a Study of Primary Infected, Recovered, and Exposed Individuals (SPoRE); and Evaluation of AVA-Vaccinated Recipients
Completed NCT01453907 - Single Dose, Weight-Based, Dose-Escalation Study With Intravenous ETI-204 in Adult Volunteers Phase 1
Completed NCT01491607 - Immunogenicity and Safety Study of a Three-Dose BioThrax® Regimen for Post-Exposure Prophylaxis in Healthy Adults Phase 3
Completed NCT03518125 - BARDA Securing Anthrax Immunity For the Elderly Phase 2
Completed NCT04660201 - Anthrax AV7909 Liquid vs Lyophilized Phase 1
Completed NCT04320485 - Evaluation of the Clinical Specificity of the Active Anthrax Detectâ„¢ Plus (AAD Plus) Lateral Flow Immunoassay (LFI)
Recruiting NCT06365073 - A Case-control Study on the Clinical Characteristics of 28-day and 90-day Death From Severe Anthrax
Completed NCT03498027 - Febrile Whole Blood Specimen Collection and Testing
Terminated NCT00964834 - Ph1 Study of Valortim and Doxycycline in Humans Phase 1
Completed NCT00063843 - Anthrax-rPA: Safety, Tolerability, Immunogenicity Phase 1
Completed NCT01624532 - A Study to Assess Dose-Response, Efficacy (Immunogenicity) and the Safety of GC1109 Phase 2
Completed NCT04148118 - A Safety and Immunogenicity of Intranasal Nanoemulsion Adjuvanted Recombinant Anthrax Vaccine in Healthy Adults Phase 1
Terminated NCT05672875 - Evaluation of the SRI B. Anthracis Lethal Factor Diagnostic System
Completed NCT01770743 - A Phase 2 Safety and Immunogenicity Study for an Anthrax Vaccine Using 3 Schedules and Two Dose Levels Phase 2
Completed NCT01867957 - Efficacy and Safety of Anthrax Vaccine, GC1109 Phase 1
Completed NCT00845650 - Safety and Pharmacokinetics Study of Anthrax Immune Globulin Intravenous (AIGIV) Phase 1/Phase 2
Completed NCT00031291 - Plasmapheresis of Anthrax-Vaccinated Subjects for Production of Anthrax Immune Globulin N/A
Not yet recruiting NCT03569514 - Observational Study Evaluating Clinical Benefit and Safety of AIGIV (ANTHRASIL®) in Patients With Systemic Anthrax
Recruiting NCT05997264 - Anthrax AV7909 Boost Evaluation Study Phase 2