- |||||||||| NuThrax (AV7909) / Emergent Biosolutions
Enrollment closed, Trial primary completion date: ABESt: Anthrax AV7909 Boost Evaluation Study (clinicaltrials.gov) - Aug 30, 2024
P2, N=220, Active, not recruiting,
Recruiting --> Active, not recruiting | Trial primary completion date: Sep 2024 --> Aug 2025
- |||||||||| NuThrax (AV7909) / Emergent Biosolutions
Trial completion date, Trial primary completion date: Anthrax AV7909 Liquid vs Lyophilized (clinicaltrials.gov) - Apr 17, 2024
P1, N=41, Completed,
Recruiting --> Active, not recruiting | Trial primary completion date: Sep 2024 --> Aug 2025 Trial completion date: Mar 2023 --> Mar 2024 | Trial primary completion date: Mar 2023 --> Nov 2023
- |||||||||| NuThrax (AV7909) / Emergent Biosolutions
Trial completion, Trial completion date, Trial primary completion date: Anthrax AV7909 Liquid vs Lyophilized (clinicaltrials.gov) - Feb 12, 2024
P1, N=41, Completed,
Trial completion date: Mar 2023 --> Mar 2024 | Trial primary completion date: Mar 2023 --> Nov 2023 Active, not recruiting --> Completed | Trial completion date: Mar 2024 --> Mar 2023 | Trial primary completion date: Nov 2023 --> Mar 2023
- |||||||||| NuThrax (AV7909) / Emergent Biosolutions
Journal: Efficacy of different AV7909 dose regimens in a nonclinical model of pulmonary anthrax. (Pubmed Central) - Dec 24, 2023
The toxin neutralizing assay (TNA) titer and anti-PA IgG responses were proportional to the protective efficacy, with a 50% TNA neutralizing factor (NF) greater than 0.1 associated with survival in animals receiving two doses of vaccine. The strong protection at relatively low TNA NF titers in this guinea pig model supports the exploration of lower doses in clinical trials to determine if these protective levels of neutralizing antibodies can be achieved in humans; however, protection with a single dose may not be feasible.
- |||||||||| NuThrax (AV7909) / Emergent Biosolutions
Enrollment open: ABESt: Anthrax AV7909 Boost Evaluation Study (clinicaltrials.gov) - Dec 7, 2023
P2, N=220, Recruiting,
The strong protection at relatively low TNA NF titers in this guinea pig model supports the exploration of lower doses in clinical trials to determine if these protective levels of neutralizing antibodies can be achieved in humans; however, protection with a single dose may not be feasible. Not yet recruiting --> Recruiting
- |||||||||| NuThrax (AV7909) / Emergent Biosolutions
Trial primary completion date: Anthrax AV7909 Liquid vs Lyophilized (clinicaltrials.gov) - Nov 19, 2023
P1, N=41, Active, not recruiting,
Not yet recruiting --> Recruiting Trial primary completion date: Mar 2023 --> Nov 2023
- |||||||||| NuThrax (AV7909) / Emergent Biosolutions
Trial completion date, Trial primary completion date: ABESt: Anthrax AV7909 Boost Evaluation Study (clinicaltrials.gov) - Oct 31, 2023
P2, N=220, Not yet recruiting,
Trial primary completion date: Mar 2023 --> Nov 2023 Trial completion date: Dec 2025 --> May 2026 | Trial primary completion date: Dec 2024 --> Jul 2024
- |||||||||| NuThrax (AV7909) / Emergent Biosolutions
Trial completion date, Trial primary completion date: Anthrax AV7909 Liquid vs Lyophilized (clinicaltrials.gov) - Oct 27, 2023
P1, N=41, Active, not recruiting,
Trial completion date: Dec 2025 --> May 2026 | Trial primary completion date: Dec 2024 --> Jul 2024 Trial completion date: Dec 2023 --> Mar 2024 | Trial primary completion date: Sep 2023 --> Mar 2023
- |||||||||| NuThrax (AV7909) / Emergent Biosolutions
Enrollment closed: Anthrax AV7909 Liquid vs Lyophilized (clinicaltrials.gov) - Oct 7, 2022
P1, N=41, Active, not recruiting,
Trial completion date: Dec 2023 --> Mar 2024 | Trial primary completion date: Sep 2023 --> Mar 2023 Recruiting --> Active, not recruiting
- |||||||||| NuThrax (AV7909) / Emergent Biosolutions
Enrollment open: Anthrax AV7909 Liquid vs Lyophilized (clinicaltrials.gov) - May 2, 2022
P1, N=40, Recruiting,
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting
- |||||||||| NuThrax (AV7909) / Emergent Biosolutions
Trial primary completion date: Anthrax AV7909 Liquid vs Lyophilized (clinicaltrials.gov) - Dec 10, 2021
P1, N=40, Not yet recruiting,
Overall, 3 intramuscular immunizations of Sprague Dawley rats with AV7909 were well tolerated, did not induce mortality or any systemic adverse effects, and did not result in any delayed toxicity. Trial primary completion date: Dec 2022 --> Aug 2023
- |||||||||| NuThrax (AV7909) / Emergent Biosolutions
Trial completion date, Trial initiation date, Trial primary completion date: Anthrax AV7909 Liquid vs Lyophilized (clinicaltrials.gov) - Sep 10, 2021
P1, N=40, Not yet recruiting,
Trial primary completion date: Dec 2022 --> Aug 2023 Trial completion date: May 2023 --> Sep 2023 | Initiation date: Sep 2021 --> Jan 2022 | Trial primary completion date: Aug 2022 --> Dec 2022
- |||||||||| NuThrax (AV7909) / Emergent Biosolutions
Trial initiation date, Trial primary completion date: Anthrax AV7909 Liquid vs Lyophilized (clinicaltrials.gov) - Jan 25, 2021
P1, N=40, Not yet recruiting,
These results suggest that the developed model can be useful in demonstrating added value of the vaccine for PEP. Initiation date: Jan 2021 --> Apr 2021 | Trial primary completion date: May 2022 --> Aug 2022
- |||||||||| NuThrax (AV7909) / Emergent Biosolutions
Trial completion: VELOCITY: An Anthrax Vaccine Clinical Study (clinicaltrials.gov) - Nov 10, 2020
P3, N=3861, Completed,
Initiation date: Jan 2021 --> Apr 2021 | Trial primary completion date: May 2022 --> Aug 2022 Active, not recruiting --> Completed
- |||||||||| Promune (agatolimod) / Pfizer, NuThrax (AV7909) / Emergent Biosolutions
Trial completion, Trial completion date: B-SAFE: BARDA Securing Anthrax Immunity For the Elderly (clinicaltrials.gov) - Jul 20, 2020
P2, N=305, Completed,
The results indicate that AV7909 has a favorable safety profile in juvenile rats. Active, not recruiting --> Completed | Trial completion date: May 2020 --> Dec 2019
- |||||||||| NuThrax (AV7909) / Emergent Biosolutions
Trial completion, Trial completion date: Velocity 2: An Anthrax Vaccine and Antibiotics Clinical Study (clinicaltrials.gov) - Jun 28, 2020
P2, N=210, Completed,
Active, not recruiting --> Completed | Trial completion date: May 2020 --> Dec 2019 Active, not recruiting --> Completed | Trial completion date: Feb 2021 --> Mar 2020
- |||||||||| NuThrax (AV7909) / Emergent Biosolutions
Enrollment closed: Velocity 2: An Anthrax Vaccine and Antibiotics Clinical Study (clinicaltrials.gov) - Feb 24, 2020
P2, N=210, Active, not recruiting,
Active, not recruiting --> Completed | Trial completion date: Feb 2021 --> Mar 2020 Recruiting --> Active, not recruiting
- |||||||||| Promune (agatolimod) / Pfizer, NuThrax (AV7909) / Emergent Biosolutions
Trial completion date: B-SAFE: BARDA Securing Anthrax Immunity For the Elderly (clinicaltrials.gov) - Jan 18, 2020
P2, N=305, Active, not recruiting,
Recruiting --> Active, not recruiting Trial completion date: Dec 2019 --> May 2020
- |||||||||| NuThrax (AV7909) / Emergent Biosolutions
Journal: Use of Anthrax Vaccine in the United States: Recommendations of the Advisory Committee on Immunization Practices, 2019. (Pubmed Central) - Jan 4, 2020
Changes from previous guidance in this report include the following: 1) a booster dose of AVA for PrEP can be given every 3 years instead of annually to persons not at high risk for exposure to Bacillus anthracis who have previously received the initial AVA 3-dose priming and 2-dose booster series and want to maintain protection; 2) during a large-scale emergency response, AVA for PEP can be administered using an intramuscular route if the subcutaneous route of administration poses significant materiel, personnel, or clinical challenges that might delay or preclude vaccination; 3) recommendations on dose-sparing AVA PEP regimens if the anthrax vaccine supply is insufficient to vaccinate all potentially exposed persons; and 4) clarification on the duration of antimicrobial therapy when used in conjunction with vaccine for PEP.These updated recommendations can be used by health care providers and guide emergency preparedness officials and planners who are developing plans to provide anthrax vaccine, including preparations for a wide-area aerosol release of B. anthracis spores. The recommendations also provide guidance on dose-sparing options, if needed, to extend the supply of vaccine to increase the number of persons receiving PEP in a mass casualty event.
- |||||||||| NuThrax (AV7909) / Emergent Biosolutions
Enrollment closed: VELOCITY: An Anthrax Vaccine Clinical Study (clinicaltrials.gov) - Jul 9, 2019
P3, N=3861, Active, not recruiting,
The recommendations also provide guidance on dose-sparing options, if needed, to extend the supply of vaccine to increase the number of persons receiving PEP in a mass casualty event. Recruiting --> Active, not recruiting
- |||||||||| Promune (agatolimod) / Pfizer, NuThrax (AV7909) / Emergent Biosolutions
Enrollment closed: B-SAFE: BARDA Securing Anthrax Immunity For the Elderly (clinicaltrials.gov) - Feb 19, 2019
P2, N=305, Active, not recruiting,
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting
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