NuThrax (AV7909) / Emergent Biosolutions - LARVOL DELTA

ABESt: Anthrax AV7909 Boost Evaluation Study (clinicaltrials.gov) - P2 | N=220 | Active, not recruiting | Sponsor: Biomedical Advanced Research and Development Authority | Recruiting ➔ Active, not recruiting | Trial primary completion date: Sep 2024 ➔ Aug 2025

Enrollment closed • Trial primary completion date

Anthrax AV7909 Liquid vs Lyophilized (clinicaltrials.gov) - P1 | N=41 | Completed | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Trial completion date: Mar 2023 ➔ Mar 2024 | Trial primary completion date: Mar 2023 ➔ Nov 2023

Trial completion date • Trial primary completion date

Anthrax AV7909 Liquid vs Lyophilized (clinicaltrials.gov) - P1 | N=41 | Completed | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Active, not recruiting ➔ Completed | Trial completion date: Mar 2024 ➔ Mar 2023 | Trial primary completion date: Nov 2023 ➔ Mar 2023

Trial completion • Trial completion date • Trial primary completion date

Efficacy of different AV7909 dose regimens in a nonclinical model of pulmonary anthrax. (PubMed, Hum Vaccin Immunother) - "The vaccine AV7909, consisting of the licensed anthrax drug substance AVA adjuvanted with CpG7909, induces high levels of toxin neutralizing antibodies in healthy adults using fewer doses than AVA. 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."

Journal

ABESt: Anthrax AV7909 Boost Evaluation Study (clinicaltrials.gov) - P2 | N=220 | Recruiting | Sponsor: Biomedical Advanced Research and Development Authority | Not yet recruiting ➔ Recruiting

Enrollment open

Anthrax AV7909 Liquid vs Lyophilized (clinicaltrials.gov) - P1 | N=41 | Active, not recruiting | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Trial primary completion date: Mar 2023 ➔ Nov 2023

Trial primary completion date

ABESt: Anthrax AV7909 Boost Evaluation Study (clinicaltrials.gov) - P2 | N=220 | Not yet recruiting | Sponsor: Biomedical Advanced Research and Development Authority | Trial completion date: Dec 2025 ➔ May 2026 | Trial primary completion date: Dec 2024 ➔ Jul 2024

Trial completion date • Trial primary completion date

Anthrax AV7909 Liquid vs Lyophilized (clinicaltrials.gov) - P1 | N=41 | Active, not recruiting | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Trial completion date: Dec 2023 ➔ Mar 2024 | Trial primary completion date: Sep 2023 ➔ Mar 2023

Trial completion date • Trial primary completion date

A Phase 3, Randomized, Double-blind, Parallel-group Trial to Evaluate the Immunogenicity and Safety of AV7909 for Post-exposure Prophylaxis of Anthrax in Healthy Adults (IDWeek 2023) - No abstract available

Clinical • P3 data • Infectious Disease

A Phase 2 Drug-Vaccine Interaction Study of AV7909 and Ciprofloxacin or Doxycycline on Antibiotic Pharmacokinetics (IDWeek 2023) - No abstract available

P2 data • PK/PD data • Infectious Disease

ABESt: Anthrax AV7909 Boost Evaluation Study (clinicaltrials.gov) - P2 | N=220 | Not yet recruiting | Sponsor: Biomedical Advanced Research and Development Authority

New P2 trial

Anthrax AV7909 Liquid vs Lyophilized (clinicaltrials.gov) - P1 | N=41 | Active, not recruiting | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Recruiting ➔ Active, not recruiting

Enrollment closed

Anthrax AV7909 Liquid vs Lyophilized (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Not yet recruiting ➔ Recruiting

Enrollment open

Anthrax AV7909 Liquid vs Lyophilized (clinicaltrials.gov) - P1; N=40; Not yet recruiting; Sponsor: National Institute of Allergy and Infectious Diseases (NIAID); Trial primary completion date: Dec 2022 ➔ Aug 2023

Clinical • Trial primary completion date

Anthrax AV7909 Liquid vs Lyophilized (clinicaltrials.gov) - P1; N=40; Not yet recruiting; Sponsor: National Institute of Allergy and Infectious Diseases (NIAID); Trial completion date: May 2023 ➔ Sep 2023; Initiation date: Sep 2021 ➔ Jan 2022; Trial primary completion date: Aug 2022 ➔ Dec 2022

Clinical • Trial completion date • Trial initiation date • Trial primary completion date

Evaluation of the AV7909 Anthrax Vaccine Toxicity in Sprague Dawley Rats Following Three Intramuscular Administrations. (PubMed, Int J Toxicol) - "In contrast, sera of rats that received saline or soluble CPG 7909 alone were negative for anti-PA antibodies. 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."

Journal • Preclinical • Immunology • Inflammation

Anthrax AV7909 Liquid vs Lyophilized (clinicaltrials.gov) - P1; N=40; Not yet recruiting; Sponsor: National Institute of Allergy and Infectious Diseases (NIAID); Initiation date: Jan 2021 ➔ Apr 2021; Trial primary completion date: May 2022 ➔ Aug 2022

Clinical • Trial initiation date • Trial primary completion date

Anthrax AV7909 Liquid vs Lyophilized (clinicaltrials.gov) - P1; N=40; Not yet recruiting; Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Clinical • New P1 trial

Efficacy of the AV7909 anthrax vaccine candidate in guinea pigs and nonhuman primates following two immunizations two weeks apart. (PubMed, Vaccine) - "The current study shows that a 0, 2-week AV7909 vaccination regimen protected guinea pigs (GPs) and nonhuman primates (NHPs) against a lethal inhalational anthrax challenge on Days 28 and 70 after the first immunization. An earlier induction of protective TNA levels using a 0, 2-week AV7909 vaccination regimen may provide benefit over the currently approved AVA PEP 0, 2, and 4-week vaccination regimen."

Clinical • Journal

VELOCITY: An Anthrax Vaccine Clinical Study (clinicaltrials.gov) - P3; N=3861; Completed; Sponsor: Emergent BioSolutions; Active, not recruiting ➔ Completed

Clinical • Trial completion

Developmental and reproductive safety evaluation of AV7909 anthrax vaccine candidate in rats. (PubMed, Birth Defects Res) - "The AV7909 vaccine, consists of the Anthrax Vaccine Adsorbed (AVA) bulk drug substance and the immunostimulatory Toll-like receptor 9 agonist oligodeoxynucleotide adjuvant CPG 7909. The antibodies were also detected in the sera of fetuses and F pups. Exposure of the fetuses and pups to maternally derived anthrax lethal toxin-neutralizing antibodies was not associated with developmental toxicity."

Journal • Immunology • Inflammation • A2M • PROS1

Comparative immunogenicity and efficacy of thermostable (lyophilized) and liquid formulation of anthrax vaccine candidate AV7909. (PubMed, Vaccine) - "AV7909 consists of the anthrax vaccine adsorbed (AVA) (Emergent BioSolutions Inc., Lansing, MI) bulk drug substance adjuvanted with the immunostimulatory oligodeoxynucleotide (ODN) compound, CPG 7909. Results demonstrated that there were no significant differences in the immunogenicity or efficacy of lyophilized AV7909 against lethal anthrax spore aerosol challenge in the guinea pig model as compared to liquid AV7909. For both vaccine formulations, logistic regression modeling showed that the probability of survival increased as the pre-challenge antibody levels increased."

Clinical • Journal

B-SAFE: BARDA Securing Anthrax Immunity For the Elderly (clinicaltrials.gov) - P2; N=305; Completed; Sponsor: Biomedical Advanced Research and Development Authority; Active, not recruiting ➔ Completed; Trial completion date: May 2020 ➔ Dec 2019

Clinical • Trial completion • Trial completion date

Repeat Dose Toxicity Study of the AV7909 Anthrax Vaccine Candidate in Juvenile Rats. (PubMed, Int J Toxicol) - "AV7909 consists of the Anthrax Vaccine Adsorbed (AVA) bulk drug substance and the immunostimulatory Toll-like receptor 9 agonist oligodeoxynucleotide adjuvant, CPG 7909. All animals in the AV7909 group demonstrated a robust neutralizing antibody response. The results indicate that AV7909 has a favorable safety profile in juvenile rats."

IO Biomarker • Journal • Preclinical • Hematological Disorders • Pediatrics • A2M

Velocity 2: An Anthrax Vaccine and Antibiotics Clinical Study (clinicaltrials.gov) - P2; N=210; Completed; Sponsor: Emergent BioSolutions; Active, not recruiting ➔ Completed; Trial completion date: Feb 2021 ➔ Mar 2020

Clinical • Trial completion • Trial completion date