CNJ-016 (vaccinia immune globulin intravenous (human)) / Emergent Biosolutions - LARVOL DELTA

VA-005 Clinical Outcomes of VIGIV Treatment of Smallpox Vaccination Complications or Vaccinia Infection (clinicaltrials.gov) - P=N/A | N=100 | Enrolling by invitation | Sponsor: Emergent BioSolutions | Trial completion date: Aug 2025 ➔ Aug 2027 | Trial primary completion date: Aug 2025 ➔ Aug 2026

Trial completion date • Trial primary completion date • Infectious Disease

It is Time to Raise the Alarm on Monkeypox - "Surely, COVID has shown us diseases know no boundaries. A growing outbreak is bound to create havoc in other parts of the world if left unchecked, uncontained and uncontrolled. And that is exactly what is happening with monkeypox today....Unlike COVID-19, monkeypox does not easily spread person to person, and requires direct contact with the infected source (person or object)."

Blog • Novel Coronavirus Disease

VA-008 ACAM2000® Vaccination of Plasma Donors for the Production of VIGIV (clinicaltrials.gov) - P4; N=3032; Completed; Sponsor: Emergent BioSolutions; Recruiting ➔ Completed; Trial completion date: Feb 2022 ➔ Aug 2021; Trial primary completion date: Dec 2021 ➔ May 2021

Trial completion • Trial completion date • Trial primary completion date

VA-005 Clinical Outcomes of VIGIV Treatment of Smallpox Vaccination Complications or Vaccinia Infection (clinicaltrials.gov) - P=N/A; N=100; Enrolling by invitation; Sponsor: Emergent BioSolutions; Trial completion date: Aug 2021 ➔ Aug 2025; Trial primary completion date: Aug 2021 ➔ Aug 2025

Clinical • Clinical data • Trial completion date • Trial primary completion date • Infectious Disease

Povidone Iodine Ointment Application to the Vaccination Site Does Not Alter Immunoglobulin G Antibody Response to Smallpox Vaccine. (PubMed) - Viral Immunol - "The postvaccination antibody binding levels of vaccinees in the PIO group did not differ from those of control vaccinees. These findings further support the topical application of PIO, starting on day 7, to reduce the viral shedding associated with smallpox vaccination."

Journal • Biosimilar

A Non-inferiority Trial to Compare MVA-BN® Smallpox Vaccine to ACAM2000® (clinicaltrials.gov) - P3; N=440; Recruiting; Sponsor: Bavarian Nordic; Not yet recruiting -> Recruiting

Enrollment open • Biosimilar • Reperfusion Injury

A Non-inferiority Trial to Compare MVA-BN® Smallpox Vaccine to ACAM2000® (clinicaltrials.gov) - P3; N=440; Completed; Sponsor: Bavarian Nordic; Active, not recruiting ➔ Completed

Clinical • Head-to-Head • Trial completion

Phase 3 Efficacy Trial of Modified Vaccinia Ankara as a Vaccine against Smallpox. (PubMed, N Engl J Med) - P3; "Immune responses and attenuation of the major cutaneous reaction suggest that this MVA vaccine protected against variola infection. (Funded by the Office of the Assistant Secretary for Preparedness and Response Biomedical Advanced Research and Development Authority of the Department of Health and Human Services and Bavarian Nordic; ClinicalTrials.gov number, NCT01913353.)."

Clinical • Journal • P3 data • P3 data

Post-Smallpox Vaccination Skin Eruption in a Marine. (PubMed, Mil Med) - "This case report includes a review of the associated literature and seeks to offer the clinician some familiarity of the skin eruptions associated with the smallpox vaccination. Self-limited skin eruptions such as autoinoculation, nonviral pustulosis, and generalized vaccinia will be distinguished from the more serious eczema vaccinatum, and from the potentially life-threatening progressive vaccinia."

Journal

Co-administration of tecovirimat and ACAM2000™ in non-human primates: Effect of tecovirimat treatment on ACAM2000 immunogenicity and efficacy versus lethal monkeypox virus challenge. (PubMed, Vaccine) - "This suggests that TPOXX may affect the immunogenicity of ACAM2000 if administered concomitantly. These studies may inform on how vaccine and TPOXX are used during a smallpox outbreak."

Clinical • Journal

Novel Treatment of a Vaccinia Virus Infection from an Occupational Needlestick - San Diego, California, 2019. (PubMed, MMWR Morb Mortal Wkly Rep) - "CDC and partners performed laboratory confirmation, contacted the study sponsor to identify the VACV strain, and provided oversight for the first case of laboratory-acquired VACV treated with tecovirimat plus intravenous vaccinia immunoglobulin (VIGIV). This investigation highlights 1) the misconception among laboratory workers about the virulence of VACV strains; 2) the importance of providing laboratorians with pathogen information and postexposure procedures; and 3) that although tecovirimat can be used to treat VACV infections, its therapeutic benefit remains unclear."

Journal

A Case Series of Smallpox Vaccination-Associated Myopericarditis: Effects on Safety and Readiness of the Active Duty Soldier. (PubMed, Mil Med) - "This can be avoided by having all soldiers who receive the smallpox vaccine screened for clinical evidence of myopericarditis at 30 days after receiving the vaccine. Contributing to the increasing rate of myopericarditis as well as the negative impact on soldier medical readiness, the continued use of the current ACAM2000 smallpox vaccine should be monitored."

Clinical • Journal

ACAM2000® Myopericarditis Registry (clinicaltrials.gov) - P=N/A; N=24; Completed; Sponsor: Emergent BioSolutions; Active, not recruiting ➔ Completed; N=200 ➔ 24; Trial completion date: Apr 2024 ➔ Feb 2019; Trial primary completion date: Apr 2024 ➔ Feb 2019

Enrollment change • Trial completion • Trial completion date • Trial primary completion date

A phase I safety study of oncolytic vaccinia virus delivered by adipose stromal vascular fraction cells. (ASCO-SITC 2019) - "Treatment with ACAM2000/SVF in patients with advanced solid tumors and AML is safe and well tolerated, with clear antitumor effects in several patients. These promising initial clinical results merit further investigation of therapeutic utility."

Clinical • Oncolytic Virus • P1 data

A phase I safety study of oncolytic vaccinia virus delivered by adipose stromal vascular fraction cells. (ASCO-SITC 2019) - "Treatment with ACAM2000/SVF in patients with advanced solid tumors and AML is safe and well tolerated, with clear antitumor effects in several patients. These promising initial clinical results merit further investigation of therapeutic utility."

Clinical • Oncolytic Virus • P1 data