Clinical trials: Smallpox
Smallpox
Post-licensure Department of Defense (DOD) Screening Accuracy Study in Military Personnel
This is a retrospective study of the Department of Defense (DoD) Smallpox Screening Form 600s (SF600s) generated during screening of service members for possible immunization with the ACAM2000® smallpox vaccine.
- Trial name
- NCT01540929
- Where
- United States
- Volunteers
- 5,001 people, healthy volunteers welcome
- Sponsor
- Emergent BioSolutions
Smallpox Vaccine Adverse Reaction
VA-008 ACAM2000® Vaccination of Plasma Donors for the Production of VIGIV
Objectives: To vaccinate plasma donors with the ACAM2000 smallpox vaccine thereby inducing an immune response resulting in high anti-vaccinia antibody titers.
- Trial name
- NCT02443623
- Testing
- Vaccination with ACAM2000
- Where
- Canada
- Volunteers
- 3,032 people, healthy volunteers welcome
- Sponsor
- Emergent BioSolutions
Myopericarditis, Small Pox
Assessment of Myocarditis After Replication-Deficient Smallpox Immunization
This is a prospective observational phase IV study of a novel, replication-deficient smallpox vaccine that has been recently been approved by FDA.
- Trial name
- PAMARDSI (NCT05513313)
- Testing
- JYNNEOS
- Volunteers
- 2,350 people, healthy volunteers welcome
- Sponsor
- Womack Army Medical Center
Smallpox, Monkeypox
Study of the Safety, Tolerability, Pharmacokinetics of NIOCH-14 in Volunteers Aged 18-50 Years
The Aim: To study safety, tolerability and pharmacokinetics of NIOCH-14 when administered orally using a set of clinical and laboratory-instrumental methods.
- Conditions
- Smallpox, Monkeypox, Cowpox, Vaccinia Virus Infection
- Trial name
- NCT05976100
- Testing
- NIOCH-14, 200 mg capsule: 1 capsule (200 mg) of NIOCH-14 once orally, NIOCH-14, 200 mg capsule: 3 capsules (200 mg each) of NIOCH-14 once orally. (Total 600 mg NIOCH-14 per day), NIOCH-14, 200 mg capsule: 6 capsules (200 mg each) of NIOCH-14 per day orally. (Total 1200 mg NIOCH-14 per day)
- Where
- Russia
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Federal Budgetary Research Institution State Research Center of Virology and Biotechnology "Vector"
Smallpox, Monkeypox
Study on Immunogenicity, Reactogenicity and Safety of the VACΔ6 Vaccine in Volunteers Aged 18-60 Years
The Aim: Study immunogenicity, confirm the safety and tolerability of different schedules of vaccination with "live cell-based vaccine against smallpox and other orthopoxvirus infections (VAC∆6 vaccine) based on vaccinia virus"…
- Conditions
- Smallpox, Monkeypox, Cowpox, Vaccinia Virus Infection
- Trial name
- NCT05846243
- Testing
- VAC∆6 vaccine (10⁷ PFU), VAC∆6 vaccine (10⁶ PFU), Live Smallpox Vaccine
- Where
- 2 sites in Russia
- Volunteers
- 334 people, healthy volunteers welcome
- Sponsor
- Federal Budgetary Research Institution State Research Center of Virology and Biotechnology "Vector"
Smallpox, Monkeypox
Safety and Tolerability Study of the VAC∆6 Vaccine in Volunteers Aged 18-40 Years
The aim of the clinical study is to study the safety and tolerability of the live cell-based vaccine against smallpox and other orthopoxvirus infections (VAC∆6 vaccine) based on vaccinia virus, in intracutaneous administration.
- Conditions
- Smallpox, Monkeypox, Cowpox, Vaccinia Virus Infection
- Trial name
- NCT05762523
- Testing
- VAC∆6 vaccine - оnce at a dose of 10⁶ PFU, VAC∆6 vaccine - once at a dose of 10⁷ PFU, VAC∆6 vaccine - twice at a dose of 10⁶ PFU
- Where
- Russia
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Federal Budgetary Research Institution State Research Center of Virology and Biotechnology "Vector"
Smallpox
Freeze-Dried MVA-BN® Lot Consistency Smallpox Trial
This is a Phase 3 multicenter trial to evaluate safety and immune response of three consecutive production lots of freeze-dried (FD) MVA-BN smallpox vaccine.
- Trial name
- NCT03699124
- Testing
- FD MVA-BN
- Where
- 12 sites in United States
- Volunteers
- 1,129 people, healthy volunteers welcome
- Sponsor
- Bavarian Nordic
Smallpox
Lyophilized IMVAMUNE® (1x10^8 TCID50) Versus Liquid IMVAMUNE® (1x10^8 TCID50) Administered Subcutaneously and a Lower Dose Liquid IMVAMUNE® (2x10^7 TCID50) Administered Intradermally
Due to recent concern of biowarfare and bioterrorism, the US government is making efforts to improve its ability to protect citizens against the smallpox virus.
- Trial name
- NCT00914732
- Testing
- MVA Smallpox Vaccine
- Where
- 8 sites in United States
- Volunteers
- 523 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Smallpox
A Phase II Trial to Compare a Liquid-frozen and a Freeze-dried Formulation of IMVAMUNE (MVA-BN®) Smallpox Vaccine in Vaccinia-naïve Healthy Subjects
A randomized, double-blind, multicenter Phase II trial to compare the immunogenicity and safety of a liquid-frozen and a freeze-dried formulation of IMVAMUNE (MVA-BN®) smallpox vaccine in vaccinia-naïve healthy subjects
- Trial name
- NCT01668537
- Testing
- LF formulation of IMVAMUNE®, FD formulation of IMVAMUNE®
- Where
- 3 sites in United States
- Volunteers
- 651 people, healthy volunteers welcome
- Sponsor
- Bavarian Nordic
Smallpox
An Open-Label Phase II Study to Evaluate Immunogenicity and Safety of a Single IMVAMUNE Booster Vaccination Two Years After the Last IMVAMUNE Vaccination in Former POX-MVA-005 Vaccinees
The study was preformed to evaluate the persistence of antibodies following vaccination with MVA-BN and to assess the immunological memory response induced by a booster vaccination with MVA-BN in subjects two years after their…
- Trial name
- NCT00686582
- Testing
- IMVAMUNE, Blood Draw Only
- Where
- Germany
- Volunteers
- 304 people, healthy volunteers welcome
- Sponsor
- Bavarian Nordic
Smallpox
A Randomized, Double-blind, Placebo-controlled Study on Immunogenicity and Safety of MVA-BN (IMVAMUNE™) Smallpox Vaccine in Healthy Subjects
The primary objective of this study is to evaluate the immune response after a single vaccination of pre-immune subjects compared to two vaccinations in naive subjects.
- Trial name
- NCT00316524
- Testing
- MVA-BN® (IMVAMUNE)
- Where
- Germany
- Volunteers
- 745 people, healthy volunteers welcome
- Sponsor
- Bavarian Nordic
Smallpox
Dose-finding Study to Evaluate Immunogenicity of Three Different Dose Levels of the IMVAMUNE (MVA-BN) Smallpox Vaccine.
The objective of the study is to find the optimal dose for the smallpox candidate vaccine IMVAMUNE (MVA-BN). For this purpose the study compares IMVAMUNE (MVA-BN) administered at three different dose levels.
- Trial name
- NCT00189956
- Testing
- IMVAMUNE (MVA-BN)
- Where
- Switzerland
- Volunteers
- 165 people, healthy volunteers welcome
- Sponsor
- Bavarian Nordic
Smallpox
A Study to Evaluate Safety and Immunogenicity of One and Two Doses of IMVAMUNE® Smallpox Vaccine in 56-80 Year Old Vaccinia-experienced Subjects
A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Evaluate Safety and Immunogenicity of One and Two Doses of IMVAMUNE® Smallpox Vaccine in 56-80 Year Old Vaccinia-Experienced Subjects
- Trial name
- NCT00857493
- Testing
- IMVAMUNE
- Where
- 4 sites in United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Bavarian Nordic
Atopic Dermatitis
A Phase II Study on Immunogenicity and Safety of MVA-BN® (IMVAMUNE™) Smallpox Vaccine in Subjects With Atopic Dermatitis
The purpose of this study is to compare the immunogenicity and safety of an investigational smallpox vaccine in subjects with atopic dermatitis to healthy volunteers.
- Trial name
- NCT00316602
- Testing
- IMVAMUNE
- Where
- 22 sites in United States, Mexico
- Volunteers
- 632 people, healthy volunteers welcome
- Sponsor
- Bavarian Nordic
Smallpox
A Trial to Evaluate Immunogenicity and Safety of Three Consecutive Production Lots of IMVAMUNE® (MVA-BN®) Smallpox Vaccine in Healthy, Vaccinia-naïve Subjects
A randomized, double-blind, placebo-controlled Phase III trial to evaluate immunogenicity and safety of three consecutive production lots of IMVAMUNE® (MVA-BN®) smallpox vaccine in healthy, vaccinia-naïve subjects.
- Trial name
- NCT01144637
- Testing
- IMVAMUNE®
- Where
- 34 sites in United States
- Volunteers
- 4,005 people, healthy volunteers welcome
- Sponsor
- Bavarian Nordic
Vaccinia
SIGA-246 to Treat Smallpox
This study will test an experimental antiviral drug called SIGA-246 for use against the smallpox virus (variola). Although smallpox has been universally eradicated, it could possibly be brought back as a bioweapon.
- Trial name
- NCT00303225
- Testing
- Vaccine: SIGA-246
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Smallpox
Phase II Trial to Assess Safety and Immunogenicity of IMVAMUNE®
Imvamune (licensed name of MVA being developed as a smallpox vaccine) has been tested in over 2,000 individuals and is on path for licensure.
- Trial name
- NCT01827371
- Testing
- MVA Smallpox Vaccine
- Where
- 6 sites in United States
- Volunteers
- 435 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Smallpox, Anthrax
VHA Clinicians and Bioterror Events: Interactive Web-based Learning
Our 4-year project uses public domain software and content developed by a University of Alabama at Birmingham (UAB) team and updates, refines, and tailors it to the unique clinician populations and electronic educational…
- Trial name
- NCT00123396
- Testing
- BioCASES and BioTESTS
- Where
- 9 sites in United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- US Department of Veterans Affairs
Smallpox
ACAM 3000 MVA at Harvard Medical School
The purpose of this study is to assess the safety of an experimental smallpox vaccine (MVA: Modified Vaccinia Ankara) and to compare the body's immune (system that fights disease) response to this vaccine.
- Trial name
- NCT00133575
- Testing
- MVA Smallpox Vaccine, Live vaccinia virus vaccine
- Where
- United States
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Smallpox
Combination Study With MVA BN and Dryvax
The overall goals of this study are to expand the available data on the safety and immunogenicity of MVA-BN in vaccinia-naive adults and to determine the optimum dose of MVA-BN to induce immune responses and attenuate Dryvax take…
- Trial name
- NCT00082446
- Testing
- Live vaccinia virus vaccine, MVA Smallpox Vaccine
- Where
- United States
- Volunteers
- 91 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)