Clinical trials: Smallpox
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
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
Orthopoxviral Disease
Safety, Tolerability, Pharmacokinetics (PK) of the Anti-Orthopox Drug, ST-246
The purpose of this study was to assess the safety, tolerability, and pharmacokinetics of two clinical doses of the anti-orthopoxvirus drug, ST-246, administered as a single daily oral dose for 14 days to healthy, fed volunteers.
- Trial name
- 246-Safety (NCT00907803)
- Testing
- ST-246 400 mg, ST-246 600 mg
- Where
- 3 sites in United States
- Volunteers
- 107 people, healthy volunteers welcome
- Sponsor
- SIGA Technologies
Smallpox, Poxvirus Infection
Evaluation of Take and Safety of a Smallpox Vaccine in Healthy Young Adults
Primary Objective: To estimate the smallpox vaccination take rate in healthy young adults not previously vaccinated with a smallpox vaccine.
- Trial name
- NCT00258947
- Testing
- Smallpox vaccine, LISTER strain, from chick embryo cells
- Where
- 6 sites in France
- Volunteers
- 230 people, healthy volunteers welcome
- Sponsor
- Sanofi
Smallpox
Dose Safety, Tolerability, and Immunogenicity of a New Smallpox Vaccine in Adults Without Previous Smallpox Vaccination
The purpose of this study is to examine the safety and the effectiveness of a new vaccine for the prevention of the disease, smallpox.
- Trial name
- NCT00053508
- Testing
- ACAM1000, vaccinia virus (calf lymph) smallpox vaccine: Dryvax
- Where
- 3 sites in United States
- Volunteers
- 274 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
HIV Infections, Smallpox
Safety Study of MVA Smallpox Vaccine in HIV-positive Subjects Who Are Vaccinia Naive
The purpose of this study is to assess the safety and immunogenicity of two MVA smallpox vaccine injections in healthy adults that are 18-35 years of age with HIV infection
- Trial name
- NCT00282581
- Testing
- MVA Smallpox Vaccine
- Where
- 6 sites in United States
- Volunteers
- 2 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Smallpox
Safety, Tolerability, and Immune Response of ACAM3000 Modified Vaccinia Ankara (MVA) Smallpox Vaccine in Adults
The purpose of this study is to gather information on the safety and the effectiveness of an investigational vaccine for the prevention of smallpox disease.
- Trial name
- NCT00079820
- Testing
- ACAM3000 MVA Vaccine
- Where
- 2 sites in United States
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Smallpox
Drug-drug Interaction Study of TPOXX When Co-administered With Phosphate Binders
An open-label, drug-drug interaction study with TPOXX and phosphate binders.
- Trial name
- NCT04485039
- Testing
- Tecovirimat, sevelamer carbonate oral tablet, sucroferric oxyhydroxide chewable tablet
- Where
- United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- SIGA Technologies
Smallpox
A Long-Term Study of Healthy Adults Vaccinated With One Dose of Smallpox Vaccine (LISTER Strain)
The purpose of this study is to provide long-term follow-up immunogenicity and safety data on participants who were vaccinated with the second-generation smallpox vaccine in Study VVL04 (NCT 00258947).
- Trial name
- NCT00998543
- Where
- 5 sites in France
- Volunteers
- 147 people, healthy volunteers welcome
- Sponsor
- Sanofi
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
Dose Study of ACAM2000 Smallpox Vaccine in Previously Vaccinated Adults
The objective of this study is to determine the minimum dose of ACAM2000 needed to produce a cutaneous reaction in at least 90% of a population of healthy adults at least 28 years of age and previously vaccinated against smallpox.
- Trial name
- NCT00053482
- Testing
- ACAM2000 Smallpox Vaccine, Vaccinia virus (calf lymph) smallpox vaccine: Dryvax®
- Where
- 3 sites in United States
- Volunteers
- 357 people, healthy volunteers welcome
- Sponsor
- Emergent BioSolutions
Smallpox, Atopic Dermatitis
Safety Study of MVA Smallpox Vaccine in Subjects With a History of Atopic Dermatitis (AD)
purpose of this study is to assess the safety and immunogenicity of two MVA smallpox vaccine injections in healthy adults that are 18-35 years of age with a history of mild to moderate Atopic Dermatitis.
- Trial name
- NCT00389103
- Testing
- MVA (smallpox vaccine)
- Where
- 3 sites in United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Myocarditis, Pericarditis
ACAM2000® Myopericarditis Registry
The purpose of this registry is to study the natural history of vaccination-related myocarditis and pericarditis and to assess possible risk factors for these conditions.
- Trial name
- NCT01395082
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Emergent BioSolutions
HIV Infections
Safety, Tolerability and Immune Response of IMVAMUNE (MVA-BN)Smallpox Vaccine in HIV Infected Patients
The purpose of this study is to gather information on the safety and immunogenicity of an investigational smallpox vaccine in HIV infected populations.
- Trial name
- NCT00189904
- Testing
- IMVAMUNE (MVA-BN)
- Where
- 5 sites in United States
- Volunteers
- 151 people
- Sponsor
- Bavarian Nordic
Smallpox
Randomized, Open-label Phase II Trial to Assess the Safety and Immunogenicity of MVA-BN Smallpox Vaccine in Immunocompromised Subjects With HIV Infection
The main purpose of this clinical trial is to generate additional safety data in a highly immunocompromised population. HIV-infected persons are considered excellent candidates to represent the highly immunocompromised population…
- Trial name
- NCT02038881
- Testing
- IMVAMUNE®
- Where
- 12 sites in United States, Puerto Rico
- Volunteers
- 87 people
- Sponsor
- Bavarian Nordic
Double-stranded DNA Virus
Study to Assess Brincidofovir Treatment of Serious Diseases or Conditions Caused by Double-stranded DNA Viruses
This was a multicenter, open-label study of oral brincidofovir (BCV) treatment of serious disease or conditions caused by double-stranded DNA (dsDNA) virus(es).
- Trial name
- NCT01143181
- Testing
- Brincidofovir
- Where
- 37 sites in United States
- Volunteers
- 210 people
- Sponsor
- Jazz Pharmaceuticals
Smallpox
Study to Assess the Safety and Immunogenicity of TPOXX® When Administered Orally for 28 Days With JYNNEOS
This study is designed to evaluate the immunogenicity profile of JYNNEOS® when 2 doses are administered subcutaneously (SC) 4 weeks apart; and potential immunological interference while concomitantly administering TPOXX or…
- Trial name
- NCT04957485
- Testing
- Tecovirimat, Smallpox and Mpox Vaccine
- Where
- 2 sites in United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- SIGA Technologies
Smallpox, Mpox
A Study to Investigate The Safety, Tolerability, And Immune Response of a Range of Doses of mRNA-1769 Compared With Placebo in Healthy Participants From ≥18 Years of Age to <50 Years of Age
The goal of this study is to assess the safety, tolerability and immunogenicity of mRNA-1769 in healthy adult participants.
- Trial name
- NCT05995275
- Testing
- mRNA-1769
- Where
- 12 sites in United Kingdom
- Volunteers
- 351 people, healthy volunteers welcome
- Sponsor
- ModernaTX, Inc.
Smallpox
Take Rate, Immunogenicity and Safety of Elstree-BN Smallpox Vaccine in Healthy Vaccinia-Naive Subjects
The purpose of this study is to assess the take rate (formation of a typical postvaccinal lesion)and the safety and immunogenicity of the smallpox vaccine Elstree-BN.
- Trial name
- NCT00189969
- Testing
- Elstree-BN
- Where
- Germany
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Bavarian Nordic
18-42 Year Old Healthy Vaccinia-naïve Subjects
A Non-inferiority Trial to Compare MVA-BN® Smallpox Vaccine to ACAM2000®
To demonstrate the efficacy of MVA-BN® in terms of vaccinia-specific Plaque Reduction Neutralization Test (PRNT) antibody response and by showing that vaccination prior to administration of ACAM2000® results in an attenuated take.
- Trial name
- NCT01913353
- Testing
- MVA BN®, ACAM2000®
- Where
- South Korea
- Volunteers
- 440 people, healthy volunteers welcome
- Sponsor
- Bavarian Nordic