Clinical trials: Smallpox
Smallpox Vaccine Adverse Reaction
VA-006 Vaccinia Vaccine (ACAM2000) for the Production of VIGIV
The purpose of this study is to vaccinate plasma donors with ACAM2000 smallpox vaccine for collection of plasma to be used in the manufacturing of Vaccinia Immune Globulin Intravenous (VIGIV).
- Trial name
- NCT01158157
- Testing
- ACAM2000
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Emergent BioSolutions
Smallpox
MVA Post-Event: Administration Timing and Boost Study
The purpose of this study is to evaluate an investigational smallpox vaccine, called IMVAMUNE®, with respect to safety and immune (body's defense system) response.
- Trial name
- NCT00437021
- Testing
- Live vaccinia virus vaccine, MVA Smallpox Vaccine
- Where
- 7 sites in United States
- Volunteers
- 226 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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 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
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
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
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
Smallpox
High Dose IMVAMUNE® in Vaccinia-Naive Individuals
The purpose of this research is to compare the ability of a new investigational smallpox vaccine called IMVAMUNE® to produce a strong immune response against smallpox disease if given as one single, higher dose compared with two…
- Trial name
- NCT00879762
- Testing
- MVA Smallpox Vaccine
- Where
- 2 sites in United States
- Volunteers
- 91 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Smallpox
Safety, Tolerability and PK of TPOXX in Adults Weighing More Than 120 KG
Safety and PK study in adults weighing more than 120 kg
- Trial name
- NCT04392739
- Testing
- Tpoxx
- Where
- United States
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- SIGA Technologies
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
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
Orthopoxviral Disease, Smallpox
Phase I Trial of an Investigational Small Pox Medication
The purpose of this study was to evaluate the pharmacokinetic parameters and safety of a single dose of ST-246 400mg Form I versus ST-246 400mg Form V capsules in fed normal healthy volunteers.
- Conditions
- Orthopoxviral Disease, Smallpox, Monkey Pox
- Trial name
- NCT00728689
- Testing
- ST-246 Days 1 - 3, ST-246 Days 11 - 13
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- SIGA Technologies
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
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
Safety and Efficacy of CJ-50300 in Healthy Volunteers
The currently available stock of smallpox vaccine would be insufficient in the face of an incident of smallpox attack. Thus, new manufacturing methods for smallpox vaccine are urgently needed because previous manufacturing…
- Trial name
- NCT00607243
- Testing
- smallpox vaccine CJ-50300
- Where
- South Korea
- Volunteers
- 123 people, healthy volunteers welcome
- Sponsor
- Seoul National University Hospital
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
Safety, Tolerability and Pharmacokinetics of TPOXX When Administered Orally for 28 Days
This is a study to assess the safety, tolerability, and PK of oral TPOXX 600 mg when administered twice daily (BID) for 28 days in adult subjects.
- Trial name
- NCT04971109
- Testing
- TPOXX
- Where
- 9 sites in United States
- Volunteers
- 467 people, healthy volunteers welcome
- Sponsor
- SIGA Technologies
HIV Infections
Safety and Immunogenicity 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. Subjects will receive two vaccinations
- Trial name
- NCT00316589
- Testing
- IMVAMUNE (MVA-BN)
- Where
- 36 sites in United States, Puerto Rico
- Volunteers
- 581 people, healthy volunteers welcome
- 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
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