Clinical trials: Smallpox
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
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
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
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
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 Trial to Assess the Safety, Tolerability, and Pharmacokinetics of the Anti-Orthopoxvirus Compound Tecovirimat
Multicenter, double-blind, placebo controlled, Phase 3 study to determine the safety and tolerability of oral tecovirimat, an anti orthopoxvirus compound, in subjects.
- Trial name
- SIGA246-008 (NCT02474589)
- Testing
- tecovirimat
- Where
- 11 sites in United States
- Volunteers
- 449 people, healthy volunteers welcome
- Sponsor
- SIGA Technologies
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
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
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
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
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
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
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
Smallpox
Effect of Dose, Safety, Tolerability 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
- NCT00053495
- Testing
- Vaccinia virus: ACAM2000 smallpox vaccine, vaccinia virus (calf lymph): Dryvax
- Where
- 4 sites in United States
- Volunteers
- 353 people, healthy volunteers welcome
- Sponsor
- Emergent BioSolutions
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
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
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 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