Clinical trials: Small Pox
Neonate, Maternal Transmission
Phase 3 Maternal Safety & Immunogenicity Trial of MVA-BN® in DRC
This Phase 3 open-label study aims to assess the safety and immune response of the MVA-BN mpox vaccine when administered subcutaneously to pregnant and postpartum women in the Democratic Republic of the Congo (DRC), a population…
- Conditions
- Neonate, Maternal Transmission, Mpox, Vaccination
- Trial name
- PregInPoxVac (NCT06844500)
- Testing
- MVA-BN standard regimen, MVA-BN standard regimen (Administered as PEP)
- Where
- Democratic Republic of the Congo
- Volunteers
- 359 people, healthy volunteers welcome
- Sponsor
- Jean-Pierre Van geertruyden
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, Cowpox
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BSY001 After Single/Multiple Doses.
A Two-Phase, Randomized, Double-Blind, Placebo-Controlled Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BSY001 for Injection Following Single or Multiple Doses in Healthy Subjects
- Conditions
- Smallpox, Cowpox, Monkeypox, Poxvirus Infection
- Trial name
- NCT07377175
- Testing
- BSY001 for Injection (37.5mg), BSY001 for Injection (75 mg), BSY001 for Injection (150 mg)
- Where
- China
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- China National Biotec Group Company Limited
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
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
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)
Mpox (Monkeypox), Smallpox
A Randomized Clinical Trial Investigating the Safety, Reactogenicity, and Immunogenicity After Immunization With an mRNA-based Mpox Vaccine Candidate in Africa
This is a randomized, double-blind, placebo-controlled study which aims to assess the safety, reactogenicity, and immunogenicity after one and two doses of BNT166a or placebo in healthy participants.
- Conditions
- Mpox (Monkeypox), Smallpox, Orthopoxvirus Infection
- Trial name
- NCT07379580
- Testing
- BNT166a
- Where
- 6 sites in Democratic Republic of the Congo, South Africa
- Volunteers
- 310 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
Smallpox
A Study of Dryvax Vaccine Against Smallpox in Previously Unvaccinated Adults
The purpose of this study is to see how many people respond to a smallpox vaccine when a sore forms where the shot was given. The world was declared free of smallpox in 1980.
- Trial name
- NCT00026611
- Testing
- Dryvax vaccine
- Where
- 4 sites in United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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
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
Smallpox
Study of Reactogenicity, Safety, Immunogenicity, and Pock Lesion Formation of a Cell-Cultured Smallpox Vaccine Compared to Dryvax®
This study will evaluate the safety and efficacy of both Dryvax® and the new cell-cultured vaccine (CCSV) in a comparative fashion.
- Trial name
- NCT00042094
- Testing
- Cell-Cultured Smallpox Vaccine compared to Dryvax®
- Where
- United States
- Volunteers
- 350 people, healthy volunteers welcome
- Sponsor
- DynPort Vaccine Company LLC, A GDIT Company
Smallpox
Safety and Immunogenicity of CJ-50300
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 is urgently needed because previous manufacturing methods…
- Trial name
- NCT00336635
- Testing
- cell-culture derived smallpox vaccine
- Where
- South Korea
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Seoul National University Hospital
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
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
Monkeypox
Smallpox Vaccine for Mpox Post-Exposure Prophylaxis: A Cluster RCT
A cluster randomized controlled trial to determine if smallpox vaccine reduces secondary cases and symptom severity in persons exposed to mpox.
- Trial name
- SMART (NCT05745987)
- Testing
- Bavarian Nordic smallpox vaccine, Typhoid VI Polysaccharide Vaccine Injectable Solution
- Where
- 10 sites in Democratic Republic of the Congo, Nigeria and 1 more
- Volunteers
- 3,000 people, healthy volunteers welcome
- Sponsor
- McMaster University
Dermatitis, Atopic, Hay Fever
Safety, Tolerability and Immune Response of IMVAMUNE (MVA-BN)Smallpox Vaccine in Patients With Atopic Disorders
The purpose of this study is to gather information on the safety and immunogenicity of an investigational smallpox vaccine in populations with atopic disorders.
- Trial name
- NCT00189917
- Testing
- IMVAMUNE (MVA-BN)
- Where
- Germany
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Bavarian Nordic
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"