Clinical trials: Smallpox
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 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
Human Immune Responses Smallpox
The purpose of this study is to attempt to identify the immune response of healthy adults to an investigational dilution of the Dryvax smallpox vaccine.
- Trial name
- NCT00068198
- Testing
- Dryvax
- Where
- United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections, HIV Seronegativity
A Phase I, Multicenter, Randomized Trial to Evaluate the Safety and Immunogenicity of Vaccinia-Derived MN HIV-1 Recombinant Envelope Glycoprotein (rgp160) of Human Immunodeficiency Virus at Two Different Vaccination Schedules
AMENDED 8/94: To expand the safety and immunogenicity profile of MN rgp160 vaccine (Immuno-AG) by administering a higher dose (800 mcg) at 0, 1, 6, and 12 months and 0, 2, 8 and 14 months (these two schedules were compared in VEU…
- Trial name
- NCT00001043
- Testing
- gp160 Vaccine (Immuno-AG)
- Where
- 2 sites in United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Smallpox
Study Evaluating the Bioequivalence of Brincidofovir Form H and Form II Tablets in Healthy Adults
The goal of this clinical trial is to evaluate whether both Form H and Form II, 100mg brincidofovir tablets are bioequivalent, when given under fasting conditions in healthy adults.
- Trial name
- BCV-001 (NCT05935917)
- Testing
- Brincidofovir
- Where
- United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Emergent BioSolutions
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
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
Smallpox
Study on Safety, Tolerability and Immunogenicity of an MVA Vaccine Administered to Healthy Subjects
The purpose of this study is to collect information on the safety, tolerability and immunogenicity of an investigational smallpox vaccine at different doses and using different routes of administration in vaccinia-naive and…
- Trial name
- NCT00189943
- Testing
- MVA-BN
- Where
- Germany
- Volunteers
- 90 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
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
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
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
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
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
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
Variola Major (Smallpox)
Safety, Reactogenicity and Immunogenicity of MVA in Hematopoietic Stem Cell Transplant (HSCT) Subjects
The purpose of this study is to compare how the body's immune system reacts to a vaccine against smallpox infection, called Modified Vaccinia Ankara (MVA) and to evaluate the safety of this vaccine.
- Trial name
- NCT00565929
- Testing
- MVA-BN
- Where
- United States
- Volunteers
- 24 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
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
Safety and Efficacy of CJ Smallpox Vaccine 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
- NCT01056770
- Testing
- smallpox vaccine CJ-50300
- Where
- South Korea
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Seoul National University Hospital
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)