Clinical trials: Smallpox
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
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
Healthy, Communicable Diseases
Vaccinia Immune Globulin in Treating or Preventing Vaccinal Infection
The purpose of this study is to follow responses to treatment with vaccinia immune globulin (VIG) for safety and clinical benefit [during HIV vaccine research].
- Trial name
- NCT00006630
- Testing
- Vaccinia Immune Globulin (Human)
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Smallpox
A Phase 4, Observational Field Study to Evaluate TPOXX in Patients With Smallpox
Phase 4, Observational Field Study in Patients Treated With TPOXX for Smallpox Disease
- Trial name
- NCT03972111
- Testing
- TPOXX 200Mg Capsule
- Where
- United States
- Sponsor
- SIGA Technologies
Healthy
Phase I Trial of Smallpox Vaccine
This study will test the safety of an experimental vaccine called Modified Vaccinia Virus Ankara (MVA) for use against the smallpox virus.
- Trial name
- NCT00046397
- Testing
- Modified Vaccinia Virus Ankara TBC-M
- Where
- United States
- Volunteers
- 195 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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
Healthy
Phase I/II Trial of Modified Vaccinia Virus Ankara (MVA) Vaccine Against Smallpox
This study will test the safety of an experimental vaccine called modified vaccinia virus ankara (MVA) and determine if it confers protection against the smallpox virus (variola).
- Trial name
- NCT00053742
- Testing
- Modified Vaccinia Virus Ankara TBC-MVA
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Smallpox
Dryvax Dilution-Prev Vacc Adults
A double-blind, randomized, dose-response study of four dilutions of Dryvax in previously vaccinated adults in order to assess the clinical success rates, humoral responses, and virus-specific actifity of cytotoxi T cells and…
- Trial name
- NCT00032708
- Testing
- Dryvax
- Where
- United States
- Volunteers
- 90 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
A Multicenter, Randomized, Placebo-Controlled, Double-Blind Trial to Evaluate the Safety and Immunogenicity of a Recombinant Vaccinia-HIV-1 IIIB Env/Gag/Pol Vaccine (TBC-3B)
To evaluate, in healthy HIV-1 seronegative vaccinia-immune and vaccinia-naive volunteers, the safety and immunogenicity of an HIV-1 candidate vaccine (TBC-3B) consisting of a live recombinant vaccinia virus expressing the env…
- Trial name
- NCT00000767
- Testing
- TBC-3B Vaccine, Smallpox Vaccine
- Where
- 5 sites in United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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 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
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
Complication of Smallpox Vaccination
VA-005 Clinical Outcomes of VIGIV Treatment of Smallpox Vaccination Complications or Vaccinia Infection
This is a post-marketing study to verify the clinical benefits of VIGIV [CNJ-016, Vaccinia Immune Globulin Intravenous (Human), sterile solution] in the resolution of complications resulting from smallpox vaccination in eligible…
- Trial name
- NCT01374984
- Testing
- VIGIV
- Volunteers
- 100 people
- Sponsor
- Emergent BioSolutions
Monkeypox
Cohort Study of Healthcare Workers Receiving Imvanex®
During an outbreak of monkeypox in the UK in 2018, a third generation smallpox vaccine, Imvanex, was used for the first time to immunise healthcare workers who had been, or were expected to be, in contact with cases of monkeypox.
- Trial name
- NCT03745131
- Testing
- Blood draw
- Where
- 5 sites in United Kingdom
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Public Health England
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
Safety and Immunogenicity Study of LC16m8, a Modified Smallpox Vaccine, in Healthy, Previously Unvaccinated Volunteers
This is a Phase I/II study evaluating the safety and immunogenicity of LC16m8, a modified vaccinia vaccine. After consent and thorough screening (including safety labs, EKG, and medical history), healthy, previously unvaccinated…
- Trial name
- NCT00103584
- Testing
- LC16m8 Smallpox Vaccine
- Where
- 4 sites in United States
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- VaxGen
Smallpox
Safety and Efficacy of CJ Smallpox Vaccine in Previously Vaccinated 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
- NCT01317238
- Testing
- smallpox vaccine CJ-50300
- Where
- South Korea
- Volunteers
- 145 people, healthy volunteers welcome
- Sponsor
- Seoul National University Hospital
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
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