Clinical trials: Vaccinia
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
Colorectal Carcinoma, CRC
Recombinant Vaccinia Virus Administered Intravenously in Patients With Metastatic, Refractory Colorectal Carcinoma
The purpose of this study is to evaluate the safety, tolerability, and efficacy of JX-594 (Pexa-Vec) administered intravenously either alone or in combination with Irinotecan in colorectal carcinoma patients who are refractory to…
- Trial name
- NCT01394939
- Testing
- JX-594, Irinotecan
- Where
- 11 sites in United States, Canada and 1 more
- Volunteers
- 52 people
- Sponsor
- Jennerex Biotherapeutics
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
Renal Cell Carcinoma
A Study of Recombinant Vaccinia Virus in Combination With Cemiplimab for Renal Cell Carcinoma
This is a Phase 1b/2a, open-label, multi-center, dose-escalation and safety/efficacy evaluation trial of Pexa-Vec plus Cemiplimab in patients with metastatic or unresectable renal cell carcinoma (RCC).
- Trial name
- NCT03294083
- Testing
- Pexastimogene Devacirepvec (Pexa-Vec), Cemiplimab
- Where
- 21 sites in United States, Australia and 1 more
- Volunteers
- 95 people
- Sponsor
- SillaJen, Inc.
Hemorrhagic Fever, Ebola
Safety, Tolerability and Immunogenicity Study of 2-dose Heterologous Regimens for Ebola Vaccines Ad26.ZEBOV/MVA-BN-Filo
The purpose of this study is to assess the safety, tolerability and immunogenicity of different vaccination schedules of Ad26.ZEBOV and MVA-BN-Filo administered intramuscularly (IM) as 2-dose heterologous regimens in healthy and…
- Trial name
- NCT02598388
- Testing
- Ad26.ZEBOV, MVA-BN-Filo
- Where
- 7 sites in United States, Kenya and 4 more
- Volunteers
- 578 people, healthy volunteers welcome
- Sponsor
- Janssen Vaccines & Prevention B.V.
Human Immunodeficiency Virus
Safety and Efficacy Study of Vaccine Schedule With Ad26.Mos.HIV and MVA-Mosaic in Human Immunodeficiency Virus (HIV)-Infected Adults
The purpose of the study is to assess: 1 safety and tolerability of adenovirus serotype 26 (Ad26) prime and Modified Vaccinia Ankara (MVA) boost versus placebo in participants on suppressive antiretroviral therapy (ART) that was…
- Trial name
- NCT02919306
- Testing
- Ad26.Mos.HIV, MVA-Mosaic
- Where
- Thailand
- Volunteers
- 27 people
- Sponsor
- Janssen Vaccines & Prevention B.V.
Hepatocellular Carinoma
A Phase 2a Study of Modified Vaccinia Virus to Treat Sorafenib-naïve Advanced Liver Cancer
This study is to determine how effectively JX-594 (Pexa-Vec) will prolong life in patients with advanced Hepatocellular Carcinoma (HCC) who have not been previously treated with sorafenib, and the safe administration of JX-594 in…
- Trial name
- FLASH (NCT01636284)
- Testing
- JX-594 recombinant vaccina GM-CSF
- Where
- 5 sites in United States, South Korea and 1 more
- Volunteers
- 16 people
- Sponsor
- Jennerex Biotherapeutics
Carcinoma, Hepatocellular
A Study of Recombinant Vaccinia Virus to Treat Unresectable Primary Hepatocellular Carcinoma
The purpose of this research study is to determine whether JX-594 (Pexa-Vec) has significant anti-tumoral activity and tolerability in primary hepatocellular carcinoma and to determine the dose to be used in further testing.
- Trial name
- NCT00554372
- Testing
- JX-594: Recombinant vaccinia virus (TK-deletion plus GM-CSF)
- Where
- 9 sites in United States, Canada and 1 more
- Volunteers
- 30 people
- Sponsor
- Jennerex Biotherapeutics
Healthy
Safety, Tolerability, and Immunogenicity Study of Homologous Ad26 Mosaic Vector Vaccine Regimens or Heterologous Ad26 Mosaic and MVA Mosaic Vector Vaccine Regimens With Glycoprotein 140 (gp140) for Human Immunodeficiency Virus (HIV) Prevention
The purpose of this study is to assess the safety and tolerability of various regimens containing adenovirus serotype 26-Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV), Modified Vaccinia Ankara (MVA)-Mosaic, and/or HIV type…
- Trial name
- NCT02315703
- Testing
- Ad26.Mos.HIV, MVA-Mosaic, gp140 DP Low-dose
- Where
- 12 sites in United States, Rwanda and 3 more
- Volunteers
- 393 people, healthy volunteers welcome
- Sponsor
- Janssen Vaccines & Prevention B.V.
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
Hepatocellular Carcinoma (HCC)
Hepatocellular Carcinoma Study Comparing Vaccinia Virus Based Immunotherapy Plus Sorafenib vs Sorafenib Alone
This is a randomized Phase 3 study to determine whether treatment with vaccinia virus based immunotherapy (Pexa-Vec) followed by sorafenib increases survival compared to treatment with sorafenib in patients with advanced…
- Trial name
- PHOCUS (NCT02562755)
- Testing
- Pexastimogene Devacirepvec (Pexa Vec), Sorafenib
- Where
- 142 sites in United States, Australia and 14 more
- Volunteers
- 459 people
- Sponsor
- SillaJen, Inc.
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
Hepatocellular Carcinoma, Liver Cancer
A Phase 2b Study of Modified Vaccinia Virus to Treat Patients Advanced Liver Cancer Who Failed Sorafenib
This study is to determine whether JX-594 (Pexa-Vec) plus best supportive care is more effective in improving survival than best supportive care in patients with advanced Hepatocellular Carcinoma (HCC) who have failed sorafenib.
- Conditions
- Hepatocellular Carcinoma, Liver Cancer, HCC
- Trial name
- TRAVERSE (NCT01387555)
- Testing
- JX-594 recombinant vaccina GM-CSF, Best Supportive Care
- Where
- 38 sites in United States, Canada and 5 more
- Volunteers
- 129 people
- Sponsor
- Jennerex Biotherapeutics
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
Carcinoma, Hepatocellular
A Study of Pexa-Vec (JX-594) Prior to Sorafenib to Treat Unresectable Primary Hepatocellular Carcinoma
The purpose of this pilot safety study is to evaluate the safety and tolerability of JX-594 (Pexa-Vec) administered intravenously and intratumorally prior to standard sorafenib therapy.
- Trial name
- NCT01171651
- Testing
- JX-594, Sorafenib
- Where
- 2 sites in South Korea
- Volunteers
- 25 people
- Sponsor
- Jennerex Biotherapeutics
Vaccination
Special Access Program IMVAMUNE®
Prophylactic smallpox vaccination for personnel actively working with or in the vicinity of replicating vaccinia virus
- Trial name
- NCT03472014
- Testing
- IMVAMUNE®
- Where
- United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Bavarian Nordic
Human Papillomavirus Infections
Safety, Reactogenicity and Immunogenicity of Adenovirus Serotype 26 (Ad26)- and Modified Vaccinia Ankara (MVA)-Vectored Vaccine Components in Otherwise Healthy Women With HPV16 or HPV18 Infection of the Cervix
The main purpose of this study is to assess safety and reactogenicity of the 3 vaccine regimens.
- Trial name
- NCT03610581
- Testing
- Ad26.HPV16, Ad26.HPV18, MVA.HPV16/18
- Where
- 12 sites in United States, Belgium
- Volunteers
- 9 people
- Sponsor
- Janssen Vaccines & Prevention B.V.
Colorectal Carcinoma
Neoadjuvant Recombinant Vaccinia Virus for Metastatic Colorectal Cancer With Liver Resection
This is a neoadjuvant Phase 2a, open-label trial in patients with metastatic colorectal carcinoma who are undergoing a complete resection of the metastatic colorectal tumors in their liver.
- Trial name
- NCT01329809
- Testing
- Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594)
- Where
- Canada
- Volunteers
- 2 people
- Sponsor
- Jennerex Biotherapeutics
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
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