Clinical trials: Vaccinia
Safety Issues
Safety and Tolerability Trial (MVA-BN-Brachyury/FPV-Brachyury)
An open-label Phase 1 trial to evaluate the safety and tolerability of MVA-BN-Brachyury priming and FPV-Brachyury boost vaccines modified to express brachyury and T-cell costimulatory molecules in patients with a metastatic or…
- Trial name
- NCT03349983
- Testing
- MVA-BN-Brachyury/ FPV-Brachyury
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Bavarian Nordic
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
Healthy
A Study to Evaluate A Range of Dose Levels of Ad26.ZEBOV and MVA-BN-Filo in Healthy Adult Participants
The purpose of this study is to demonstrate the non-inferiority of a heterologous prime-boost regimen using Ad26.ZEBOV as prime and MVA-BN-Filo as boost administered at different doses at a 56-day interval versus the same regimen…
- Trial name
- NCT02543567
- Testing
- Ad26.ZEBOV 5*10^10 viral particles (vp), Ad26.ZEBOV 2*10^10 (vp), Ad26.ZEBOV 0.8*10^10 (vp)
- Where
- 6 sites in United States
- Volunteers
- 525 people, healthy volunteers welcome
- Sponsor
- Janssen Vaccines & Prevention B.V.
Healthy
A Safety and Immunogenicity Study of Heterologous Prime-Boost Ebola Vaccine Regimens in Healthy Participants
The purpose of this study is to test the safety and immunogenicity of MVA-BN-Filo and Ad26.ZEBOV as heterologous prime-boost vaccine regimens in healthy adult participants.
- Trial name
- NCT02313077
- Testing
- MVA-BN-filo, Ad26. ZEBOV
- Where
- United Kingdom
- Volunteers
- 87 people, healthy volunteers welcome
- Sponsor
- Crucell Holland BV
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
Advanced Solid Tumors
A Study to Evaluate Combination Therapy of Oncolytic Vaccinia Virus (hV01) and PD-1 Inhibitor in Advanced Solid Tumors.
The purpose of this study is to evaluate the safety and primary efficacy of the combination therapy of recombinant human IL-21-expressing oncolytic vaccinia virus (hV01) and the PD-1 Inhibitor Tislelizumab in patients with…
- Trial name
- NCT07185243
- Testing
- recombinant human IL-21-expressing oncolytic vaccinia virus injection
- Where
- China
- Volunteers
- 24 people
- Sponsor
- Hangzhou Converd Co., Ltd.
Peritoneal Carcinomatosis
A Study of GL-ONC1, an Oncolytic Vaccinia Virus, in Patients With Advanced Peritoneal Carcinomatosis
The purpose of this study is to determine whether GL-ONC1, an attenuated vaccinia virus, is safe when administered to patients with peritoneal carcinomatosis via an infusion within the abdominal cavity through an implanted…
- Trial name
- NCT01443260
- Testing
- GL-ONC1
- Where
- Germany
- Volunteers
- 9 people
- Sponsor
- Genelux GmbH
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
Healthy
A Safety and Immunogenicity Study of Heterologous and Homologous Prime-Boost Ebola Vaccine Regimens in Healthy Participants
The purpose of this study is to test the safety and immunogenicity of MVA-BN-Filo and Ad26.ZEBOV as heterologous and homologous prime-boost vaccine regimens in healthy adult participants.
- Trial name
- NCT02325050
- Testing
- MVA-BN-Filo, Ad26. ZEBOV
- Where
- United States
- Volunteers
- 164 people, healthy volunteers welcome
- Sponsor
- Janssen Vaccines & Prevention B.V.
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.
HIV Infections
Safety and Immunogenicity Study of Recombinant Modified Vaccinia Virus Ankara (MVA) Virus to Treat HIV Infection
At the end of 2004 there were more than 40 million people infected worldwide with HIV, with an estimated 16,000 new infections every day (Joint United Nations Programme on HIV/AIDS [UNAIDS], 2004).
- Trial name
- NCT00386633
- Testing
- MVA-mBN32
- Where
- Germany
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Bavarian Nordic
Metastatic Cancer, Solid Tumors
A Study of an Intratumoral Oncolytic Virus in Patients With Advanced Metastatic Solid Tumors
The purpose of this study is to assess the safety and tolerability of ASP9801 and to determine the recommended phase 2 dose (RP2D).
- Conditions
- Metastatic Cancer, Solid Tumors, Advanced Cancer
- Trial name
- NCT03954067
- Testing
- ASP9801, Pembrolizumab
- Where
- 17 sites in United States
- Volunteers
- 72 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Treatment-Refractory Solid Tumors
A Phase 1 Study of OTS-412 (Recombinant Oncolytic Vaccinia Virus) in Treatment-refractory Solid Tumor Patients
This clinical trial aims to determine whether the administration of the investigational drug OTS-412, OTS-412 in combination with hydroxyurea or hydroxyurea/atezolizumab is safe and effective for patients with various types of…
- Trial name
- NCT07170592
- Testing
- OTS-412, Hydroxyurea (HU), Atezolizumab
- Volunteers
- 24 people
- Sponsor
- Bionoxx Inc.
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.
Solid Tumor, Microsatellite Stable Colorectal Cancer
Study of TBio-6517 Given Alone or in Combination With Pembrolizumab in Solid Tumors
To determine the recommended Phase 2 dose (RP2D) of TBio-6517 when administered by direct injection into tumor(s) or intravenously and when combined with pembrolizumab in patients with solid tumors (RIVAL-01).
- Conditions
- Solid Tumor, Microsatellite Stable Colorectal Cancer, HPV Positive Oropharyngeal Squamous Cell Carcinoma, Cervical Cancer
- Trial name
- RAPTOR (NCT04301011)
- Testing
- TBio-6517, Pembrolizumab
- Where
- 11 sites in United States, Canada and 1 more
- Volunteers
- 27 people
- Sponsor
- Turnstone Biologics, Corp.
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
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
HPV Infection, CIN1
Prime-boost Vaccine Study in Women With Low-grade Cervical HPV Lesions
A Phase 1b/2 multi-centre study evaluating the safety, efficacy and immunogenicity of prime-boost vaccines ChAdOx1-HPV and MVA-HPV in women with HPV related low grade cervical lesions.
- Trial name
- NCT04607850
- Testing
- ChAdOx1-HPV, MVA-HPV
- Where
- 16 sites in Belgium, Estonia and 1 more
- Volunteers
- 108 people
- Sponsor
- Barinthus Biotherapeutics