NCT00062907UnknownPhase 1
Phase I Open-Label Dose Escalation Trial Evaluating The Safety And Immunogenicity Of Sequential Administration Of Recombinant DNA And Adenovirus Expressing L523S Protein In Patients With Early Stage Non-Small Cell Lung Cancer
Conditions
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- Corixa Corporation
- Enrollment
- 9
- Locations
- 10
Study Overview
Brief Summary
The purpose of this trial is to examine the safety and immunogenicity of a therapeutic vaccine regimen with recombinant DNA and adenovirus expressing L523S protein in patients with early stage non-small cell lung cancer. The vaccine regimen will consist of two fixed doses of recombinant DNA (pVAX/L523S) followed by two doses of recombinant adenovirus (Ad/L523S). The trial will evaluate the dose escalation of Ad/L523S through three cohorts of patients.
Detailed Description
The primary objective of the study is to evaluate the safety of the vaccine regimen administered as two doses of pVAX/L523S and two doses of Ad/L523S.
The secondary objectives of the study are:
- To provide initial evidence as to whether CD8+ and CD4+ T cell responses specific for L523S protein can be elicited by two doses of pVAX/L523S followed by two doses of Ad/L523S
- To provide initial evidence as to whether antibody responses specific for L523S protein can be elicited by two doses of pVAX/L523S followed by two doses of Ad/L523S
- To investigate the extent to which dose escalation of Ad/L523S affects the elicited immune response
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Investigators
Study Sites (10)
Loading locations...
Similar Trials
Terminated
Phase 1
Safety and Immunogenicity of RVM-V001 in Healthy Individuals Previously Vaccinated With BNT162b2 and mRNA-1273Infectious DiseaseCOVID-19NCT05420077RVAC Medicines (US), Inc.13
Completed
Phase 1
A Clinical Trial to Evaluate Safety, Tolerability, and Immunogenicity of Adjuvanted HIV-1 Fusion Peptide Conjugate Vaccine Alone or in Prime-Boost Regimens With Adjuvanted HIV-1 Envelope Trimer 4571 and HIV-1 Trimer 6931 Vaccines in Healthy AdultsHIVNCT05470400National Institute of Allergy and Infectious Diseases (NIAID)44
Unknown
Phase 1
Safety and Immunogenicity of an Intranasal RSV Vaccine Expressing SARS-CoV-2 Spike Protein (COVID-19 Vaccine) in AdultsCovid19NCT04798001Meissa Vaccines, Inc.130
Recruiting
Phase 1
A Study of BGC515 Capsules in Subjects With Advanced Solid TumorsMesotheliomaEpithelioid Hemangioendothelioma(EHE)Solid TumorNCT06452160BridGene Biosciences Inc.103
Completed
Phase 1
Study to Evaluate the Safety of a Single Escalating Dose of ACRX-100 in Adults With Ischemic Heart FailureHeart FailureNCT01082094Juventas Therapeutics, Inc.17