drugset / Trial / NCT04049864
DNA Vaccination Against Neuroblastoma
Phase 0
Unknown
12 enrolled
Belarusian Research Center for Pediatric Oncology, Hematology and Immunology
NaSingle-groupOpen-labelTreatment
Summary
This is pilot open-label study to evaluate the safety and immunogenicity of a DNA vaccine strategy in relapsed neuroblastoma patients following chemotherapy and HSC transplantation. The combined form of the vaccine includes an intramuscular injection of the DNA-polyethylenimine conjugate and oral administration using the attenuated Salmonella enterica as DNA vaccine carriers. Objectives of the study: 1. To assess safety and document local and systemic toxicity to combined DNA vaccine 2. To determine immunogenicity of the vaccine 3. To evaluate clinical response to vaccination. Control of minimal residual disease in bone marrow and duration of remission.
Timeline
- Start
- 2019-01-09
- Primary completion
- 2023-12-31
- Completion
- 2023-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | DNA vaccine | Vaccine | 400 ug | Intramuscular |
| Subject | DNA vaccine | Vaccine | 500 ug | Intramuscular |
| Subject | Salmonella oral vaccine | Unknown | 1e+10 unknown | Oral |
| Background | Lenalidomide | Other / unclassified | 25 mg | — |