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.
Phase:
Early Phase 1
Details
Lead Sponsor:
Belarusian Research Center for Pediatric Oncology, Hematology and Immunology