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DNA Vaccination Against Neuroblastoma

NCT04049864 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2022-03-02

No results posted yet for this study

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.

Conditions

  • Relapsed Neuroblastoma

Interventions

BIOLOGICAL

DNA vaccine

conjugate of plasmid DNA with linear polyethylenimine 20 kDa (PEI) One dose includes 400 µg of DNA and 500 µg of PEI.

BIOLOGICAL

Salmonella oral vaccine

suspension 10\^10 CFU of an attenuated Salmonella enterica serovar typhimurium strain (SS2017) containing the plasmid of the corresponding DNA vaccine.

DRUG

Lenalidomide

Lenalidomide is prescribed in a dose of 25 mg / day in a course of three weeks starting 7 days before the first vaccination course and ending on the day of the last vaccination course.

Sponsors & Collaborators

  • Belarusian Research Center for Pediatric Oncology, Hematology and Immunology

    lead OTHER

Principal Investigators

  • Inna V Proleskovskaya, PhD, MD · Belarussian Research Center for Pediatric Oncology, Hematology and Immunology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-09
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • Belarus

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04049864 on ClinicalTrials.gov