NCT04049864

DNA Vaccination Against Neuroblastoma

Status unknown EARLY_PHASE1 Last updated 2 March 2022

What this trial tests

EARLY_PHASE1 trial testing DNA vaccine in Relapsed Neuroblastoma in 12 participants. Status unknown.

Timeline

9 January 2019

Primary endpoint
31 December 2023

31 December 2023

Quick facts

Lead sponsor	Belarusian Research Center for Pediatric Oncology, Hematology and Immunology
Phase	EARLY_PHASE1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	12
Start date	9 January 2019
Primary completion	31 December 2023
Estimated completion	31 December 2023
Sites	1 location across Belarus

Drugs / interventions tested

• DNA vaccine — full drug profile →
• Salmonella oral vaccine — full drug profile →
• Lenalidomide — full drug profile →

Conditions studied

• Relapsed Neuroblastoma — all drugs for Relapsed Neuroblastoma →

Sponsor

Belarusian Research Center for Pediatric Oncology, Hematology and Immunology — full company profile →

Who can join

Adults 1 to 20, any sex, with Relapsed Neuroblastoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Next-Generation Vaccines: Nanoparticle-Mediated DNA and mRNA Delivery.
   Ho W, Gao M, Li F, Li Z, et al · · 2021 · cited 176× · PMID 33458958 · DOI 10.1002/adhm.202001812
2. Targeted Cancer Immunotherapy: Nanoformulation Engineering and Clinical Translation.
   Yu M, Yang W, Yue W, Chen Y. · · 2022 · cited 35× · PMID 36257824 · DOI 10.1002/advs.202204335
3. Microbiome engineering: engineered live biotherapeutic products for treating human disease.
   Rutter JW, Dekker L, Owen KA, Barnes CP. · · 2022 · cited 34× · PMID 36185459 · DOI 10.3389/fbioe.2022.1000873
4. Pediatric Drug Development: Reviewing Challenges and Opportunities by Tracking Innovative Therapies.
   Domingues C, Jarak I, Veiga F, Dourado M, et al · · 2023 · cited 33× · PMID 37896191 · DOI 10.3390/pharmaceutics15102431
5. Bacterial-Based Methods for Cancer Treatment: What We Know and Where We Are.
   Rommasi F. · · 2022 · cited 32× · PMID 34780046 · DOI 10.1007/s40487-021-00177-x
6. Beyond Lipids: Exploring Advances in Polymeric Gene Delivery in the Lipid Nanoparticles Era.
   Jogdeo CM, Siddhanta K, Das A, Ding L, et al · · 2024 · cited 22× · PMID 38842816 · DOI 10.1002/adma.202404608
7. Integration of <i>Salmonella</i> into Combination Cancer Therapy.
   Al-Saafeen BH, Fernandez-Cabezudo MJ, Al-Ramadi BK. · · 2021 · cited 22× · PMID 34203478 · DOI 10.3390/cancers13133228
8. Cancer Vaccines in the Immunotherapy Era: Promise and Potential.
   Verma C, Pawar VA, Srivastava S, Tyagi A, et al · · 2023 · cited 21× · PMID 38140187 · DOI 10.3390/vaccines11121783