Evidence map›Paper›PMID 33326254›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2021

Survival Impact of Anti-GD2 Antibody Response in a Phase II Ganglioside Vaccine Trial Among Patients With High-Risk Neuroblastoma With Prior Disease Progression.

Irene Y Cheung, Nai-Kong V Cheung, Shakeel Modak, Audrey Mauguen, Yi Feng, Ellen Basu, Stephen S Roberts, Govind Ragupathi, Brian H Kushner

Erratum issued Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT00911560 (Phase I/II Trial of a Bivalent Vaccine With Escalating Doses of the Immunological Adjuvant OPT-821, in Combination With Oral β-glucan for High-Risk Neuroblastoma), which is not on this map. Cited by 69 papers.

0numbers the graph read from it
0cells of the map it votes in
69citing papers in PubMed
6.1field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00911560 phase1 / phase2completednot on this map

Phase I/II Trial of a Bivalent Vaccine With Escalating Doses of the Immunological Adjuvant OPT-821, in Combination With Oral β-glucan for High-Risk Neuroblastoma

TypeinterventionalSponsorMemorial Sloan Kettering Cancer CenterRan2009 to 2026Enrolled374ConditionsNeuroblastomaArmsadjuvant OPT-821 in a vaccine containing two antigens (GD2L and GD3L) covalently linked to KLH, oral β-glucan
3 · Its place in the literature

Who cites it

69 citing papers in PubMed, 108 citations in OpenAlex.

  1. A Phase II Trial of Naxitamab plus Stepped-up Dosing of GM-CSF for Patients with High-Risk Neuroblastoma in First Complete Remission.Clinical cancer research : an official journal of the American Association for Cancer Research · 2025
    Trial
  2. Trial
  3. Trial
  4. Trial
  5. Review
  6. Article
  7. Article
  8. Targeted therapies in pediatric oncology: A start.Molecular therapy. Oncology · 2026
    Review
  9. Review
  10. Review
  11. Review
  12. Immunotherapeutic Strategies Targeting GD2-Expressing Malignancies.Advances in experimental medicine and biology · 2026
    Review
  13. Review
  14. Review
  15. Review
  16. Review
  17. Article
  18. The Involvement of CSRP1 in Neuroblastoma Differentiation and Apoptosis Impacting Tumor-Suppressive Therapeutic Responses.FASEB journal : official publication of the Federation of American Societies for Experimental Biology · 2025
    Article
  19. Review
  20. Review

9 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 1 institution in 1 country.

Irene Y CheungDepartments of Pediatrics, Memorial Sloan Kettering Cancer Center, New York, NY.
Nai-Kong V CheungDepartments of Pediatrics, Memorial Sloan Kettering Cancer Center, New York, NY.
Shakeel ModakDepartments of Pediatrics, Memorial Sloan Kettering Cancer Center, New York, NY.
Audrey MauguenEpidemiology-Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY.
Yi FengDepartments of Pediatrics, Memorial Sloan Kettering Cancer Center, New York, NY.
Ellen BasuDepartments of Pediatrics, Memorial Sloan Kettering Cancer Center, New York, NY.
Stephen S RobertsDepartments of Pediatrics, Memorial Sloan Kettering Cancer Center, New York, NY.
Govind RagupathiMedicine, Memorial Sloan Kettering Cancer Center, New York, NY.
Brian H KushnerDepartments of Pediatrics, Memorial Sloan Kettering Cancer Center, New York, NY.
Memorial Sloan Kettering Cancer Center · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

purposeAnti-GD2 monoclonal antibody (mAb) has proven efficacy in high-risk neuroblastoma (HR-NB). A small phase I GD2/GD3 vaccine trial (n = 15) described long-term survival and a favorable safety profile among patients with a history of disease progression (PD). The kinetics of mounting antibody response to vaccine and its prognostic impact on survival are now investigated in a phase II study (ClinicalTrials.gov identifier: NCT00911560). PATIENTS AND

methodsOne hundred two patients with HR-NB who achieved remission after salvage therapies were enrolled in this trial. They received seven subcutaneous injections of GD2/GD3 vaccine spanning 1 year plus oral β-glucan starting at week 6 after the third dose of vaccine. Serum anti-vaccine antibody titers were quantified by enzyme-linked immunosorbent assay. Single nucleotide polymorphisms (SNPs) were determined by quantitative polymerase chain reaction. Kaplan-Meier and landmark Cox Regression models were used for survival estimates.

resultsPatients had a history of one (63%), two (21%), or three to six (16%) episodes of PD. 82% of them progressed following anti-GD2 mAb (m3F8/dinutuximab/naxitamab) therapy. Vaccine-related toxicities were self-limited injection-associated local reactions and fever without any > grade 3 toxicities. The progression-free survival (PFS) was 32% ± 6%, and the overall survival (OS) was 71% ± 7% at 5 years. Serum anti-GD2 (immunoglobulin G1 [IgG1] and IgM) and anti-GD3 (IgG1) titers showed notable increases following the initiation of β-glucan at week 6. There was an association between IgG1 titer and SNP rs3901533 of dectin-1, the β-glucan receptor. Multivariable analyses showed that anti-GD2-IgG1 titer ≥ 150 ng/mL by week 8 was associated with favorable PFS and OS, while having prior episodes of PD and the time from last PD to vaccine were associated with PFS.

conclusionGD2/GD3 vaccine plus β-glucan elicited robust antibody responses in patients with HR-NB with prior PD. Higher anti-GD2-IgG1 titer was associated with improved survival.

Indexed as

Immunogenicity, VaccineAdjuvants, Immunologicbeta-GlucansBiomarkersBrain NeoplasmsCancer VaccinesChildChild, PreschoolDectin-1Disease ProgressionFemaleGangliosidesGlioblastomaHumansImmunoglobulin GInfantAdjuvants, Immunologicbeta-GlucansBiomarkersCancer VaccinesCLEC7A protein, humanDectin-1ganglioside, GD2ganglioside, GD3GangliosidesImmunoglobulin GLectins, C-Type

Identifiers

PMID33326254
PMCPMC8253584
OpenAlexW3113319163

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.