Clinical Trial of a Therapeutic Vaccine With NY-ESO-1 in Combination With the Adjuvant Monophosphoryl Lipid A (MPLA)

Phase I Clinical Trial of a Therapeutic Vaccine for Malignancies, Comprising the Tumor Antigen NY-ESO-1 in Combination With the Adjuvant MPLA of Bordetella Pertussis. Evaluation of Toxicity and Immunogenicity

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01584115

Enrollment

Registered

2012-04-24

Start date

2012-07-31

Completion date

2013-07-31

Last updated

2012-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer., Lung Cancer., Melanoma., Ovarian Cancer.

Keywords

Cancer., Melanoma., Ovarian cancer., Lung cancer., NY-ESO-1., MPLA (monophosphoryl lipid A)., Tumor antigen., Bordetella pertussis.

Brief summary

This study is a clinical trial phase I/II. Its goal is to determine the safety, tolerability, immunogenicity and efficacy of a therapeutic vaccine with the tumor antigen NY-ESO-1 combined with the adjuvant MPLA from B. pertussis in cancer patients.

Detailed description

The safety and immunogenicity of the vaccine with the antigen NY-ESO-1 in combination with the MPLA will be evaluated in a phase 1 clinical trial conducted in patients with malignancies that express the antigen (lung, ovarian and melanoma). This study will involve 15 patients, who will receive 250 mcg of NY-ESO-1 and 100 mcg of MPLA.

Interventions

BIOLOGICALNY-ESO-1 combined with MPLA

Each patient will receive six doses of the formulation, administered intra-muscular, with an interval of 4 weeks between doses, and the first immunization performed 6 weeks after the completion of standard treatment. NY-ESO-1 (250 mcg) amd MPLA (100 mcg).

BIOLOGICALNY-ESO-1 combined with MPLA vaccine

Immunization os cancer patients with NY-ESO-1 combined with MPLA vaccine

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

* In this study, will be included fifteen patients aged over 18 years, with a confirmed diagnosis of malignant neoplasms, which have proven NY-ESO-1 expression by immunohistochemistry and have undergone the standard treatment.

Exclusion criteria

* Will be excluded from the study patients with continuous use of systemic steroids, immunosuppressive agents and antibiotics, and with severe chronic systemic disease.

Design outcomes

Primary

Measure	Time frame	Description
Safety	Six months after immunization.	CTCAE (Common Terminology Criteria for Adverse Events)

Secondary

Measure	Time frame	Description
Immunogenicity	Six months after immunization.	IgG against NY-ESO-1 (ELISA). NY-ESO-1-specific T cells CD4+ and CD8+ (ELISPOT and FACs - flow citometry with tetramers).

Countries

Brazil

Contacts

Primary ContactPedro Giavina-Bianchi, PhD,MD

pbianchi@usp.br(5511) 26616098

Backup ContactMarcelo V Aun, MD

marcelovivoloaun@yahoo.com.br(5511) 26616225

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026