Phase I Active Immunotherapy Trial With a Combination of Two Chimeric (Trastuzumab-like and Pertuzumab-like)Human Epidermal Growth Factor Receptor 2 (HER-2) B Cell Peptide Vaccine Emulsified in ISA 720 and Nor-MDP Adjuvant in Patients With Advanced Solid Tumors

This phase I trial studies the side effects and best dose of vaccine therapy in treating patients with metastatic solid tumors. Vaccines made from antibodies and peptides combined with tumor cells may help the body build an effective immune response to kill tumor cells.

Start Date21 Jun 2011

Sponsor / Collaborator

Ohio State University Comprehensive Cancer Center

100 Clinical Results associated with HER-2 vaccine(Ohio State University Comprehensive Cancer Center)

100 Translational Medicine associated with HER-2 vaccine(Ohio State University Comprehensive Cancer Center)

100 Patents (Medical) associated with HER-2 vaccine(Ohio State University Comprehensive Cancer Center)

Literatures (Medical) associated with HER-2 vaccine(Ohio State University Comprehensive Cancer Center)

01 Sep 2023·Journal of nephrology

Clinical efficacy of the fourth dose of the BNT162b2 vaccine in maintenance dialysis patients.

Article

Author: Grupper, Ayelet ; Nacasch, Naomi ; Wand, Ori ; Cohen-Hagai, Keren ; Benchetrit, Sydney ; Hornik-Lurie, Tzipi ; Shashar, Moshe ; Einbinder, Yael

BACKGROUND AND OBJECTIVESHighly effective vaccines against severe acute respiratory syndrome virus 2 have been developed and administered worldwide. However, protection from coronavirus disease 2019 is not absolute and an optimal vaccination regimen needs to be established. This study assessed the clinical efficacy of the coronavirus disease 2019 vaccine among dialysis patients receiving 3 or 4 doses of vaccine.DESIGN, SETTING, PARTICIPANTS, AND MEASUREMENTSThis retrospective study was conducted using the electronic database of Clalit Health Maintenance Organization in Israel. Chronic dialysis patients treated with either hemodialysis or peritoneal dialysis during the coronavirus disease 2019 pandemic were included. We compared clinical outcomes of patients who had received three or four doses of the severe acute respiratory syndrome virus 2 vaccine.RESULTSThis study included 1,030 patients on chronic dialysis, with a mean age of 68 ± 13 years. Among them, 502 patients had received 3 doses of the vaccine and 528 received 4 doses. Severe acute respiratory syndrome virus 2 infection rates, severe COVID-19 that resulted in hospitalizations, COVID-19-related mortality and all-cause mortality rates were lower among chronic dialysis patients who received a fourth dose of vaccine as compared to those who received only 3 doses (after controlling for age, sex and comorbidities). Despite lower mortality rates observed with the Omicron variant, the fourth dose was significantly associated with reduced COVID-19-related mortality (1.7% vs. 3.8%, p = 0.04). Odds ratio for COVID-19-related mortality was 0.44 with 95% CI 0.2-0.98.CONCLUSIONSAs seen in the general population and with previous vaccine boosters, the fourth dose of the BNT162b2 vaccine reduced rates of severe COVID-19-related hospitalization and mortality among chronic dialysis patients. Further studies are needed to establish the optimal regimens of vaccination for patients on chronic dialysis.

01 Dec 2021·Open Forum Infectious DiseasesQ3 · MEDICINE

Clinical Considerations During Breakthrough Coronavirus Disease 2019 Infections in Vaccinated Individuals With Autoimmunity

Q3 · MEDICINE

ArticleOA

Author: Pei, Luxin ; Sereti, Irini ; Rocco, Joseph M ; Galindo, Frances ; Laidlaw, Elizabeth

This problem is complicated further by the wide variety of immunosuppressive conditions and immune-modulating therapies these patients receive, both of which significantly impact post vaccination immune responses.To further evaluate her vaccine induced antibody responses, 2 serol. platforms were used to quant. assess SARS-CoV-2 anti-S antibodies in addition to the prior Elecsys-Roche antibody binding assay.Results were compared between our index patient and 4 age-matched control women (mean age, 58.5 years [range, 51-65 years]) who had also completed 2 doses of the mRNA-1273 vaccine.

01 Oct 2020·The BreastQ2 · MEDICINE

Metronomic oral chemotherapy with cyclophosphamide plus capecitabine combined with trastuzumab (HEX) as first line therapy of HER-2 positive advanced breast cancer: A phase II trial of the Gruppo Oncologico Italia Meridionale (GOIM)

Q2 · MEDICINE

ArticleOA

Author: Rizzi, Daniele ; Cinieri, Saverio ; Giotta, Francesco ; Lorusso, Vito ; Colucci, Giuseppe ; Ciccarese, Mariangela ; Quaranta, Annamaria ; Prete, Salvatore Del ; Maiello, Evaristo ; Caliolo, Chiara ; Orlando, Laura ; Schiavone, Paola ; Cinefra, Margherita ; Di Maio, Massimo ; Romito, Sante ; Aieta, Michele ; Fedele, Palma ; Pisconti, Salvatore

BACKGROUNDThe combination of chemotherapy plus anti HER-2 agents is the mainstay of HER-2 positive advanced breast cancer (ABC) therapy. We conducted a phase II trial testing activity and safety of trastuzumab and metronomic capecitabine/cyclophosphamide (HEX) as first-line therapy in HER-2 positive ABC. Methods. Patients at first relapse or with synchronous metastasis were treated with trastuzumab (4 mg/kg, biweekly) plus oral capecitabine (1500 mg/daily) and cyclophosphamide (50 mg/daily). Primary endpoint was objective response rate (ORR), secondary endpoints progression-free survival (PFS), clinical benefit rate (CBR; PR + CR + SD for ≥ 24 weeks) and tolerability. Optimal two-stage design was applied.RESULTSSixty patients with measurable ABC, tumors scored as +3 for HER-2 or FISH +, untreated for advanced disease were enrolled. Median age was 62.5 years, visceral metastases were present in most patients (57.9%). Median number of cycles was 16 (range 1-98). ORR was 56.7% (95% CI, 44.1-68.4%), with 5 CR (8.3%) and 29 PR (48.3%). Fifteen patients had SD (25%). The CBR was 78.2%. Nine progressions were observed (15%). Median PFS was 11 months. One year PFS was 47.7%. Median OS was 45.9 months. Worst toxicities were grade 3 hand-foot syndrome in 2 pts (3.3%), grade 3 anaemia in 2 pts (3.3%), grade 2 nausea in 2 pts (3.3%) and grade 3-4 diarrhea in 2 pts (3.3%). Cardiac toxicity grade 1 was reported in 1 pt.CONCLUSIONSCombination of trastuzumab and metronomic oral chemotherapy has clinical activity. The tolerability was excellent and allowed the prolonged delivery of treatment.

100 Deals associated with HER-2 vaccine(Ohio State University Comprehensive Cancer Center)

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Malignant Solid Neoplasm	Phase 1	US	Ohio State University Comprehensive Cancer Center	21 Jun 2011
Breast Cancer	Phase 1	US	Ohio State University Comprehensive Cancer Center	21 Jun 2011
Colonic Cancer	Phase 1	US	Ohio State University Comprehensive Cancer Center	21 Jun 2011
Gastrointestinal Stromal Tumors	Phase 1	US	Ohio State University Comprehensive Cancer Center	21 Jun 2011
Metastatic Solid Tumor	Phase 1	US	Ohio State University Comprehensive Cancer Center	21 Jun 2011
Ovarian Cancer	Phase 1	US	Ohio State University Comprehensive Cancer Center	21 Jun 2011

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