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HPV融合蛋白疫苗临床试验 美国2013年完成，中国刚开始
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| 我国HPV融合蛋白疫苗即将进入临床试验阶段 |
新华社北京３月２９日电（记者胡浩）记者２９日从国家“８６３”计划项目课题组了解到，我国“人类乳头瘤病毒（ＨＰＶ）融合蛋白疫苗”研发取得重要进展，即将进入临床试验阶段。
“人类乳头瘤病毒（ＨＰＶ）融合蛋白疫苗”项目为国家“８６３”计划项目，由中国医学科学院肿瘤研究所、中科院上海生命科学研究院等多家科研院所的几十位专家和科研工作者参与，历经十几年研发攻关，经过病理、药理、药效、药常规及工艺路线试验论证，获得高效表达的工程菌株，为临床试验和产业化奠定基础。
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Trial record 2 of 2 for: Human papillomavirus fusion protein vaccine
HPV融合蛋白疫苗即临床试验，美国2003年开始，2013年完成。
Vaccine Therapy in Preventing Cervical Cancer in Patients With Cervical Intraepithelial Neoplasia
Purpose| Condition | Intervention | Phase |
|---|---|---|
| Cervical Cancer Cervical Intraepithelial Neoplasia Grade 3 Human Papilloma Virus Infection | Biological: HspE7 Procedure: therapeutic conventional surgery Other: laboratory biomarker analysis | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Evaluation Of SGN-00101 (HSP-E7) Fusion Protein In Women With Cervical Intraepithelial Neoplasia 3, CIN 3 |
Complete histologic regression of all CIN 3 lesions [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
Fisher's exact test (and if feasible, Chi-Square test) will be conducted to see if the probability of responding in the investigational arm is significantly different from the controls actively accrued to this study. The conditional distribution used in Fisher's exact test will be used to calculate a 90% confidence interval for the odds ratio of observing a response in the investigational arm to the control arm.Frequency and severity of adverse events assessed by Common Toxicity Criteria (CTC) version 2.0 [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
| Enrollment: | 84 |
| Study Start Date: | June 2004 |
| Primary Completion Date: | January 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Arm I (HspE7) Patients receive SGN-00101 subcutaneously once on weeks 1, 4, and 8 in the absence of disease progression. At week 15, all patients undergo large loop excision of the transformation zone under colposcopy. | Biological: HspE7 Given subcutaneously Other Names: Procedure: therapeutic conventional surgery
Undergo large loop excision Other: laboratory biomarker analysisCorrelative studies |
| Experimental: Arm II (control) Patients receive standard care. At week 15, all patients undergo large loop excision of the transformation zone under colposcopy. | Procedure: therapeutic conventional surgery Undergo large loop excision Other: laboratory biomarker analysisCorrelative studies |
Detailed Description:
PRIMARY OBJECTIVES:
I. Determine the efficacy of SGN-00101, in terms of complete histologic regression, in patients with grade III cervical intraepithelial neoplasia.
II. Determine the toxicity of this drug in these patients.
SECONDARY OBJECTIVES:
I. Determine change in lesion size in these patients after treatment with this drug.
II. Compare histologic response before and after treatment with this drug in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients receive SGN-00101 subcutaneously once on weeks 1, 4, and 8 in the absence of disease progression.
Arm II: Patients receive standard care.
At week 15, all patients undergo large loop excision of the transformation zone under colposcopy.
Patients are followed at 19 weeks, every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 28-84 patients (14-42 per treatment arm) will be accrued for this study within 12-48 months.
Eligibility| Ages Eligible for Study: | 17 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Histologically confirmed grade III cervical intraepithelial neoplasia
Confirmed by biopsy or colposcopy
Positive for human papilloma virus 16
No endocervical glandular dysplasia
No adenocarcinoma in situ
Performance status - GOG 0-2
No life-threatening or serious hematological disorder
No life-threatening or serious hepatic disorder
No life-threatening or serious renal disorder
No life-threatening or serious cardiac disorder
No life-threatening or serious respiratory disorder
HIV negative
Must be immunocompetent
No history of autoimmune disease
No life-threatening or serious immunological disorder
No prior or concurrent severe allergic disease
No concurrent human papilloma viral infection other than type 16
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No life-threatening or serious gastrointestinal disorder
No life-threatening or serious endocrine disorder
No invasive malignancy within the past 5 years except nonmelanoma skin cancer
No concurrent chronic or systemic steroids
No prior organ transplantation
No prior cancer therapy that would preclude study therapy
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00054041
| United States, Pennsylvania | |
| Gynecologic Oncology Group | |
| Philadelphia, Pennsylvania, United States, 19103 | |
| Principal Investigator: | Cornelia Trimble | Gynecologic Oncology Group |
More InformationNo publications provided
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00054041 History of Changes |
| Other Study ID Numbers: | NCI-2012-02513 GOG-0197 U10CA027469 CDR0000269709 |
| Study First Received: | February 5, 2003 |
| Last Updated: | January 23, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
| Papillomavirus Infections Carcinoma in Situ Cervical Intraepithelial Neoplasia Neoplasms Uterine Cervical Neoplasms Virus Diseases Carcinoma DNA Virus Infections Genital Diseases, Female | Genital Neoplasms, Female Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Tumor Virus Infections Urogenital Neoplasms Uterine Cervical Diseases Uterine Diseases Uterine Neoplasms |
ClinicalTrials.gov processed this record on March 28, 2016
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