A Pilot Clinical Trial Assessing the Safety and Feasibility of Intramuscular Administration of the TA-CIN Vaccine as Adjuvant Therapy for Patients With History of HPV16 Associated Cervical Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Safety and Feasibility as Assessed by Number of Participants With Treatment-related Adverse Events
研究概览
简要总结
This study will be looking at what dose of the TA-CIN vaccine is safe and effective in patients with a history of HPV16-associated cervical cancer.
详细描述
This is a randomized, multi-center, open label pilot study. The primary goal of this study is to determine the safety of TA-CIN vaccine as adjuvant therapy, and to assess evidence of induction of HPV antigen-specific immunologic response when administered at different locations (arm or thigh). In this pilot study, a single dose level (100µg) assessment of the safety and tolerability of administering TA-CIN vaccine three times to either the arm versus the thigh of patients who have previously been treated for HPV16-related cervical cancer in the past year and are documented to have no evidence of disease recurrence based on standard-of-care imaging and/or clinical assessment upon eligibility.
A total of 14 patients will be enrolled to assess the safety of TA-CIN vaccine via different injection sites as adjuvant therapy. Safety assessments will continue for a period for 1 month after the last vaccination. Few or no serious adverse events (SAEs) are expected from this regimen and routes of administration. The motivation for the design is to confirm that the dose and site of injection implemented here has minimal or no systemic toxicity, as well as determining the preferred injection site that can elicit more potent immune response.
The study will consist of the following parts:
- Screening evaluation
- Dosing period and response assessments
- Follow-up visits after last dose
Screening Evaluation:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with HPV16 related stage IB1-IV cervical cancer who completed definitive treatment within 12 months
- •Patients with no evidence of disease recurrence within 8 weeks of enrollment
- •Documented to have HPV16 nucleic acid within the cervical tumor specimen as determined by in situ hybridization
- •Fresh-frozen or paraffin-embedded material must be available for in situ hybridization testing for HPV16 nucleic acid for central confirmation
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1
- •Adequate organ function as defined by study-specified laboratory tests
- •Ability to understand and willingness to sign a written informed consent document
- •Willing and able to comply with study schedule and other protocol requirements
排除标准
- •Currently have or have history of certain study-specified heart, liver, kidney, lung, neurological, immune or other medical conditions
- •Patients with a diagnosis of immunosuppression or prolonged, active use of immunosuppressive agents such as systemic steroids
- •Prior HPV vaccination
- •Had surgery, chemotherapy, or radiation therapy within 28 days prior to receiving study drug
- •Another investigational product within 28 days prior to receiving study drug
- •Active or chronic HIV, HBV, or HCV infection
- •Pregnant or lactating
- •Patients who have an active autoimmune disease
- •Patients with a recognized immunodeficiency disease or are being chronically treated with immunosuppressive drugs
- •Women of childbearing potential
- •Patients with non-healed wounds
- •A history of current or recent concurrent malignancy (≤5 years) except basal cell cancer.
- •Inability to understand or unwillingness to sign an informed consent document
研究组 & 干预措施
TA-CIN administration via thigh
Each dose of TA-CIN vaccine is fixed, 100µg. Patients will receive 3 doses of the TA-CIN 4 weeks apart (Weeks 1, 5, and 9), administered in the thigh. Patients will be followed for 2 years after the 1st dose is given.
干预措施: TA-CIN (thigh) (Biological)
TA-CIN administration via arm
Each dose of TA-CIN vaccine is fixed, 100µg. Patients will receive 3 doses of the TA-CIN 4 weeks apart (Weeks 1, 5, and 9), administered in the arm. Patients will be followed for 2 years after the 1st dose is given.
干预措施: TA-CIN (arm) (Biological)
结局指标
主要结局
Safety and Feasibility as Assessed by Number of Participants With Treatment-related Adverse Events
时间窗: Up to 24 months following the first dose of study vaccine
Safety and feasibility of intramuscular TA-CIN vaccine via arm or thigh as assessed by number of participants with with a history of HPV16 associated IB1-IV cervical cancer experiencing treatment-emergent adverse events as defined by CTCAE v4.0.
次要结局
- Mononucleocyte Response(up to 4 years)
- Antibody Response as Measured by Level of Circulating Antibody in Peripheral Blood(up to 4 years)
- T-Cell Response as Measured by Level of Circulating T-cells in Peripheral Blood(up to 4 years)