Longitudinal Tracking of Bone Marrow Plasma Cell Responses to Licensed Human Vaccines
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Primary Outcome Measure
研究概览
简要总结
This study is being done to understand and measure how the immune system responds to and remembers different types of vaccines. To do this, four vaccines approved by the U.S. Food and Drug Administration (FDA) will be given simultaneously to participants. Participants will be volumteers who are healthy adults (18 years old or older) and willing to receive the yearly trivalent inactivated influenza vaccine (TIV), the tetanus, diphtheria, and acellular pertussis vaccine (Tdap), the nonvalent HPV (HPV) vaccine, hepatitis A virus (HAV) vaccine and undergo study procedures.
Procedures will include:
- medical history relevant to the study, including medications and vaccines received.
- Vitals (blood pressure, pulse) and temperature
- Height and weight.
- Physical exams.
- Receive the TIV, Tdap, HPV, and HAV vaccines.
- Blood samples collected for immunologic tests and genetic analysis.
- Donate bone marrow by needle aspiration at a maximum of seven visits.
- Complete memory aid every evening for 7 days after vaccination
Optional Procedures include:
- Donate bone marrow core biopsies at the same visits
- Ultrasound of lymph nodes and fine needle aspirates of lymph nodes in both arm pits at a maximum of eight separate visits
There will be a screening visit and and a Day 1 where vaccinations will occur and subsequent visits at Day 8, Day 14, Day 29, Day 57, Day 121, Day 181, Day 366, Day 546, and Day 731.
At each of these visits health status, vital signs and blood collection will occur.
A bone marrow aspirate and lymph node aspirate will be collected at screening.
The six additional bone marrow aspirates will be repeated at D29, D91, D181, D366, D546, and D731. The optional bone marrow core biopsy will also be repeated at that time.
Up to seven separate visits will be scheduled for the follow-up lymph node aspirates (D29, D57, D91, D181, D366, D546, and D731)
Study participation will be 24 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy participants over 18 years of age.
- •Able to understand and give informed consent.
- •Willing to receive TIV, Tdap, HPV, and HAV vaccinations
- •In stable health, as determined by medical history and targeted physical exam related to this history.
- •Willing to give BMA samples
- •For those willing to give FNA or BMCB samples, Willing to:
- •give FNA specimens OR give BMCB specimens OR give both FNA and BMCB specimens
排除标准
- •Has a history of severe allergic reaction to any component of the TIV, Tdap, HPV, or HAV vaccines, including allergic reactions to neomycin, yeast or prior severe reaction after vaccination including anaphylaxis or encephalopathy within 7 days of vaccination.
- •Has a current or previous diagnosis of immunocompromising condition to include human immunodeficiency virus, immune-mediated disease requiring immunosuppressive treatment, or other immunosuppressive condition.
- •Has received systemic immunosuppressants or immune-modifying drugs for > 14 days in total within 6 months prior to Screening (for corticosteroids ≥ 10 mg/day of prednisone equivalent) or is anticipating the need for immunosuppressive treatment at any time during participation in the study.
- •Is acutely ill or febrile (temperature >38.0 C [100.4F] less than 72 hours prior to or at the day 1 visit. Participants who meet this criteria may be rescheduled.
- •Currently has symptomatic acute or unstable chronic disease requiring medical or surgical care, to include significant change in therapy or hospitalization, at the discretion of the investigator.
- •History of excessive alcohol consumption, drug abuse, psychiatric conditions, social conditions or occupational conditions that in the opinion of the investigator would preclude compliance with the study.
- •Has received any vaccine ≤ 28 days prior to the injection (Day 1) or plans to receive a vaccine within 28 days before or after the study injection. These participants may be rescheduled.
- •Has received the 2025-2026 influenza trivalent, inactivated vaccine or quadrivalent, inactivated vaccine.
- •Has received any quadrivalent or trivalent inactivated influenza, Tdap, HPV, or HAV vaccines ≤ 180 days prior to the injection (Day 1).
- •Pregnant women and nursing mothers or women who are planning to become pregnant for the study duration.
- •Have donated blood, blood products or bone marrow within 30 days before study vaccination, plan to donate blood at any time during the duration of participant study participation, or plan to donate blood within 30 days after the last blood draw.
- •Any condition in the opinion of the investigator that would interfere with the proper conduct of the trial.
- •Coagulopathy (primary or iatrogenic) which would contraindicate bone marrow aspirate or core biopsy for participants willing to have those procedures done
研究组 & 干预措施
Vaccination
four licensed vaccines administered intramuscularly at a single visit: trivalent inactivated influenza vaccine (TIV) and the tetanus, diphtheria and acellular pertussis vaccine (Tdap) in the left arm, and the nonavalent HPV vaccine (HPV) and hepatitis A (HAV) vaccines in the right arm.
干预措施: nonavalent HPV vaccine (HPV) (Biological)
Vaccination
four licensed vaccines administered intramuscularly at a single visit: trivalent inactivated influenza vaccine (TIV) and the tetanus, diphtheria and acellular pertussis vaccine (Tdap) in the left arm, and the nonavalent HPV vaccine (HPV) and hepatitis A (HAV) vaccines in the right arm.
干预措施: hepatitis A (HAV) vaccines (Biological)
Vaccination
four licensed vaccines administered intramuscularly at a single visit: trivalent inactivated influenza vaccine (TIV) and the tetanus, diphtheria and acellular pertussis vaccine (Tdap) in the left arm, and the nonavalent HPV vaccine (HPV) and hepatitis A (HAV) vaccines in the right arm.
干预措施: trivalent inactivated influenza vaccine (TIV) (Biological)
Vaccination
four licensed vaccines administered intramuscularly at a single visit: trivalent inactivated influenza vaccine (TIV) and the tetanus, diphtheria and acellular pertussis vaccine (Tdap) in the left arm, and the nonavalent HPV vaccine (HPV) and hepatitis A (HAV) vaccines in the right arm.
干预措施: tetanus, diphtheria and acellular pertussis vaccine (Tdap) (Biological)
结局指标
主要结局
Primary Outcome Measure
时间窗: day 29
The antibody titer for influenza strains at d29 when compared to baseline
次要结局
- Frequency of serious adverse events(at days 29, 57, 91, 181, 366, 546, and 731)