Immunogenicity and Safety of Trivalent Influenza Vaccine in Non-pregnant HIV- Infected Women: An Open Label Trial.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Immunogenicity of Trivalent Influenza Vaccine (TIV)by measuring Hemagglutination Inhibition Assays (HAI)
研究概览
简要总结
The overall aim of this project is to evaluate the immunogenicity of TIV vaccination in HIV-infected non-pregnant women in 2013. Safety data including solicited local and systemic reactions to the vaccine will also be assessed.
详细描述
Schedule of Events
Visit 1 (enrollment) Informed Consent Form (ICF) signed Inclusion/ exclusion/ Withdrawal criteria Medical history Targeted physical exam Blood draw TIV administered Diary card dispensed
Local/ systematic reactions
Visit 2: 1 month post enrolment (28-35 days) Inclusion/ exclusion/ Withdrawal criteria Medical history Targeted physical exam Blood draw Diary card collected Local/ systematic reactions reviewed
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 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •(i) Documented to be HIV-1 infected on one assay used in the Prevention of Mother to Child Transmission (PMTCT)/ other program undertaken within 12 weeks of study enrolment.
- •Able to understand and comply with planned study procedures.
- •Provides written informed consent prior to initiation of study.
- •Not pregnant at time of enrolment (confirmed by urine testing). If pregnant in past year, participant must be at least 6 months post delivery at time of enrolment.
- •Women age ≥ 18 years to < 39 years.
排除标准
- •Receipt of TIV, other than through the study, during the current and previous two influenza seasons, documented by medical history or record.
- •Receipt of any live licensed vaccine ≤ 28 days or any other vaccine (except for tetanus toxoid vaccine) ≤ 14 days prior to study-vaccine.
- •Receipt of a non-licensed agent (vaccine, drug, biologic, device, blood product, or medication) ≤ 28 days prior to vaccination in this study, unless study approval is obtained.
- •Any significant (in the opinion of the site investigator) acute illness and/or oral temperature greater than or equal to 38 degrees C ≤ 24 hours prior to study entry.
- •Use of anti-cancer systemic chemotherapy or radiation therapy ≤ 48 weeks of study enrollment, or has immunosuppression as a result of an underlying illness or treatment.
- •Long term use of glucocorticoids, including oral or parenteral prednisone ≥ 20 mg/day or equivalent for more than 2 consecutive weeks (or 2 weeks total) ≤ 12 weeks of study entry, or high-dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or equivalent) ≤ 12 weeks before study entry (nasal and topical steroids are allowed).
- •Receipt of immunoglobulin or other blood products (with exception of Rho D immune globulin) ≤ 12 weeks prior to enrollment in this study or is scheduled to receive immunoglobulin or other blood products.
- •Receipt of Interleukin 2, IFN, GMCSF or other immune mediators ≤ 12 weeks before enrollment.
- •Uncontrolled major psychiatric disorder.
- •History of a severe adverse reaction to previous TIV.
- •Any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.
结局指标
主要结局
Immunogenicity of Trivalent Influenza Vaccine (TIV)by measuring Hemagglutination Inhibition Assays (HAI)
时间窗: one month post vaccination
Humoral immunity will be measured by hemagglutination inhibition (HAI) assay, which has been extensively used for this purpose. In healthy individuals, HAI titers ≥1:10 indicate presence of influenza-specific antibodies and ≥1:40 protection against infection and disease. In this study we will use the following definitions to assess the humoral immune response to TIV: HAI titers \<1:10 = seronegative; HAI titers ≥1:10 = seropositive; HAI titers ≥1:40 = sero-protective titers; and sero-conversion will be defined as HAI titers from \<1:10 to ≥1:40 or ≥4-fold increase if pre-vaccination titers were ≥1:10.
次要结局
- impact of vaccination on T-cell activation and on T- and B-cell subpopulations(one month post vaccination)
- Impact of Vaccination of Cell Mediated Immune (CMI) Responses(one month post vaccination)
- Local and Systemic solicited reactions to TIV(1 week and one month post vaccination)
- safety outcome measures of TIV(within one month post vaccination)
研究者
Michelle Groome
Investigator
University of Witwatersrand, South Africa