Immunogenicity and Safety of Trivalent Influenza Vaccine in Non-pregnant HIV-infected Women
Immunogenicity and Safety of Trivalent Influenza Vaccine in Non-pregnant HIV- Infected Women: An Open Label Trial.
研究概览
详细说明
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
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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Gauteng
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Soweto、Gauteng、南非
- Nrf/Dst Vpd Rmpru
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
(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.
Exclusion Criteria:
- 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.
学习计划
研究是如何设计的?
设计细节
- 主要用途:基础科学
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Trivalent Inactivated Influenza Vaccine
Single dose, intramuscular injection from a pre-filled syringe WHO recommendation for influenza vaccines for 2013 for the Southern-hemisphere included the following vaccine strains:
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WHO recommendation for influenza vaccines for 2013 for the Southern-hemisphere included the following vaccine strains:
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Immunogenicity of Trivalent Influenza Vaccine (TIV)by measuring Hemagglutination Inhibition Assays (HAI)
大体时间:one month post vaccination
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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.
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one month post vaccination
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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impact of vaccination on T-cell activation and on T- and B-cell subpopulations
大体时间:one month post vaccination
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T-lymphocyte activation assays will be performed using state-of-the art polychromatic flow cytometry.
The T- and B-cell phenotypes are assessed by flow cytometry using freshly thawed Peripheral Blood Mononuclear Cells (PBMC).
Cells are stained using monoclonal antibodies against the comparator molecules.
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one month post vaccination
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Impact of Vaccination of Cell Mediated Immune (CMI) Responses
大体时间:one month post vaccination
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Interferon(IFN)Enzyme Linked Immuno Spot (ELISPOT) responses will be used to assess CMI responses to influenza vaccines.PBMCs will be separated and stimulated with influenza virus corresponding to the vaccine strains.
Spots will be visualized with a ELISPOT plate reader.
Results will be reported as Spot Forming Cells(SFC)/106 PBMCs.
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one month post vaccination
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Local and Systemic solicited reactions to TIV
大体时间:1 week and one month post vaccination
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Participants will remain in the clinic for at least 30 minutes after vaccination so that clinic personnel can observe participants for any potential adverse reactions.Report of vaccine-related local (redness, swelling, tenderness, itching,) and systemic (fever, malaise, myalgia, nausea, headache, rash) adverse events will be solicited at day 7 and day 28.
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1 week and one month post vaccination
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safety outcome measures of TIV
大体时间:within one month post vaccination
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Safety and tolerability of the study vaccine will be monitored by means of Adverse Events (AEs) and toxicity reports presenting laboratory and clinical data.Toxicities will be classified by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events,
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within one month post vaccination
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合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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