Immunogenicity and Safety of Trivalent Influenza Vaccine in Pregnant and Nonpregnant HIV Uninfected Women
Immunogenicity and Safety of Trivalent Influenza Vaccine in Pregnant and Non-pregnant HIV-Uninfected Women: An Open Label Trial
研究概览
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
-
-
GP
-
Soweto、GP、南非、2055
- Nrf/Dst Vpd Rmpru
-
-
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:
Inclusion Criteria: All women
(i) Documented to be HIV-1 uninfected on one assay used in the Prevention of Mother to Child Transmission (PMTCT)/ other program undertaken within 12 weeks of study enrolment.
(ii) Able to understand and comply with planned study procedures. (iii) Provides written informed consent prior to initiation of study. (iv) Women age ≥ 18 years to < 39 years.
Inclusion Criteria: pregnant women
(i) Gestational age ≥20 weeks to <36 weeks documented by the approximate date of the last menstrual period and corroborated by physical exam and sonar report if available.
Exclusion Criteria:
Exclusion Criteria: All women
(i) Receipt of TIV, other than through the study, during the current influenza season documented by medical history or record.
(ii) Receipt of any live licensed vaccine ≤ 28 days or any other vaccine (except for tetanus toxoid vaccine) ≤ 14 days prior to study-vaccine.
(iii) Receipt of a non-licensed agent (vaccine, drug, biologic, device, blood product, or medication) ≤ 28 days prior to vaccination in this study, or expects to receive another non-licensed agent before delivery unless study approval is obtained.
(iv) 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.
(v) 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.
(vi) 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).
(vii) 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 (with the exception of Rho D immune globulin) during pregnancy or for the first 24 weeks after delivery.
(viii) Receipt of immune mediators ≤ 12 weeks before enrollment. (ix) Uncontrolled major psychiatric disorder. (x) History of a severe adverse reaction to previous TIV. (xi) 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.
Exclusion Criteria: pregnant women
(i) Receipt of corticosteroids for preterm labor ≤ 14 days before study entry. (ii) Pregnancy complications (in the current pregnancy) such as pre-term labor, hypertension (Blood Pressure (BP) >140/90 in the presence of proteinuria or BP >150/100, with or without proteinuria or currently on antihypertensive medication) or pre-eclampsia.
-
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 |
---|---|
实验性的:Trivalent Influenza Vaccine
The formulation based on the WHO recommendation for influenza vaccines for 2013 for the Southern-hemisphere included the following vaccine strains:
Dose: Single Dose 0.5 mL of TIV from pre-filled syringe. |
The formulation based on the WHO recommendation for influenza vaccines for 2013 for the Southern-hemisphere included the following vaccine strains:
The vaccine to be used in the study in 2013 is Vaxigrip (Sanofi Pasteur), or other equivalent licensed vaccine should the latter not be available, which will be procured commercially in pre-filled syringes. Using aseptic technique, participants will be injected with 0.5 mL of TIV from pre-filled syringe.
其他名称:
|
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 |
---|---|---|
Compare the immunogenicity of Trivalent Influenza Vaccine (TIV) in pregnant compared to non-pregnant Human Immunodeficiency Virus (HIV)-uninfected women.
大体时间:one month post-vaccination
|
Hemagglutination inhibition assays (HAI)will be performed to assess the immunogenicity of TIV.
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.
|
one month post-vaccination
|
Evaluate the immunogenicity of Trivalent Influenza Vaccine (TIV) in pregnant Human Immunodeficiency Virus (HIV)-uninfected women at time of delivery
大体时间:one week post delivery for the pregnant cohort
|
Hemagglutination inhibition assays (HAI)will be performed to assess the immunogenicity of TIV.
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.
|
one week post delivery for the pregnant cohort
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Determine the impact of vaccination on T-cell activation and regulatory B and T cells subpopulations in pregnant and non-pregnant women.
大体时间:one month post vaccination and one week post delivery in pregnant cohort
|
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
|
one month post vaccination and one week post delivery in pregnant cohort
|
2.2.2. Determine the impact of vaccination on cell-mediated immune responses to each influenza strain in HIV-uninfected pregnant and non-pregnant women
大体时间:one month post vaccination
|
Interferon (IFN)- Enzyme Linked Immuno Spot (ELISPOT) responses will be assessed on fresh PBMCs.
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.
|
one month post vaccination
|
Determine the dynamics of transplacental transfer of maternal Hemagglutinin (HA) antibodies to their newborns.
大体时间:one week post delivery in pregnant cohort
|
The study will assess the effect of TIV administration during pregnancy on transplacental influenza-specific antibody transfer to the fetus.
HAI titers will be measured in infants within one week of birth.
Using the 1:40 HAI titer as a defining threshold of protection against wild type influenza, we will determine the proportion of infants protected against influenza at birth.
|
one week post delivery in pregnant cohort
|
Determine antibodies against TIV present in breast milk
大体时间:in week post delivery
|
Influenza specific antibodies measures by HAI titres in the breastmilk will be measured.
Mothers will express breastmilk into sterile containers to collect the samples.
|
in week post delivery
|
Compare local and systemic solicited reactions to TIV in pregnant and non-pregnant HIV-uninfected women.
大体时间:one month post vaccination
|
Participants will remain in the clinic for at least 30 minutes after vaccination so that clinic personnel can observe for any potential adverse reactions to the vaccine. 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 by means of a participant diary card. Serious Adverse Events (SAEs) will be reported. |
one month post vaccination
|
Describe safety outcome measures (maternal and foetal) of TIV-vaccination of HIV-uninfected pregnant women.
大体时间:one month post vaccination and one week post delivery in pregnant cohort
|
Safety and tolerability of the study vaccine will be monitored by means of Adverse Events (AEs) and toxicity reports presenting laboratory and clinical data.
The data to be reviewed by the protocol team will be pooled across treatment arms.In addition to monthly toxicity reviews by the Core Team, the study will be monitored by a Safety Monitoring Committee (SMC).
The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events is used
|
one month post vaccination and one week post delivery in pregnant cohort
|
Describe obstetric outcomes in HIV-uninfected pregnant women who received TIV
大体时间:one week post delivery in pregnant cohort
|
Data will be collected from birth records including low birth weight (<2 500 g), premature delivery (<37 weeks), emergency caesarean section
|
one week post delivery in pregnant cohort
|
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
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
Trivalent Influenza Vaccine的临床试验
-
QIAGEN Gaithersburg, Inc完全的呼吸道合胞病毒感染 | 甲型流感 | 鼻病毒 | 乙型流感 | QIAGEN ResPlex II Advanced Panel | 人类副流感病毒 1 引起的感染 | 副流感 2 型 | 3 型副流感 | 副流感 4 型 | 人类偏肺病毒 A/B | 柯萨奇病毒/埃可病毒 | B/C/E 型腺病毒 | 冠状病毒亚型 229E | 冠状病毒亚型 NL63 | 冠状病毒亚型 OC43 | 冠状病毒亚型 HKU1 | 人类博卡病毒 | Artus 流感 A/B RT-PCR 检测美国
-
Erasme University HospitalRoche Diagnostics; LHUB-ULB终止
-
SENAI CIMATEC招聘中
-
Federal Budgetary Research Institution State Research...完全的
-
Sidney Kimmel Comprehensive Cancer Center at Johns...招聘中