Long Term Follow-up of Immunological Pattern and Pregnancy Outcomes in Women Previously Enrolled in a Phase 1b Clinical Trial With the PRIMVAC Placental Malaria Candidate Vaccine
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Cross-reactivity against different VAR2CSA variants expressed on the surface of erythrocytes parasitized by various strains of Plasmodium falciparum by flow cytometry
研究概览
简要总结
Study Population: Participants of the previous PRIMVAC vaccine trial and women aged 18 to 35 years
Sample Size: 90
Study duration: 21 months
Subject duration: 12 months if pregnancy doesn't occurred. In case of pregnancy, the participant will be followed up until the delivery.
Study Design: Long term observational study comparing the immunology trend of 3 groups of i) women who received the PRIMVAC Vaccine or Placebo during the phase 1b trial in Burkina Faso; ii) women of the same age and nulligravid who did not participate in the phase 1b trial iii) women of the same age and primigravid who did not participate in the phase 1b trial
Co Primary objectives
- To assess the dynamics of humoral immune response to the vaccine antigen during long term follow up of the study participants
- To evaluate the functional durability of the humoral immune responses of women who participated in the phase 1b vaccine trial compared to women of the same age
Secondary objectives
- To assess the cellular immune response during the follow-up period
- To assess the incidence of clinical malaria on study participants
- To assess the prevalence of Placental Malaria in study participants and adverse outcomes such as maternal anemia, low birth weight, stillbirth and prematurity.
详细描述
It is a long-term observational study comparing the immunology trend of 3 groups of women:
- Women who received the PRIMVAC Vaccine or Placebo during the phase 1b trial in Burkina Faso
- Women of the same age and nulligravid who did not participate in the phase 1b trial
- Women of the same age and primigravid who did not participate in the phase 1b trial
The proposed cohort study will build on the previous phase 1b study which was conducted within the health district of Saponé (ClinicalTrials.gov Identifier: NCT02658253). The enrolment and follow up of the subjects will last 12 months. Pregnancy which occurred during the follow up period will monitored until the delivery. An additional six months is necessary for sample analysis in the laboratory, the data analysis and the preparation of reports and publications.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Any participant of the previous PRIMVAC vaccine phase Ib trial
- •Nulligravid and primigravid women aged 18-35 years
- •Residing in study region and environs
- •Available and willing to participate in follow-up for the duration of study
- •Participant who accept blood sample collection
- •Appear to be in generally good health based on clinical and laboratory investigation
- •Signed informed consent
排除标准
- •Participants who refused to sign informed consent
- •Use of an investigational or non-registered drug or vaccine other than the previous study vaccine
- •Chronic administration of immunosuppressants or other immune-modifying drugs
- •Confirmed or suspected immunosuppressive or immunodeficient condition
- •Confirmed or suspected autoimmune disease
- •Simultaneous participation in any interventional clinical trial
- •Women of control groups with positif pregnancy test at the enrolment
结局指标
主要结局
Cross-reactivity against different VAR2CSA variants expressed on the surface of erythrocytes parasitized by various strains of Plasmodium falciparum by flow cytometry
时间窗: month 0
VAR2CSA variants
Geometric mean titer of antibodies
时间窗: month 12
Level of total Immunoglobin (IgG) and the level of the isotypic subtypes (IgG1, IgG2, IgG3, IgG4)
Percentage of binding inhibitory activity using various VAR2CSA expressing strains by CSA-binding inhibition assay (BIA) at different timepoints during the twelve months of follow up.
时间窗: month 0
binding inhibitory activity
次要结局
未报告次要终点