Optimising Protection for Pregnant Women and Infants With Maternal Vaccination
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Immunogenicity against the 4 influenza strains included in the 2017-2019 Southern Hemisphere Influenza vaccine pre and post vaccination in obese and non-obese women
研究概览
简要总结
This study has been designed to investigate if:
- BMI affects the immunogenicity of influenza and pertussis vaccines given during pregnancy.
- If pertussis vaccine co-administered with influenza vaccine impacts on the immunogenicity of the influenza vaccine.
- If BMI affects transplacental antibody transfer efficiency following maternal vaccinations.
详细描述
A clinical observation study to determine whether obesity during pregnancy is associated with altered immunogenicity of influenza and pertussis vaccines during pregnancy. The study will also assess vaccine specific antibody concentrations in cord blood collected from vaccinated women at the time of delivery to estimate any effect of obesity on transplacental transfer of antibodies and will measure and compare cytokine profiles between obese and non-obese participants to determine any correlation with immune responses. This study will enrol 150 pregnant women (50 obese and 100 non-obese) during 2017-2019 to receive a recommended, licensed influenza vaccine (FluQuadri) as well as pertussis vaccination (Adacel) for women enrolled in their third trimester, as part of routine antenatal care. Local and systemic adverse events will be captured using a 7 day diary card and unexpected or serious adverse events will be recorded for the duration of the study. Blood samples will be collected to measure antigen specific vaccine antibody responses. The proportion of influenza vaccine recipients achieving seroprotective antibody titres at 4 weeks post vaccination and persisting at 6 months post vaccination be compared between obese and non-obese recipients.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Participants who, in the opinion of the study staff, can and will comply with the requirements of the protocol (eg. return for follow-up visits, blood collection etc).
- •Pregnant women aged 18 years and over at the time of vaccination.
- •Able to understand the information sheet and provide a written informed consent.
排除标准
- •Any major illness that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in the study, or interfere with the evaluation of the study objectives.
- •History of serious medical conditions (eg cardiac, respiratory, renal, hepatic disorders, diabetes requiring treatment with insulin).
- •History of seasonal influenza or dTpa vaccination within the last 6 months prior to enrolment.
- •History of any immunosuppressive condition or currently on immunosuppressive medication.
- •Any contraindication to influenza or dTpa immunisation.
- •Anaphylaxis following a previous dose of any influenza or pertussis containing vaccine.
- •History of anaphylaxis to egg.
- •Past history of Guillain Barre Syndrome.
- •Bleeding diathesis or condition associated with prolonged bleeding that may contraindicate intramuscular injection or blood draw.
- •Receipt of immunoglobulins, blood or blood products within the past 6 months.
结局指标
主要结局
Immunogenicity against the 4 influenza strains included in the 2017-2019 Southern Hemisphere Influenza vaccine pre and post vaccination in obese and non-obese women
时间窗: 1 month post vaccination
1. Hl titres (as measured by Haemagglutination Inhibition Assay). 1. Proportion with antibody titres (HI\>=40) following vaccination.
次要结局
- Persistence of antibodies to pertussis antigens(6 months post vaccination.)
- Antibodies to pertussis antigens(1 month post vaccination compared with baseline (pre vaccination).)
- Persistence of antibodies to the 4 influenza strains included in the 2017-2019(6 months post vaccination)
研究者
Professor Helen Marshall
Senior Medical Officer, Director Vaccinology and Immunology Research Trials Unit
Women's and Children's Hospital, Australia