Effects of Exposure to Per- and Polyfluoroalkyl Substances (PFAS) on Innate and Adaptive Immune Responses to Tetanus-diphtheria (Td) Vaccination Among Adults in a Community-based Panel Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in Tetanus-diphtheria Specific IgG by PFNA Exposure Category
研究概览
简要总结
This clinical trial aims to investigate how exposure to Perfluorononanoic acid (PFNA), a type of per- and polyfluoroalkyl substance (PFAS), affects the immune response to the standard tetanus and diphtheria (Td) vaccine. The study focuses on participants from a community with known prior PFNA exposure through contaminated drinking water. The main question it aims to answer is:
- Does exposure to PFNA weaken the body's initial immune response, leading to lower levels of protective antibodies after vaccination?
Participants will:
- Receive Tetanus and Diphtheria (Td) booster vaccination
- Visit the study office 7 times over a 30-day period
- Have blood and saliva collected at each study visit
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 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participated in the Paulsboro PFAS Health Study
- •Provided a blood sample for the Paulsboro PFAS Health Study
- •Weigh at least 110 pounds
排除标准
- •Currently Pregnant
- •History of difficult blood draws
- •History of adverse reaction to prior vaccinations
- •Currently taking immune suppressants
- •Recent dental surgery or dental procedure within 4 weeks of starting study
- •Had a Td booster in the past 10 years
研究组 & 干预措施
All participants
All participants will be vaccinated during their first study visit using TENIVAC (Tetanus and Diphtheria Toxoids Adsorbed).TENIVAC will be administered intramuscularly as recommended in the subject's deltoid muscle at a dose of 0.5 mL.
干预措施: TENIVAC (Biological)
结局指标
主要结局
Change in Tetanus-diphtheria Specific IgG by PFNA Exposure Category
时间窗: 30 days
Quantitative measurement of tetanus and diphtheria specific IgG antibodies in serum collected at baseline (pre-vaccination) and Day 30 post-vaccination. Change is expressed as log₂ transformed fold change: log₂(day30 IgG / baseline IgG). IgG concentrations were measured using commercially available ELISA kits following the manufacturer's instructions. Serum PFNA levels were measured prior to enrollment. IgG was measured at baseline and 30 days post vaccination.
次要结局
未报告次要终点
研究者
Robert Laumbach MD, MPH
Associate Professor
Rutgers, The State University of New Jersey