Phase 4
N=20
PFAS Exposure and Immune Response to Vaccination in Adults
Innate Inflammatory Response · Vaccination · Diphtheria · Tetanus · Environmental Exposure
Bottom Line
View on ClinicalTrials.gov: NCT06588530 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Dec 2025
Primary outcome: Primary: Change in Tetanus-diphtheria Specific IgG by PFNA Exposure Category — 3.54; 3.39; 2.44; 2.43 log2(fold change) — p=.85
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- TENIVAC (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Rutgers, The State University of New Jersey
- Primary completion
- Jan 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Tetanus-diphtheria Specific IgG by PFNA Exposure Category |
3.54; 3.39; 2.44; 2.43 | .85 |
Summary
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
Eligibility Criteria
Inclusion Criteria
- Participated in the Paulsboro PFAS Health Study
- Provided a blood sample for the Paulsboro PFAS Health Study
- Weigh at least 110 pounds
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT06588530). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.