PFAS Exposure and Immune Response to Vaccination in Adults

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

Completed

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Key information

Conditions

Innate Inflammatory Response Actinomycetales Infections Adult Antibodies Bacterial Infections Bacterial Infections and Mycoses Clostridium Infections Corynebacterium Infections Diphtheria Environmental Exposure Gram-Positive Bacterial Infections Immunity Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Pollution; Exposure Tetanus Vaccination Vaccine

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

EOHSI Paulsboro Office

Paulsboro, New Jersey, 08066, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TENIVAC

Biological

TENIVAC (Tetanus and Diphtheria Toxoids Adsorbed) is an active immunization for the prevention of tetanus and diphtheria in persons 7 years of age and older.

Other names: Tetanus and Diphtheria Toxoids Adsorbed, Td

Primary outcomes

Change in Tetanus-diphtheria Specific IgG by PFNA Exposure Category

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Registry information

Official study title

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

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Sep 19, 2024
Registry last updated: Dec 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed