MedDataX Logo

PFAS Exposure and Immune Response to Vaccination in Adults

NCT ID: NCT06588530

Last Updated: 2025-12-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-04

Study Completion Date

2025-01-08

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Environmental Exposure Vaccine Antibodies Adult Immunity Pollution; Exposure Vaccination Diphtheria Tetanus Innate Inflammatory Response

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

PFAS Perfluoroalkyl substances Polyfluoroalkyl substances Vaccine fluorocarbons tetanus-diphtheria vaccine prospective study Adaptive immunity innate immunity PFNA, Perfluorononanoic Acid

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

TENIVAC

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

TENIVAC

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.

Intervention Type BIOLOGICAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Tetanus and Diphtheria Toxoids Adsorbed Td

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Rutgers, The State University of New Jersey

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Robert Laumbach MD, MPH

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Robert Laumbach, MD

Role: PRINCIPAL_INVESTIGATOR

Rutgers, The State University of New Jersey

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

EOHSI Paulsboro Office

Paulsboro, New Jersey, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Pro2024000644

Identifier Type: -

Identifier Source: org_study_id