PFAS Exposure and Immune Response to Vaccination in Adults

Phase 4

Completed

• Conditions: Innate Inflammatory Response; Vaccination; Diphtheria; Tetanus; Environmental Exposure; Vaccine; Antibodies; Adult; Immunity; Pollution; Exposure
• Interventions: Biological: TENIVAC

• Registration Number: NCT06588530
• Lead Sponsor: Rutgers, The State University of New Jersey

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-06
• Study First Submitted QC: 2024-09-06
• Study First Posted: 2024-09-19
• Study Start: 2024-11-04
• Primary Completion: 2025-01-08
• Study Completion: 2025-01-08
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All participants	TENIVAC	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.

Primary Outcome Measures

Name	Time	Method
Change in Tetanus-diptheria specific IgG	30 days	Specific antibodies produced following vaccination

Trial Locations

Locations (1)

EOHSI Paulsboro Office; 🇺🇸 Paulsboro, New Jersey, United States