PFAS Exposure and Immune Response to Vaccination in Adults

NCT06588530 | Completed Phase 4 Results FDA Drug

• 1 other identifier: Pro2024000644
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in Tetanus-diphtheria Specific IgG by PFNA Exposure Category

  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.

  30 days

Study Arms (1)

All participants

EXPERIMENTAL

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.

Biological: TENIVAC

Interventions

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.

Also known as: Tetanus and Diphtheria Toxoids Adsorbed, Td

All participants

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participated in the Paulsboro PFAS Health Study
• Provided a blood sample for the Paulsboro PFAS Health Study
• Weigh at least 110 pounds

You may not qualify if:

• 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

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

EOHSI Paulsboro Office

Paulsboro, New Jersey, 08066, United States

Location

MeSH Terms

Conditions

Inflammation; Diphtheria; Tetanus

Interventions

Diphtheria-Tetanus Vaccine; Tetanus Toxoid

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Corynebacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Clostridium Infections

Intervention Hierarchy (Ancestors)

Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures; Diphtheria Toxoid; Toxoids; Vaccines, Combined

Results Point of Contact

• Title: Dr. Robert Laumbach
• Organization: Rutgers University

laumbach@eohsi.rutgers.edu

1-848-445-6084

Study Officials

• Robert Laumbach, MD

  Rutgers, The State University of New Jersey

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 6, 2024
• First Posted: September 19, 2024
• Study Start: November 4, 2024
• Primary Completion: January 8, 2025
• Study Completion: January 8, 2025
• Last Updated: December 30, 2025
• Results First Posted: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)