PFAS Exposure and Immune Response to Vaccination in Adults

Rutgers The State University of New Jersey

Status and phase: Completed; Phase 4

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

Treatments: Biological: TENIVAC

Study type: Interventional

Funder types: Other

Identifiers

NCT06588530

Pro2024000644

Details and patient eligibility

About

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

Enrollment: 20 patients

Sex: All

Ages: 18 to 89 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

20 participants in 1 patient group

All participants

Experimental group

Description:

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.

Treatment:

Biological: TENIVAC