Vaccine Response with Chemical Exposure

Overseen by Robert Laumbach, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Rutgers, The State University of New Jersey

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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

Research Team

Robert Laumbach, MD

Principal Investigator

Rutgers, The State University of New Jersey

Eligibility Criteria

This trial is for adults who have been exposed to PFNA through contaminated drinking water. It's designed to see if this exposure affects how their immune system responds to the Td vaccine. Participants will need to visit the study office seven times over a month and provide blood and saliva samples.

Inclusion Criteria

Provided a blood sample for the Paulsboro PFAS Health Study

I weigh at least 110 pounds.

Participated in the Paulsboro PFAS Health Study

Exclusion Criteria

Currently Pregnant

History of difficult blood draws

History of adverse reaction to prior vaccinations

Treatment Details

Interventions

• TENIVAC (Cancer Vaccine)

Trial Overview The clinical trial is testing whether prior exposure to PFNA impacts the effectiveness of the TENIVAC (Td) booster shot, by measuring antibody levels in participants' blood and saliva after vaccination.

Participant Groups

Group I: All participants Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

Dr. Jonathan Holloway

Rutgers, The State University of New Jersey

Chief Executive Officer since 2020

PhD in History from Yale University

Dr. Brian Strom

Rutgers, The State University of New Jersey

Chief Medical Officer since 2014

MD from Rutgers New Jersey Medical School