Vaccine Response with Chemical Exposure

Overseen By Fatima Haynes, MS

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Rutgers, The State University of New Jersey

Must not be taking: Immune suppressants

Disqualifiers: Pregnancy, Difficult blood draws, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 7

Duration: 4 weeks

20 Participants Needed

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

Will I have to stop taking my current medications?

If you are currently taking immune suppressants, you will need to stop taking them to participate in this trial.

Is the vaccine generally safe for humans?

Vaccines are generally safe, with serious allergic reactions being very rare, occurring in about 1 in 1,500,000 doses. Most side effects are mild, like pain or swelling at the injection site, and serious side effects are uncommon. ^{1 2 3 4 5}

How does the drug TENIVAC differ from other treatments for chemical exposure?

TENIVAC is a vaccine typically used to prevent tetanus and diphtheria, and its use in the context of chemical exposure is unique because it is not a standard treatment for this condition. The trial may explore how the vaccine's immune response is affected by chemical exposure, which is not a common focus for other treatments. ^{6 7 8 9 10}

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Tetanus and Diphtheria (Td) booster vaccination and have blood and saliva collected at each visit

4 weeks

7 visits (in-person)

Follow-up

Participants are monitored for changes in Tetanus-diphtheria specific IgG levels

4 weeks

Treatment Details

Interventions

• TENIVAC

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+

Findings from Research

Between 2004 and 2006, the Netherlands Pharmacovigilance Center Lareb received a total of 914 reports of possible adverse events associated with vaccinations, with most reports coming from health professionals who frequently administered vaccines.

Despite an increase in the proportion of vaccine-related adverse event reports from 1.5% to approximately 6% after 2002, the data did not provide evidence to question the safety of vaccines, indicating that adverse events are relatively rare and difficult to directly link to vaccination.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Adverse events following vaccination reported to the Netherlands Pharmacovigilance Center Lareb in 2004-2006]. Labadie, J., van Grootheest, AC.[2008]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Vaccine hypersensitivity--update and overview. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

[Adverse events following vaccination reported to the Netherlands Pharmacovigilance Center Lareb in 2004-2006]. [2008]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Cutaneous adverse reactions following anti-infective vaccinations. [2018]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Establishment of a novel safety assessment method for vaccine adjuvant development. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Ten years of vaccinovigilance in Italy: an overview of the pharmacovigilance data from 2008 to 2017. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Transepidermal induction of contact hypersensitivity in mice with a water-soluble hapten. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

A retrospective study of clinical, physiologic and immunologic changes in workers exposed to toluene diisocyanate. [2013]

8. Germany pubmed.ncbi.nlm.nih.gov

Refinement of the relative alkylation index (RAI) model for skin sensitization and application to mouse and guinea-pig test data for alkyl alkanesulphonates. [2019]

9. China pubmed.ncbi.nlm.nih.gov

[Analysis of subgroups of lymphocyte in peripheral blood among dermatitis medicamentosa-like of trichloroethylene patients and healthy exposed workers]. [2013]

10. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[The anti-influenza immunity of workers subjected to exposure to chemical substances]. [2020]