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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how exposure to a chemical called PFNA might affect the immune system's response to the tetanus and diphtheria (Td) vaccine. The study focuses on individuals from a community with PFNA in their drinking water. Participants will receive a booster vaccine (TENIVAC) and undergo multiple blood and saliva tests to determine if their immune system produces enough protective antibodies. Suitable candidates include those who participated in the Paulsboro PFAS Health Study, weigh at least 110 pounds, have not received a Td booster in the last 10 years, and have no history of difficult blood draws. As a Phase 4 trial, this research aims to understand how the already FDA-approved and effective treatment benefits more patients.

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.

What is the safety track record for TENIVAC?

Research has shown that TENIVAC, the vaccine used in this study, is generally well-tolerated. It is commonly used to prevent tetanus and diphtheria. Available safety information suggests that the ingredients in TENIVAC do not pose significant health risks at the given doses.

The vaccine has been widely used and does not contain substances known to cause cancer or genetic changes, so it is not expected to cause cancer or alter genes.

In summary, TENIVAC is considered safe, with the main side effects usually being mild, such as soreness at the injection site. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike other vaccines for tetanus and diphtheria, which are typically used under ordinary conditions, TENIVAC is being studied to understand its effectiveness when the body is exposed to certain chemicals. Most vaccines work by stimulating the immune system to fight off infections, but researchers are curious to see if chemical exposure affects this response. This study is exciting because it could reveal important information about vaccine effectiveness in environments with chemical exposure, helping to ensure people are protected in various real-world scenarios.

What evidence suggests that this trial's treatment could be effective for vaccine response with chemical exposure?

Research has shown that TENIVAC, the booster vaccine for tetanus and diphtheria, effectively strengthens the body's defenses against these diseases. One study found that individuals who received TENIVAC had higher levels of protective antibodies compared to those who did not. These antibodies play a crucial role in preventing infections like tetanus and diphtheria. Additionally, receiving repeat doses of tetanus and diphtheria vaccines has proven to be safe and continues to enhance the immune system over time. Overall, TENIVAC is recognized for its ability to build strong protection against tetanus and diphtheria. ^{2 4 6 7 8}

Who Is on the Research Team?

Robert Laumbach, MD

Principal Investigator

Rutgers, The State University of New Jersey

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. fda.gov fda.gov/media/76610/download

Package Insert-TENIVAC TENIVAC may be used to complete the primary immunization series for tetanus and diphtheria, following one or two doses of Diphtheria and Tetanus Toxoids and ...

2. nctm.tamu.edu nctm.tamu.edu/wp-content/uploads/2024/01/Tenivac-Clinical-Review.pdf

Tetanus and Diphtheria Toxoids Adsorbed for Adult Use This BLA contains clinical safety and immunogenicity data from three "historical" studies that were originally submitted in 1986, as well as from four more ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12474341/

Safety and Immunogenicity of Single-Dose of Adsorbed ... The GMC of antibodies against tetanus toxoid in the investigational group was higher than that in the control group (4.721 IU/mL vs. 3.627 IU/mL ...

4. cdc.gov cdc.gov/mmwr/volumes/69/wr/mm6903a5.htm

Use of Tetanus Toxoid, Reduced Diphtheria ... Repeat doses of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine at 5- and 10-year intervals are safe and immunogenic.

5. tdvax.com tdvax.com/

TdVax Each 0.5 mL dose of MassBiologics' TDVAX is formulated to contain the following active ingredients: 2 Lf of tetanus toxoid and 2 Lf of diphtheria toxoid.

6. vaxserve.com vaxserve.com/assets/pdf/MSDS_Tenivac.pdf

TENIVAC MSDS It has been determined that the product or diluent ingredients do not pose a physical or health hazard at the percentages present in the mixtures based on the.

7. imgcdn.mckesson.com imgcdn.mckesson.com/CumulusWeb/Click_and_learn/SDS_AKORN_TET_DIPTH_ADLT_PF_SD_10X.pdf

SDS: Tetanus and Diphtheria Toxoids Adsorbed Occupational Safety and Health. Administration (OSHA):. Not considered to be a carcinogen. Mutagenicity: No data available. Aspiration Hazard: No data available ...

8. vaccineshoppe.com vaccineshoppe.com/image.cfm?doc_id=12617&image_type=product_pdf

Diphtheria and Tetanus Toxoids Adsorbed ... No safety and immunogenicity data are available on the concomitant administration of Diphtheria and. Tetanus Toxoids Adsorbed with other US licensed vaccines.