Innate Inflammatory ResponsePhase 4NCT06588530

PFAS Exposure and Immune Response to Vaccination in Adults

A Phase 4 study testing TENIVAC in people with Innate Inflammatory Response and Vaccination, run by Rutgers, The State University of New Jersey at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 89 yearsHealthy volunteers can take part
Conditions the study is for: Innate Inflammatory Response, Vaccination, Diphtheria
What is being tested?: TENIVAC
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteUnited States
Study dates: 4 Nov 2024to 8 Jan 2025
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 89 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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 locations and contacts

1 site in 1 country.

United States1 site

EOHSI Paulsboro Office
Paulsboro, New Jersey, 08066

Other trials in United States

About this study

Official title: Effects of Exposure to Per- and Polyfluoroalkyl Substances (PFAS) on Innate and Adaptive Immune Responses to Tetanus-diphtheria (Td) Vaccination Among Adults in a Community-based Panel Study

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: Innate Inflammatory Response, Vaccination, Diphtheria, Tetanus, Environmental Exposure, Vaccine
Being tested: TENIVAC
Keywords: PFAS, Perfluoroalkyl substances, Polyfluoroalkyl substances, Vaccine, fluorocarbons, tetanus-diphtheria vaccine, prospective study, Adaptive immunity, innate immunity, PFNA, Perfluorononanoic Acid
Medical subject headings: Inflammation, Diphtheria, Tetanus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TENIVACBiological
Also called Tetanus and Diphtheria Toxoids Adsorbed, Td
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.

Study groups in NCT06588530
Study group	Role	What they receive
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. Receives: Biological: TENIVAC

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Nov 20248 Jan 2025

First posted19 Sep 2024
Study start4 Nov 2024
Primary completion8 Jan 2025
Study completion8 Jan 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Innate Inflammatory ResponseStudies of the same condition, open and under way.
More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06588530
Sponsor's protocol ID: Pro2024000644
Status last verified: Dec 2025
First submitted: 6 Sep 2024
Last updated: 30 Dec 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Innate Inflammatory Response trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Exposure to Per- and Polyfluoroalkyl Substances (PFAS) on Innate and Adaptive Immune Responses to Tetanus-diphtheria (Td) Vaccination Among Adults in a Community-based Panel Study
ClinicalTrials.gov ID: NCT06588530
Acronym / sponsor ID: Pro2024000644
Conditions: Innate Inflammatory Response, Vaccination, Diphtheria, Tetanus, Environmental Exposure, Vaccine
Keywords: PFAS, Perfluoroalkyl substances, Polyfluoroalkyl substances, Vaccine, fluorocarbons, tetanus-diphtheria vaccine, prospective study, Adaptive immunity
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Rutgers, The State University of New JerseyUniversity, hospital or other
Study start: 4 Nov 2024 (actual)
Primary completion: 8 Jan 2025 (actual)
Study completion: 8 Jan 2025 (actual)
First posted: 19 Sep 2024 (actual)
Results: Posted 30 Dec 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
All participants	Experimental	Biological: TENIVACAll 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 may qualify

Ages: 18 to 89 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TENIVACAlso: Tetanus and Diphtheria Toxoids Adsorbed, TdTENIVAC (Tetanus and Diphtheria Toxoids Adsorbed) is an active immunization for the prevention of tetanus and diphtheria in persons 7 years of age and older.	Biological	All participants

Primary outcome

Change in Tetanus-diphtheria Specific IgG by PFNA Exposure Category
Time frame: 30 days
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.

Results and safety

Results posted to the registry on 30 Dec 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
High PFNA Exposure	10	10
Low PFNA Exposure	10	10

Primary outcome: Change in Tetanus-diphtheria Specific IgG by PFNA Exposure Category

Time frame: 30 days. Mean (Standard Deviation). Unit: log2(fold change)

Measure	High PFNA Exposure n = 10	Low PFNA Exposure n = 10
Change in Tetanus IgG	3.54 (1.83)	3.39 (1.91)
Change in Diphtheria IgG	2.44 (1.47)	2.43 (1.60)

High PFNA Exposure vs Low PFNA Exposure: Mean Difference (Net): 0.15, p = .85, Wilcoxon (Mann-Whitney)
High PFNA Exposure vs Low PFNA Exposure: Mean Difference (Net): .01, p = .85, Wilcoxon (Mann-Whitney)

Population analysed: All participants with IgG measurements at baseline and Day 30

Adverse events

Time frame: 30 days after vaccination. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
High PFNA Exposure	0 of 10 (0%)	0 of 10 (0%)	0 of 10
Low PFNA Exposure	0 of 10 (0%)	0 of 10 (0%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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RecruitingObservational study
Study of the Effect of Innate on the Inflammatory Response to Endotoxin
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Recruiting
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Serratus Posterior Superior Intercostal Plane Block (SPSIPB), Breast Cancer
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Inflammation
Active, not recruiting
COMPArative Study of the Consequence on innaTe Immune Response du to Bacterial or Viral Infection in Patients Admitted to Intensive Care Unit
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Robert Laumbach, MD principal investigator

Rutgers, The State University of New Jersey

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing TENIVAC in people with Innate Inflammatory Response and Vaccination, run by Rutgers, The State University of New Jersey at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Tetanus-diphtheria Specific IgG by PFNA Exposure Category (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06588530.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2025.