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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:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TENIVAC | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Laumbach, MD | Rutgers, The State University of New Jersey | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| EOHSI Paulsboro Office | Paulsboro | New Jersey | 08066 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | High PFNA Exposure | Serum Perfluorononanoic acid (PFNA) was previously measured. Participants whose pre-enrollment serum PFNA concentrations were in the higher exposure range, defined as falling within the 4th or 5th quintiles of the PFNA distribution. All participants received a single 0.5 mL intramuscular dose of TENIVAC (Tetanus and Diphtheria Toxoids Adsorbed) at Visit 1. Td-specific IgG concentrations were measured at baseline and 30 days post-vaccination. |
| FG001 | Low PFNA Exposure | Serum Perfluorononanoic acid (PFNA) was previously measured. Participants whose pre-enrollment serum PFNA concentrations were in the lower exposure range, defined as falling within the 1st, 2nd, and 3rd quintiles of the PFNA distribution. All participants received a single 0.5 mL intramuscular dose of TENIVAC (Tetanus and Diphtheria Toxoids Adsorbed) at Visit 1. Td-specific IgG concentrations were measured at baseline and 30 days post-vaccination. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | High PFNA Exposure | Serum Perfluorononanoic acid (PFNA) was previously measured. Participants whose pre-enrollment serum PFNA concentrations were in the higher exposure range, defined as falling within the 4th or 5th quintiles of the PFNA distribution. All participants received a single 0.5 mL intramuscular dose of TENIVAC (Tetanus and Diphtheria Toxoids Adsorbed) at Visit 1. Td-specific IgG concentrations were measured at baseline and 30 days post-vaccination. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All participants with IgG measurements at baseline and Day 30 | Posted | Mean | Standard Deviation | log2(fold change) | 30 days |
|
30 days after vaccination
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | High PFNA Exposure | Serum Perfluorononanoic acid (PFNA) was previously measured. Participants whose pre-enrollment serum PFNA concentrations were in the higher exposure range, defined as falling within the 4th or 5th quintiles of the PFNA distribution. All participants received a single 0.5 mL intramuscular dose of TENIVAC (Tetanus and Diphtheria Toxoids Adsorbed) at Visit 1. Td-specific IgG concentrations were measured at baseline and 30 days post-vaccination. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Robert Laumbach | Rutgers University | 1-848-445-6084 | laumbach@eohsi.rutgers.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 3, 2025 | Dec 2, 2025 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 3, 2025 | Dec 2, 2025 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| D004165 | Diphtheria |
| D013742 | Tetanus |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003354 | Corynebacterium Infections |
| D000193 | Actinomycetales Infections |
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| ID | Term |
|---|---|
| D022422 | Diphtheria-Tetanus Vaccine |
| D013745 | Tetanus Toxoid |
| ID | Term |
|---|---|
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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|
| BG001 | Low PFNA Exposure | Serum Perfluorononanoic acid (PFNA) was previously measured. Participants whose pre-enrollment serum PFNA concentrations were in the lower exposure range, defined as falling within the 1st, 2nd, and 3rd quintiles of the PFNA distribution. All participants received a single 0.5 mL intramuscular dose of TENIVAC (Tetanus and Diphtheria Toxoids Adsorbed) at Visit 1. Td-specific IgG concentrations were measured at baseline and 30 days post-vaccination. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index (BMI) | Count of Participants | Participants |
|
| OG001 | Low PFNA Exposure | Serum Perfluorononanoic acid (PFNA) was previously measured. Participants whose pre-enrollment serum PFNA concentrations were in the lower exposure range, defined as falling within the 1st, 2nd, and 3rd quintiles of the PFNA distribution. All participants received a single 0.5 mL intramuscular dose of TENIVAC (Tetanus and Diphtheria Toxoids Adsorbed) at Visit 1. Td-specific IgG concentrations were measured at baseline and 30 days post-vaccination. |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Low PFNA Exposure | Serum Perfluorononanoic acid (PFNA) was previously measured. Participants whose pre-enrollment serum PFNA concentrations were in the lower exposure range, defined as falling within the 1st, 2nd, and 3rd quintiles of the PFNA distribution. All participants received a single 0.5 mL intramuscular dose of TENIVAC (Tetanus and Diphtheria Toxoids Adsorbed) at Visit 1. Td-specific IgG concentrations were measured at baseline and 30 days post-vaccination. | 0 | 10 | 0 | 10 | 0 | 10 |
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| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D003015 | Clostridium Infections |
| D004168 |
| Diphtheria Toxoid |
| D014121 | Toxoids |
| D017778 | Vaccines, Combined |