A Phase 4 interventional study of TENIVAC in Innate Inflammatory Response, Vaccination and Diphtheria, sponsored by Rutgers, The State University of New Jersey. Completed at 1 site in United States. Open to participants aged 18 Years to 89 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-30.
Sponsored by Rutgers, The State University of New Jersey · Phase 4, Interventional, and Basic science
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:
267 studies on the registry are indexed under Diphtheria; 17 are open to participants now.
This study's enrollment of 20 is below the median of 448 across 241 interventional studies indexed under Diphtheria.
Browse Diphtheria studies →Rutgers, The State University of New Jersey is the lead sponsor of 506 studies on the registry; 131 are open to participants now.
Of its 39 completed or terminated interventional studies of FDA-regulated products, 31 (79%) have results posted.
Compared within Diphtheria, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Inflammation. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Exclusion Criteria:
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.
Biological: TENIVAC
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.
Also known as: Tetanus and Diphtheria Toxoids Adsorbed, Td
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.
Time frame: 30 days
| Milestone | High PFNA Exposure | Low PFNA Exposure |
|---|---|---|
| Started | 10 | 10 |
| Completed | 10 | 10 |
| Not completed | 0 | 0 |
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.
| log2(fold change) | High PFNA Exposure | Low PFNA Exposure |
|---|---|---|
| Change in Tetanus IgG | 3.54 ± 1.83 | 3.39 ± 1.91 |
| Change in Diphtheria IgG | 2.44 ± 1.47 | 2.43 ± 1.60 |
Collected over 30 days after vaccination. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| High PFNA Exposure | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Low PFNA Exposure | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Age, Continuous(years) | High PFNA Exposure | Low PFNA Exposure | Total |
|---|---|---|---|
| Mean | 50.2 (31 to 68) | 49.3 (31 to 70) | 49.75 (31 to 70) |
| Sex: Female, Male(Participants) | High PFNA Exposure | Low PFNA Exposure | Total |
|---|---|---|---|
| Female | 4 | 4 | 8 |
| Male | 6 | 6 | 12 |
| Race (NIH/OMB)(Participants) | High PFNA Exposure | Low PFNA Exposure | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 4 | 9 | 13 |
| White | 6 | 1 | 7 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | High PFNA Exposure | Low PFNA Exposure | Total |
|---|---|---|---|
| United States | 10 | 10 | 20 |
| Body Mass Index (BMI)(Participants) | High PFNA Exposure | Low PFNA Exposure | Total |
|---|---|---|---|
| Healthy (18.5 - 24.9 *kg/m^2*) | 1 | 2 | 3 |
| Overweight (25.0 - 29.9 *kg/m^2*) | 4 | 3 | 7 |
| Obesity (30.0 or above*kg/m^2*) | 5 | 5 | 10 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
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Studies of the drug tested here: Tetanus and Diphtheria Toxoids Adsorbed
Rutgers, The State University of New Jersey →