Adult, Antibodies, Diphtheria, Environmental Exposure, Immunity, Innate Inflammatory Response, Pollution; Exposure, Tetanus, Vaccination, Vaccine
Conditions
Keywords
PFAS, Perfluoroalkyl substances, Polyfluoroalkyl substances, Vaccine, fluorocarbons, tetanus-diphtheria vaccine, prospective study, Adaptive immunity, innate immunity, PFNA, Perfluorononanoic Acid
Brief summary
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
Interventions
BIOLOGICALTENIVAC
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.
Sponsors
Rutgers, The State University of New Jersey
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
Yes
Inclusion criteria
* Participated in the Paulsboro PFAS Health Study * Provided a blood sample for the Paulsboro PFAS Health Study * Weigh at least 110 pounds
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Tetanus-diphtheria Specific IgG by PFNA Exposure Category | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 10 |
| 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. | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | Low PFNA Exposure | Total | High PFNA Exposure |
|---|---|---|---|
| Age, Continuous | 49.3 years | 49.75 years | 50.2 years |
| Body Mass Index (BMI) Healthy (18.5 - 24.9 *kg/m^2*) | 2 Participants | 3 Participants | 1 Participants |
| Body Mass Index (BMI) Obesity (30.0 or above*kg/m^2*) | 5 Participants | 10 Participants | 5 Participants |
| Body Mass Index (BMI) Overweight (25.0 - 29.9 *kg/m^2*) | 3 Participants | 7 Participants | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 13 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 7 Participants | 6 Participants |
| Region of Enrollment United States | 10 participants | 20 participants | 10 participants |
| Sex: Female, Male Female | 4 Participants | 8 Participants | 4 Participants |
| Sex: Female, Male Male | 6 Participants | 12 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
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.
Time frame: 30 days
Population: All participants with IgG measurements at baseline and Day 30
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High PFNA Exposure | Change in Tetanus-diphtheria Specific IgG by PFNA Exposure Category | Change in Tetanus IgG | 3.54 log2(fold change) | Standard Deviation 1.83 |
| High PFNA Exposure | Change in Tetanus-diphtheria Specific IgG by PFNA Exposure Category | Change in Diphtheria IgG | 2.44 log2(fold change) | Standard Deviation 1.47 |
| Low PFNA Exposure | Change in Tetanus-diphtheria Specific IgG by PFNA Exposure Category | Change in Tetanus IgG | 3.39 log2(fold change) | Standard Deviation 1.91 |
| Low PFNA Exposure | Change in Tetanus-diphtheria Specific IgG by PFNA Exposure Category | Change in Diphtheria IgG | 2.43 log2(fold change) | Standard Deviation 1.6 |
Comparison: Tetanusp-value: 0.85Wilcoxon (Mann-Whitney)
Comparison: Diphtheriap-value: 0.85Wilcoxon (Mann-Whitney)