Trial Outcomes & Findings for PFAS Exposure and Immune Response to Vaccination in Adults (NCT NCT06588530)
NCT ID: NCT06588530
Last Updated: 2025-12-30
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
20 participants
Primary outcome timeframe
30 days
Results posted on
2025-12-30
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
PFAS Exposure and Immune Response to Vaccination in Adults
Baseline characteristics by cohort
| Measure |
High PFNA Exposure
n=10 Participants
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.
|
Low PFNA Exposure
n=10 Participants
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.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.2 years
n=174 Participants
|
49.3 years
n=166 Participants
|
49.75 years
n=167 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=174 Participants
|
4 Participants
n=166 Participants
|
8 Participants
n=167 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=174 Participants
|
6 Participants
n=166 Participants
|
12 Participants
n=167 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=174 Participants
|
0 Participants
n=166 Participants
|
0 Participants
n=167 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=174 Participants
|
0 Participants
n=166 Participants
|
0 Participants
n=167 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=174 Participants
|
0 Participants
n=166 Participants
|
0 Participants
n=167 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=174 Participants
|
9 Participants
n=166 Participants
|
13 Participants
n=167 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=174 Participants
|
1 Participants
n=166 Participants
|
7 Participants
n=167 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=174 Participants
|
0 Participants
n=166 Participants
|
0 Participants
n=167 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=174 Participants
|
0 Participants
n=166 Participants
|
0 Participants
n=167 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=174 Participants
|
10 participants
n=166 Participants
|
20 participants
n=167 Participants
|
|
Body Mass Index (BMI)
Healthy (18.5 - 24.9 *kg/m^2*)
|
1 Participants
n=174 Participants
|
2 Participants
n=166 Participants
|
3 Participants
n=167 Participants
|
|
Body Mass Index (BMI)
Overweight (25.0 - 29.9 *kg/m^2*)
|
4 Participants
n=174 Participants
|
3 Participants
n=166 Participants
|
7 Participants
n=167 Participants
|
|
Body Mass Index (BMI)
Obesity (30.0 or above*kg/m^2*)
|
5 Participants
n=174 Participants
|
5 Participants
n=166 Participants
|
10 Participants
n=167 Participants
|
PRIMARY outcome
Timeframe: 30 daysPopulation: All participants with IgG measurements at baseline and Day 30
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.
Outcome measures
| Measure |
High PFNA Exposure
n=10 Participants
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.
|
Low PFNA Exposure
n=10 Participants
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.
|
|---|---|---|
|
Change in Tetanus-diphtheria Specific IgG by PFNA Exposure Category
Change in Tetanus IgG
|
3.54 log2(fold change)
Standard Deviation 1.83
|
3.39 log2(fold change)
Standard Deviation 1.91
|
|
Change in Tetanus-diphtheria Specific IgG by PFNA Exposure Category
Change in Diphtheria IgG
|
2.44 log2(fold change)
Standard Deviation 1.47
|
2.43 log2(fold change)
Standard Deviation 1.60
|
Adverse Events
High PFNA Exposure
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Low PFNA Exposure
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place