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NCT06588530 · ClinicalTrials.gov registry record · Phase 4
PFAS Exposure and Immune Response to Vaccination in Adults
A Phase 4 study of Diphtheria and Tetanus, sponsored by Rutgers, The State University of New Jersey.
- Completed
- Registry status
- Phase 4
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT06588530: Completed Phase 4 study of Diphtheria and Tetanus, sponsored by Rutgers, The State University of New Jersey.
NCT06588530 is a Phase 4 study of Diphtheria and Tetanus that has completed, run by Rutgers, The State University of New Jersey. The registered enrollment target is 20 participants, below the 1,865-participant average among 15 other Diphtheria trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06588530, a Phase 4 study of Diphtheria and Tetanus, has completed, sponsored by Rutgers, The State University of New Jersey.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study 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
Primary Outcome
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.
Conditions Studied
Interventions
- BIOLOGICAL TENIVAC
Study Locations (1)
New Jersey
- EOHSI Paulsboro Office - Paulsboro
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2024-11-04 |
| Est. Completion | 2025-01-08 |
| Phase | Phase 4 |
What the finished NCT06588530 record still lists
NCT06588530 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 1,865-participant average among 15 other Diphtheria trials with a reported enrollment target (99% lower).
The record links to 10 conditions, with Diphtheria appearing as the primary indexed condition, and to 1 intervention - of which TENIVAC is the first listed.
NCT06588530 reports a single indexed study location in New Jersey.
Frequently Asked Questions
What is clinical trial NCT06588530 about?
NCT06588530 is a clinical study titled "PFAS Exposure and Immune Response to Vaccination in Adults". 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 exposu...
What is the current status of trial NCT06588530?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 20 participants. The study started on 2024-11-04. Estimated completion is 2025-01-08.
What conditions does trial NCT06588530 study?
This clinical trial studies the following conditions: Diphtheria, Tetanus, Environmental Exposure, Vaccination, Adult.
What interventions are being tested in trial NCT06588530?
The interventions under investigation include: TENIVAC (BIOLOGICAL).
Who is sponsoring clinical trial NCT06588530?
This trial is sponsored by Rutgers, The State University of New Jersey, which has 413 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06588530 being conducted?
This trial has 1 study location across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06588530's enrollment target sits among peer trials
20 15th of 15 higher than 1 of 15 other Diphtheria trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diphtheria trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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