CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 20 enrolled
Drug / intervention
TENIVACbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06588530
NCT06588530Phase 4Completed
CompareCT.gov

Effects of Exposure to Per- and Polyfluoroalkyl Substances (PFAS) on Innate and Adaptive Immune Responses to Tetanus-diphtheria (Td) Vaccination Among Adults in a Community-based Panel Study

Rutgers, The State University of New Jersey·interventional·Posted Sep 19, 2024·Updated Dec 30, 2025

In Brief

A Phase 4 clinical trial evaluating TENIVAC for Innate Inflammatory Response and 9 related conditions. Completed, enrolled 20 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInnate Inflammatory Response, Vaccination, Diphtheria, Tetanus, Environmental Exposure, Vaccine, Antibodies, Adult, Immunity, Pollution; Exposure
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20252026
First PostedSep 19, 2024
Enrollment StartNov 4, 2024
Primary CompletionJan 8, 2025
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 1.8 years ago

Interventions

TENIVACbiological

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.