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Cancer Vaccine

Vaccine Response with Chemical Exposure

Phase 4

Waitlist Available

Led By Robert Laumbach, MD

Research Sponsored by Rutgers, The State University of New Jersey

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Weigh at least 110 pounds

Be older than 18 years old

Must not have

Currently taking immune suppressants

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Drug Has Already Been Approved

Summary

"This trial aims to see how exposure to a certain chemical called PFNA affects the immune response to the tetanus and diphtheria vaccine. The study will involve people from a community that has been

Who is the study for?

This trial is for adults who have been exposed to PFNA through contaminated drinking water. It's designed to see if this exposure affects how their immune system responds to the Td vaccine. Participants will need to visit the study office seven times over a month and provide blood and saliva samples.

What is being tested?

The clinical trial is testing whether prior exposure to PFNA impacts the effectiveness of the TENIVAC (Td) booster shot, by measuring antibody levels in participants' blood and saliva after vaccination.

What are the potential side effects?

While not explicitly listed, side effects may include those commonly associated with vaccines such as soreness at injection site, mild fever, fatigue, headache or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I weigh at least 110 pounds.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am currently on immune suppressants.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Tetanus-diptheria specific IgG

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

1Treatment groups

Experimental Treatment

Group I: All participantsExperimental Treatment1 Intervention

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.

0 / 2Eligibility criteria met