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Vaccine

Salmonella Typhi Vaccine for Immune Deficiency

Q: Has the Salmonella typhi polysaccharide vaccine been authorized by the FDA?

<p>Salmonella typhi polysaccharide <a href="https://www.withpower.com/clinical-trials/vaccine">vaccine</a>'s safety has been determined to be a 1 as this is an early stage trial with little evidence of efficacy and limited data regarding risk.</p>

Phase 1

Waitlist Available

Led By Larry Borish, MD

Research Sponsored by University of Virginia

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4-6 weeks

Awards & highlights

Study Summary

This trial is testing if a low level of immunoglobulin E in the blood is a sign of developing immunity problems.

Who is the study for?

This trial is for adults aged 18-80 with normal or high levels of certain immune system proteins (IgG, IgA, and IgM) and an undetectable level of serum immunoglobulin E (IgE). Participants should be able to follow the study schedule and procedures. Those with a history of frequent infections, immunodeficiency, recent immunosuppression treatment, or low immune protein levels cannot join.Check my eligibility

What is being tested?

The study investigates whether having an undetectable amount of serum IgE can indicate the start of an immune deficiency. It involves individuals who have been seen at the University of Virginia Asthma, Allergy, and Immunology clinics as well as control subjects from a specific previous study.See study design

What are the potential side effects?

Since this trial involves a vaccine test (Salmonella typhi polysaccharide vaccine), potential side effects may include local reactions like pain or swelling at the injection site, fever, fatigue, headache and possible allergic responses.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4-6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4-6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4-6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Vaccination response

Secondary outcome measures

Epsilon germline transcript production

Trial Design

1Treatment groups

Experimental Treatment

Group I: VaccineExperimental Treatment1 Intervention

Subjects who meet enrollment criteria will be administered a single intramuscular dose of the Salmonella typhi polysaccharide vaccine

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Salmonella typhi polysaccharide vaccine

2019

Completed Phase 1

~40

Do I qualify?Apply below to find out

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

University of VirginiaLead Sponsor

753 Previous Clinical Trials

1,244,994 Total Patients Enrolled

CSL BehringIndustry Sponsor

194 Previous Clinical Trials

1,211,185 Total Patients Enrolled

Jeffrey Modell FoundationUNKNOWN

2 Previous Clinical Trials

250 Total Patients Enrolled

Media Library

Salmonella typhi polysaccharide vaccine (Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT03968211 — Phase 1

Immune Deficiency Research Study Groups: Vaccine

Immune Deficiency Clinical Trial 2023: Salmonella typhi polysaccharide vaccine Highlights & Side Effects. Trial Name: NCT03968211 — Phase 1

Salmonella typhi polysaccharide vaccine (Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03968211 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any past experiments that have utilized Salmonella typhi polysaccharide vaccine?

"Currently, there are two clinical studies underway investigating the efficacy of a Salmonella typhi polysaccharide vaccine. Neither is in Phase 3 yet. Charlottesville, Virginia serves as the main hub for many trials surrounding this therapy, however there are additional testing sites available."

Answered by AI

Is there an ongoing recruitment process for this clinical experiment?

"As found in the clinicaltrials.gov registry, this trial is currently recruiting patients. It was first published on July 1st 2019 and last amended on May 16th 2022."

Answered by AI

Is this investigation accepting individuals aged 40 and above?

"This research program is seeking volunteers aged 18 and above, with a maximum age of 80 years."

Answered by AI

Can you provide an estimate of the total size of this research cohort?

"Affirmative. The clinical trial is actively recruiting, as evidenced by the information provided on clinicaltrials.gov. It was initially posted on July 1st 2019 and has since been updated as recently as May 16th 2022 with a goal of enrolling 45 patients from one medical centre."

Answered by AI

Is this experimental endeavor unprecedented in its field?

"Since 2019, Salmonella typhi polysaccharide vaccine has been studied extensively. CSL Behring was the first to sponsor a trial in that year with 45 participants taking part. As of today, Phase 1 drug approval is granted and there are two active studies occurring across 2 countries over one city."

Answered by AI

Has the Salmonella typhi polysaccharide vaccine been authorized by the FDA?

"Salmonella typhi polysaccharide vaccine's safety has been determined to be a 1 as this is an early stage trial with little evidence of efficacy and limited data regarding risk."

Answered by AI

For whom is this experimental research appropriate?

"45 individuals, aged between 18 and 80 years old, are sought to join this trial. The ideal candidates must be able to commit to the scheduled visits along with having a prior diagnosis of low IgE levels from the University of Virginia Asthma, Allergy and Immunology clinics."

Answered by AI

Recent research and studies

Journal of Clinical ImmunologyJournal

Low Serum Ige Is a Sensitive and Specific Marker for Common Variable Immunodeficiency (CVID)

Lawrence, Monica G., Thamiris V. Palacios-Kibler, Lisa J. Workman, Alexander J. Schuyler, John W. Steinke, Spencer C. Payne, Emily C. McGowan, et al.. 2018. “Low Serum Ige Is a Sensitive and Specific Marker for Common Variable Immunodeficiency (CVID)”. Journal of Clinical Immunology. Springer Science and Business Media LLC. doi:10.1007/s10875-018-0476-0.

clinicaltrials.govStudy

Undetectable IgE as a Sentinel Biomarker for Humoral Immunodeficiency

Larry Borish, MD 2019. "Undetectable IgE as a Sentinel Biomarker for Humoral Immunodeficiency". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03968211.