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Vaccine

ZVL >5 years previously for Shingles

Phase 1
Waitlist Available
Led By Adriana Weinberg, MD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
General good health
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up until vzv dna is undetectable in the blood, measured up to day 7
Awards & highlights

Study Summary

This trial plans to give a "challenge" dose of shingles to people who have already been vaccinated in order to learn more about how the body prevents shingles.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You are in good overall health.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~until vzv dna is undetectable in the blood, measured up to day 7
This trial's timeline: 3 weeks for screening, Varies for treatment, and until vzv dna is undetectable in the blood, measured up to day 7 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Magnitude of Varicella-Zoster Virus (VZV) DNAemia

Trial Design

4Treatment groups
Active Control
Group I: ZVL >5 years previouslyActive Control1 Intervention
Participants have received Zostavax (ZVL) at least 5 years previously. Will be administered intradermal vOka varicella zoster virus (ZVL) in non-dominant deltoid. A skin biopsy will be performed at the injection site on 20 subjects.
Group II: No previous ZVLActive Control2 Interventions
Participants who've never received a shingles vaccine will be given the 2 standard doses of RZV. Six months later they will be given the intradermal dose of vOka varicella zoster virus (ZVL) in the non-dominant deltoid.
Group III: ZVL 6-12 months previouslyActive Control1 Intervention
Participants who received ZVL 6-12 months previously will be administered an intradermal dose of vOka varicella zoster virus (ZVL) in non-dominant deltoid.
Group IV: SRX >5 years previouslyActive Control1 Intervention
Participants have received Shingrix at least 5 years previously. Will be administered intradermal vOka varicella zoster virus (ZVL) in non-dominant deltoid. A skin biopsy will be performed at the injection site on 20 subjects.

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,726 Previous Clinical Trials
2,141,571 Total Patients Enrolled
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,261 Previous Clinical Trials
5,482,901 Total Patients Enrolled
Adriana Weinberg, MDPrincipal InvestigatorUniversity of Colorado, Denver
4 Previous Clinical Trials
448 Total Patients Enrolled

Frequently Asked Questions

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

Are there any historic studies that have utilized ZVL over a five-year period?

"Presently, 25 different trials concerning the effects of ZVL >5 years previously are in progress with 10 studies on Phase 3. Although a few experiments regarding this subject matter originate from Lake Mary, Florida, there exists 781 distinct sites around the world conducting related research."

Answered by AI

What is the aggregate amount of individuals participating in this clinical investigation?

"Affirmative. According to the data hosted on clinicaltrials.gov, this medical trial launched on July 28th 2020 and is currently enrolling eligible patients. 140 participants are needed from 1 site for this research project."

Answered by AI

Are there any criteria preventing me from joining this experiment?

"This medical experiment is searching for 140 participants aged between 50 and 85 with a diagnosis of herpes zoster. To qualify, individuals must be in general good health, postmenopausal women may not have the capability to bear children, those allocated to ARM 1 will require proof of immunization from ZVL or SRX at least 5 years ago while those assigned to ARM 2 need evidence that they were vaccinated using ZVL within 6-12 months prior enrolment; lastly, persons appointed to ARM 3 cannot have had any form of shingles vaccination before."

Answered by AI

Is there an opportunity for patients to participate in this experiment currently?

"Affirmative. The information found on clinicaltrials.gov indicates that this medical trial is currently looking for participants, having been initially posted on July 28th 2020 and updated as recently as February 18th 2022. 140 patients must be enrolled across 1 different site."

Answered by AI

What risks are posed to individuals who had ZVL more than five years ago?

"Due to the limited data demonstrating both efficacy and safety, ZVL's score on a scale from 1-3 was assigned as an estimation of '1' by our team at Power."

Answered by AI
~22 spots leftby Mar 2025