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Vaccine

RNA Vaccine for Shingles

Phase 2
Recruiting
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Prior history of heart disease (eg, heart failure, recent coronary artery disease, cardiomyopathies, pericarditis, or myocarditis).
Women who are pregnant or breastfeeding.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline (before vaccination 1), at 1- and 4-weeks after each vaccination and 6-months after last vaccination
Awards & highlights

Study Summary

This trial studies the safety, side effects and immune response of a VZV modRNA vaccine in adults ages 50-69. Participants receive different doses and formulations, and may stay in the study for up to 5 years.

Who is the study for?
Healthy adults aged 50-69 can join this vaccine trial against shingles. They must be able to follow the study plan and not have heart disease, bleeding issues, or a history of severe vaccine reactions. Pregnant women, those on immunosuppressants, or with recent other vaccines are excluded.Check my eligibility
What is being tested?
The trial is testing different candidates of a modified RNA shingles vaccine compared to an approved one (Shingrix). It's in two parts: Phase 1 tests safety and immune response with various doses/formulations; Phase 2 uses findings from Phase 1 for further evaluation over up to five years.See study design
What are the potential side effects?
Possible side effects include typical reactions at the injection site like pain and swelling, general symptoms such as fever or fatigue, allergic responses, and potentially others based on individual health conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a history of heart disease.
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I am not pregnant or breastfeeding.
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I am between 50 and 69 years old.
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I am taking or plan to take drugs that weaken my immune system.
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I have had Guillain-Barré syndrome in the past.
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I have had shingles before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline (before vaccination 1), at 1- and 4-weeks after each vaccination and 6-months after last vaccination
This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline (before vaccination 1), at 1- and 4-weeks after each vaccination and 6-months after last vaccination for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall study: Percentage of participants from both substudies reporting adverse events
Overall study: Percentage of participants from both substudies reporting local reactions
Overall study: Percentage of participants from both substudies reporting medically attended adverse events
+15 more
Secondary outcome measures
Overall study: Geometric mean concentrations (GMCs) of glycoprotein E antibodies in evaluable immunogenicity participants in both substudies
Overall study: Geometric mean fold rise (GMFR) from before vaccination to each subsequent timepoint in evaluable immunogenicity participants from both substudies
Overall study: Proportion of evaluable immunogenicity participants from both substudies with vaccine response in glycoprotein E antibodies from baseline to each subsequent timepoint
+6 more

Trial Design

16Treatment groups
Experimental Treatment
Active Control
Group I: Substudy B (SSB): Group 1Experimental Treatment1 Intervention
Selected Vaccine candidate/dose-level/dosing schedule
Group II: SubStudy A (SSA): Group 1Experimental Treatment1 Intervention
Candidate 1, Dose Level 1, lyophilized, 0, 2 months schedule
Group III: SSA: Group 7Experimental Treatment1 Intervention
Candidate 3, Frozen, 0, 2 months schedule
Group IV: SSA: Group 5Experimental Treatment1 Intervention
Candidate 1, Dose Level 2, Frozen, 0, 6 months schedule
Group V: SSA: Group 4Experimental Treatment1 Intervention
Candidate 1, Dose Level 2, frozen, 0, 2 months schedule
Group VI: SSA: Group 3Experimental Treatment1 Intervention
Candidate 1, Dose Level 3, lyophilized, 0, 2 months schedule
Group VII: SSA: Group 2Experimental Treatment1 Intervention
Candidate 1, Dose Level 2, lyophilized, 0, 2 months schedule
Group VIII: SSA: Group 13Experimental Treatment1 Intervention
Candidate 2, Dose level 4, lyophilized, 0, 2 months schedule
Group IX: SSA: Group 12Experimental Treatment1 Intervention
Candidate 2, Dose level 3, lyophilized, 0, 2 months schedule
Group X: SSA: Group 11Experimental Treatment2 Interventions
Candidate 2, Dose level 2, lyophilized, 0, 2 months schedule
Group XI: SSA: Group 10Experimental Treatment1 Intervention
Candidate 1, Dose level 4, lyophilized, 0, 6 months schedule
Group XII: SSA- Group 6Experimental Treatment1 Intervention
Candidate 2, frozen, 0, 2 months schedule
Group XIII: SSA: Group 14Active Control1 Intervention
Shingrix, 0, 2 months schedule
Group XIV: SSA: Group 8Active Control1 Intervention
Shingrix, 0, 2 months schedule
Group XV: SSA: Group 9Active Control1 Intervention
Shingrix, 0, 6 months schedule
Group XVI: SSB: Group 2Active Control1 Intervention
Shingrix

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,570 Previous Clinical Trials
10,915,126 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,476 Previous Clinical Trials
8,091,321 Total Patients Enrolled

Media Library

Shingrix (Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT05703607 — Phase 2
Shingles Clinical Trial 2023: Shingrix Highlights & Side Effects. Trial Name: NCT05703607 — Phase 2
Shingrix (Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05703607 — Phase 2
Shingles Research Study Groups: SSA: Group 14, SSA: Group 11, SSA: Group 10, SSA: Group 12, SSA: Group 13, SubStudy A (SSA): Group 1, SSA: Group 2, SSA: Group 3, SSA: Group 4, SSA: Group 5, SSA- Group 6, SSA: Group 7, SSA: Group 8, SSA: Group 9, Substudy B (SSB): Group 1, SSB: Group 2
Shingles Patient Testimony for trial: Trial Name: NCT05703607 — Phase 2

Frequently Asked Questions

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

Has SSA- Group 6 received regulatory authorization from the FDA?

"The safety of SSA- Group 6 was rated a 2 out of 3 due to the Phase 2 trial status, indicating some evidence for its safety but not yet any sufficient data supporting efficacy."

Answered by AI

Is this research endeavor enrolling participants who are aged 55 or older?

"This trial is only available to those aged 50-69. However, there are 9 other studies open for minors below the age of 18 and 36 programs that accommodate seniors over 65 years old."

Answered by AI

Is there a current opportunity for prospective participants to join this research?

"Affirmative. Data on clinicaltrials.gov confirms that this healthcare trial, which was inaugurated on January 25th 2023, is actively recruiting individuals to participate in the study. Approximately 900 volunteers are required to be sourced from 10 different medical centres."

Answered by AI

How many participants are involved in this experiment?

"Correct. According to information found on clinicaltrials.gov, the trial is currently open for participant recruitment and was initially published on January 25th 2023 with a subsequent update conducted on February 6th 2023. Currently, 900 patients are being sought after at 10 different medical sites."

Answered by AI

How many locations are participating in this experiment?

"Patients are able to enroll in this trial at East-West Medical Research Institute in Honolulu, Hawaii, Centennial Medical Group in Elkridge, Maryland and Associates of Cardiology PA in Silver Spring Nebraska. Additionally, 10 other healthcare centres have been given permission to conduct the study as well."

Answered by AI

Do I meet the criteria to partake in this research?

"This clinical trial seeks to recruit up 900 participants aged 50-69 years of age. Those interested should meet the following criteria: Substudy A requiring male or female applicants, healthy individuals with no known HIV/HCV/HBV infection, readiness and capability to comply with all study visits, tests and procedures; as well as ability to provide signed informed consent that adheres to ICD regulations and protocol requirements."

Answered by AI

What therapeutic effects are investigators expecting to observe through this clinical trial?

"According to Pfizer, the main outcome measured in this trial is SSA: The proportion of individuals with abnormal troponin I laboratory values over a 6-month period post vaccination. Additionally, other secondary outcomes are being assessed including SSB: Geometric mean concentrations (GMCs) of glycoprotein E antibodies and Overall study: Geometric mean concentrations (GMCs) of glycoprotein E antibodies in evaluable immunogenicity participants from both substudies as reported by the central laboratory."

Answered by AI

Who else is applying?

What state do they live in?
California
Michigan
What site did they apply to?
Centennial Medical Group
Diablo Clinical Research, Inc.
C.S. Mott Clinical Research Center (CRC)
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

I am kinda Unique and like to help medical scientists.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
A Study to Learn About a Modified RNA Vaccine Against Shingles in Healthy Adults
2023. "A Study to Learn About a Modified RNA Vaccine Against Shingles in Healthy Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05703607.
All > Meridian > Honolulu
~503 spots leftby Dec 2025
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