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Virus Vaccine
Shingrix Vaccine for Shingles
Phase 2
Waitlist Available
Led By Nadine Rouphael, MD
Research Sponsored by Emory University
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 day 1 from day 0, day 7 from day 0, day 61 from day 60, day 67 from day 60
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to understand how the immune system responds to the Shingrix® vaccine in older adults. The study will involve healthy participants in two different age groups. The vaccine helps the body build defenses against the virus that causes shingles, preventing its reactivation. Shingrix® is a newer version of the shingles vaccine that has shown promising results in many studies.
Eligible Conditions
- Shingles
- Chickenpox
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 from day 0, day 7 from day 0, day 61 from day 60, day 67 from day 60
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 from day 0, day 7 from day 0, day 61 from day 60, day 67 from day 60
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Innate Immune Signatures Post-vaccine Dose
Secondary study objectives
Safety of Zoster Vaccine Recombinant, Adjuvanted
Side effects data
From 2023 Phase 2 trial • 38 Patients • NCT040479797%
Upper Respiratory Infection
3%
Rash maculo-papular
3%
Ureteroscopy with lithotripsy
3%
Hypertension emergency
3%
Peripheral Neuropathy
3%
Automobile accident
3%
Allergic rhinitis
3%
Vertigo
3%
Reconstructive surgery 3rd, 4th, 5th phalange
3%
Itching
100%
80%
60%
40%
20%
0%
Study treatment Arm
Younger Group
Older Group
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Younger GroupExperimental Treatment1 Intervention
Participants between the ages of 50 to 60 years will receive two doses of Zoster vaccine recombinant, adjuvanted (Shingrix®)
Group II: Older GroupExperimental Treatment1 Intervention
Participants who are ≥70 year old will receive two doses of Zoster vaccine recombinant, adjuvanted (Shingrix®)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Shingrix®
2019
Completed Phase 2
~40
Find a Location
Who is running the clinical trial?
Emory UniversityLead Sponsor
1,691 Previous Clinical Trials
2,603,778 Total Patients Enrolled
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,313 Previous Clinical Trials
5,547,641 Total Patients Enrolled
Nadine Rouphael, MDPrincipal Investigator - Emory University
Emory University Hospital Midtown, Select Specialty Hospital-Atlanta
St Joseph'S University (Medical School)
Emory University School Of Medicine (Residency)
16 Previous Clinical Trials
865 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have certain health conditions or are taking medications that weaken your immune system.You have had severe reactions to vaccines in the past.You have had a severe allergic reaction to any part of the vaccines in the past.You have had shingles in the past.You have a history of problems with bleeding.You have any other medical problems or test results that the study doctor thinks could make it risky for you to participate in the study, make it difficult for you to follow the study rules, or affect the accuracy of the study results.You have a history of alcohol or drug abuse, or mental health conditions that might make it difficult for you to follow the trial instructions or understand the results.
Research Study Groups:
This trial has the following groups:- Group 1: Younger Group
- Group 2: Older Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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