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Virus Vaccine
Shingrix Vaccine Safety and Immunogenicity in People With HIV
Phase 1 & 2
Recruiting
Led By Maura M Manion, M.D.
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
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 months 3 and 12
Awards & highlights
Study Summary
This trial will study how the Shingrix vaccine affects people with HIV's immune response. Eligible participants aged 18+ must have HIV, and healthy people aged 50+ are also needed. Participants will have 4 clinic visits and complete a diary card.
Who is the study for?
This trial is for adults over 18 with HIV who have a viral load under control and are on stable antiretroviral therapy, or elite controllers. Healthy volunteers over 50 can also join. Participants must agree to use contraception if they can become pregnant. Exclusions include pregnancy, breastfeeding, recent shingles or chickenpox vaccines, certain acute illnesses, immunoglobulin treatments within the past 90 days, and severe allergies to Shingrix components.Check my eligibility
What is being tested?
The study tests how well the Shingrix vaccine boosts immune response in people with HIV compared to healthy older adults. It involves at least four clinic visits over a year where participants receive two shots of Shingrix and provide blood samples through regular draws and possibly apheresis (a process that separates white blood cells from drawn blood).See study design
What are the potential side effects?
Possible side effects of the Shingrix vaccine may include pain at the injection site, muscle pain, tiredness, headache, shivering, fever, stomach issues like nausea or vomiting. Side effects will be tracked using a memory tool between visits and discussed during follow-up phone calls.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ months 3 and 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~months 3 and 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Fold change of anti-gE antibody concentrations evaluated regularly through the end of study (months 3 and 12) by CD4 count (< 300 and >= 300)
Secondary outcome measures
Antibodies
Antibodies
Grade 3 and/or Grade 4 Shingrix ARs (solicited and unsolicited local and systemic).
Trial Design
1Treatment groups
Experimental Treatment
Group I: ShingrixExperimental Treatment1 Intervention
Shingrix will be administered in two 0.5-mL doses approximately 2 months apart.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Shingrix
2019
Completed Phase 4
~500
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,270 Previous Clinical Trials
5,485,012 Total Patients Enrolled
Maura M Manion, M.D.Principal InvestigatorNational Institute of Allergy and Infectious Diseases (NIAID)
1 Previous Clinical Trials
70 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am over 50, healthy, with no chronic issues or immune problems.I have had chickenpox or shingles in the last month.I do not have a severe illness right now.I received the Zostavax vaccine in the last year.I haven't taken any immune-suppressing drugs in the last 6 months.I plan to only receive specified vaccines in the next 2 months.I am over 18, HIV positive, with a low viral load and no recent severe infections.I haven't received immunoglobulins or blood products in the last 90 days.
Research Study Groups:
This trial has the following groups:- Group 1: Shingrix
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment open at this time for participants in the research?
"According to the data from clinicaltrials.gov, this medical trial is no longer accepting new patients as its last update was dated November 11th 2022. However, there are currently 34 other trials that are actively seeking participants for their studies."
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