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Tests treatment safety and results for Herpes Zoster
Official title Safety and Immunogenicity of Recombinant Varicella Zoster Virus Vaccine in People With HIV Who Have a CD4 Count Less Than 300 or Greater Than or Equal to 300 and a Healthy Control Population
ClinicalTrials.gov ID: NCT05580458
What this study is testing
What is Shingrix?
Shingrix is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for herpes zoster.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Background: Shingles is a painful, blistering rash caused by the same virus that causes chickenpox. Shingrix is a vaccine approved to prevent shingles in healthy adults over age 50 and in immunocompromised adults over age 18.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- General Individuals must meet all of the following criteria to be eligible for study participation:
- Able to provide informed consent.
- Participants of childbearing potential must agree to use at least 1 acceptable method of contraception when engaging in sexual activities that can...
- Hormonal contraception.
- Male or female condom.
You likely can't join if
- Individuals meeting any of the following criteria will be excluded from study participation:
- Previous receipt of Shingrix vaccine at any time.
- Receipt of Zostavax within the past 12 months.
- History of severe allergic reaction to any component of Shingrix.
- Diagnosed varicella or herpes zoster episode within the past 1 month. Subject will be eligible for SHINGRIX vaccine once symptoms of herpes zoster...
- Immunocompromised (other than HIV for the PWH cohort) within the past 6 months (eg, due to a malignancy other than skin cancer).
See the full eligibility criteria
- General Individuals must meet all of the following criteria to be eligible for study participation:
- Able to provide informed consent.
- Participants of childbearing potential must agree to use at least 1 acceptable method of contraception when engaging in sexual activities that can result in pregnancy, beginning at screening through month 3. Acceptable...
- Hormonal contraception.
- Male or female condom.
- Diaphragm or cervical cap with a spermicide.
- Intrauterine device.
- Has a primary care provider. Additional for People with HIV:
- PWH must also meet all the following criteria to be eligible for study participation:
- \>= 18 years of age.
- Seropositive for HIV-1 (documented or confirmed at screening).
- Documented viral load \< 100 copies/mL within 90 days of screening and documented viral suppression defined as viral load consistently \<100 copies/mL with at least one documented viral load \< 40 copies/mL within 12...
- Currently on a stable antiretroviral regimen (minimum of 6 months of a stable ART regimen; changes for side effects, drug interaction, or convenience allowed), or is an elite controller (maintains undetectable viral...
- No active/uncontrolled opportunistic infections (patients on chronic maintenance therapy would be considered as controlled). Additional for Healthy Volunteers: Healthy volunteers must also meet all of the following...
- \>= 50 years of age.
- No uncontrolled chronic medical issues that per the discretion of the PI or designee would compromise the safety of the research participant.
- No underlying immunodeficiencies (including negative HIV test at screening).
- Individuals meeting any of the following criteria will be excluded from study participation:
- Previous receipt of Shingrix vaccine at any time.
- Receipt of Zostavax within the past 12 months.
- History of severe allergic reaction to any component of Shingrix.
- Diagnosed varicella or herpes zoster episode within the past 1 month. Subject will be eligible for SHINGRIX vaccine once symptoms of herpes zoster episode have resolved.
- Immunocompromised (other than HIV for the PWH cohort) within the past 6 months (eg, due to a malignancy other than skin cancer).
- Current moderate or severe acute illness (ie, febrile illness, seizure, myocardial infarction, cerebrovascular accident, pulmonary embolism) that in the opinion of the principal investigator, would make the subject...
- Pregnancy or breastfeeding.
- Receipt of an investigational agent, investigational vaccine, or licensed live virus vaccine within 30 days prior to screening.
- Planned receipt of any vaccine (investigational or ACIP-recommended) between months 0 and 2 except for the tetanus, diphtheria, and pertussis vaccine [TDaP], Pneumovax, inactivated influenza vaccines, and COVID-19...
- Administration of immunoglobulins or any blood products within 90 days preceding the first dose of vaccine or planned administration during the study period.
- Chronic administration (\>= 15 consecutive days) of immunosuppressive or other immune-modifying drugs within 6 months before screening. (Prednisone \< 20 mg/day or equivalent, corticosteroid nasal spray or inhaler, and...
- Uncontrolled psychiatric disease per physician evaluation, current substance use, or inappropriate conduct unsuitable for a research study.
- Any condition that could compromise, in the investigator's opinion, the participant's safety or the study outcomes. Participants will be selected in an equitable manner from the available pool of potentially eligible...
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.