NCT05580458Toboroz1/2. fázis
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
Phase 1/2 Open-label Trial of Safety and Zoster Immunogenicity Evaluation for People With HIV With CD4 Counts Under and Above 300 and Healthy Volunteers Following Shingrix Vaccination (ZEUS)
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. nov. 5.
Rövid összefoglaló (regiszter, angolul)
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. Researchers want to learn more about how people with HIV respond to Shingrix. Objective: To learn how Shingrix affects the immune response in people with HIV. Eligibility: People aged 18 years and older with HIV. Healthy people aged 50 years or older are also needed. Design: Participants will have at least 4 clinic visits in 1 year. Participants will be screened. They will have a physical exam with blood and urine tests. At their first visit, participants will receive Shingrix as a shot in the upper arm. They will have a rectal swab; a cotton swab will be inserted into the rectum and rotated gently to collect bacteria. Participants will receive a second shot of Shingrix 2 months after the first one. They will visit the clinic again 3 and 12 months after the first shot. Participants will receive a 28-day memory tool. They will write down their symptoms between clinic visits. They will have up to 4 phone calls to talk about side effects of the shot. Participants may undergo apheresis: They will lie still while blood is drawn from a needle in one arm. The blood will pass through a machine that separates out the white blood cells. The remaining blood will be given back through a second needle in their other arm....
- Állapot (regiszter)
- Toboroz
- Fázis (regiszter)
- 1/2. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 225 (tervezett)
- Első benyújtás
- 2022. okt. 8.
- Kezdés
- 2023. márc. 13.
- Elsődleges befejezés
- 2027. febr. 1.
- Fő szponzor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Betegségek
- HIV-fertőzés
- NCT-szám
- NCT05580458
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 1/2. fázis
- Tervezett résztvevők: 225
- 2023. márc. 13. és az elsődleges befejezés (2027. febr. 1.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- Previous receipt of Shingrix vaccine at any time.
- 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.
- 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 vaccine which may be given at least 8 days before and/or at least 14 days after each study agent injection (at month 0/month 2).
- 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 topical steroids are not exclusionary).
Más betegség
- History of severe allergic reaction to any component of Shingrix.
- 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 unsuitable for the study.
- Uncontrolled psychiatric disease per physician evaluation, current substance use, or inappropriate conduct unsuitable for a research study.
Laborértékek
- 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 individuals, without regard to factors such as sex, race, ethnicity, socioeconomic status, etc, except for age.
- Medical record review may be used for determining eligibility. If a clinical laboratory evaluation is available for review at the screening timepoint, but was obtained prior to protocol consent, the laboratory test does not have to be repeated for the purposes of confirming eligibility under the protocol.
Egyéb
- Individuals meeting any of the following criteria will be excluded from study participation:
- Receipt of Zostavax within the past 12 months.
- Pregnancy or breastfeeding.
A regiszterben nem jelölt feltételek
- INCLUSION CRITERIA:
- General Inclusion Criteria:
- 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 methods of contraception include the following:
- Hormonal contraception.
- Male or female condom.
- Diaphragm or cervical cap with a spermicide.
- Intrauterine device.
- Has a primary care provider.
- Additional Inclusion Criteria 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 months prior to screening.
- 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 loads in the absence of any treatment for a period of 12 months prior to screening visit).
- No active/uncontrolled opportunistic infections (patients on chronic maintenance therapy would be considered as controlled).
- Additional Inclusion Criteria for Healthy Volunteers:
- Healthy volunteers must also meet all of the following criteria to be eligible for study participation:
- >= 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).
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket is fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| National Institutes of Health Clinical Center | Bethesda | Egyesült Államok | Toboroz |
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