Efficacy and safety of the new recombinant subunit vaccine for varicella zoster virus in people living with HIV

Not Applicable

• Conditions: Prevention of herpes zoster in people living with HIV; Infections and Infestations

• Registration Number: ISRCTN15045512
• Lead Sponsor: niversity of Rome Tor Vergata

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2024-03-05
• Last Update Posted: 18 March 2024
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

1. People living with HIV (PLWHIV) =18 years old, on antiretroviral treatment, virally suppressed (HIVRNA <50 copies/ml in the last 6 months)
2. Able to provide informed consent
3. Available CD4 cell count in the last 6 months

Exclusion Criteria

1. Age <18 years old
2. Active herpes zoster episode at enrollment
3. Acute disease/fever at enrollment
4. Known allergy to vaccine component
5. Other than HIV immunosuppressive condition or treatment. Prednisone <20 mg/day, or equivalent, is allowed. Inhaled and topical steroids are allowed
6. Pregnancy
7. Lactation
8. Women planning to become pregnant or planning to discontinue contraceptive methods

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
HZ/su vaccine immunogenicity will be evaluated through the analysis of humoral immunity and vaccine response rate (VRR) in PLWHIV according to the current LTCD4 absolute count (cells/mm3). To this purpose, anti-glycoprotein E (gE) antibodies concentration will be assessed for the whole population at baseline (M0) and 1 month (± 14 days) after the second Hz/su vaccine dose (M2+1). Humoral vaccine response rate (VRR) is defined as a fourfold increase over baseline (prior to vaccination) anti-gE concentration (mUI/ml).