Prevention of herpes zoster in people living with HIV Infections and Infestations
Conditions
Interventions
The present study will investigate the immunologic response and safety of the HZ/su vaccine in PLWHIV on effective antiretroviral treatment, according to the immunological situation.
Three infectious
Sponsors
University of Rome Tor Vergata
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. HZ/su reactogenicity and safety profile verified after each of the two scheduled doses in PLWHIV according to current LTCD4 absolute count (cells/mm3), using a semi-structured questionnaire investigating local and systemic symptoms, 1 week after both the first and the second dose. A follow-up visit assessing possible further adverse events and/or HZ episodes will be scheduled 6 months (±1 month) after HZ/su vaccine dose 2 (M2 +6). 2. HZ/su vaccine immunogenicity evaluated through analysis of cell-mediated immunity and vaccine response rate (VRR) in PLWHIV according to current LTCD4 absolute count (cells/mm3) In a subgroup of 100 patients (50 for each LTCD4 stratum), cell-mediated immunity will be investigated at baseline (M0) and 1 month (+/- 14 days) after the second HZ/su vaccine dose (M2 +1), using an intracellular cytokine staining (ICS) assay for Interferon-gamma, IL-2, TNF-alpha, and an IFN-gamma release assay (IGRA). Cell-mediated vaccine response rate (VRR) is defined as a twofold increase over baseline (prior to vaccination) of gE-specific polypositive LTCD4 (for ICS) and a twofold increase over baseline (prior to vaccination) of gE-specific IFN-gamma production (for IGRA). 3. HZ/su vaccine immunogenicity verified through analysis of humoral and cell-mediated immunity and vaccine response rate (VRR) in PLWHIV according to the current LTCD4/CD8 ratio. In a subgroup of 100 patients (50 for each LTCD4 stratum), cell-mediated immunity will be investigated at baseline (M0) and one month (+/- 14 days) after the second HZ/su vaccine dose (M2 +1), using an intracellular cytokine staining (ICS) assay for Interferon-gamma, IL-2, TNF-alpha, and an IFN-gamma release assay (IGRA). Cell-mediated vaccine response rate (VRR) is defined as a twofold increase over baseline (prior to vaccination) of gE-specific polypositive LTCD4 (for ICS) and a twofold increase over baseline (prior to vaccination) of gE-specific IFN-gamma production (for IGRA). | — |
Countries
Italy
Contacts
Public ContactMarco;Giulia C. Iannetta;Marchetti
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Outcome results
None listed