Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2018
Safety and Immunogenicity of Zoster Vaccine Live in Human Immunodeficiency Virus-Infected Adults With CD4+ Cell Counts >200 Cells/mL Virologically Suppressed on Antiretroviral Therapy.
Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00851786 (A Phase II, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of ZOSTAVAX®), which is not on this map. Cited by 18 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase II, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of ZOSTAVAX® (Zoster Vaccine Live) in Human Immunodeficiency Virus (HIV)-1-Infected Adults on Potent Combination ART With Conserved Immune Function
Who cites it
18 citing papers in PubMed, 3 syntheses or guidelines pooled it, 27 citations in OpenAlex.
- Immunogenicity and safety of live attenuated and recombinant/inactivated varicella zoster vaccines in people living with HIV: A systematic review.Human vaccines & immunotherapeutics · 2024Pooled it
- Efficacy, effectiveness, and safety of herpes zoster vaccine in the immunocompetent and immunocompromised subjects: A systematic review and network meta-analysis.Frontiers in immunology · 2022Pooled it
- Herpes Zoster Risk in Immunocompromised Adults in the United States: A Systematic Review.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2020Pooled it
- Article
- Immune response to the recombinant herpes zoster vaccine in people living with HIV over 50 years of age compared to non-HIV age-/gender-matched controls (SHINGR'HIV): a multicenter, international, non-randomized clinical trial study protocol.BMC infectious diseases · 2024Article
- Immunogenicity and Efficacy of Vaccination in People Living with Human Immunodeficiency Virus.Viruses · 2023Review
- Living with HIV and Getting Vaccinated: A Narrative Review.Vaccines · 2023Review
- Herpes Zoster Vaccines.The Journal of infectious diseases · 2021Article
- Incidence of Herpes Zoster in HIV-Infected Patients Undergoing Antiretroviral Therapy: A Systematic Review and Meta-analysis.Journal of clinical medicine · 2021Review
- Impact of COVID-19 on people living with HIV: A review.Journal of virus eradication · 2020Review
- Observational
- Immune Correlates of Herpes Zoster in People Living with HIV on Effective Antiretroviral Therapy.AIDS research and human retroviruses · 2019Article
- HIV and Aging: Reconsidering the Approach to Management of Comorbidities.Infectious disease clinics of North America · 2019Review
- Consensus statements on vaccination in patients with haemophilia-Results from the Italian haemophilia and vaccinations (HEVA) project.Haemophilia : the official journal of the World Federation of Hemophilia · 2019Article
- Herpes Zoster Rates Continue to Decline in People Living With Human Immunodeficiency Virus but Remain Higher Than Rates Reported in the General US Population.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2019Article
- Safety of live attenuated varicella-zoster vaccine in patients with underlying illnesses compared with healthy adults: a prospective cohort study.BMC infectious diseases · 2019Article
- Herpes Zoster and Herpes Zoster Vaccine Rates Among Adults Living With and Without HIV in the Veterans Aging Cohort Study.Journal of acquired immune deficiency syndromes (1999) · 2018Article
- Low Rates of Vaccination for Herpes Zoster in Older People Living With HIV.AIDS research and human retroviruses · 2018Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
17 authors at 12 institutions in 1 country.
Funding
Abstract
Background: Herpes zoster (HZ) risk is increased in human immunodeficiency virus (HIV)-infected persons. Live attenuated zoster vaccine (ZV) reduces HZ incidence and severity in adults; safety and immunogenicity data in HIV-infected adults are limited. Methods: We conducted a randomized, double-blind, placebo-controlled trial in HIV-infected adults virally suppressed on antiretroviral therapy (ART). Participants, stratified by CD4+ count (200-349 or ≥350 cells/µL), were randomized 3:1 to receive ZV or placebo on day 0 and week 6. The primary endpoint was serious adverse event or grade 3/4 signs/symptoms within 6 weeks after each dose. Immunogenicity (varicella zoster virus [VZV]-specific glycoprotein enzyme-linked immunosorbent assay and interferon-γ enzyme-linked immunospot assay responses) was assessed at 6 and 12 weeks postvaccination. Results: Of 395 participants (296 ZV vs 99 placebo), 84% were male, 47% white, 29% black, and 22% Hispanic; median age was 49 years. Safety endpoints occurred in 15 ZV and 2 placebo recipients (5.1% [95% confidence interval {CI}, 2.9%-8.2%] vs 2.1% [95% CI, .3%-7.3%]; P = .26). Injection site reactions occurred in 42% of ZV (95% CI, 36.3%-47.9%) vs 12.4% of placebo recipients (95% CI, 6.6%-20.6%) (P < .001). Week 12 median natural log VZV antibody titer was higher for ZV (6.30 [Q1, Q3, 5.64, 6.96]) vs placebo (5.48 [Q1, Q3, 4.63, 6.44]; P < .001) overall and in the high CD4+ stratum (P = .003). VZV antibody titers were similar after 1 or 2 ZV doses. Polymerase chain reaction-confirmed HZ occurred in 2 participants (1 ZV; 1 placebo); none was vaccine strain related. Conclusions: Two doses of ZV in HIV-infected adults suppressed on ART with CD4+ counts ≥200 cells/µL were safe and immunogenic. Clinical Trials Registration: NCT00851786.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.