ArticleEClinicalMedicine2020
Immunogenicity and safety of the AS04-HPV-16/18 and HPV-6/11/16/18 human papillomavirus vaccines in asymptomatic young women living with HIV aged 15-25 years: A phase IV randomized comparative study.
Article in EClinicalMedicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01031069 (Safety and Immunogenicity of Cervarix™ in Human Immunodeficiency Virus Infected Females), which is not on this map. Cited by 8 papers.
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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.
Safety and Immunogenicity of Cervarix™ in Human Immunodeficiency Virus Infected Females
Who cites it
8 citing papers in PubMed, 10 citations in OpenAlex.
- Understanding human papillomavirus vaccine response and efficacy in people living with HIV: A systematic mixed studies review and meta-analysis.PLOS global public health · 2024Article
- Efficacy and Durability of Immune Response after Receipt of HPV Vaccines in People Living with HIV.Vaccines · 2023Review
- Immunogenicity, safety, and efficacy of the HPV vaccines among people living with HIV: A systematic review and meta-analysis.EClinicalMedicine · 2022Article
- Advances in Infectious Disease Vaccine Adjuvants.Vaccines · 2022Review
- Immunogenicity of a Two-Dose Human Papillomavirus Vaccine Schedule in HIV-Infected Adolescents with Immune Reconstitution.Vaccines · 2022Article
- Trends in Adult and Elderly Vaccination: Focus on Vaccination Practices in Tunisia and Morocco.Frontiers in public health · 2022Review
- Cervical cancer prevention and control in women living with human immunodeficiency virus.CA: a cancer journal for clinicians · 2021Review
- Novel Production of Bovine Papillomavirus Pseudovirions in Tobacco Plants.Pathogens (Basel, Switzerland) · 2020Article
Corrections and comments
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Authors and funding
29 authors at 13 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundWomen living with HIV (WLWH) are at higher risk of acquisition and progression of human papillomavirus (HPV) infection. Evidence on effect of HPV vaccination in this population is limited.
methodsThis phase IV randomized controlled observer-blind study assessed immunogenicity and safety of two HPV vaccines (AS04-HPV-16/18 vs. 4vHPV) given in WLWH (stage 1) and HIV- females aged 15-25 years. Co-primary endpoints were to demonstrate, in WLWH subjects, non-inferiority (and if demonstrated, superiority) of AS04-HPV-16/18 vs. 4vHPV for HPV-16 and HPV-18 by pseudovirion-based neutralization assay (PBNA) at month 7 and safety. Non-inferiority criteria was lower limit (LL) of the 95% confidence interval (CI) of the GMT ratio AS04-HPV-16/18/4vHPV above 0.5, in the according to protocol population. NCT01031069.
findingsAmong 873 subjects recruited between 26-Oct-2010 and 14-May-2015, 546 were randomized (1:1) and received at least one vaccine dose (total vaccinated cohort, TVC): 257 were WLWH (129 AS04-HPV-16/18; 128 4vHPV) and 289 were subjects without HIV (144 AS04-HPV-16/18; 145 4vHPV). Baseline CD4 cell count in WLWH was at least 350 cells/mm
interpretationBoth vaccines showed an acceptable safety profile in all subjects. Despite the absence of an immunological correlate of protection for HPV, differences in immune responses elicited by the vaccines especially for HPV-18 may translate into longer lasting or more robust protection against cervical cancer with the AS04-HPV-16/18 vaccine in WLWH.
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