Evidence map›Paper›PMID 28720147›Full record

Trial reportAIDS research and therapy2017

Safety and immunogenicity of the quadrivalent human papillomavirus (qHPV) vaccine in HIV-positive Spanish men who have sex with men (MSM).

Carmen Hidalgo-Tenorio, Jessica Ramírez-Taboada, Concepción Gil-Anguita, Javier Esquivias, Mohamed Omar-Mohamed-Balgahata, Antonio SamPedro, Miguel Lopez-Ruz, Juan Pasquau

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in AIDS research and therapy, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04270773 (Immunogenicity and Safety of a 9-valent Human Papillomavirus Vaccine in HIV-positive Women.), which is not on this map. Cited by 13 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 4 pooled it
2.2field-weighted citation impact, top 12% of its field
1 · What the graph read from 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.

2 · The registry

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.

NCT04270773 phase4unknown statusnot on this mapstarted 2020, after this paper: background citation

Immunogenicity and Safety of a 9-valent Human Papillomavirus Vaccine in HIV-positive Women.

TypeinterventionalSponsorUniversity Hospital Virgen de las NievesRan2020 to 2024Enrolled158ConditionsHIV Infections, HPV InfectionArmsHuman Papillomavirus 9-valent Vaccine, Recombinant
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 4 syntheses or guidelines pooled it, 25 citations in OpenAlex.

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  13. The situation of vaccines for the prevention of infections in adults: An opinion paper on the situation in Spain.Revista espanola de quimioterapia : publicacion oficial de la Sociedad Espanola de Quimioterapia · 2019
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 2 institutions in 1 country.

Carmen Hidalgo-TenorioInfectious Disease Service, University Hospital Virgen de las Nieves, Granada, Spain. chidalgo72@gmail.com.
Jessica Ramírez-TaboadaInfectious Disease Service, University Hospital Virgen de las Nieves, Granada, Spain.
Concepción Gil-AnguitaInfectious Disease Service, University Hospital Virgen de las Nieves, Granada, Spain.
Javier EsquiviasPathology Service, University Hospital Virgen de las Nieves, Granada, Spain.
Mohamed Omar-Mohamed-BalgahataInfectious Disease Unit of the Hospital Ciudad de Jaén, Jaén, Spain.
Antonio SamPedroMicrobiology Service, University Hospital Virgen de las Nieves, Granada, Spain.
Miguel Lopez-RuzInfectious Disease Service, University Hospital Virgen de las Nieves, Granada, Spain.
Juan PasquauInfectious Disease Service, University Hospital Virgen de las Nieves, Granada, Spain.
Hospital Universitario Virgen de las Nieves · ESComplejo Hospitalario de Jaén · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSafety and immunogenicity of the quadrivalent human papillomavirus (qHPV) vaccine were evaluated in HIV-positive Spanish MSM. The prevalence of High Squamous Intraepithelial Lesions (HSIL) and genotypes of high-risk human papillomavirus (HR-HPV) were also determined, as well as risk factors associated with the presence of HR-HPV in anal mucosa.

methodsThis is a randomised, double blind, placebo-controlled trial of the quadrivalent HPV (qHPV) vaccine. The study enrolled from May 2012 to May 2014. Vaccine and placebo were administered at 0, 2 and 6 months (V1, V2, V3 clinical visits). Vaccine antibody titres were evaluated at 7 months. Cytology (Thin Prep

resultsPatients (n = 162; mean age 37.9 years) were screened for inclusion; 14.2% had HSIL, 73.1% HR-HPV and 4.5% simultaneous infection with HPV16 and 18. Study participants (n = 129) were randomized to qHPV vaccine or placebo. The most common adverse event was injection-site pain predominating in the placebo group [the first dose (83.6% vs. 56.1%; p = 0.0001]; the second dose (87.8% vs. 98.4%; p = 0.0001); the third dose (67.7% vs. 91.9%; p = 0.0001). The vaccine did not influence either the viral load of HIV or the levels of CD4. Of those vaccinated, 76% had antibodies to HPV vs. 30.2% of those receiving placebo (p = 0.0001). In the multivariate analysis, Older age was associated with lower HR-HPV infection (RR 0.97; 95% CI 0.96-0.99), and risk factor were viral load of HIV >200 copies/µL (RR 1.42 95% CI 1.17-1.73) and early commencement of sexual activity (RR 1.35; 95% CI 1.001-1.811).

conclusionsThis trial showed significantly higher anti-HR-HPV antibody titres in vaccinated individuals than in unvaccinated controls. There were no serious adverse events attributable to the vaccine. In our cohort, 1 of every 7 patients had HSIL and the prevalence of combined infection by genotypes 16 and 18 was low. This suggests that patients could benefit from receiving qHPV vaccine. Older age was the main protective factor against HR-HPV infection, and non-suppressed HIV viremia was a risk factor. CLINICAL

trial registrationISRCTN14732216 ( http://www.isrctn.com/ISRCTN14732216 ).

Indexed as

AdultAnal CanalAntibodies, ViralAnus NeoplasmsCD4 Lymphocyte CountCoinfectionDouble-Blind MethodHIV InfectionsHomosexuality, MaleHuman papillomavirus 16Human papillomavirus 18Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18HumansMalePapillomavirus InfectionsPlacebosAntibodies, ViralHuman Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18PlacebosAnal cancerHigh squamous intra-epithelial lesions (HSIL)Human immunodeficiency virus (HIV)Low squamous intra-epithelial lesion (LSIL)Men having sex with men (MSM)Quadrivalent HPV vaccine

Identifiers

PMID28720147
PMCPMC5516305
OpenAlexW2737658237

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

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.