Evidence map›Paper›PMID 35853188›Full record

ArticleHuman vaccines & immunotherapeutics2022

Effectiveness, immunogenicity, and safety of the quadrivalent HPV vaccine in women and men aged 27-45 years.

Ivette Maldonado, Manuel Plata, Mauricio Gonzalez, Alfonso Correa, Claudia Nossa, Anna R Giuliano, Elmar A Joura, Alex Ferenczy, Brigitte M Ronnett, Mark H Stoler and 8 more

2 registry-linked trialsOpen access · goldAbstract read
In one paragraph

Article in Human vaccines & immunotherapeutics, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 23 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 4 pooled it
4.7field-weighted citation impact, top 4% 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.

NCT00090220 phase3completednot on this map

Safety, Immunogenicity, and Efficacy of Gardasil (V501 (Human Papilloma Virus [Types 6, 11, 16, 18] Recombinant Vaccine) in Mid-Adult Women - The FUTURE III (Females United to Unilaterally Reduce Endo/Ectocervical Cancer) Study

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2004 to 2015Enrolled3,819ConditionsHealthy Adult Female Participants, Prevention, Papillomavirus Infection, Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18ArmsQuadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine, Comparator: Placebo
NCT01432574 phase2completednot on this map

A Phase II Study of Gardasil in Human Papillomavirus Research The Mid-Adult Male Vaccine Study - The MAM STUDY

TypeinterventionalSponsorH. Lee Moffitt Cancer Center and Research InstituteRan2013 to 2020Enrolled150ConditionsHuman PapillomavirusArmsGardasil
3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 4 syntheses or guidelines pooled it, 33 citations in OpenAlex.

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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

18 authors at 11 institutions in 4 countries.

Ivette MaldonadoDepartment of Obstetrics & Gynaecology, Fundación Santa Fe de Bogotá, Bogotá, Colombia.
Manuel PlataDepartment of Gynaecology, Fundación Cardioinfantil, Bogotá, Colombia.
Mauricio GonzalezGinecologo Oncologo, Instituto Nacional de Cancerología, Bogotá, Colombia.
Alfonso CorreaClínica del Country, Bogotá, Colombia.
Claudia NossaCafam, Bogotá, Colombia.
Anna R GiulianoCenter for Immunization and Infection Research in Cancer, Moffitt Cancer Center and Research Institute, Tampa, FL, USA.ORCID 0000-0002-5440-8859
Elmar A JouraDepartment of Obstetrics & Gynaecology, Medical University of Vienna, Vienna, Austria.ORCID 0000-0003-0885-1013
Alex FerenczyDepartment of Gynecologic Pathology and Cytopathology, University Health Center and Jewish General Hospital, Montreal, Quebec, Canada.
Brigitte M RonnettJohns Hopkins Gynecologic Pathology Consultation Service, The Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Mark H StolerDepartment of Pathology, University of Virginia Health System, Charlottesville, VA, USA.
Hao Jin ZhouMerck & Co., Inc, Rahway, NJ, USA.
Amita JoshiMerck & Co., Inc, Rahway, NJ, USA.
Rituparna DasMerck & Co., Inc, Rahway, NJ, USA.
Oliver BautistaMerck & Co., Inc, Rahway, NJ, USA.
Thomas GroupMerck & Co., Inc, Rahway, NJ, USA.
Alain LuxembourgMerck & Co., Inc, Rahway, NJ, USA.
Alfred SaahMerck & Co., Inc, Rahway, NJ, USA.
Ulrike Kirsten BuchwaldMerck & Co., Inc, Rahway, NJ, USA.ORCID 0000-0002-6671-0115
Merck & Co., Inc., Rahway, NJ, USA (United States) · USClínica Santa María · COFundación Santa Fe de Bogotá · COFundación Universitaria Cafam · COInstitute of Cardiology · COInstituto Nacional de Cancerología · COJewish General Hospital · CAJohns Hopkins University · USMedical University of Vienna · ATMoffitt Cancer Center · USUniversity of Virginia Health System · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Among women aged 27-45 years, the quadrivalent human papillomavirus (qHPV; HPV6/11/16/18) vaccine was generally well tolerated, efficacious, and immunogenic in the placebo-controlled FUTURE III study (NCT00090220; n = 3253). The qHPV vaccine was also generally well tolerated and highly immunogenic in men aged 27-45 years who participated in the single-cohort mid-adult male (MAM) study (NCT01432574; n = 150). Here, we report results of a long-term follow up (LTFU) extension of FUTURE III with up to 10 years follow-up. To understand the relevance of the mid-adult women LTFU study in the context of mid-adult men vaccination, we report results from post-hoc, cross-study immunogenicity analyses conducted to compare immunogenicity (geometric mean titers; GMTs) at 1-month post-qHPV vaccine dose 3 in women and men aged 27-45 years versus women and men aged 16-26 years from prior efficacy studies. The qHPV vaccine demonstrated durable protection against the combined endpoint of HPV6/11/16/18-related high-grade cervical dysplasia and genital warts up to 10 years (median 8.9) post-dose 3 and sustained HPV6/11/16/18 antibody responses through approximately 10 years in women aged 27-45 years. Efficacy of qHPV vaccine in men aged 27-45 years was inferred based on the cross-study analysis of qHPV vaccine immunogenicity demonstrating non-inferior HPV6/11/16/18 antibody responses in men aged 27-45 years versus 16-26 years. In conclusion, durable effectiveness of the qHPV vaccine was demonstrated in women 27-45 years of age, and vaccine efficacy was inferred in men 27-45 years of age based on the serological results.

Indexed as

Papillomavirus InfectionsPapillomavirus VaccinesAdultAntibodies, ViralClinical Studies as TopicFemaleHuman Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18HumansImmunogenicity, VaccineMaleMiddle AgedPapillomaviridaeVaccines, CombinedAntibodies, ViralHuman Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18Papillomavirus VaccinesVaccines, Combinedclinical trialeffectivenesshuman papillomavirusimmunogenicitymid-adult personsqHPV vaccine

Identifiers

PMID35853188
PMCPMC9481115
OpenAlexW4286219234

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.