Evidence map›Paper›PMID 29269325›Full record

Trial reportPapillomavirus research (Amsterdam, Netherlands)2018

Efficacy, immunogenicity, and safety of a 9-valent human papillomavirus vaccine in Latin American girls, boys, and young women.

Ángela María Ruiz-Sternberg, Edson D Moreira, Jaime A Restrepo, Eduardo Lazcano-Ponce, Robinson Cabello, Arnaldo Silva, Rosires Andrade, Francisco Revollo, Santos Uscanga, Alejandro Victoria and 14 more

Open access · goldAbstract readClinical Trial, Phase IIClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in Papillomavirus research (Amsterdam, Netherlands), 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 1 pooled it
1.6field-weighted citation impact, top 16% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 1 synthesis or guideline 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

24 authors at 15 institutions in 6 countries.

Ángela María Ruiz-SternbergClinical Research Group, Universidad del Rosario, Bogotá, Colombia. Electronic address: angela.ruiz@urosario.edu.co.
Edson D MoreiraAssociação Obras Sociais Irmã Dulce and Oswaldo Cruz Foundation, Brazilian Ministry of Health, Bahia, Brazil.
Jaime A RestrepoFoundation Clinical Research Center CIC, Medellín, Colombia.
Eduardo Lazcano-PonceResearch Center on Public Health, National Institute of Public Health, Cuernavaca, Morelos, Mexico.
Robinson CabelloVia Libre Association, Lima, Peru.
Arnaldo SilvaHospital Nacional Arzobispo Loayza, Lima, Peru.
Rosires AndradeDepartamento de Tocoginecologia da Universidade Federal do Paraná, Curitiba, Brazil.
Francisco RevolloCentro de Investigaciones, Hospital Universitario San Ignacio, Bogotá, Colombia.
Santos UscangaArké Estudios Clínicos S.A. de C.V., Mexico City, Mexico.
Alejandro VictoriaDepartment of Obstetrics and Gynecology, Fundacion Valle del Lili, Cali, Colombia.
Ana María GuevaraResearch Unit, Pablo Tobon Uribe Hospital, Medellin, Colombia.
Joaquín LunaDepartamento de Ginecología y Obstetricia Clínica Colsanitas, Fundación Universitaria Sanitas, Bogotá, Colombia.
Manuel PlataDepartment of Gynecology, Fundación Cardioinfantil, Bogotá, Colombia.
Claudia Nossa DominguezCAFAM, Bogotá, Colombia.
Edison FedrizziDepartment of Gynecology and Obstetrics, University of Santa Catarina, Florianópolis, Santa Catarina, Brazil.
Eugenio SuarezGynecological Oncology Division Hospital Clinico San Borja Arriaran Universidad de Chile Campus Centro, Santiago, Chile.
Julio C ReinaDepartment of Pediatrics, Universidad del Valle and Centro Medico Imbanaco, Cali, Colombia.
Misoo C EllisonMerck & Co., Inc., Kenilworth, NJ, USA.
Erin MoellerMerck & Co., Inc., Kenilworth, NJ, USA.
Michael RitterMerck & Co., Inc., Kenilworth, NJ, USA.
Christine ShieldsMerck & Co., Inc., Kenilworth, NJ, USA.
Miguel CashatMerck & Co., Inc., Kenilworth, NJ, USA.
Gonzalo PerezMerck & Co., Inc., Kenilworth, NJ, USA.
Alain LuxembourgMerck & Co., Inc., Kenilworth, NJ, USA.
Merck & Co., Inc., Rahway, NJ, USA (United States) · USFundação Oswaldo Cruz · BRFundación Universitaria Cafam · COFundación Universitaria Sanitas · COFundación Valle del Lili · COHospital Pablo Tobon Uribe · COHospital San Borja Arriarán · CLHospital Universitario San Ignacio · COInstitute of Cardiology · COInstituto Nacional de Salud Pública · MXUniversidad del Rosario · COUniversidad del Valle · COUniversidade Federal de Santa Catarina · BRUniversidade Federal do Paraná · BRVia Libre · PE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundA 9-valent human papillomavirus (HPV6/11/16/18/31/33/45/52/58; 9vHPV) vaccine was developed to expand coverage of the previously developed quadrivalent (HPV6/11/16/18; qHPV) vaccine.

methodsEfficacy, immunogenicity, and safety outcomes were assessed in Latin American participants enrolled in 2 international studies of the 9vHPV vaccine, including a randomized, double-blinded, controlled with qHPV vaccine, efficacy, immunogenicity, and safety study in young women aged 16-26 years, and an immunogenicity and safety study in girls and boys aged 9-15 years. Participants (N=5312) received vaccination at Day 1, Month 2, and Month 6. Gynecological swabs were collected regularly in young women for cytological and HPV DNA testing. Serum was analyzed for HPV antibodies in all participants. Adverse events (AEs) were also monitored in all participants.

resultsThe 9vHPV vaccine prevented HPV 31-, 33-, 45-, 52-, and 58-related high-grade cervical, vulvar, and vaginal dysplasia with 92.3% efficacy (95% confidence interval 54.4, 99.6). Anti-HPV6, 11, 16, and 18 geometric mean titers at Month 7 were similar in the 9vHPV and qHPV vaccination groups. Anti-HPV antibody responses following vaccination were higher among girls and boys than in young women. Most (>99%) 9vHPV vaccine recipients seroconverted for all 9 HPV types at Month 7. Antibody responses to the 9 HPV types persisted over 5 years. The most common AEs were injection-site related, mostly of mild to moderate intensity.

conclusionsThe 9vHPV vaccine is efficacious, immunogenic, and well tolerated in Latin American young women, girls, and boys. These data support 9vHPV vaccination programs in Latin America, a region with substantial cervical cancer burden.

Indexed as

Immunogenicity, VaccineAdolescentAdultAntibodies, ViralChildDNA, ViralDouble-Blind MethodFemaleHispanic or LatinoHumansLatin AmericaMalePapillomaviridaePapillomavirus InfectionsPapillomavirus VaccinesSeroconversionAntibodies, ViralDNA, ViralPapillomavirus Vaccines9vHPVCervical cancerHuman papillomavirusPersistent infectionVaccine

Identifiers

PMID29269325
PMCPMC5887018
OpenAlexW2775918433

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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Registered trials

None linked

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.