Evidence map›Paper›PMID 23242542›Full record

Trial reportThe Journal of infectious diseases2013

Safety and immunogenicity of human papillomavirus-16/18 AS04-adjuvanted vaccine: a randomized trial in 10-25-year-old HIV-Seronegative African girls and young women.

Papa Salif Sow, Deborah Watson-Jones, Nancy Kiviat, John Changalucha, Khardiata Diallo Mbaye, Joelle Brown, Kouro Bousso, Bazil Kavishe, Aura Andreasen, Macoumba Toure and 7 more

Registry-linked trialAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Journal of infectious diseases, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00481767 (Study to Assess the Immunogenicity and Safety of GlaxoSmithKline), which is not on this map. Cited by 35 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed, 8 pooled it
–field-weighted citation impact
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.

NCT00481767 phase3completednot on this map

Study to Assess the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' HPV Vaccine GSK580299 in Healthy Female Subjects Aged 10-25 Years.

TypeinterventionalSponsorGlaxoSmithKlineRan2007 to 2010Enrolled676ConditionsHuman Papillomavirus (HPV) InfectionArmsCervarix, Placebo Al(OH)3
3 · Its place in the literature

Who cites it

35 citing papers in PubMed, 8 syntheses or guidelines pooled it.

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  7. [Safety of human papillomavirus 6, 11, 16 and 18 (recombinant): systematic review and meta-analysis].Revista paulista de pediatria : orgao oficial da Sociedade de Pediatria de Sao Paulo · 2015
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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

17 authors.

Papa Salif SowCHU Fann, Service des Maladies Infectieuses, Dakar (Fann), Senegal.
Deborah Watson-Jones
Nancy Kiviat
John Changalucha
Khardiata Diallo Mbaye
Joelle Brown
Kouro Bousso
Bazil Kavishe
Aura Andreasen
Macoumba Toure
Saidi Kapiga
Philippe Mayaud
Richard Hayes
Marie Lebacq
Marjan Herazeh
Florence Thomas
Dominique Descamps

Funding

Medical Research Council G0700837Medical Research Council G0901756Wellcome Trust
6 · The paper itself

Abstract

backgroundCervical cancer is a major public health problem for women in sub-Saharan Africa. Availability of a human papillomavirus (HPV) vaccine could have an important public health impact.

methodsIn this phase IIIb, double-blind, randomized, placebo-controlled, multicenter trial (NCT00481767), healthy African girls and young women seronegative for human immunodeficiency virus (HIV) were stratified by age (10-14 or 15-25 years) and randomized (2:1) to receive either HPV-16/18 AS04-adjuvanted vaccine (n = 450) or placebo (n = 226) at 0, 1, and 6 months. The primary objective was to evaluate HPV-16/18 antibody responses at month 7. Seropositivity rates and corresponding geometric mean titers (GMTs) were measured by enzyme-linked immunosorbent assay.

resultsIn the according-to-protocol analysis at month 7, 100% of initially seronegative participants in the vaccine group were seropositive for both anti-HPV-16 and anti-HPV-18 antibodies (n = 130 and n = 128 for 10-14-year-olds, respectively; n = 190 and n = 212 for 15-25-year-olds). GMTs for HPV-16 and HPV-18 were higher in 10-14-year-olds (18 423 [95% confidence interval, 16 185-20 970] and 6487 [5590-7529] enzyme-linked immunosorbent assay units (EU)/mL, respectively) than in 15-25-year-olds (10 683 [9567-11 930] and 3743 [3400-4120] EU/mL, respectively). Seropositivity was maintained at month 12. No participant withdrew owing to adverse events. No vaccine-related serious adverse events were reported.

conclusionsThe HPV-16/18 AS04-adjuvanted vaccine was highly immunogenic and had a clinically acceptable safety profile when administered to healthy HIV-seronegative African girls and young women.

Indexed as

Adjuvants, ImmunologicAdolescentAdultAfrica South of the SaharaAluminum HydroxideAntibodies, ViralChildDouble-Blind MethodDrug-Related Side Effects and Adverse ReactionsEnzyme-Linked Immunosorbent AssayFemaleHuman papillomavirus 16Human papillomavirus 18HumansLipid APapillomavirus InfectionsAdjuvants, ImmunologicAluminum HydroxideAntibodies, ViralASO4 mixtureLipid APapillomavirus VaccinesPlacebos

Identifiers

PMID23242542
PMCPMC3636781

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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.