Evidence map›Paper›PMID 21628666›Full record

Trial reportThe Journal of infectious diseases2011

Safety and immunogenicity of a monovalent 2009 influenza A/H1N1v vaccine adjuvanted with AS03A or unadjuvanted in HIV-infected adults: a randomized, controlled trial.

Odile Launay, Corinne Desaint, Christine Durier, Pierre Loulergue, Xavier Duval, Christine Jacomet, Gilles Pialoux, Jade Ghosn, François Raffi, David Rey and 9 more

Open access · greenAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in The Journal of infectious diseases, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 2 pooled it
5.6field-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.

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

23 citing papers in PubMed, 2 syntheses or guidelines pooled it, 46 citations in OpenAlex.

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  4. Safety and immunogenicity of 2009 pH1N1 vaccination in HIV-infected pregnant women.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2013
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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

19 authors at 11 institutions in 2 countries.

Odile LaunayUniversité Paris Descartes, France. odile.launay@cch.aphp.fr
Corinne Desaint
Christine Durier
Pierre Loulergue
Xavier Duval
Christine Jacomet
Gilles Pialoux
Jade Ghosn
François Raffi
David Rey
Faiza Ajana
Nathalie Colin de Verdière
Jacques Reynes
Valérie Foubert
François Roman
Jeanne-Marie Devaster
Jean-François Delfraissy
Jean-Pierre Aboulker
ANRS 151 HIFLUVAC Study Group and the French Clinical Vaccinology Network (Réseau National d'Investigation Clinique en Vaccinologie REIVAC)
Inserm · FRAssistance Publique – Hôpitaux de Paris · FRGlaxoSmithKline (Belgium) · BEBicêtre Hospital · FRCentre Hospitalier de Tourcoing · FRClinical Investigation Center Plurithematic Tours · FRHôpital Cochin · FRHôpital Gui de Chauliac · FRHôpitaux Universitaires de Strasbourg · FRSorbonne Université · FRUniversité Paris Cité · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundHuman immunodeficiency virus (HIV)-infected patients have decreased immune response to vaccines. Few data are available about pandemic flu vaccination in this population.

methodsWe conducted a multicenter, patient-blinded, randomized trial in a cohort of HIV-infected adults. Patients received 2 injections 21 days apart of a AS03(A)-adjuvanted H1N1v vaccine containing 3.75 μg hemagglutinin (HA) or a nonadjuvanted H1N1v vaccine containing 15 μg HA to assess hemagglutination inhibition (HI) response and safety.

resultsA total of 309 patients were randomized, and 306 were vaccinated. After the first vaccine dose, HI titers ≥1:40 were observed in 93.4% of the patients in the adjuvanted group (A group) (n = 155) and in 75.5% in the nonadjuvanted group (B group) (n = 151) (P < .001); seroconversion rates were 88.8% and 71.2%, and factor increases in geometric mean titers (GMT) of 21.9 and 15.1, respectively. After 2 injections, 98.6% of patients of the A group and 92.1% of the B group demonstrated HI titers ≥1:40 (P = .018); seroconversion rates were 96.5% and 87.1%, respectively, and factor increases in GMT were 45.5 and 21.2, respectively. The majority of adverse events were mild to moderate in severity; no impact on CD4+ cell count or viral load has been detected.

conclusionsIn HIV-1-infected adults, the AS03(A)-adjuvanted H1N1v vaccine yielded a higher immune response than did the nonadjuvanted one, with no impact on HIV infection.

Indexed as

Adjuvants, ImmunologicAdultAntibodies, ViralFemaleHemagglutination Inhibition TestsHIV InfectionsHumansInfluenza A Virus, H1N1 SubtypeInfluenza, HumanInfluenza VaccinesMaleMiddle AgedSqualeneAdjuvants, ImmunologicAntibodies, ViralInfluenza VaccinesSqualene

Identifiers

PMID21628666
PMCPMC3307156
OpenAlexW2110646933

What OpenQuestion holds

Textmetadata
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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.