Evidence map›Paper›PMID 21148531›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2011

Trivalent inactivated influenza vaccine in African adults infected with human immunodeficient virus: double blind, randomized clinical trial of efficacy, immunogenicity, and safety.

Shabir A Madhi, Mhairi Maskew, Anthonet Koen, Locadiah Kuwanda, Terry G Besselaar, Dhamari Naidoo, Cheryl Cohen, Martine Valette, Clare L Cutland, Ian Sanne

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00757900 (Efficacy of Influenza Vaccine in HIV Infected Adults), which is not on this map. Cited by 40 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
40citing papers in PubMed, 3 pooled it
4.7field-weighted citation impact, top 5% 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.

NCT00757900 phase4completednot on this map

Efficacy of Influenza Vaccine in HIV Infected Adults

TypeinterventionalSponsorUniversity of Witwatersrand, South AfricaRan2008 to 2008Enrolled507ConditionsHIV, Influenza, Vaccination, HIV InfectionsArmsMUTAGRIP
3 · Its place in the literature

Who cites it

40 citing papers in PubMed, 3 syntheses or guidelines pooled it, 94 citations in OpenAlex.

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  20. Impact of Human Immunodeficiency Virus on the Burden and Severity of Influenza Illness in Malawian Adults: A Prospective Cohort and Parallel Case-Control Study.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2018
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors at 5 institutions in 2 countries.

Shabir A MadhiDepartment of Science and Technology/ National Research Foundation, Vaccine Preventable Diseases, University of Witwatersrand, South Africa. madhis@rmpru.co.za
Mhairi Maskew
Anthonet Koen
Locadiah Kuwanda
Terry G Besselaar
Dhamari Naidoo
Cheryl Cohen
Martine Valette
Clare L Cutland
Ian Sanne
University of the Witwatersrand · ZANational Health Laboratory Service · ZAHospices Civils de Lyon · FRNational Research Foundation · ZARespiratory and Meningeal Pathogens Research Unit · ZA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundData on the efficacy of trivalent, inactivated influenza vaccine (TIV) in HIV-infected adults, particularly in Africa, are limited. This study evaluated the safety, immunogenicity, and efficacy of TIV in HIV-infected adults.

methodsIn Johannesburg, South Africa, we undertook a randomized, double-blind, placebo-controlled trial involving 506 HIV-infected adults. Subjects included 157 individuals who were antiretroviral treatment (ART) naive and 349 on stable-ART. Participants were randomly assigned to receive TIV or normal saline intramuscularly. Oropharyngeal swabs were obtained at illness visits during the influenza season and tested by shell vial culture and RT PCR assay for influenza virus. Immune response was evaluated by hemagglutinin antibody inhibition assay (HAI) in a nested cohort. The primary study outcome involved vaccine efficacy against influenza confirmed illness. This trial is registered with ClinicalTrials.gov, number NCT00757900.

resultsThe efficacy of TIV against confirmed influenza illness was 75.5% (95% CI: 9.2%-95.6%); with a risk difference of 0.18 per 100 person-weeks in TIV recipients. Among TIV recipients, seroconversion, measured by HAI titers, was evident in 52.6% for H1N1, 60.8% for H3N2, and 53.6% for influenza B virus. This compared with 2.2%, 2.2%, and 4.4% of placebo recipients (P < .0001). The frequency of local and systemic adverse events post-immunization was similar between study groups.

conclusionsTIV immunization is safe and efficacious in African HIV-infected adults without underlying co-morbidities. Further evaluation of effectiveness is warranted in severely immunocompromized HIV-infected adults and those with co-morbidities such as tuberculosis.

Indexed as

AdolescentAdultAntibodies, ViralAnti-HIV AgentsAntiretroviral Therapy, Highly ActiveDouble-Blind MethodFemaleHemagglutination Inhibition TestsHIV InfectionsHumansInfluenza A Virus, H1N1 SubtypeInfluenza A Virus, H3N2 SubtypeInfluenza B virusInfluenza, HumanInfluenza VaccinesMaleAntibodies, ViralAnti-HIV AgentsInfluenza VaccinesPlacebosRNA, ViralVaccines, Inactivated

Identifiers

PMID21148531
OpenAlexW1967114815

What OpenQuestion holds

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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.