Evidence map›Paper›PMID 26486702›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2016

Randomized Controlled Trial to Compare Immunogenicity of Standard-Dose Intramuscular Versus Intradermal Trivalent Inactivated Influenza Vaccine in HIV-Infected Men Who Have Sex With Men in Bangkok, Thailand.

Shikha Garg, Prasert Thongcharoen, Prabda Praphasiri, Anupong Chitwarakorn, Pornchai Sathirapanya, Stefan Fernandez, Kamonthip Rungrojcharoenkit, Wannee Chonwattana, Philip A Mock, Wichuda Sukwicha and 7 more

Registry-linked trialOpen access · bronzeAbstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01538940 (Randomized Controlled Trial to Compare the Immunogenicity of Intramuscular Versus Intradermal Trivalent Inactivated Split Virion Influenza Vaccine in HIV-infected Men Who Have Sex With Men in Bangkok, Thailand), which is not on this map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
0.7field-weighted citation impact, top 26% 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.

NCT01538940 phase4completednot on this map

Randomized Controlled Trial to Compare the Immunogenicity of Intramuscular Versus Intradermal Trivalent Inactivated Split Virion Influenza Vaccine in HIV-infected Men Who Have Sex With Men in Bangkok, Thailand

TypeinterventionalSponsorCenters for Disease Control and PreventionRan2011 to 2015Enrolled415ConditionsInfluenzaArmsIntradermal vaccine, Intramuscular vaccine
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 16 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. Article
  6. Review
  7. Review
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 at 5 institutions in 2 countries.

Shikha GargDivision of HIV/AIDS Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention.
Prasert ThongcharoenSirirajHospital, Bangkok, Thailand.
Prabda PraphasiriThailand Ministry of Public Health-US CDC Collaboration, Centers for Disease Control and Prevention.
Anupong ChitwarakornDepartment of Disease Control, Ministry of Public Health, Nonthaburi.
Pornchai SathirapanyaSirirajHospital, Bangkok, Thailand.
Stefan FernandezArmed Forces Research Institute of Medical Sciences.
Kamonthip RungrojcharoenkitArmed Forces Research Institute of Medical Sciences.
Wannee ChonwattanaThailand Ministry of Public Health-US CDC Collaboration, Centers for Disease Control and Prevention.
Philip A MockThailand Ministry of Public Health-US CDC Collaboration, Centers for Disease Control and Prevention.
Wichuda SukwichaThailand Ministry of Public Health-US CDC Collaboration, Centers for Disease Control and Prevention.
Jacqueline M KatzInfluenza Division, Centers for Disease Control and Prevention, Atlanta, Georgia.
Marc-Alain WiddowsonInfluenza Division, Centers for Disease Control and Prevention, Atlanta, Georgia.
Marcel E CurlinDivision of HIV/AIDS Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention.
Robert V GibbonsArmed Forces Research Institute of Medical Sciences.
Timothy H HoltzDivision of HIV/AIDS Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention.
Fatimah S DawoodInfluenza Division, Centers for Disease Control and Prevention, Atlanta, Georgia.
Sonja J OlsenInfluenza Division, Centers for Disease Control and Prevention, Atlanta, Georgia.
Centers for Disease Control and Prevention · USMinistry of Public Health · THArmed Forces Research Institute of Medical Science · THNational Center for HIV/AIDS Viral Hepatitis STD and TB Prevention · USSiriraj Hospital · TH

Funding

ACL HHS U01GH000152CGH CDC HHS 5U01GH000152CGH CDC HHS U01 GH000152Intramural CDC HHS CC999999
6 · The paper itself

Abstract

backgroundIndividuals infected with human immunodeficiency virus (HIV) are at increased risk for severe influenza, yet immune responses to standard-dose intramuscular (IM) influenza vaccine are suboptimal in this population. Intradermal (ID) delivery of influenza vaccine might improve immune response through enhanced stimulation of dendritic cells.

methodsWe conducted a randomized, double-blind, controlled trial to compare the immunogenicity of off-label standard-dose (15 µg) ID vs standard-dose (15 µg) IM inactive influenza vaccine in HIV-infected men in Bangkok, Thailand. The primary study outcome was seroconversion (minimum titer of 1:40 and ≥4-fold rise in antibody titer) at 1 month postvaccination based on serum hemagglutination inhibition antibody titers against each vaccine strain. Adverse events (AEs) in the 7 days following vaccination were also assessed.

resultsWe enrolled 400 HIV-infected participants; 200 were randomly assigned to receive IM and 200 ID vaccine. Vaccine arms were well-balanced with respect to age, CD4 cell count, HIV RNA load, and antiretroviral treatment. Percentage of seroconversion to all (ID 14% vs IM 15%; P = .8) or at least 1 (ID 69% vs IM 68%; P = .7) of the 3 vaccine strains did not differ significantly between ID vs IM vaccine recipients. A higher proportion of participants who received ID vaccine had mild injection-site AEs compared with participants who received IM vaccine (77% vs 27%).

conclusionsThere were no significant differences in the immunogenicity of standard-dose ID vs IM influenza vaccine in this HIV-infected population in Thailand. Additional strategies to enhance immune responses to influenza vaccine among HIV-infected persons are needed. CLINICAL TRIALS REGISTRATION: NCT01538940.

Indexed as

Homosexuality, MaleAdolescentAdultAntibodies, ViralDouble-Blind MethodDrug-Related Side Effects and Adverse ReactionsHemagglutination Inhibition TestsHIV InfectionsHumansInfluenza, HumanInfluenza VaccinesInjections, IntradermalInjections, IntramuscularMaleMiddle AgedThailandAntibodies, ViralInfluenza VaccinesVaccines, InactivatedHIVimmunogenicityinfluenzaintradermalvaccine

Identifiers

PMID26486702
PMCPMC4707082
OpenAlexW2226174505

What OpenQuestion holds

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LicenceTDM
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.