Evidence map›Paper›PMID 19237568›Full record

Trial reportProceedings of the National Academy of Sciences of the United States of America2009

Adjuvanted H5N1 vaccine induces early CD4+ T cell response that predicts long-term persistence of protective antibody levels.

Grazia Galli, Duccio Medini, Erica Borgogni, Luisanna Zedda, Monia Bardelli, Carmine Malzone, Sandra Nuti, Simona Tavarini, Chiara Sammicheli, Anne K Hilbert and 5 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Proceedings of the National Academy of Sciences of the United States of America, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00382187 (A Phase II, Randomized, Controlled, Observer-blind, Single-Center Study to Evaluate Safety and Immunogenicity of Two Doses, Administered Three Weeks Apart, and a Six Month Booster Dose of Two Surface Antigen Adjuvanted With MF59C.1 Influenza Vaccines Containing 7.5 Micrograms or 15 Micrograms of A/H5N1 Influenza Antigen and of a Non-adjuvanted Influenza Vaccine Containing 15 Micrograms of A/H5N1 Influenza Antigen, in Adults), which is not on this map. Cited by 126 papers.

0numbers the graph read from it
0cells of the map it votes in
126citing papers in PubMed
18.3field-weighted citation impact, top 1% 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.

NCT00382187 phase2completednot on this map

A Phase II, Randomized, Controlled, Observer-blind, Single-Center Study to Evaluate Safety and Immunogenicity of Two Doses, Administered Three Weeks Apart, and a Six Month Booster Dose of Two Surface Antigen Adjuvanted With MF59C.1 Influenza Vaccines Containing 7.5 Micrograms or 15 Micrograms of A/H5N1 Influenza Antigen and of a Non-adjuvanted Influenza Vaccine Containing 15 Micrograms of A/H5N1 Influenza Antigen, in Adults

TypeinterventionalSponsorNovartis VaccinesRan2006 to 2008Enrolled40ConditionsInfluenzaArmsMF59 adjuvanted H5N1 influenza vaccine
3 · Its place in the literature

Who cites it

126 citing papers in PubMed, 257 citations in OpenAlex.

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  5. HCMV glycoprotein B subunit vaccine efficacy mediated by nonneutralizing antibody effector functions.Proceedings of the National Academy of Sciences of the United States of America · 2018
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66 more citing papers are in PubMed but not listed here.

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

15 authors at 2 institutions in 2 countries.

Grazia GalliResearch Center, Novartis Vaccines and Diagnostics, Via Fiorentina 1, Siena 53100, Italy.
Duccio Medini
Erica Borgogni
Luisanna Zedda
Monia Bardelli
Carmine Malzone
Sandra Nuti
Simona Tavarini
Chiara Sammicheli
Anne K Hilbert
Volker Brauer
Angelika Banzhoff
Rino Rappuoli
Giuseppe Del Giudice
Flora Castellino
Novartis (Italy) · ITNovartis (Germany) · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Immune responses to vaccination are tested in clinical trials. This process usually requires years especially when immune memory and persistence are analyzed. Markers able to quickly predict the immune response would be very useful, particularly when dealing with emerging diseases that require a rapid response, such as avian influenza. To address this question we vaccinated healthy adults at days 1, 22, and 202 with plain or MF59-adjuvanted H5N1 subunit vaccines and tested both cell-mediated and antibody responses up to day 382. Only the MF59-H5N1 vaccine induced high titers of neutralizing antibodies, a large pool of memory H5N1-specific B lymphocytes, and H5-CD4(+) T cells broadly reactive with drifted H5. The CD4(+) response was dominated by IL-2(+) IFN-gamma(-) IL-13(-) T cells. Remarkably, a 3-fold increase in the frequency of virus-specific total CD4(+) T cells, measurable after 1 dose, accurately predicted the rise of neutralizing antibodies after booster immunization and their maintenance 6 months later. We suggest that CD4(+) T cell priming might be used as an early predictor of the immunogenicity of prepandemic vaccines.

Indexed as

Adjuvants, ImmunologicAdultAntibodies, ViralAntibody FormationCD4-Positive T-LymphocytesCell ProliferationDose-Response Relationship, ImmunologicHumansImmunologic MemoryInfluenza A Virus, H5N1 SubtypeInfluenza VaccinesNeutralization TestsPhenotypePolysorbatesSqualeneTh1 CellsAdjuvants, ImmunologicAntibodies, ViralInfluenza VaccinesMF59 oil emulsionPolysorbatesSqualene

Identifiers

PMID19237568
PMCPMC2646626
OpenAlexW1965145857

What OpenQuestion holds

Textmetadata
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.