Evidence map›Paper›PMID 24732325›Full record

ArticleHuman vaccines & immunotherapeutics2014

A dose-ranging study in older adults to compare the safety and immunogenicity profiles of MF59®-adjuvanted and non-adjuvanted seasonal influenza vaccines following intradermal and intramuscular administration.

Giovanni Della Cioppa, Uwe Nicolay, Kelly Lindert, Geert Leroux-Roels, Frédéric Clement, Flora Castellino, Cristina Galli, Nicola Groth, Yotam Levin, Giuseppe Del Giudice

Registry-linked trialOpen access · bronzeAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Human vaccines & immunotherapeutics, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00848848 (A Phase Ib, Multi-Center, Randomized, Observer-Blind, Proof of Concept, Dose- and Formulation-Ranging Study to Evaluate Safety, Tolerability, and Immunogenicity of One Dose of Trivalent Inactivated Influenza Vaccine in Different Presentations), which is not on this map. Cited by 16 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 5 pooled it
1.7field-weighted citation impact, top 16% 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.

NCT00848848 phase1completednot on this map

A Phase Ib, Multi-Center, Randomized, Observer-Blind, Proof of Concept, Dose- and Formulation-Ranging Study to Evaluate Safety, Tolerability, and Immunogenicity of One Dose of Trivalent Inactivated Influenza Vaccine in Different Presentations (Intramuscular and Intradermal Delivery), Dosages (Regular or Higher A/H3N2 Content) and Doses of Adjuvant Administered to Healthy Elderly Aged ≥ 65 Years

TypeinterventionalSponsorSeqirusRan2008 to 2009Enrolled450ConditionsInfluenzaArmsTrivalent Influenza Vaccine, Trivalent Influenza Vaccine + high A, Trivalent Influenza Vaccine + ¼ dose adjuvant, Trivalent Influenza Vaccine + high A + ¼ dose adjuvant, Trivalent Influenza Vaccine + ½ dose adjuvant
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 5 syntheses or guidelines pooled it, 32 citations in OpenAlex.

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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

10 authors at 4 institutions in 3 countries.

Giovanni Della CioppaNovartis Vaccines; Cambridge, MA USA.
Uwe NicolayNovartis Vaccines; Cambridge, MA USA.
Kelly LindertNovartis Vaccines; Cambridge, MA USA.
Geert Leroux-RoelsCentre for Vaccinology; CEVAC; Ghent University and University Hospital; Belgium.
Frédéric ClementCentre for Vaccinology; CEVAC; Ghent University and University Hospital; Belgium.
Flora CastellinoNovartis Vaccines; Cambridge, MA USA.
Cristina GalliNovartis Vaccines; Cambridge, MA USA.
Nicola GrothNovartis Vaccines; Cambridge, MA USA.
Yotam LevinNanoPass Technologies; Nes Ziona, Israel.
Giuseppe Del GiudiceNovartis Vaccines; Cambridge, MA USA.
Novartis (China) · CNGhent University · BEGhent University Hospital · BEIsrael Institute for Biological Research · IL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

unlabelledStrategies to optimize responses to seasonal influenza vaccination in older adults include the use of adjuvants, higher antigen doses, and intradermal delivery. In this study adults aged ≥65 years (n = 450) received a single dose of 1 of 2 non-adjuvanted trivalent influenza vaccine (TIV) formulations administered intradermally (ID), both containing 6 µg of A/H1N1 and B, differing in A/H3N2 content (6 µg or 12 µg), or a single dose of 1 of 8 TIV formulations administered intramuscularly (IM) all containing 15 µg of A/H1N1 and B, differing in A/H3N2 hemagglutinin (HA) content (15 µg or 30 µg) and/or in MF59(®) adjuvant content (0%, 25%, 50%, or 100% of the standard dose). This paper focuses on the comparisons of low-dose non-adjuvanted ID, full-dose non-adjuvanted IM and full-dose MF59-adjuvanted IM formulations (n = 270). At day 22 post-vaccination, at least one European licensure immunogenicity criterion was met by all groups against all 3 strains; however, all three criteria were met against all 3 vaccine strains by the low-dose non-adjuvanted ID and the full-dose MF59-adjuvanted IM groups only. The full-dose MF59-adjuvanted IM group elicited significantly higher immune response vs. the low-dose non-adjuvanted ID formulations for most comparisons. The full-dose MF59 adjuvanted IM groups were associated with increased pain at the site of injection (P<0.01) compared to the ID groups, and the low-dose non-adjuvanted ID groups were associated with increased erythema, induration, and swelling at the injection site (P<0.0001) and unsolicited AEs compared with the IM groups. There were no differences between IM and ID groups in the frequencies of subjects experiencing solicited systemic reactions. Overall, while MF59 adjuvantation increased pain at the site of injection, and intradermal delivery increased unsolicited adverse events, erythema, induration, and swelling at the injection site, both strategies of vaccination strongly enhanced the immunogenicity of seasonal influenza vaccine in older adults compared with conventional non-adjuvanted intramuscular delivery.

trial registrationhttp://www.clinicaltrials.gov: NCT00848848.

Indexed as

Dose-Response Relationship, ImmunologicAdjuvants, ImmunologicAgedAged, 80 and overDrug-Related Side Effects and Adverse ReactionsFemaleHumansInfluenza A Virus, H1N1 SubtypeInfluenza A Virus, H3N2 SubtypeInfluenza B virusInfluenza, HumanInfluenza VaccinesInjections, IntradermalInjections, IntramuscularMalePolysorbatesAdjuvants, ImmunologicInfluenza VaccinesMF59 oil emulsionPolysorbatesSqualeneadjuvantinfluenzaintradermalMF59seasonalvaccine

Identifiers

PMID24732325
PMCPMC5396251
OpenAlexW2053330025

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.