Phase 4 randomized trial of intradermal low-antigen-content inactivated influenza vaccine versus standard-dose intramuscular vaccine in HIV-1-infected adults.
Identifieur interne : 000139 ( PubMed/Curation ); précédent : 000138; suivant : 000140Phase 4 randomized trial of intradermal low-antigen-content inactivated influenza vaccine versus standard-dose intramuscular vaccine in HIV-1-infected adults.
Auteurs : Filippo Ansaldi [Italie] ; Laura Valle ; Daniela De Florentiis ; Valentina Parodi ; Giuseppe Murdaca ; Bianca Bruzzone ; Paolo Durando ; Maurizio Setti ; Giancarlo IcardiSource :
- Human vaccines & immunotherapeutics [ 2164-554X ] ; 2012.
Descripteurs français
- KwdFr :
- ARN viral (sang), Adulte, Adulte d'âge moyen, Anticorps antiviraux (sang), Antigènes viraux (administration et posologie), Antigènes viraux (immunologie), Effets secondaires indésirables des médicaments (épidémiologie), Femelle, Humains, Infections à VIH (immunologie), Injections intradermiques, Injections musculaires, Mâle, Numération des lymphocytes CD4, Sous-type H1N1 du virus de la grippe A (immunologie), Sous-type H2N2 du virus de la grippe A (immunologie), Tests d'inhibition de l'hémagglutination, Vaccins antigrippaux (administration et posologie), Vaccins antigrippaux (effets indésirables), Vaccins antigrippaux (immunologie), Vaccins inactivés (administration et posologie), Vaccins inactivés (effets indésirables), Vaccins inactivés (immunologie), Virus influenza B (immunologie).
- MESH :
- administration et posologie : Antigènes viraux, Vaccins antigrippaux, Vaccins inactivés.
- effets indésirables : Vaccins antigrippaux, Vaccins inactivés.
- immunologie : Antigènes viraux, Infections à VIH, Sous-type H1N1 du virus de la grippe A, Sous-type H2N2 du virus de la grippe A, Vaccins antigrippaux, Vaccins inactivés, Virus influenza B.
- sang : ARN viral, Anticorps antiviraux.
- épidémiologie : Effets secondaires indésirables des médicaments.
- Adulte, Adulte d'âge moyen, Femelle, Humains, Injections intradermiques, Injections musculaires, Mâle, Numération des lymphocytes CD4, Tests d'inhibition de l'hémagglutination.
English descriptors
- KwdEn :
- Adult, Antibodies, Viral (blood), Antigens, Viral (administration & dosage), Antigens, Viral (immunology), CD4 Lymphocyte Count, Drug-Related Side Effects and Adverse Reactions (epidemiology), Female, HIV Infections (immunology), Hemagglutination Inhibition Tests, Humans, Influenza A Virus, H1N1 Subtype (immunology), Influenza A Virus, H2N2 Subtype (immunology), Influenza B virus (immunology), Influenza Vaccines (administration & dosage), Influenza Vaccines (adverse effects), Influenza Vaccines (immunology), Injections, Intradermal, Injections, Intramuscular, Male, Middle Aged, RNA, Viral (blood), Vaccines, Inactivated (administration & dosage), Vaccines, Inactivated (adverse effects), Vaccines, Inactivated (immunology).
- MESH :
- chemical , administration & dosage : Antigens, Viral, Influenza Vaccines, Vaccines, Inactivated.
- chemical , adverse effects : Influenza Vaccines, Vaccines, Inactivated.
- chemical , blood : Antibodies, Viral, RNA, Viral.
- chemical , immunology : Antigens, Viral, Influenza Vaccines, Vaccines, Inactivated.
- epidemiology : Drug-Related Side Effects and Adverse Reactions.
- immunology : HIV Infections, Influenza A Virus, H1N1 Subtype, Influenza A Virus, H2N2 Subtype, Influenza B virus.
- Adult, CD4 Lymphocyte Count, Female, Hemagglutination Inhibition Tests, Humans, Injections, Intradermal, Injections, Intramuscular, Male, Middle Aged.
Abstract
This study evaluated safety, tolerability and immunogenicity of intradermal (ID) trivalent inactivated split influenza vaccine, with a lower antigen content (9 mcg HA per strain) than the conventional intramuscular one (15 mcg), in HIV-1-infected adults younger than 60 years. A total of 54 HIV-1-positive participants were enrolled and randomly assigned to receive a single dose of either ID-administered low-antigen-content split inactivated vaccine or intramuscularly-administered (IM) standard-dose inactivated split vaccine. Subjects were provided with a diary to monitor any local and/or systemic reactions to the vaccine for 7 days following vaccination. Serum samples were collected before, 28 days and 90 days after immunization. The plasma HIV-RNA and CD4+ T-lymphocyte count were checked at day 0 and day 90. Serum hemagglutination-inhibition (HI) activity for the three influenza strains included in the vaccine composition was measured to assess the antibody response at one month and 3 months after vaccination. Both vaccines showed optimal safety and tolerability profiles. All the three Committee for Medicinal Products for Human Use immunogenicity criteria for vaccine approval in adults younger than 60 were met by both vaccines against A(H1N1) and A(H3N2) viruses. Both vaccines met mean-fold-increase and seroprotection criteria but failed seroconversion criteria against B virus. No difference in terms of post-vaccination geometric mean titers, mean fold increase, seroprotection and seroconversion rates were found comparing ID and IM vaccines. In conclusion, the recently available low-antigen-content ID vaccine is safe, well-tolerated and as immunogenic as IM standard-dose influenza vaccine.
DOI: 10.4161/hv.20347
PubMed: 22832261
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virus de la grippe A</term><term>Vaccins antigrippaux</term><term>Vaccins inactivés</term><term>Virus influenza B</term></keywords><keywords scheme="MESH" qualifier="immunology" xml:lang="en"><term>HIV Infections</term><term>Influenza A Virus, H1N1 Subtype</term><term>Influenza A Virus, H2N2 Subtype</term><term>Influenza B virus</term></keywords><keywords scheme="MESH" qualifier="sang" xml:lang="fr"><term>ARN viral</term><term>Anticorps antiviraux</term></keywords><keywords scheme="MESH" qualifier="épidémiologie" xml:lang="fr"><term>Effets secondaires indésirables des médicaments</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adult</term><term>CD4 Lymphocyte Count</term><term>Female</term><term>Hemagglutination Inhibition Tests</term><term>Humans</term><term>Injections, Intradermal</term><term>Injections, Intramuscular</term><term>Male</term><term>Middle Aged</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Adulte</term><term>Adulte d'âge moyen</term><term>Femelle</term><term>Humains</term><term>Injections intradermiques</term><term>Injections musculaires</term><term>Mâle</term><term>Numération des lymphocytes CD4</term><term>Tests d'inhibition de l'hémagglutination</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">This study evaluated safety, tolerability and immunogenicity of intradermal (ID) trivalent inactivated split influenza vaccine, with a lower antigen content (9 mcg HA per strain) than the conventional intramuscular one (15 mcg), in HIV-1-infected adults younger than 60 years. A total of 54 HIV-1-positive participants were enrolled and randomly assigned to receive a single dose of either ID-administered low-antigen-content split inactivated vaccine or intramuscularly-administered (IM) standard-dose inactivated split vaccine. Subjects were provided with a diary to monitor any local and/or systemic reactions to the vaccine for 7 days following vaccination. Serum samples were collected before, 28 days and 90 days after immunization. The plasma HIV-RNA and CD4+ T-lymphocyte count were checked at day 0 and day 90. Serum hemagglutination-inhibition (HI) activity for the three influenza strains included in the vaccine composition was measured to assess the antibody response at one month and 3 months after vaccination. Both vaccines showed optimal safety and tolerability profiles. All the three Committee for Medicinal Products for Human Use immunogenicity criteria for vaccine approval in adults younger than 60 were met by both vaccines against A(H1N1) and A(H3N2) viruses. Both vaccines met mean-fold-increase and seroprotection criteria but failed seroconversion criteria against B virus. No difference in terms of post-vaccination geometric mean titers, mean fold increase, seroprotection and seroconversion rates were found comparing ID and IM vaccines. In conclusion, the recently available low-antigen-content ID vaccine is safe, well-tolerated and as immunogenic as IM standard-dose influenza vaccine.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">22832261</PMID><DateCompleted><Year>2013</Year><Month>05</Month><Day>15</Day></DateCompleted><DateRevised><Year>2018</Year><Month>11</Month><Day>13</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">2164-554X</ISSN><JournalIssue CitedMedium="Internet"><Volume>8</Volume><Issue>8</Issue><PubDate><Year>2012</Year><Month>Aug</Month></PubDate></JournalIssue><Title>Human vaccines & immunotherapeutics</Title><ISOAbbreviation>Hum Vaccin Immunother</ISOAbbreviation></Journal><ArticleTitle>Phase 4 randomized trial of intradermal low-antigen-content inactivated influenza vaccine versus standard-dose intramuscular vaccine in HIV-1-infected adults.</ArticleTitle><Pagination><MedlinePgn>1048-52</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.4161/hv.20347</ELocationID><Abstract><AbstractText>This study evaluated safety, tolerability and immunogenicity of intradermal (ID) trivalent inactivated split influenza vaccine, with a lower antigen content (9 mcg HA per strain) than the conventional intramuscular one (15 mcg), in HIV-1-infected adults younger than 60 years. A total of 54 HIV-1-positive participants were enrolled and randomly assigned to receive a single dose of either ID-administered low-antigen-content split inactivated vaccine or intramuscularly-administered (IM) standard-dose inactivated split vaccine. Subjects were provided with a diary to monitor any local and/or systemic reactions to the vaccine for 7 days following vaccination. Serum samples were collected before, 28 days and 90 days after immunization. The plasma HIV-RNA and CD4+ T-lymphocyte count were checked at day 0 and day 90. Serum hemagglutination-inhibition (HI) activity for the three influenza strains included in the vaccine composition was measured to assess the antibody response at one month and 3 months after vaccination. Both vaccines showed optimal safety and tolerability profiles. All the three Committee for Medicinal Products for Human Use immunogenicity criteria for vaccine approval in adults younger than 60 were met by both vaccines against A(H1N1) and A(H3N2) viruses. Both vaccines met mean-fold-increase and seroprotection criteria but failed seroconversion criteria against B virus. No difference in terms of post-vaccination geometric mean titers, mean fold increase, seroprotection and seroconversion rates were found comparing ID and IM vaccines. In conclusion, the recently available low-antigen-content ID vaccine is safe, well-tolerated and as immunogenic as IM standard-dose influenza vaccine.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Ansaldi</LastName><ForeName>Filippo</ForeName><Initials>F</Initials><AffiliationInfo><Affiliation>I.R.C.C.S. "A.O.U. San Martino-IST"; Genoa, Italy. filippo.ansaldi@unige.it</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Valle</LastName><ForeName>Laura</ForeName><Initials>L</Initials></Author><Author ValidYN="Y"><LastName>de Florentiis</LastName><ForeName>Daniela</ForeName><Initials>D</Initials></Author><Author ValidYN="Y"><LastName>Parodi</LastName><ForeName>Valentina</ForeName><Initials>V</Initials></Author><Author ValidYN="Y"><LastName>Murdaca</LastName><ForeName>Giuseppe</ForeName><Initials>G</Initials></Author><Author ValidYN="Y"><LastName>Bruzzone</LastName><ForeName>Bianca</ForeName><Initials>B</Initials></Author><Author ValidYN="Y"><LastName>Durando</LastName><ForeName>Paolo</ForeName><Initials>P</Initials></Author><Author ValidYN="Y"><LastName>Setti</LastName><ForeName>Maurizio</ForeName><Initials>M</Initials></Author><Author ValidYN="Y"><LastName>Icardi</LastName><ForeName>Giancarlo</ForeName><Initials>G</Initials></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D017429">Clinical Trial, Phase IV</PublicationType><PublicationType UI="D003160">Comparative Study</PublicationType><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2012</Year><Month>08</Month><Day>01</Day></ArticleDate></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>Hum Vaccin Immunother</MedlineTA><NlmUniqueID>101572652</NlmUniqueID><ISSNLinking>2164-5515</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D000914">Antibodies, Viral</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D000956">Antigens, Viral</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D007252">Influenza Vaccines</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D012367">RNA, Viral</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D015164">Vaccines, Inactivated</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D000328" MajorTopicYN="N">Adult</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000914" MajorTopicYN="N">Antibodies, Viral</DescriptorName><QualifierName UI="Q000097" MajorTopicYN="N">blood</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D000956" MajorTopicYN="N">Antigens, Viral</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName><QualifierName UI="Q000276" MajorTopicYN="N">immunology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D018791" MajorTopicYN="N">CD4 Lymphocyte Count</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D064420" MajorTopicYN="N">Drug-Related Side Effects and Adverse Reactions</DescriptorName><QualifierName UI="Q000453" MajorTopicYN="N">epidemiology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D015658" MajorTopicYN="N">HIV Infections</DescriptorName><QualifierName UI="Q000276" MajorTopicYN="Y">immunology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D006385" MajorTopicYN="N">Hemagglutination Inhibition Tests</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D053118" MajorTopicYN="N">Influenza A Virus, H1N1 Subtype</DescriptorName><QualifierName UI="Q000276" MajorTopicYN="N">immunology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D053121" MajorTopicYN="N">Influenza A Virus, H2N2 Subtype</DescriptorName><QualifierName UI="Q000276" MajorTopicYN="N">immunology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D009981" MajorTopicYN="N">Influenza B virus</DescriptorName><QualifierName UI="Q000276" MajorTopicYN="N">immunology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D007252" MajorTopicYN="N">Influenza Vaccines</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName><QualifierName UI="Q000009" MajorTopicYN="Y">adverse effects</QualifierName><QualifierName UI="Q000276" MajorTopicYN="Y">immunology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D007271" MajorTopicYN="N">Injections, Intradermal</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D007273" MajorTopicYN="N">Injections, Intramuscular</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D012367" MajorTopicYN="N">RNA, Viral</DescriptorName><QualifierName UI="Q000097" MajorTopicYN="N">blood</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D015164" MajorTopicYN="N">Vaccines, Inactivated</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName><QualifierName UI="Q000276" MajorTopicYN="N">immunology</QualifierName></MeshHeading></MeshHeadingList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="entrez"><Year>2012</Year><Month>7</Month><Day>27</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2012</Year><Month>7</Month><Day>27</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2013</Year><Month>5</Month><Day>17</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">22832261</ArticleId><ArticleId IdType="pii">20347</ArticleId><ArticleId IdType="doi">10.4161/hv.20347</ArticleId><ArticleId IdType="pmc">PMC3551875</ArticleId></ArticleIdList><ReferenceList><Reference><Citation>Lancet. 1992 Jun 20;339(8808):1549</Citation><ArticleIdList><ArticleId IdType="pubmed">1351231</ArticleId></ArticleIdList></Reference><Reference><Citation>Vaccine. 2011 Nov 15;29(49):9209-13</Citation><ArticleIdList><ArticleId IdType="pubmed">21974995</ArticleId></ArticleIdList></Reference><Reference><Citation>J Clin Invest. 1993 Dec;92(6):2587-96</Citation><ArticleIdList><ArticleId 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