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Phase 4 randomized trial of intradermal low-antigen-content inactivated influenza vaccine versus standard-dose intramuscular vaccine in HIV-1-infected adults.
Hum Vaccin Immunother. 2012 Aug; 8(8):1048-52.HV

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.

Authors+Show Affiliations

I.R.C.C.S. "A.O.U. San Martino-IST"; Genoa, Italy. filippo.ansaldi@unige.itNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase IV
Comparative Study
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

22832261

Citation

Ansaldi, Filippo, et al. "Phase 4 Randomized Trial of Intradermal Low-antigen-content Inactivated Influenza Vaccine Versus Standard-dose Intramuscular Vaccine in HIV-1-infected Adults." Human Vaccines & Immunotherapeutics, vol. 8, no. 8, 2012, pp. 1048-52.
Ansaldi F, Valle L, de Florentiis D, et al. Phase 4 randomized trial of intradermal low-antigen-content inactivated influenza vaccine versus standard-dose intramuscular vaccine in HIV-1-infected adults. Hum Vaccin Immunother. 2012;8(8):1048-52.
Ansaldi, F., Valle, L., de Florentiis, D., Parodi, V., Murdaca, G., Bruzzone, B., Durando, P., Setti, M., & Icardi, G. (2012). Phase 4 randomized trial of intradermal low-antigen-content inactivated influenza vaccine versus standard-dose intramuscular vaccine in HIV-1-infected adults. Human Vaccines & Immunotherapeutics, 8(8), 1048-52. https://doi.org/10.4161/hv.20347
Ansaldi F, et al. Phase 4 Randomized Trial of Intradermal Low-antigen-content Inactivated Influenza Vaccine Versus Standard-dose Intramuscular Vaccine in HIV-1-infected Adults. Hum Vaccin Immunother. 2012;8(8):1048-52. PubMed PMID: 22832261.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Phase 4 randomized trial of intradermal low-antigen-content inactivated influenza vaccine versus standard-dose intramuscular vaccine in HIV-1-infected adults. AU - Ansaldi,Filippo, AU - Valle,Laura, AU - de Florentiis,Daniela, AU - Parodi,Valentina, AU - Murdaca,Giuseppe, AU - Bruzzone,Bianca, AU - Durando,Paolo, AU - Setti,Maurizio, AU - Icardi,Giancarlo, Y1 - 2012/08/01/ PY - 2012/7/27/entrez PY - 2012/7/27/pubmed PY - 2013/5/17/medline SP - 1048 EP - 52 JF - Human vaccines & immunotherapeutics JO - Hum Vaccin Immunother VL - 8 IS - 8 N2 - 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. SN - 2164-554X UR - https://www.unboundmedicine.com/medline/citation/22832261/Phase_4_randomized_trial_of_intradermal_low_antigen_content_inactivated_influenza_vaccine_versus_standard_dose_intramuscular_vaccine_in_HIV_1_infected_adults_ L2 - https://www.tandfonline.com/doi/full/10.4161/hv.20347 DB - PRIME DP - Unbound Medicine ER -