Safety and Immunogenicity of Two Influenza Virus Subunit Vaccines, with or without MF59 Adjuvant, Administered to Human Immunodeficiency Virus Type 1-Seropositive and -Seronegative Adults

Abstract

؉ cell count were observed at any time point. The results showed good safety and immunogenicity for both vaccines under study for both uninfected and HIV-1-infected adults, confirming current recommendations for immunization of this high-risk category.

Discordance between antibody and T cell responses in recipients of trivalent inactivated influenza vaccine

“…However, the inactivated influenza vaccine may have activated memory CD4 T cells and through their cytokine producing functions and ability to co-stimulate CD8 T cells, these CD4 cells were able to stimulate the proliferation of CD8 CD45RA+ T cells. Our data expand on the results from a recent, open, randomized, comparative clinical trial comparing an adjuvanted and non-adjuvanted subunit influenza vaccine, in which CFSE assays detected a significant increase in the frequency of the proliferating CD3 CD4 T cell population ( CD3/CD8 T cells were not analyzed) [32]. Similarly, in a study of eight individuals who received the influenza vaccine, Long et al found no increases in the frequencies of NK or CD8 T cells as a proportion of lymphocyte subset but did find, using intracellular cytokine staining, that there were increases in IFNγ producing CD8 T cells detected post vaccination after stimulation with virus [33] Our results would seem to similarly suggest that the overall population of CD8 T cells is stable post vaccination but that there is a subset of cells (CD45RA+), that is altered after vaccination.…”

Long-Term Immunogenicity after One and Two Doses of a Monovalent MF59-Adjuvanted A/H1N1 Influenza Virus Vaccine Coadministered with the Seasonal 2009-2010 Nonadjuvanted Influenza Virus Vaccine in HIV-Infected Children, Adolescents, and Young Adults in a Randomized Controlled Trial

“…The immune reconstitution of our patients was quite good for the duration of the study, and this might explain why one dose and two doses of pandemic vaccine were equally effective. Another possible explanation for our results is that the monovalent MF59-adjuvanted pandemic influenza vaccine has a better immunogenic profile than conventional nonadjuvanted vaccines, being especially advantageous for children, adults with chronic disease, elders, and immunocompromised patients (5,9,10,14). Of course, another explanation for our findings is that the baseline seroprotection rate was very low (about 3%) in both study groups.…”

Passive surveillance of adverse events of an MF59-adjuvanted H1N1v vaccine during the pandemic mass vaccinations

“…[12][13][14] Previous clinical studies have demonstrated that an MF59-adjuvanted seasonal trivalent influenza vaccine induced higher and broader antibody responses compared with nonadjuvanted vaccines, especially in subjects with low prevaccination antibody titers and with a confirmed safety profile in vulnerable populations, including the elderly, those with underlying chronic conditions and children. 9,[12][13][14][15][16][17][18][19][20][21][22][23] The EMA had initially recommended a 2-dose administration schedule at least 21 days apart for the centrally authorized pandemic vaccines based on existing data from H5N1 vaccines. 24,25 Subsequently published immunogenicity and safety data from H1N1v clinical trials demonstrated that the administration of a single dose of vaccine would be sufficient to elicit robust immune responses that comply with international licensing criteria.…”