Safety and Immunogenicity of a Monovalent 2009 Influenza A/H1N1v Vaccine Adjuvanted With AS03A or Unadjuvanted in HIV-Infected Adults: A Randomized, Controlled Trial

Abstract

Background. Human immunodeficiency virus (HIV)-infected patients have decreased immune response to vaccines. Few data are available about pandemic flu vaccination in this population.Methods. We conducted a multicenter, patient-blinded, randomized trial in a cohort of HIV-infected adults. Patients received 2 injections 21 days apart of a AS03 A -adjuvanted H1N1v vaccine containing 3.75 lg hemagglutinin (HA) or a nonadjuvanted H1N1v vaccine containing 15 lg HA to assess hemagglutination inhibition (HI) response and safety.Results. A total of 309 patients were randomized, and 306 were vaccinated. After the first vaccine dose, HI titers $1:40 were observed in 93.4% of the patients in the adjuvanted group (A group) (n 5 155) and in 75.5% in the nonadjuvanted group (B group) (n 5 151) (P , .001); seroconversion rates were 88.8% and 71.2%, and factor increases in geometric mean titers (GMT) of 21.9 and 15.1, respectively. After 2 injections, 98.6% of patients of the A group and 92.1% of the B group demonstrated HI titers $1:40 (P 5 .018); seroconversion rates were 96.5% and 87.1%, respectively, and factor increases in GMT were 45.5 and 21.2, respectively. The majority of adverse events were mild to moderate in severity; no impact on CD41 cell count or viral load has been detected.Conclusions. In HIV-1-infected adults, the AS03 A -adjuvanted H1N1v vaccine yielded a higher immune response than did the nonadjuvanted one, with no impact on HIV infection.Two large studies performed before the era of highly active antiretroviral therapy (HAART) evidenced high numbers of hospital admissions and high mortality related to seasonal influenza in human immunodeficiency virus (HIV)-infected patients [1,2]. In the post-HAART era, the number of

Long-term immunogenicity of two doses of 2009 A/H1N1v vaccine with and without AS03A adjuvant in HIV-1-infected adults

“…We reported recently in HIV-1-infected adults that a twodose schedule of 2009 A/H1N1v vaccine was more immunogenic than a single dose 1 month after the vaccination; moreover, the AS03 A -adjuvanted H1N1v vaccine yielded a higher short-term immune response than the nonadjuvanted vaccine with no impact on HIV infection [6]. We now report the durability of the immune response up to 1 year after vaccination.…”

“…The HIFLUVAC trial was a phase 2, randomized, patient-blinded trial conducted in 18 ANRS-labeled centers in France as described previously [6].…”

Immune reconstitution and vaccination outcome in HIV-1 infected children

“…84,85 However, the rate of consequences due to natural A(H1N1) infection was similar between HIV-1 infected subjects and healthy controls and the efficacy of diverse formulations of influenza vaccines (with or without different adjuvants coupled to the influenza antigens) in both adults and children, was reported in several studies. [86][87][88][89] Nonetheless, the numerous studies undergone during the A(H1N1) pandemic represented a great occasion for increasing the knowledge on immunological undetectable HIV-1 viral load and high CD4 + T-cell counts but treated later in time. 36 Altogether, this suggests that early HIV-1 suppression may help preserving the ability of T-and B-cells to respond to DTP in HIV-1 infected children.…”

Immunization of HIV-infected adult patients — French recommendations

“…46,47 Few studies have investigated the clinical efficacy of the influenza vaccine in this population but they agree that the vaccine is clinically effective, with a relative risk reduction of 66 % for the development of symptomatic disease in HIV-infected individuals. 48,49 A randomized trial conducted in Africa in 2008 showed a 75.5% reduction in risk in a population of HIV-infected adults who had a CD4 count >100/mm 3 and no associated co morbidities. 50 A recent systematic review indicates that influenza vaccination is effective in preventing laboratory confirmed influenza infection in HIV-infected adults with a pooled efficacy of 85%.…”