Safety and Immunogenicity of Hepatitis A Vaccine in Human Immunodeficiency Virus–Infected Patients: A Double‐Blind, Randomized, Placebo‐Controlled Trial

Abstract

The safety and immunogenicity of inactivated hepatitis A (HepA) vaccine was assessed in 133 hepatitis A virus-seronegative, human immunodeficiency virus (HIV)-infected adults. Patients were randomly assigned to receive, in a blinded fashion, either 2 doses of vaccine (1440 enzyme-linked immunosorbent assay units) or placebo 6 months apart. Seroconversion at month 9 was observed in 68% of those with CD4 cell counts >/=200 cells/mm(3) but in only 9% of those with lower CD4 cell counts (P=.004). HepA vaccine was well tolerated and had no effect on the course of HIV infection or plasma HIV RNA load.

Role of CD4 Count in Immunity Development After Hepatitis A and B Vaccination Among HIV-Infected Patients: Kentucky, 2002-2007

“…Studies have reported that high CD4 counts typically lead to HAV/HBV vaccine response among vaccinated HIV-infected patients. [8][9][10][11][12] However, no definitive literature has established exactly which CD4 count is the best point at which to administer vaccinations.…”

Vaccination in HIV-Infected Adults

“…Most HIV-infected adults develop antibody responses to HAV vaccination with seroconversion rates of 68-96%, 66,67 with seroresponses varying by CD4 counts. For example, in a study of early-diagnosed HIV patients, those with a CD4 cell count ‡ 300 cells/mm 3 had a seroconversion rate of 100% versus 87% among those with a CD4 count of < 300 cells/ mm 3 .…”

“…48,57,59,67,112 The dangers of delaying vaccination include the risk of infection and the potential missed opportunity for vaccination due to lost follow-up. 117 In general, the administration of vaccines should occur at the initial HIV visit, or shortly thereafter in cases in which prevaccination testing is needed.…”

“…4,7 If responses are not adequate after the initial vaccination, revaccination after CART initiation and a sustained increase in CD4 count can be considered, especially for HAV and HBV vaccines. 7 Several studies have found that higher CD4 counts, 48,57,67,112 suppressed HIV viral loads, 32,48,112,118 and receipt of effective CART 48,59 predict better response rates. Among early-diagnosed HIV patients, vaccines should be immediately administered since this group has near normal immune responses.…”

Determinants of Hepatitis A Vaccine Immunity in a Cohort of Human Immunodeficiency Virus-Infected Children Living in Switzerland

“…While seroconversion reaches 100% in healthy adult and pediatric individuals after 2 doses of Havrix (GlaxoSmithKline Biologicals, Rixensart, Belgium) (2), studies with adult HIV-positive patients showed significantly lower percentages (48.5 to 94%) (16,21,22,24,33,35,39). Duration of protection, currently estimated to be more than 20 years in healthy individuals (12), also seems to be shorter in HIV-positive patients (35).…”