Immunological efficacy of a three-dose schedule of hepatitis A vaccine in HIV-infected adults: HEPAVAC study.
BACKGROUND
The immunogenicity of vaccines, including vaccine against hepatitis A virus (HAV), is impaired in patients with HIV infection, requiring revised immunization regimens.


METHODS
We evaluated the immunological efficacy and safety of a 3-dose schedule of hepatitis A vaccine in HIV-infected adults. HAV-seronegative HIV-infected adults were randomized to receive either 3 doses of 1440 UI of hepatitis A vaccine (HAVRIX; GlaxoSmithKline, Marly le Roi, France) at weeks 0, 4, and 24 (46 patients) or 2 doses 24 weeks apart (49 patients).


RESULTS
At week 28, seroconversion, defined as an anti-HAV antibody >or=20 mIU/mL, occurred in 82.6% and 69.4% of patients in the 3-dose and the 2-dose group, respectively (P = 0.13, intent-to-treat analysis, missing data = nonresponder), and in 88.4% and 72.3% of patients in the 3-dose and the 2-dose group, respectively (P = 0.06, observed analysis). Only 37.9% of patients experienced seroconversion after 1 vaccine dose (intent-to-treat analysis). Anti-HAV antibody geometric mean titers were 323 and 132 mIU/mL in the 3-dose group and 138 and 67 mIU/mL in the 2-dose group, respectively, 28 (P = 0.03) and 72 weeks (P = 0.05) after the first vaccine dose. There were no serious adverse events associated with the vaccine. Multivariate analysis showed no treatment group effect but indicated that absence of tobacco smoking (odds ratio = 2.92, 95% confidence interval: 1.07 to 7.97; P = 0.04) was an independent predictor of response to HAV vaccine.


CONCLUSIONS
In HIV-infected adults, immunogenicity of hepatitis A vaccine is poor. Three doses of vaccine were safe and increased antibody titers.
Launay
Odile
O
Université Paris Descartes, Faculté de Médecine, Paris, France. odile.launay@cch.aphp.fr
Grabar
Sophie
S
Gordien
Emmanuel
E
Desaint
Corinne
C
Jegou
David
D
Abad
Sébastien
S
Girard
Pierre-Marie
PM
Bélarbi
Linda
L
Guérin
Corinne
C
Dimet
Jérôme
J
Williams
Virginie
V
Krivine
Anne
A
Salmon
Dominique
D
Lortholary
Olivier
O
Rey
David
D
D000293:Adolescent; D000328:Adult; D018791:CD4 Lymphocyte Count; D004334:Drug Administration Schedule; D005260:Female; D015658:HIV Infections / Q000276:immunology*; D035922:Hepatitis A Antibodies / Q000097:blood; D022362:Hepatitis A Vaccines / Q000008:administration & dosage* / Q000276:immunology; D006801:Humans; D008297:Male; D008875:Middle Aged; D012907:Smoking / Q000276:immunology; D014611:Vaccination
D035922:Hepatitis A Antibodies; D022362:Hepatitis A Vaccines