Immune response to hepatitis B vaccine in HIV-infected subjects using granulocyte-macrophage colony-stimulating factor (GM-CSF) as a vaccine adjuvant: ACTG study 5220.

TitleImmune response to hepatitis B vaccine in HIV-infected subjects using granulocyte-macrophage colony-stimulating factor (GM-CSF) as a vaccine adjuvant: ACTG study 5220.
Publication TypeJournal Article
Year of Publication2010
AuthorsOverton ET, Kang M, Peters MG, Umbleja T, Alston-Smith BL, Bastow B, Demarco-Shaw D, Koziel MJ, Mong-Kryspin L, Sprenger HL, Yu JY, Aberg JA
JournalVaccine
Volume28
Issue34
Pagination5597-604
Date Published2010 Aug 2
ISSN1873-2518
KeywordsAdjuvants, Immunologic, Adult, Antibody Formation, Female, Granulocyte-Macrophage Colony-Stimulating Factor, Hepatitis B, Hepatitis B Antibodies, Hepatitis B Vaccines, HIV Infections, Humans, Male, Middle Aged, Pilot Projects
Abstract

HIV-infected persons are at risk for HBV co-infection which is associated with increased morbidity and mortality. Unfortunately, protective immunity following HBV vaccination in HIV-infected persons is poor. This randomized, phase II, open-label study aimed to evaluate efficacy and safety of 40 mcg HBV vaccine with or without 250 mcg GM-CSF administered at day 0, weeks 4 and 12. HIV-infected individuals >or=18 years of age, CD4 count >or=200 cells/mm(3), seronegative for HBV and HCV, and naïve to HBV vaccination were eligible. Primary endpoints were quantitative HBsAb titers and adverse events. The study enrolled 48 subjects. Median age and baseline CD4 were 41 years and 446 cells/mm(3), 37 were on ART, and 26 subjects had undetectable VL. Vaccination was well tolerated. Seven subjects in the GM-CSF arm reported transient grade >or=2 signs/symptoms (six grade 2, one grade 3), mostly aches and nausea. GM-CSF had no significant effect on VL or CD4. Four weeks after vaccination, 26 subjects (59%) developed a protective antibody response (HBsAb >or=10 mIU/mL; 52% in the GM-CSF arm and 65% in the control arm) without improved Ab titer in the GM-CSF vs. control arm (median 11 mIU/mL vs. 92 mIU/mL, respectively). Response was more frequent in those with CD4 >or=350 cells/mm(3) (64%) than with CD4 <350 cells/mm(3) (50%), though not statistically significant. GM-CSF as an adjuvant did not improve the Ab titer or the development of protective immunity to HBV vaccination in those receiving an accelerated vaccine schedule. Given the common routes of transmission for HIV and HBV, additional HBV vaccine research is warranted.

DOI10.1016/j.vaccine.2010.06.030
Alternate JournalVaccine
PubMed ID20600512
PubMed Central IDPMC2943846
Grant ListAI 68634 / AI / NIAID NIH HHS / United States
AI 68636 / AI / NIAID NIH HHS / United States
AI 69434 / AI / NIAID NIH HHS / United States
AI 69471 / AI / NIAID NIH HHS / United States
AI 69474 / AI / NIAID NIH HHS / United States
AI 69484-02 / AI / NIAID NIH HHS / United States
AI 69495 / AI / NIAID NIH HHS / United States
AI 69501 / AI / NIAID NIH HHS / United States
AI 69511 / AI / NIAID NIH HHS / United States
AI 69513 / AI / NIAID NIH HHS / United States
AI 69532 / AI / NIAID NIH HHS / United States
AI027665 / AI / NIAID NIH HHS / United States
AI038855 / AI / NIAID NIH HHS / United States
AI068634 / AI / NIAID NIH HHS / United States
AI069495 / AI / NIAID NIH HHS / United States
AI069532 / AI / NIAID NIH HHS / United States
RR 024160 / RR / NCRR NIH HHS / United States
U01 AI027665-110001 / AI / NIAID NIH HHS / United States
U01 AI038855 / AI / NIAID NIH HHS / United States
U01 AI038855-04 / AI / NIAID NIH HHS / United States
U01 AI068634 / AI / NIAID NIH HHS / United States
U01 AI068634-01 / AI / NIAID NIH HHS / United States
U01 AI068636 / AI / NIAID NIH HHS / United States
U01 AI068636-01 / AI / NIAID NIH HHS / United States
U01 AI069495 / AI / NIAID NIH HHS / United States
U01 AI069495-01 / AI / NIAID NIH HHS / United States
U01 AI069502 / AI / NIAID NIH HHS / United States
U01 AI069532 / AI / NIAID NIH HHS / United States
U01 AI069532-01 / AI / NIAID NIH HHS / United States
UL1 RR024160 / RR / NCRR NIH HHS / United States