G-395. ACTG 5220: Hepatitis B Vaccine Responses in HIV-Infected Persons Using Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF)
Session: Poster Session: Vaccines for Adults
Saturday, October 25, 2008: 12:00 AM
Room: Hall C
Background: HIV-infected persons are at risk for HBV co-infection with increased morbidity & mortality. This study aimed to improve HBV vaccine responses by using higher dose HBV vaccine, accelerating the vaccine schedule & using adjuvant GM-CSF. Methods: Randomized, phase II, open-label study to evaluate efficacy & safety of 40mcg HBV vaccine with or without 250mcg GM-CSF at weeks 0, 4 & 12. HIV-infected individuals >18 yrs of age, CD4 count >200 cells/mm3, seronegative for HBV & HCV, & naïve to HBV vaccination were stratified by HIV viral load (VL). Primary results on week 16 seroconversion & safety data are presented. Results: 48 subjects were enrolled: median age 41 yrs; 38 men, 10 women; 26 White, 15 Black, 7 Hispanic. Median nadir CD4:157 cells/mm3; baseline CD4: 446 cells/mm3; 37 on ART & 25 had undetectable VL at baseline. Vaccination was well tolerated: 7 subjects in the GM-CSF group reported transient Grade >2 signs/symptoms (6 Gr 2, 1 Gr 3), mostly aches & nausea. GM-CSF had no significant effect on VL or CD4. 4 weeks post vaccination, 26 subjects (54%) developed a protective Ab response (HBsAb >10mIU/mL) without improved response in the GM-CSF group (46% vs. 63%, p=0.86). Nadir CD4, baseline CD4 & VL did not affect responses (p=0.66, 0.46, 0.80, respectively). Response was more frequent in those with CD4 >350 c/mm3 (64%) than with CD4 <350 c/mm3 (50%), though not statistically significant (p=0.46). Conclusions: GM-CSF as an adjuvant did not improve the development of protective immunity to HBV vaccination. Overall response rates in this study are in the upper range of other trials evaluating HBV vaccination in HIV-infected persons.
for the A5220 Protocol Team, Barbara Bastow, RN, BSN2, Beverly Alston-Smith, MD3, Edgar Overton, MD4, Ji Yu, MPH5, Judith Aberg, MD, FIDSA6, Margaret Koziel, MD7, Marion Peters, MD8, Minhee Kang, MS, PhD9, Triin Umbleja, MSc9 and  E. T. Overton,
Tibotec Role(s): Research Relationship, Scientific Advisor (Review Panel or Advisory Committee), Speaker's Bureau, Received: Research Support, Speaker Honorarium, Consulting Fee.
Gilead Sciences Role(s): Research Relationship, Speaker's Bureau, Received: Research Support, Speaker Honorarium.
Bristol Meyers Squibb Role(s): Speaker's Bureau, Received: Speaker Honorarium.
Boehringer Ingelheim Role(s): Scientific Advisor (Review Panel or Advisory Committee), Speaker's Bureau, Received: Speaker Honorarium, Consulting Fee.
Glaxo Smith Kline Role(s): Research Relationship, Scientific Advisor (Review Panel or Advisory Committee), Speaker's Bureau, Received: Research Support, Speaker Honorarium, Consulting Fee., (1)ACTG, (2)NIH, (3)Washington University School of Medicine, St. Louis, MO, (4)Frontier Science, (5)NY University/Bellevue Hospital Ctr., New York, NY, (6)Beth Israel Deaconess Medical Center, (7)University of California, (8)Harvard School of Public Health


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