Division of Infectious Diseases, HIV Unit, Department of Internal Medicine, University Hospitals of Geneva, Switzerland.
HIV Med. 2012 Apr;13(4):207-18. doi: 10.1111/j.1468-1293.2011.00961.x. Epub 2011 Nov 7.
We aimed to determine the antibody responses and effect on viral load of the AS03-adjuvanted pandemic H1N1 vaccine in HIV-infected patients.
A total of 121 HIV-infected patients and 138 healthy subjects were enrolled in a prospective, open-label study. Healthy subjects received one dose and HIV-infected patients two doses of the AS03-adjuvanted split influenza A/09/H1N1 vaccine (Pandemrix®; GlaxoSmithKline, Brentford, United Kingdom.) at an interval of 3-4 weeks. The study was extended in 2010/2011 for 66 patients. Geometric mean titres (GMTs), seroprotection rates (post-vaccination titre ≥ 1:40) and HIV-1 RNA levels were measured before and 4 weeks after immunization.
After two immunizations, the seroprotection rate (94.2 vs. 87%, respectively) and GMT (376 vs. 340, respectively) in HIV-infected patients were as high as in healthy subjects after one dose, regardless of CD4 cell count. Four weeks after immunization, HIV RNA was detected in plasma samples from 40 of 68 (58.0%) previously aviraemic patients [median 152 HIV-1 RNA copies/mL; interquartile range (IQR) 87-509 copies/mL]. Subsequent measures indicated that HIV RNA levels had again declined to <20 copies/mL in most patients (27 of 34; 79.4%). Following (nonadjuvanted) influenza immunization in 2010/2011, HIV RNA levels only slightly increased (median final level 28 copies/mL) in three of 66 (4.5%) previously aviraemic patients, including two of 25 (8%) patients in whom an increase had been elicited by AS03-adjuvanted vaccine the year before.
Most HIV-infected patients developed seroprotection after two doses of AS03-adjuvanted pandemic vaccine. A transient effect on HIV RNA levels was observed in previously aviraemic patients. A booster dose of the nonadjuvanted influenza vaccine containing the A/09/H1N1 strain the following year did not reproduce this finding, indicating a non-antigen-specific adjuvant effect.
我们旨在确定 AS03 佐剂的大流行性 H1N1 疫苗在 HIV 感染者中的抗体反应和对病毒载量的影响。
共纳入 121 例 HIV 感染者和 138 例健康受试者进行前瞻性、开放性研究。健康受试者接受一剂，HIV 感染者在 3-4 周的间隔内接受两剂 AS03 佐剂的裂解流感 A/09/H1N1 疫苗（Pandemrix®；葛兰素史克，英国布伦特福德）。2010/2011 年，该研究扩展至 66 例患者。在免疫接种前和 4 周后测量几何平均滴度（GMT）、血清保护率（接种后滴度≥1:40）和 HIV-1 RNA 水平。
两次免疫后，HIV 感染者的血清保护率（94.2%比 87%）和 GMT（376 比 340）与健康受试者接种一剂后的水平相当，而与 CD4 细胞计数无关。在 68 例先前无病毒血症的患者中，有 40 例（58.0%）在免疫接种后 4 周时在血浆样本中检测到 HIV RNA[中位数为 152 HIV-1 RNA 拷贝/mL；四分位距（IQR）87-509 拷贝/mL]。随后的测量表明，大多数患者（34 例中的 27 例；79.4%）的 HIV RNA 水平再次降至<20 拷贝/mL。在 2010/2011 年进行（非佐剂）流感免疫接种后，在 66 例先前无病毒血症的患者中，只有 3 例（4.5%）的 HIV RNA 水平略有升高（中位数最终水平为 28 拷贝/mL），包括 25 例患者中的 2 例（8%），这 2 例患者在一年前接种 AS03 佐剂疫苗时已引起升高。
大多数 HIV 感染者在接受两剂 AS03 佐剂大流行疫苗后产生血清保护。在先前无病毒血症的患者中观察到对 HIV RNA 水平的短暂影响。次年接种含有 A/09/H1N1 株的非佐剂流感疫苗的加强剂量未再现这一发现，表明存在非抗原特异性佐剂效应。
