Immunogenicity of ALVAC-HIV vCP1521 in infants of HIV-1-infected women in Uganda (HPTN 027): the first pediatric HIV vaccine trial in Africa.
Immunogenicity of ALVAC-HIV vCP1521 in infants of HIV-1-infected women in Uganda (HPTN 027): the first pediatric HIV vaccine trial in Africa.
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DOI：
10.1097/01.qai.0000435600.65845.31
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发表时间：
2014-03-01
期刊：
影响因子：
--
通讯作者：
HPTN 027 protocol team
中科院分区：
文献类型：
--
作者：
Kaleebu P;Njai HF;Wang L;Jones N;Ssewanyana I;Richardson P;Kintu K;Emel L;Musoke P;Fowler MG;Ou SS;Jackson JB;Guay L;Andrew P;Baglyos L;Cao H;HPTN 027 protocol team
尽管预防策略取得了成功，但 HIV-1 感染的母婴传播仍然是 HIV-1 感染的重要原因。测试保护性 HIV-1 疫苗仍然是重中之重。非洲首个儿科 HIV-1 疫苗研究评估了 ALVAC-HIV vCP1521 (ALVAC) 对乌干达 HIV-1 感染妇女所生婴儿的免疫原性。 HPTN 027 是一项随机、双盲、安慰剂对照的 I 期试验，旨在评估 ALVAC 在 60 名 HIV-1 感染母亲所生婴儿中的安全性和免疫原性，这些婴儿的 CD4 计数 > 500 个细胞/μL，这些婴儿随机接受 ALVAC 疫苗或安慰剂。 ALVAC-HIV vCP1521 是一种减毒重组金丝雀痘病毒，表达 HIV-1 进化枝 E env、进化枝 B gag 和蛋白酶基因产物。婴儿在出生时、4 周、8 周和 12 周时接种 ALVAC 或安慰剂疫苗。使用 IFN-γ ELISpot、CFSE 增殖、细胞内细胞因子染色、结合和中和抗体测定来评估细胞和体液免疫反应。费舍尔精确检验用于比较研究组之间的阳性反应。 24 个月龄时检测到低水平的抗原特异性 CD4 和 CD8 T 细胞反应（细胞内细胞因子测定）（CD4 – 6/36 疫苗与 1/9 安慰剂；CD8 – 5/36 疫苗与 0/9 安慰剂）。与安慰剂相比，疫苗接种者的细胞免疫反应率没有显着趋势。存在最小的结合抗体反应并且未检测到中和抗体。暴露于 HIV-1 的婴儿能够对 ALVAC 疫苗产生低水平的细胞免疫反应，类似于成人的反应。
Maternal-to-child-transmission of HIV-1 infection remains a significant cause of HIV-1 infection despite successful prevention strategies. Testing protective HIV-1 vaccines remains a critical priority. The immunogenicity of ALVAC-HIV vCP1521 (ALVAC) in infants born to HIV-1 infected women in Uganda was evaluated in the first pediatric HIV-1 vaccine study in Africa. HPTN 027 was a randomized, double blind, placebo-controlled phase I trial to evaluate the safety and immunogenicity of ALVAC in 60 infants born to HIV-1 infected mothers with CD4 counts > 500 cell/μL that were randomized to the ALVAC vaccine or placebo. ALVAC-HIV vCP1521 is an attenuated recombinant canarypox virus expressing HIV-1 clade E env, clade B gag and protease gene products. Infants were vaccinated at birth, 4, 8 and 12 weeks of age with ALVAC or placebo. Cellular and humoral immune responses were evaluated using IFN-γ ELISpot, CFSE proliferation, intracellular cytokine staining, binding and neutralizing antibody assays. Fisher's exact test was used to compare positive responses between study arms. Low levels of antigen specific CD4 and CD8 T cell responses (intracellular cytokine assay) were detected at 24 months (CD4 – 6/36 vaccine vs. 1/9 placebo; CD8 – 5/36 vaccine vs. 0/9 placebo) of age. There was a non-significant trend toward higher cellular immune response rates in vaccine recipients compared to placebo. There were minimal binding antibody responses and no neutralizing antibodies detected. HIV-1 exposed infants are capable of generating low levels of cellular immune responses to ALVAC vaccine, similar to responses seen in adults.
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影响因子：
56.3
作者：
Gray, Glenda E.;Allen, Mai;Moodie, Zoe;Churchyard, Gavin;Bekker, Linda-Gail;Nchabeleng, Maphoshane;Mlisana, Koleka;Metch, Barbara;de Bruyn, Guy;Latka, Mary H.;Roux, Surita;Mathebula, Matsontso;Naicker, Nivashnee;Ducar, Constance;Carter, Donald K.;Puren, Adrien;Eaton, Niles;McElrath, M. Julie;Robertson, Michael;Corey, Lawrence;Kublin, James G.
通讯作者：
Kublin, James G.
影响因子：
3.8
作者：
Leroy, V;Karon, JM;Wiktor, SZ
通讯作者：
Wiktor, SZ
影响因子：
3.8
作者：
McFarland, Elizabeth J.;Johnson, Daniel C.;Lambert, John S.
通讯作者：
Lambert, John S.
影响因子：
6.4
作者：
Borkowsky, W;Wara, D;Jimenez, E
通讯作者：
Jimenez, E
HIV-1 疫苗功效试验的免疫相关分析。
DOI：
10.1056/nejmoa1113425
发表时间：
2012-04-05
期刊：
The New England journal of medicine
影响因子：
--
作者：
Haynes BF;Gilbert PB;McElrath MJ;Zolla-Pazner S;Tomaras GD;Alam SM;Evans DT;Montefiori DC;Karnasuta C;Sutthent R;Liao HX;DeVico AL;Lewis GK;Williams C;Pinter A;Fong Y;Janes H;DeCamp A;Huang Y;Rao M;Billings E;Karasavvas N;Robb ML;Ngauy V;de Souza MS;Paris R;Ferrari G;Bailer RT;Soderberg KA;Andrews C;Berman PW;Frahm N;De Rosa SC;Alpert MD;Yates NL;Shen X;Koup RA;Pitisuttithum P;Kaewkungwal J;Nitayaphan S;Rerks-Ngarm S;Michael NL;Kim JH
通讯作者：
Kim JH