Optimization and validation of an ELISA assay for the determination of antibody responses to CN54gp140 and AIDSVAX BE for use in the Phase IIb PrEPVacc vaccine trial.
Optimization and validation of an ELISA assay for the determination of antibody responses to CN54gp140 and AIDSVAX BE for use in the Phase IIb PrEPVacc vaccine trial.
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DOI：
10.1371/journal.pone.0275927
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发表时间：
2022
期刊：
影响因子：
3.7
通讯作者：
Serwanga, Jennifer
中科院分区：
文献类型：
--
作者：
Gombe, Ben;Streatfield, Claire;Leal, Lorna;Opio, Solomon;Joseph, Sarah;Weber, Jonathan;Hare, Jonathan;Kaleebu, Pontiano;Serwanga, Jennifer
PrEPVacc是一项国际、多中心、双盲疫苗研究，比较了包括DNA/AIDSVAX BE和DNA/CN 54 gp 140在内的实验性联合疫苗方案与安慰剂对照。同时，在研究中心当前PrEP可用性情况下，将每日口服PrEP与每日Truvada的疗效进行比较。一个重要的临床试验结果是通过接种诱导的体内抗体滴度的准确测量。在这里，我们报告了在乌干达病毒研究所对CN 54 gp 140和AIDSVAX BE的两种ELISA的验证，证明了用于评估人血清中抗体终点滴度的精密度、特异性和耐用性。这是确定疫苗接种是否能在有感染艾滋病毒风险的人群中提供抗艾滋病毒保护的关键终点。
PrEPVacc is an international, multi-centre, double-blind vaccine study comparing experimental combination vaccine regimens including DNA/AIDSVAX BE and DNA/CN54gp140 with placebo control. Simultaneously, daily oral PrEP is compared for efficacy against daily Truvada in the context of the current PrEP availability situation at the study sites. An important clinical trial outcome is the accurate measurement of in vivo antibody titer induced through vaccination. Here we report the validation of two ELISAs for CN54gp140 and AIDSVAX BE at Uganda Virus Research Institute that demonstrates precision, specificity, and robustness for assessing the reciprocal antibody end point titer in human serum. This is a critical endpoint for determining whether vaccination can provide any protection against HIV in populations at risk of acquiring HIV.
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DOI：
10.1093/infdis/jis367
发表时间：
2012-08-01
期刊：
The Journal of infectious diseases
影响因子：
--
作者：
Montefiori DC;Karnasuta C;Huang Y;Ahmed H;Gilbert P;de Souza MS;McLinden R;Tovanabutra S;Laurence-Chenine A;Sanders-Buell E;Moody MA;Bonsignori M;Ochsenbauer C;Kappes J;Tang H;Greene K;Gao H;LaBranche CC;Andrews C;Polonis VR;Rerks-Ngarm S;Pitisuttithum P;Nitayaphan S;Kaewkungwal J;Self SG;Berman PW;Francis D;Sinangil F;Lee C;Tartaglia J;Robb ML;Haynes BF;Michael NL;Kim JH
通讯作者：
Kim JH
影响因子：
7.8
作者：
Joachim A;Msafiri F;Onkar S;Munseri P;Aboud S;Lyamuya EF;Bakari M;Billings E;Robb ML;Wahren B;Mhalu FS;Sandström E;Rao M;Nilsson C;Biberfeld G
通讯作者：
Biberfeld G
影响因子：
64.8
作者：
Caskey M;Klein F;Lorenzi JC;Seaman MS;West AP Jr;Buckley N;Kremer G;Nogueira L;Braunschweig M;Scheid JF;Horwitz JA;Shimeliovich I;Ben-Avraham S;Witmer-Pack M;Platten M;Lehmann C;Burke LA;Hawthorne T;Gorelick RJ;Walker BD;Keler T;Gulick RM;Fätkenheuer G;Schlesinger SJ;Nussenzweig MC
通讯作者：
Nussenzweig MC
影响因子：
5.4
作者：
Harel, Ofer;Schisterman, Enrique F.;Ruopp, Marcus D.
通讯作者：
Ruopp, Marcus D.
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