临床试验测试较广泛中和抗体对艾滋病毒的抗体证明了针对敏感菌株的功效

概念证明的AMP研究证明，称为VRCO1的宽度中和抗体（BNAB）有效地在预防艾滋病毒株到对BNAB敏感的30％菌株的菌株。这一发现在撒哈拉以南非洲和美国和南美洲。VRCO1没有阻止收购艾滋病毒，以抵抗BNAB的菌株。由于抗性菌株在这些区域中构成了近70％的循环菌株，因此VRCO1臂与安慰剂臂之间没有差异，在整体预防HIV孵化方面。通过测量病毒对抗体中和的中和的易感性的实验室测试来评估对BNAB的敏感性。

两项研究（HVTN 704 / HPTN 085和HVTN 703 / HPTN 081）于2016年开放，并成功地注册了4,623名参与者。AMP学习由国家过敏和传染病（NIAID），部分国家卫生研究院的一部分提供赞助和资助。这些研究由HIV疫苗试验网络（HVTN）和HIV预防试验网络（HPTN）共同进行。

NIAID疫苗研究中心(VRC)于2010年从一名艾滋病毒感染者的血液中分离出VRC01，随后制造了用于AMP研究的抗体。AMP研究的数据是在2021年1月26日由第四届国际艾滋病预防研究会议(HIVR4P)主办的新闻发布会上首次报道的。VRC01对预防HIV感染的有效性为75%菌株that were susceptible to the bnAb (in vitro sensitivity to the antibody had an IC80 of <1 μg/ml) in cisgender men and transgender persons vulnerable to HIV acquisition in South America, Switzerland and the U.S., and in cisgender women vulnerable to HIV acquisition in Sub-Saharan Africa. The AMP data were published today in the新英格兰医学杂志。

对一个人暴露的HIV菌株的VRC01的易感性是抗体如何预防艾滋病毒孵化的关键决定因素。在试验期间获得VRC01敏感HIV菌株的参与者中，艾滋病病毒症发病率为VRC01受试者每100人为0.2，为安慰剂收件人每100人为0.86人。Results were similar in the HVTN 704/HPTN 085 trial conducted among cisgender men and transgender persons in the U.S., Switzerland and South America (exposed primarily to subtype B variants) and in the HVTN 703/HPTN 081 trial in cisgender women in Sub-Saharan Africa (exposed primarily to subtype C variants).

“AMP试验旨在确定BNAB的长期施用是否可以降低HIV孵化，如果群体中的循环病毒对BNAB的敏感性会影响预防疗效，并且如果测量这种易感性将是预防疗效的生物标志物。All three of these questions were answered by these two trials," said Larry Corey, M.D., AMP Protocol Chair and Principal Investigator, HVTN Leadership Operations Center, which is based at the Fred Hutchinson Cancer Research Center.

Cisgender men and transgender persons who have sex with cisgender men were enrolled from communities in Brazil, Peru, Switzerland, and the U.S. in HVTN 704/HPTN 085. Cisgender women were enrolled from communities in Botswana, Kenya, Malawi, Mozambique, South Africa, Tanzania, and Zimbabwe in HVTN 703/HPTN 081. The median age of participants enrolled in HVTN 704/HPTN 085 is 28 years, and 31.6% are White, and 15.1% Black, and 57.1% Latinx. In HVTN 703/HPTN 081, the median age of participants is 26 years, and 98.9% are Black. Study participants were randomized to receive intravenous infusions of VRC01 at 10 mg/kg (active lower dose), VRC01 at 30 mg/kg (active higher dose), or placebo administered every eight weeks (total of 10 intravenous infusions). Testing for HIV infection occurred every four weeks, and participants were followed for two years. PrEP use was evenly distributed among the randomized study arms. VRC01 was well-tolerated by participants in both trials, and no safety concerns were identified.

结果表明需要多于一个单一的BNAB来预防艾滋病病毒性收购。类似于抗逆转录病毒药物，需要开发联合单克隆抗体鸡尾酒，以便在这些社区中流通的艾滋病病毒毒素群体的不同群体提供有效的保护。

HPTN首席研究员、AMP协议主席、医学博士Myron Cohen表示:“AMP试验的结果将有助于未来临床开发中的高效长效bnAbs组合试验的开发。”他还是北卡罗来纳大学教堂山分校全球健康和传染病研究所所长。“我们期待着利用这些知识，继续朝着终结艾滋病毒的目标前进。”

全球艾滋病毒仍有超过170万新案例;自大流行开始以来，超过7500万人获得艾滋病毒艾滋病毒，超过3200万人从艾滋病相关疾病中死亡。需要安全有效的预防艾滋病毒疫苗和其他艾滋病毒预防技术尽可能紧急。

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