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Associations Between Gender and Solicited Adverse Events After Passive Infusion of VRC01 or Placebo in HVTN 704/HPTN 085 期刊论文

编号：

37E2E532575C310880C5F072B012C4BE
作者：

Theodore, Deborah A.^[1] Neradilek, Moni^[2] Gillespie, Kevin^[2] Edupuganti, Srilatha^[3] Hinojosa, Juan Carlos^[4] Lama, Javier R.^[5,6] de la Grecca, Robert^[2] Wu, Yi H.^[1] Davis, Annet^[7,8] Mangini, Daniel^[8] Andrew, Philip^[9] Marovich, Mary A.^[10] Zwerski, Sheryl^[10] Broder, Gail^[2] Andrasik, Michele P.^[2] Castor, Delivette^[1] Roxby, Alison C.^[2,6] Cohen, Myron^[11] Huang, Yunda^[2,6] Karuna, Shelly T.^[2] Sobieszczyk, Magdalena E.^[1]
语种：

英文
期刊：

JAIDS-JOURNAL OF ACQUIRED IMMUNE DEFICIENCY SYNDROMES ISSN：1525-4135 2025 年 98 卷 4 期 (340 - 345) ; APR 1
疾病分类：

艾滋病
关键词：

HIV prevention transgender participants clinical trials
摘要：

Background: Realizing the potential of HIV prevention options requires understanding product tolerability across diverse groups vulnerable to HIV acquisition. Gender minority (GM) individuals are understudied in clinical trials. Setting: HVTN 704/HIV Prevention Trials Network 085, a phase 2b randomized HIV prevention trial, enrolled MSM and transgender participants from Brazil, Peru, Switzerland, and the United States to receive an infusion every 8 weeks (10 total) of VRC01 30 mg/kg, VRC01 10 mg/kg, or placebo. Solicited adverse events (AEs) were recorded for 3 days after each infusion. Methods: Gender was defined by self-report and sex assigned-at-birth. Multivariate mixed logistic models were used to estimate the association between gender (cisgender men [CM] vs. GM participants [transgender women, transgender men, or another gender]) and solicited AE frequency and severity. Results: GM participants reported more solicited AEs than CM among all participants (adjusted OR 1.59, 95% CI: 1.20 to 2.10, P = 0.001) and among placebo recipients (1.72, 1.05 to 2.81, P = 0.031). The severity of solicited AEs (occurrence of grade 2 and higher event) did not significantly differ overall (1.83, 0.79 to 4.20, P = 0.174) or among placebo recipients (3.05, 0.76 to 12.32, P = 0.112). Grade 2 events were reported after 1% and 2% of total infusions among CM and GM participants, respectively. Grade 3-4 events were rare overall (<0.1%). Completion of 10 infusions was high (78.6%) and slightly higher in CM (79.2%) than GM participants (73%). Conclusions: This is the first report of associations between gender and solicited AEs after monoclonal antibody infusion. GM participants reported more events; severity was low. HIV prevention trials must engage and support GM individuals to best evaluate tolerability of novel agents.
推荐引用方式
GB/T 7714：

Theodore Deborah A.,Neradilek Moni,Gillespie Kevin, et al. Associations Between Gender and Solicited Adverse Events After Passive Infusion of VRC01 or Placebo in HVTN 704/HPTN 085 [J].JAIDS-JOURNAL OF ACQUIRED IMMUNE DEFICIENCY SYNDROMES,2025,98(4):340-345.
APA：

Theodore Deborah A.,Neradilek Moni,Gillespie Kevin,Edupuganti Srilatha,&Sobieszczyk Magdalena E..(2025).Associations Between Gender and Solicited Adverse Events After Passive Infusion of VRC01 or Placebo in HVTN 704/HPTN 085 .JAIDS-JOURNAL OF ACQUIRED IMMUNE DEFICIENCY SYNDROMES,98(4):340-345.
MLA：

Theodore Deborah A., et al. "Associations Between Gender and Solicited Adverse Events After Passive Infusion of VRC01 or Placebo in HVTN 704/HPTN 085" .JAIDS-JOURNAL OF ACQUIRED IMMUNE DEFICIENCY SYNDROMES 98,4(2025):340-345.
数据来源自科睿唯安Web of Science核心合集
入库时间：

2025/3/11 15:57:37
更新时间：

2025/3/11 15:57:37

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