PrEP Biopharm Ltd, 105 Lock Street, Ste 205, Newark, NJ 07103, USA; Janssen Research & Development, Turnhoutseweg 30, B-2340 Beerse, Belgium.
Janssen Research & Development, Turnhoutseweg 30, B-2340 Beerse, Belgium.
Antiviral Res. 2018 May;153:70-77. doi: 10.1016/j.antiviral.2018.03.005. Epub 2018 Mar 19.
PrEP-001 Nasal Powder, a proprietary formulation of polyriboinosinic and polyribocytidylic acid effectively elicits a cellular innate immune response in nasal epithelium. The aim of these 2 studies was to investigate the safety and efficacy of PrEP-001 prophylaxis against rhinovirus (HRV-A16) and influenza-A (H3N2-IAV).
Healthy subjects randomly received 2 doses of PrEP-001 or placebo, 48 and 24 h pre-challenge with 10 TCID of HRV-A16 (Study 1) or H3N2-IAV (Study 2).
In Study 1, PrEP-001 reduced median total symptom score from 38.5 to 4.5 (p = 0.004), median symptom duration from 6.0 to 1.7 days and median mucus production from 15 g to 3 g. The percentage of subjects classified as ill was reduced 3-fold (placebo 73%, PrEP-001 23%, p = 0.002). In Study 2, PrEP-001 reduced median total symptom score from 8.0 to 4.1 (p = 0.021), median symptom duration from 4.6 to 3.7 days and median mucus production from 3.6 g to 1.5 g. The percentage of subjects classified as ill was reduced 2-fold (placebo 48%, PrEP-001 24%, p = 0.064). PrEP-001 reduced peak viral shedding in both studies, as assessed by qRT-PCR of nasal lavage. Seroconversion rates were comparable between placebo and PrEP-001 (Study 1: 77% [both arms]; Study 2: placebo 73%, PrEP-001 80%). PrEP-001 was well-tolerated, with no clinically significant adverse events.
PrEP-001 reduced the number of individuals with clinical illness and attenuated severity and duration of HRV-A16 and H3N2-IAV infections without compromising seroconversion, and was well-tolerated. This supports further evaluation of PrEP-001 as a potential pan-viral prophylaxis for upper respiratory tract infections.
Study 1, HRV-A16 study: EudraCT Number 2012-005579-14 (study conducted before ClinicalTrials.gov registration required). Study 2, H3N2-IAV study: EudraCT Number 2015-002895-26 and ClinicalTrials.gov: NCT03220048.
PrEP-001 鼻用粉末是一种专利的聚肌胞和聚胞苷酸制剂，能有效地在鼻上皮引发细胞固有免疫反应。这两项研究的目的是调查 PrEP-001 预防鼻病毒（HRV-A16）和流感 A（H3N2-IAV）的安全性和有效性。
健康受试者随机接受 2 剂 PrEP-001 或安慰剂，在 HRV-A16（研究 1）或 H3N2-IAV（研究 2）挑战前 48 和 24 小时给予 10TCID。
在研究 1 中，PrEP-001 将中位总症状评分从 38.5 降至 4.5（p=0.004），中位症状持续时间从 6.0 天降至 1.7 天，中位粘液产生量从 15g 降至 3g。被归类为患病的受试者比例降低了 3 倍（安慰剂 73%，PrEP-001 23%，p=0.002）。在研究 2 中，PrEP-001 将中位总症状评分从 8.0 降至 4.1（p=0.021），中位症状持续时间从 4.6 天降至 3.7 天，中位粘液产生量从 3.6g 降至 1.5g。被归类为患病的受试者比例降低了 2 倍（安慰剂 48%，PrEP-001 24%，p=0.064）。PrEP-001 在两项研究中均通过鼻灌洗液的 qRT-PCR 检测降低了病毒峰值脱落，在两项研究中均减少了 HRV-A16 和 H3N2-IAV 感染的个体数量，降低了临床疾病的严重程度和持续时间，而不影响血清转化率。PrEP-001 耐受性良好，无临床显著不良事件。
PrEP-001 降低了 HRV-A16 和 H3N2-IAV 感染的个体中出现临床疾病的数量，并减轻了感染的严重程度和持续时间，同时不影响血清转化率，且耐受性良好。这支持进一步评估 PrEP-001 作为治疗上呼吸道病毒感染的潜在泛病毒预防药物。
研究 1，HRV-A16 研究：EudraCT 编号 2012-005579-14（在要求在 ClinicalTrials.gov 注册之前进行的研究）。研究 2，H3N2-IAV 研究：EudraCT 编号 2015-002895-26 和 ClinicalTrials.gov：NCT03220048。
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