One-week intramuscular or intradermal pre-exposure prophylaxis with human diploid cell vaccine or Vero cell rabies vaccine,followed by simulated post-exposure prophylaxis at one year: A phase III,open-label,randomized, controlled trial to assess immunogenicity and safety

Shorter rabies pre-exposure prophylaxis (PrEP) regimens may offer improved convenience and feasibility over classic 3-week regimens, for example in regions with poor access to vaccines or for travelers to rabies-endemic regions. In this multicenter, open-label, controlled trial, 570 healthy participants aged 2–64 years were randomized to receive: 1-week PrEP (vaccination days [D]0 and 7; Group 1) or classic 3-week PrEP regimen (D0, D7, and D21; Group 2) with one 1.0 mL intramuscular [IM] dose of human diploid cell culture rabies vaccine (HDCV) at each visit; 1-week PrEP with two 0.1 mL intradermal (ID) HDCV doses at each visit (Group 3); or 1-week PrEP with one 0.5 mL IM dose (Group 4) or two 0.1 mL ID doses (Group 5) of Vero cell rabies vaccine (PVRV) at each visit. Participants received simulated post-exposure prophylactic (PEP) vaccination (two IM or ID doses of HDCV or PVRV three days apart) one year later. Rabies virus neutralizing antibody titers and seroconversion (titers ≥ 0.5 IU/mL) rates were assessed 14 days and up to 1 year post-PrEP, and pre- and post-PEP. Safety was assessed throughout the study. Seroconversion rates were high 14 days post-last PrEP injection (ranging from 96.7 % to 97.2 % across groups 1, 3–5; 1-week PrEP) and reached 100 % in Group 2 (3-week PrEP). Non-inferiority of Group 1 versus Group 2 in terms of seroconversion rates 14 days post-last PrEP injection (primary objective) was not demonstrated. After simulated PEP, all groups showed rapid and robust immune responses, with all but one participant achieving seroconversion (titers ≥ 0.5 IU/mL). There were no safety concerns, and the tolerability profiles of the vaccines were similar across the groups.A 1-week, IM or ID PrEP regimen with HDCV or PVRV provided efficacious priming, enabling rapid robust anamnestic responses to simulated PEP 1 year later across age groups.ClinicalTrials.gov number: NCT03700242.WHO Universal Trial Number (UTN): U1111-1183-5743.     

Serum-free purified Vero rabies vaccine is safe and immunogenic in children: Results of a randomized phase II pre-exposure prophylaxis regimen study

BackgroundA serum-free, highly purified Vero rabies vaccine (PVRV-NG) has been developed with no animal or human components and low residual DNA content. A phase II randomized clinical study aimed to demonstrate the non-inferiority of the immune response and assess the safety profile of PVRV-NG versus a licensed human diploid cell culture rabies vaccine (HDCV) in a pre-exposure regimen in healthy children and adolescents in the Philippines.MethodologyChildren aged 2–11 years and adolescents aged 12–17 years were randomized (2:1) to receive three injections of either PVRV-NG or HDCV (on day [D] 0, D7 and D28). Rabies virus-neutralizing antibodies (RVNA) were measured at D0, D42 and 6 months after the first injection (month [M] 6). Safety was assessed during the vaccination period and up to 28 days after the last vaccination. Serious adverse events were followed until 6 months after last vaccination.Principal findings342 healthy participants (171 children and 171 adolescents) were randomized and followed for 6 months after the last dose. All participants in both groups had an RVNA titer ≥ 0.5 IU/ml at D42, demonstrating non-inferiority in seroconversion rate for PVRV-NG versus HDCV. Over 90% of participants had RVNA titer ≥ 0.5 IU/ml at M6. PVRV-NG was well tolerated after each vaccination and up to 6 months following the last dose. There were no major safety concerns during the study, and the type and severity of solicited adverse events was similar for both treatment groups.ConclusionsThis study demonstrated the non-inferior immune profile of PVRV-NG compared with HDCV in a pre-exposure setting within a pediatric population. PVRV-NG was well tolerated with no safety concerns. This study is registered at ClinicalTrials.gov (NCT01930357) and EU Clinical Trials Register (2015–003203-30).     

Safety and immunogenicity of a serum-free purified Vero rabies vaccine in healthy adults: A randomised phase II pre-exposure prophylaxis study

A serum-free, highly purified Vero cell rabies vaccine (PVRV-NG) is under development. We previously demonstrated that pre-exposure prophylaxis (PrEP) with PVRV-NG had a satisfactory safety profile and was immunogenically non-inferior to the licensed purified Vero cell rabies vaccine in adults. Here, we evaluated the safety and immunogenic non-inferiority of PrEP with PVRV-NG compared to the licensed human diploid cell vaccine (HDCV) in healthy adults (NCT01784874). Participants received three vaccinations (days 0, 7, and 28) as PrEP with or without a booster injection after 12 months. Rabies virus neutralising antibodies (RVNA) were evaluated on days 0, 28 (subgroup only), and 42, and Months 6, 12, and 12 + 14 days (booster group only). Non-inferiority (first primary objective) was based on the proportion of participants with RVNA titres ≥ 0.5 IU/mL (World Health Organization criteria for seroconversion) on day 42, expected to be ≥ 99% (second primary objective). Safety was evaluated after each dose and monitored throughout the study. At day 42, PVRV-NG was non-inferior to HDCV and the first primary objective was met; seroconversion was observed for 98.3% of PVRV-NG recipients and 99.1% of HDCV recipients. As < 99% of participants in the PVRV-NG group had RVNA titres ≥ 0.5 IU/mL, the second primary objective was not met. Booster vaccination produced a strong increase in RVNA titres for all groups, primed with PVRV-NG or HDCV. RVNA geometric mean titres tended to be higher for HDCV than PVRV-NG primary vaccine recipients. In a complementary evaluation using alternative criteria for seroconversion (complete virus neutralization at 1:5 serum dilution), 99.6% and 100% of participants in the PVRV-NG and HDCV groups, respectively, achieved seroconversion across the vaccine groups. No major safety concerns were observed during the study. PVRV-NG was well tolerated, with a similar safety profile to HDCV in terms of incidence, duration, and severity of adverse events after primary and booster vaccinations.ClinicalTrials.gov number: NCT01784874.     

Immunogenicity and safety study of Indirab: A Vero cell based chromatographically purified human rabies vaccine

A chromatographically purified Vero cell rabies vaccine, Indirab manufactured by Bharat Biotech International Limited, Hyderabad, India was subjected to safety and immunogenicity studies by both intramuscular and intradermal routes of administration in parallel with a reference vaccine, Verorab. A Pre-exposure study was undertaken in 239 subjects by intramuscular (IM) route (Study I), Post-exposure study in 188 patients by intramuscular route (Study II) and Simulated post-exposure study in 134 subjects by intradermal (ID) route (Study III). All subjects in these studies were administered with either the test or the reference vaccine as per WHO approved intramuscular and intradermal regimens. The blood samples were collected on days 0, 14 and 35 in case of Study 1, and days 0, 14, 28 and 90 in case of studies II and III. In all studies both vaccine groups had adequate antibody titers (>0.5 IU/mL) on all days tested post-vaccination and there was no significant difference in the titers observed (p > 0.05). Some side effects like pain, induration, itching and fever were noted in both vaccine groups in all studies. Both vaccines were well tolerated. Hence it can be concluded that Indirab is as safe and immunogenic as Verorab when administered by both intramuscular and intradermal routes.     

Single-visit, 4-site intradermal (ID) rabies vaccination induces robust immune responses 5 years after 1-week, 4-site ID primary post-exposure prophylaxis in the Philippines

BackgroundIn a randomized controlled study (NCT01622062) a 1-week, 4-site intradermal (ID, 4-4-4-0-0) post-exposure prophylaxis (PEP) rabies vaccination regimen with purified Vero cell rabies vaccine (PVRV, Verorab®, Sanofi Pasteur), either without (Group 1) or with (Group 2) purified equine rabies immunoglobulin (ERIG), patients in the Philippines achieved seroconversion rates at Day 14 that were non-inferior to that of the updated Thai Red Cross (TRC) 28-day, 2-site (2-2-2-0-2) ID regimen with ERIG (Group 3). Presented here are the annual immunogenicity data up to five years after the last primary dose, and the immunogenicity and safety data following simulated PEP with single-visit, 4-site ID regimen.MethodsRabies virus neutralizing antibodies (RVNA) were determined by rapid fluorescent focus inhibition test (RFFIT). Participants (n = 397) received simulated PEP vaccination ID at Year 5 and RVNAs were assessed at Day 11 post-vaccination.ResultsSeroconversion rates (RVNA titres ≥ 0.5 IU/mL) during annual follow-up remained >95% in Group 1 and were relatively stable at 80–90% in Group 2, but decreased from 80% to 64% in Group 3. RVNA geometric mean titres (GMTs) in Group 1 were consistently higher than in the other two groups, and those in Group 3 were generally lower than in the other two groups. There was a clear anamnestic response to vaccination in all groups, with all participants achieving RVNA titres ≥ 0.5 IU/mL at Day 11 post-simulated PEP booster vaccination. There were no safety concerns raised during annual follow-up and with simulated post-exposure vaccination with PVRV.ConclusionThe shortened, 1-week, 4-site ID regimen with PVRV achieved persistently higher RVNA titres than the updated 2-site TRC regimen, and more participants remained seroprotected up to five years after the last dose of primary immunization. Simulated post-exposure with 4-site ID rapidly induced an anamnestic response indicative of robust protection.     

沈阳市MSM参加HIV暴露前预防性用药临床试验的接受意愿调查

目的 探讨沈阳市MSM对事件驱动型（在性行为的前后特定时点）暴露前预防性用药（PrEP）预防HIV感染的接受意愿及其相关因素。方法 采用非概率抽样方法招募MSM研究对象,通过访谈式问卷调查获取社会背景学和性行为特征信息、PrEP知晓度、对特鲁瓦达（Truvada）不同服药方式的接受意愿,采用多因素logistic回归分析不同服药方式的相关因素。结果 292名MSM参加调查,PrEP知晓率为34.2%,接受事件驱动型服药方案的58.2%（170/292）高于接受日服型（每日定时）服药方案的48.3%（141/292）（χ²=5.785,P=0.02）。半年内男性性伴数>2人（aOR=1.7,95%CI：1.1~2.7）、关心药物有效性（aOR=6.4,95%CI：2.2~18.9）是接受两种服药方式共有的相关因素。存在HIV阳性性伴（aOR=8.1,95%CI：1.0~63.3）、自评HIV中高感染风险（aOR=2.6,95%CI：1.2~6.0）是接受事件驱动型服药方案独有的相关因素。结论 事件驱动型服药方案相比于日服型更易被MSM群体接受。对无法坚持每日服药、自身具有HIV危险感知意识的MSM建议推荐事件驱动型方案。     

A randomized non-inferiority clinical study to assess post-exposure prophylaxis by a new purified vero cell rabies vaccine (Rabivax-S) administered by intramuscular and intradermal routes

BackgroundRabies is a 100% fatal disease but preventable with vaccines and immunoglobulins. We have developed a new purified vero cell rabies vaccine (Rabivax-S) and evaluated its safety and immunogenicity in post-exposure prophylaxis by intramuscular (IM) and intradermal (ID) routes.MethodsThis was a randomized active-controlled non-inferiority study in 180 individuals (age 5 years and above) with suspected rabies exposure (90 each with WHO Category II and Category III exposures). The participants received either Rabivax-S (1 mL IM; five doses), Rabivax-S (0.1 mL ID; eight doses) or purified chick embryo cell vaccine (PCEC, Rabipur®) (1 mL IM; five doses). The IM doses were given on Day 0, 3, 7, 14 and 28 while the ID doses were given on days 0, 3, 7 and 28. Category III patients also received a human rabies immunoglobulin (HRIG) on Day 0. Adverse events (AEs) were recorded with diary cards till day 42. Rabies neutralizing antibody levels were measured on day 0, 7, 14, 28 and 42.ResultsIn both the category II and III patients, the geometric mean concentration (GMC) ratios of Rabivax-S IM and Rabivax-S ID groups to PCEC IM were more than 1, thus proving the non-inferiority. GMCs were similar or higher in Rabivax-S groups at all the time points. Seroresponse against rabies (RFFIT titre ⩾ 0.5 IU/mL) was achieved in all participants. Mostly mild local and systemic adverse events were reported across the three groups and all resolved without sequelae.ConclusionsRabivax-S was well tolerated and showed immunogenicity comparable to a licensed rabies vaccine by both IM and ID routes in post-exposure prophylaxis.Registry No.: CTRI/2012/11/003135     

A serum-free,purified vero cell rabies vaccine is safe and as immunogenic as the reference vaccine Verorab™ for pre-exposure use in healthy adults: Results from a randomized controlled phase-II trial

Background

Verorab™ was licensed in 1985 for both pre- and post-exposure prophylaxis of rabies. The next generation purified Vero cell rabies vaccine (PVRV-NG) is a highly purified vaccine. We performed a phase II clinical study in adults in France to assess its immunological non-inferiority and clinical safety for pre-exposure prophylaxis.

Methods

In a randomized phase-II trial, 384 healthy adult subjects were randomized (2:1) to receive a three-dose primary series of PVRV-NG or Verorab. One year later, the PVRV-NG group received a PVRV-NG booster while the Verorab group participants were randomized to receive a booster of PVRV-NG or Verorab for. Rabies virus neutralizing antibodies (RVNA) were evaluated on days 0, 28 (subgroup), 42, months 6, 12 and 12 + 14 days. Safety was evaluated for seven days after each dose. Adverse event between doses, until 28 days after the final dose was recorded. Serious adverse events were recorded up to 6 months after the last dose.

Results

The criterion for non-inferiority was met in the per-protocol analysis set and confirmed in the full analysis set (FAS). In the FAS, 99.6% and 100% of subjects had RVNA titers ≥0.5 IU/mL in PVRV-NG and Verorab groups, respectively. While RVNA levels gradually decreased over the 12-month period, at 6 and 12 months after vaccination >89% and >77%, respectively, in both groups had RVNA titers ≥0.5 IU/mL. The PVRV-NG booster induced a strong response, irrespective of the vaccine given for the primary series. PVRV-NG was safe and well tolerated and its safety profile was similar to Verorab for unsolicited adverse events and solicited systemic reactions. The incidence of solicited injection-site reactions was lower with PVRV-NG than with Verorab after the primary series and the booster dose.

Conclusions

PVRV-NG was shown to be at least as immunogenic as Verorab and to present a similar safety profile.     

Intradermal post-exposure rabies vaccination with purified Vero cell rabies vaccine: Comparison of a one-week, 4-site regimen versus updated Thai Red Cross regimen in a randomized non-inferiority trial in the Philippines

Background

Rabies post-exposure prophylaxis (PEP) via intradermal (ID) administration is standard practice in Asia. Accumulating evidence suggests that PEP shortened to 3 visits in one week does not adversely affect seroconversion rates or immune memory.

A comparative study on the safety and immunogenicity of purified duck embryo cell vaccine (PDEV,Vaxirab) with purified chick embryo cell vaccine (PCEC,Rabipur) and purifed vero cell rabies vaccine (PVRV,Verorab)

Rabies is a fatal but preventable disease. Cell culture vaccines (CCV) and purified duck embryo vaccines (PDEV) are currently recommended by WHO for post-exposure prophylaxis. In India, a PDEV (Vaxirab) is being manufactured and is in use since 2003. In the present study, we have evaluated the safety, immunogenicity and tolerance of this vaccine with two other WHO approved CCVs, viz., purified chick embryo cell vaccine (PCEC, Rabipur) and purified vero cell rabies vaccine (PVRV, Veroroab). This study was an open label, randomized phase IV comparative clinical trial. A total of 152 people bitten by dogs and other animals were recruited from 4 different centres from India. They were randomly assigned to receive one of the vaccines by Essen intramuscular regimen (52 subjects received Vaxirab and 50 each Rabipur and Verorab) and rabies immunoglobulin was also administered in all category III exposures. Their blood samples were collected on day 0 (prior to vaccination), 14, 28, 90 and 180. Side effects if any were monitored. The rabies neutralizing antibody titers in their blood samples were estimated by the rapid fluorescent focus inhibition test (RFFIT). Subjects in all three groups had neutralizing antibody titers by day 14 (>0.5 IU/mL) and geometric mean titers (GMT) observed for different vaccines on all days tested did not vary significantly (p > 0.5). Side effects observed were minimal and did not vary significantly among the groups. The results of the present study indicate that PDEV (Vaxirab) is as safe, tolerable and immunogenic as both PCEC (Rabipur) and PVRV (Verorab). Thus this vaccine can be a good alternative to WHO approved CCVs for rabies post-exposure prophylaxis.     

MSM人群对HIV暴露前预防知识知晓及相关因素研究

目的  了解不同城市和年份的男男性行为者(men who have sex with men, MSM)对HIV暴露前预防(pre-exposure prophylaxis, PrEP)知识知晓变化情况及其影响因素。方法  依托社区组织分别在2019年和2021年采用电子问卷收集北京市、深圳市和昆明市的MSM人群的基本社会人口学情况、PrEP知识知晓、行为学情况等,并进行相关因素分析。结果  共调查4 889名MSM,其中2019年2 399人,2021年2 490人。2019年PrEP知识知晓占6.29%,2021年占25.02%。多因素logistic回归分析模型分析结果显示,2019年调查对象PrEP知识知晓促进因素包括年龄在25~ < 35岁(OR=1.685, 95% CI: 1.007~2.821)和≥35岁(OR=29.01, 95% CI: 1.156~3.497)、咨询过PrEP(OR=1.731, 95% CI: 1.050~2.855)、暴露后预防(post-exposure prophylaxis, PEP)知识知晓(OR=3.178, 95% CI: 2.079~4.860)。2021年调查对象PrEP知识知晓相关因素包括文化程度(本科/大专：OR=3.291, 95% CI: 1.595~6.793;研究生及以上：OR=4.507, 95% CI: 2.104~9.652)、曾咨询过PrEP(OR=2.591, 95% CI: 1.906~3.521)、PEP知识知晓(OR=5.855, 95% CI: 3.071~11.161)、使用过PEP(OR=1.619, 95% CI: 1.191~2.200)、使用助性剂(OR=0.623, 95% CI: 0.492~0.789)、一年内检测次数为3~4次(OR=2.140, 95% CI: 1.265~3.619)和≥5次(OR=3.414, 95% CI: 1.987~5.865)。结论  2021年MSM的PrEP知识知晓水平较2019年大幅度提高,但总体仍然低。影响知晓水平的相关因素包括MSM年龄、文化程度、进行过HIV检测、知晓及应用过PEP措施等,应继续采取综合性的措施加强对MSM人群关于PrEP的宣传教育,提高其对PrEP正确的认知。     

Safety and immunogenicity of two freeze-dried Vero cell rabies vaccines for human use in post-exposure prophylaxis

To provide basis for human rabies vaccination in China, the safety and immunogenicity of two freeze-dried Vero cell rabies vaccines for human use were assessed. A total of 250 volunteers were enrolled and divided into two groups: volunteers in Group A (n = 200) were vaccinated five doses of Speeda Vero cell rabies vaccine manufactured by Liaoning Chengda Biotechnology Co. Ltd. on day 0, 3, 7, 14, 28 after exposure. Volunteers in Group B (n = 50) were treated with Verorab Vero cell rabies vaccine manufactured by Sanofi Pasteur on the same schedule. The local and systematic adverse reactions were observed. Serum neutralizing antibody levels of 80 individuals in Group A and 50 individuals in Group B were tested with RFFIT on day 7, 14, 45, 180, 360 after the first dose. The seroconversion rates in Groups A and B were 40.3% and 37.0% on day 7 after the first dose, 95.5% and 97.7% on day 14, 100% and 100% on day 45, 100% and 100% on day 180, 89.1% and 89.5% on day 360 respectively, indicating no significant differences between the two groups. And no significant differences were found between the neutralizing antibody geometric mean titers (GMTs) of the two groups on day 7, 14, 45, 180 and 360 after the first dose, with the GMTs of day 14, 45, 180 and 360 all higher than 0.5 IU/ml. Antibody levels of the two groups peaked around 2 weeks after the full vaccination program, followed by a 55% decrease up to day 180 and another 76% decrease up to day 360. Both groups experienced occasions of transient fever, rash, edema, and scleroma after vaccination. Neither group had any severe adverse reactions. It was concluded that both vaccines showed satisfactory safety and immunogenicity. Booster vaccination is recommended following another exposure after six months since the full vaccination program.     

Immunogenicity and safety of two-visit,intradermal pre-exposure rabies prophylaxis simultaneously administrated with chimeric live-attenuated Japanese encephalitis vaccine in children living in rabies and Japanese encephalitis endemic country

BackgroundReducing the number of doses required for pre-exposure prophylaxis (PrEP) would make it more feasible and cost-effective to implement in children at the highest risk of rabies exposure in Asia. We studied immune response of 2-site intradermal (ID) injection of rabies vaccine on days 0 and 28 for rabies PrEP simultaneously administrated with live-attenuated Japanese encephalitis chimeric virus vaccine (JE-CV) for children living in endemic area.Research design and methodsSeronegative children (n = 49) aged 12–16 months were randomized 2:1 into two groups: Group A subjects were vaccinated with 0.1-mL ID injection of purified Vero cell rabies vaccine (PVRV), each at two sites on day (D) 0 and D28; Group B subjects were vaccinated with conventional 0.5-mL intramuscular PVRV on D0, D7 and D28. Both groups received one dose of JE-CV subcutaneously on D0 and D365. Rabies virus neutralizing antibody (RVNA) titers were measured on D0, D42 and D365 after vaccination; Japanese Encephalitis (JE) neutralizing antibody titers were determined on D0, D42, D365 and D379.ResultsAll children had RVNA ≥ 0.5 IU/mL on D42 (geometric mean titers [GMTs] of RVNA 14.35 IU/mL [Group A] and 14.83 IU/mL [Group B], p > 0.05]). On D365, RVNA GMTs of subjects in group A and B were 1.50 IU/mL and 2.00 IU/mL (p > 0.05), respectively. All children had seroprotection following booster dose of JE-CV. There were no vaccine-related SAEs observed.ConclusionThe 2-site ID PrEP with PVRV on days 0 and 28 co-administrated with JE-CV are safe and immunogenic.     

暗娼对HIV暴露前预防药物的认知及使用意愿研究进展

暗娼在性行为过程中处于弱势地位,HIV感染风险较高。在暗娼中推广暴露前预防（PrEP）药物可以预防感染HIV。本文综述了暗娼对PrEP药物的认知情况、使用意愿、影响因素和潜在风险补偿,为扩大PrEP药物在该人群中的运用提供参考依据。     

男男性行为人群HIV暴露前预防需求与使用障碍研究

目的 了解MSM对HIV暴露前预防（PrEP）的实际需求及阻碍其使用的相关因素。方法 通过同性社交Blued 6.5.0软件、MSM同伴推荐等方法招募MSM为调查对象，估算样本量600人。利用"问卷星"平台，在调查员的指导下进行匿名电子问卷调查，调查内容包括一般情况、PrEP相关知识和使用意愿与顾虑、PrEP实际需求及PrEP使用自我效能等。结果 共调查622名MSM，知晓和曾使用过PrEP的比例分别为56.4%（351/622）和4.3%（27/622）；67.2%（418/622）有PrEP实际需求，PrEP使用自我效能良好的为21.2%（132/622）。结构方程模型分析结果显示，PrEP相关知识和使用顾虑对PrEP使用自我效能发挥直接正向作用，效应系数分别为0.08和0.13，自我歧视是由于PrEP使用顾虑而间接影响PrEP使用自我效能，效应系数为0.035；广义线性混合模型分析结果表明，曾使用过PrEP可增加使用自我效能（OR=5.55）；PrEP相关知识和使用顾虑每增加1分，PrEP使用自我效能分别增加0.14倍和0.07倍。担心药物副作用、预防效果和费用者分别占61.1%（380/622）、60.1%（374/622）和53.2%（331/622）；期望获取PrEP服务途径主要为CDC（75.6%，470/622）、MSM社会组织（65.4%，407/622）和互联网（63.8%，397/622）。结论 MSM对PrEP呈现高需求与低使用的较大差距，PrEP相关知识缺乏、自我歧视、对药物预防效果、副作用及费用的顾虑是阻碍MSM使用PrEP的因素，故需要建立适合MSM特点的PrEP服务模式，以满足MSM对PrEP干预的需求。     

广西地区650 名男男性行为者对暴露前预防HIV感染接受意愿及其影响因素研究

目的 了解广西地区男男性行为者(MSM)对暴露前预防(PrEP)HIV感染的接受意愿及其影响因素.方法 采用滚雪球法招募650名MSM,利用自行设计的调查问卷一对一面访,了解MSM与艾滋病相关的高危行为、对PrEP的知晓情况及接受意愿.结果 假设PrEP使用的药物安全、有效且免费提供,有91.9%的MSM表示愿意服用药物.自述愿意服药的原因主要为可降低HⅣ感染的风险,不愿意服用药物的原因主要为担心药物的副作用和怀疑药物的效果.logistic回归分析显示,与接受PrEP意愿有关的因素为"是否通过朋友介绍性伴"(OR=6.21,P=0.020)、"是否有能力预防HIV感染"(OR=O.32,P=0.010)、"是否拒绝与不使用安全套的人发生性行为"(OR=0.34,P=0.010)、"是否建议朋友接受PrEP"(OR=39.32,P=0.000).结论 药物的安全性、有效性及费用可能是影响广西地区MSM接受PrEP的主要因素,免费提供安全、有效且副作用小的药物可能是推广PrEP的较好方式;以同伴教育的方式宣传PrEP可能会提高其接受意愿.

Abstract：

Objective To study the acceptability of pre-exposure prophylaxis (PrEP) to prevent the transmission of HIV among men who have sex with men (MSM) in Guangxi, China.Methods Snow-balling methods were used to recruit 650 MSM in Guangxi. Questionnaires and interview were administrated to these 650 men, using a self-designed questionnaire and face to face interviews to collect information on HIV-related risk behaviors, knowledge and acceptability of PrEP.effective, safe and free of charge', 597 (91.9%) of the 650 MSM claimed that they would accept it,who refused to use it, most of them said that were afraid of the side-effect and doubted on the effectiveness of PrEP. Data from logistic regression analysis showed that those who had found partners through friends (OR=6.21, P=0.020) and those who would advise his friend to use PrEP (OR=39.32, P=0.000) were more likely to accept PrEP. Those who thought they could protect themselves from HIV infection (OR=0.32, P=0.010) or not having sex with the ones who refused to use a condom (OR=0.34, P=0.010) were less likely to accept PrEP. Conclusion Effectiveness, safety and cost seemed to be the main influential factors related to the acceptability of PrEP. Peer education might improve the acceptability of PrEP.     

我国24个城市男男性行为者HIV暴露前预防用药现状及相关因素分析

目的了解我国MSM对HIV暴露前预防(PrEP)的认知和用药现状及影响因素。方法 2021年8月25日至9月5日通过男性社交平台Blued 7.5软件在我国24个城市招募MSM 2 447人参与线上问卷调查, 调查内容包括社会人口学、PrEP知晓和用药与高危性行为等信息。采用三分类二水平logistic回归分析MSM的PrEP用药相关因素。采用SPSS 24.0和SAS 9.4软件进行统计学分析。结果在MSM研究对象2 447人中, 听说过PrEP者1 712人(69.96%), 曾用药者437人(17.86%), 正在用药者274人(11.20%), 停用者163人(6.66%);437人曾用药者多数采用了按需用药方式, 用药方案采用替诺福韦+恩曲他滨的占61.88%(388/627), 人均用量为1.12片/周, 获取药物以互联网为主, 选择药物更关注PrEP用药的预防效果;163人停药最常见原因是认为没有HIV感染的风险。logistic回归分析结果显示, MSM中PrEP用药与年龄、月均收入、最近1年发生无保护肛交、最近1年使用助性剂和被诊断出患有性病等因素存在统计学关联, 其...     

大学生男男性行为者对艾滋病暴露前预防知识知晓及其影响因素

目的 了解我国大城市大学生MSM对艾滋病暴露前药物预防（PrEP）知识知晓情况及其影响因素。方法 采用网上问卷调查方式收集北京、深圳、昆明三市的大学生中男男性行为者（MSM）的基本情况、行为学特征、艾滋病防治知识知晓、PrEP知识知晓情况,并以PrEP知识知晓为因变量,进行单因素和logistic回归模型多因素分析。结果 共调查293名大学生MSM,平均年龄为21.0(20.8～21.2)岁,本科生占91.1%。调查对象中男性伴数多于1个者占38.9%,每次性行为都使用安全套者占68.0%,近一年内29.4%未进行HIV检测。大学生MSM中艾滋病防治知识知晓率为 92.2%(270/293),PrEP知识知晓率为34.5%,74.7%听说过PrEP; 53.6%认为PrEP作用是预防HIV,73.7%认为接受PrEP同时要使用安全套。多因素分析结果显示,近3个月每次同性行为使用安全套（OR=3.394,95% CI:1.179～9.773),近一年内HIV检测次数大于2次（OR=2.181.95% CI:1.062～4.479）是大学生MSM知晓PrEP的影响因素。结论 大学生对于PrEP的正确认知仍不足,但出于对自身健康的关心,能主动获取PrEP相关的知识和信息,应结合高校内艾滋病防治知识宣传和健康教育,进行PrEP知识宣传和健康教育。     

The performative function of expectations in translating treatment to prevention: The case of HIV pre-exposure prophylaxis,or PrEP

This paper is about expectations of oral PrEP, ‘a pill a day’ HIV pre-exposure prophylaxis that could be the first systemic form of HIV prevention for sexual or needle stick exposures. If found safe and effective—a difficult criteria to establish and, as such, is central to this paper—PrEP has the potential to significantly alter HIV prevention, well ahead of a vaccine or topical microbicide. Hence, despite uncertainty about PrEP's viability, the potential significance of its impact on the HIV field requires early planning. In order to address this potentiality, we use a methodological approach drawn from the sociology of expectations to examine interviews with United States-based scientific stakeholders in the trialing of PrEP. We identify how PrEP is anticipated as both stable object and process involving multiple contingencies. These divergent conceptions enable us to illuminate a range of social, cultural, ethical, pharmaceutical and medical possibilities understood to potentially arise with PrEP. Further, they lead us to propose that the multiple contingencies that enact PrEP as an emergent entity offer scope for rethinking PrEP and, more broadly, the challenges of HIV prevention.