Safety and Viral Shedding of Live Attenuated Influenza Vaccine (LAIV) in Chinese Healthy Juveniles and Adults: A Phase â Randomized, Double-Blind, Placebo-Controlled Study.

This study was a randomized, double-blind, placebo-controlled study to evaluate the safety and viral shedding of live attenuated influenza vaccine (LAIV) in Chinese healthy juveniles and adults. A total of 80 Eligible volunteers were divided into two age groups (≥18 and 3-17 years old). Volunteers were randomly and equally assigned to the experimental group and placebo-controlled group by ratio of 3:1 in each age group. Vaccination was carried out in steps. Totally, 34 (56.67%) adverse events and 24 (40.00%) adverse reactions of the LAIV group were reported. Most adverse reactions were grade 1 and grade 2, and the incidence of adverse reactions that grade 3 was 5%. The most common local reaction was runny nose/nasal congestion (n = 4, 6.67%). And the most common general reaction was fever (n = 10, 16.67%). There were no statistically significant differences in the incidence of total adverse reactions, different grades of adverse reactions, and symptoms between the experimental group and placebo-controlled group. No severe adverse events were reported. Three subjects (5.00%) had been detected vaccine strains on the 3rd day after LAIV vaccination; one was type B and the other two were H3N2. Four subjects (6.67%) had been detected with vaccine strains on the 7th day after LAIV vaccination, all were H3N2. There were no subjects detected carrying the influenza virus on the 15th day after vaccination. There were no statistically significant differences in the positive rate of vaccine strains of influenza virus between the experimental group and placebo-controlled group. The vaccine was well tolerated and not associated with increased rates in adverse reactions or the occurrence of severe adverse events. Pathogenicity of shed vaccine virus to surrounding people was not observed. Thus, Phase Ⅱ study can be carried out as scheduled.

Neutralizing antibody activity, safety and immunogenicity of human anti-rabies virus monoclonal antibody (Ormutivimab) in Chinese healthy adults: A phase â ¡b randomized, double-blind, parallel-controlled study.

OBJECTIVE: This study was a randomized, double-blind, parallel-controlled trail to evaluate the rabies virus neutralizing activity（RVNA）, safety and immunogenicity of Ormutivimab + rabies vaccine in Chinese healthy adults. METHODS: Subjects were randomly and equally assigned to 4 groups (20 IU/kg Omtv + vaccine, 40 IU/kg Omtv + vaccine, 20 IU/kg HRIG + vaccine, and placebo + vaccine). Subjects received vaccine as the WHO Essen regime combined with Omutivimab、HRIG or placebo on Day 0. The study lasted for 43 days. RESULTS: A total of 240 subjects were simultaneously assigned to both FAS and SS. Fifty subjects with baseline RVNA > 0.05 IU/ml (detection limit) were excluded, 190 were included into mITT. All the subjects from 40 IU/kg Omtv + vaccine group had a protection level of RNVA (≥0.5 IU/ml, WHO) on Day 14, and those in 20 IU/kg Omtv + vaccine group and placebo + vaccine group converted positive 100 % on Day 28. In contrast to 20 IU/kg HRIG + vaccine and placebo + vaccine, Ormutivimab + vaccine provided a higher RVNA during Days 0 to 7. And RVNA in 40 IU/kg Omtv + vaccine and 20 IU/kg Omtv + vaccine groups were always higher than 20 IU/kg HRIG + vaccine group during the whole study. Although anti-Omtv antibody were detected in some subjects, it did not influence the RVNA. The incidence of adverse reactions was significantly lower in 20 IU/kg Omtv + vaccine group (17.2 %) than in 40 IU/kg Omtv + vaccine (36.7 %) and 20 IU/kg HRIG + vaccine groups (40.3 %). CONCLUSION: Compared with HRIG + vaccine and placebo + vaccine, Omtv + vaccine provided higher RNVA for earlier immune protection. The interference of Ormutivimab on the long-term immune protection induced by rabies vaccine is weaker than HRIG. At the same dose, the adverse reactions of Omtv + vaccine group were less than HRIG + vaccine group. REGISTRATION: ClinicalTrials.gov #NCT02559921.

Immunogenicity, safety and antibody persistence of a purified vero cell cultured rabies vaccine (Speeda) administered by the Zagreb regimen or Essen regimen in post-exposure subjects.

AIM: To compare the safety, immunogenicity and long-term effect of a purified vero cell cultured rabies vaccine in post-exposure subjects following 2 intramuscular regimens, Zagreb or Essen regimen. METHODS: Serum samples were collected before vaccination and on days 7, 14, 42, 180 and 365 post vaccination. Solicited adverse events were recorded for 7 d following each vaccine dose, and unsolicited adverse events throughout the entire study period. This study was registered with ClinicalTrials.gov (NCT01821911 and NCT01827917). RESULTS: No serious adverse events were reported. Although Zagreb regimen had a higher incidence of adverse reactions than Essen regimen at the first and second injection, the incidence was similar at the third and fourth injection between these 2 groups as well. At day 42, 100% subjects developed adequate rabies virus neutralizing antibody concentrations (≥ 0.5IU/ml) for both regimens. At days 180 and 365, the antibody level decreased dramatically, however, the percentage of subjects with adequate antibody concentrations still remained high (above 75% and 50% respectively). None of confirmed rabies virus exposured subjects had rabies one year later, and percentage of subjects with adequate antibody concentrations reached 100% at days 14 and 42. CONCLUSIONS: Rabies post-exposure prophylaxis vaccination with PVRV following a Zagreb regimen had a similar safety, immunogenicity and long-term effect to the Essen regimen in China.

Impact of Antiretroviral Therapy on the Spread of Human Immunodeficiency Virus in Chaoyang District, Beijing, China: Using the Asian Epidemic Model.

BACKGROUND: Successful antiretroviral therapy (ART) has been demonstrated to be effective in reducing the infectivity of human immunodeficiency virus (HIV). We conducted a study to predict the potential effect of ART on the spread of HIV in Chaoyang District, Beijing, China, using the Asian Epidemic Model (AEM). METHODS: The AEM baseline workbook was used to determine the current infection status and to project the future spread of HIV under current conditions. We changed the input on the ART coverage from 2014 to 2025 and also modified the treatment eligibility in the AEM intervention workbook, in order to allow for analysis of the projected downstream impact of ART. RESULTS: By gradually increasing the ART coverage rate from 29.7% (rate of 2013) to 40.0%, 50.0%, 60.0%, 70.0%, 80.0%, and 90.0% (at CD4+ ≤350 cells/µl), and by changing the dates of coverage from 2014 to 2020, the number of new infections showed a cumulative decline of 0.60%, 1.59%, 2.94%, 5.33%, 9.32%, and 14.98%, respectively. After 2020, the projected rates of infection rebounded slightly, so with the exception of the years with very high coverage (90.0%), new infections continued to decrease. When we changed the initial threshold of therapy to CD4+ cell counts ≤500 cells/µl, new infections decreased 6.00%, 11.64%, 15.92%, 21.11%, 26.92%, 33.05%, and 38.75%, respectively, under varying ART coverages. CONCLUSION: Our study demonstrates that the early initiation of ART for people living with HIV/acquired immune deficiency syndrome (AIDS) has a positive effect in slowing the spread of HIV.

Bisphenol A Metabolites and Bisphenol S in Paired Maternal and Cord Serum.

Human studies show associations between maternal bisphenol A (BPA) exposure and developmental effects in children, yet biomonitoring of BPA metabolites in maternal and fetal serum remains limited, and less is known for BPA alternatives. BPA-glucuronide, BPA-sulfate, and bisphenol S (BPS) were quantified in 61 pairs of maternal and cord sera from Chinese participants. Total BPS was only detectable in four maternal (<0.03-0.07 ng/mL) and seven cord sera (<0.03-0.12 ng/mL), indicating low exposure but providing the first evidence that BPS crosses the human placenta. Total BPA metabolites in cord serum were significantly higher than in maternal serum (p < 0.05), suggesting that these may be formed in the fetus or cleared more slowly from the fetoplacental compartment. Unlike the pharmacokinetic results from controlled oral exposure studies in which BPA-glucuronide is the major BPA metabolite, here, BPA-sulfate was the dominant metabolite (GM: 0.06 and 0.08 ng/mL), significantly higher than BPA-glucuronide (GM: 0.02 and 0.04 ng/mL) (p < 0.01) in both maternal and cord sera. Moreover, the proportion of BPA-sulfate increased with total BPA. These are the first human data for BPA metabolites in paired maternal and cord serum, and results suggest that the human fetus and pregnant mother have unique exposure to BPA metabolites. Direct analysis of BPA metabolites in serum provides complementary information for evaluating early life-stage exposure and risks of BPA.

Immunogenicity and safety of purified vero cell rabies vaccine (PVRV) produced by Liaoning Cheng Da Co. under Zagreb 2-1-1 or 5-dose Essen regimen in Chinese adults aged 50 and above.

BACKGROUND: Two kinds of regimens (2-1-1 and 1-1-1-1-1) can be selected after Zagreb regimen(2-1-1)of PVRV was officially approved in Beijing in January 2015. Up to now, the subjects for most studies about the comparison between Zagreb and Essen regimen are under 50 y old, rarely at and above. Aging of the immune system may result in decreasing efficacy of vaccination, especially for adults aged above 65-70 y. This study compared the safety and immunogenicity of the Zagreb and Essen regimen in Chinese adults aged 50 and above with the goal to provide a supplemental data for this age group. METHODS: A total of 114 cases were divided into 2 groups randomly, received PVRV under the Zagreb and Essen regimens respectively. Serum samples were collected at D0, D7, D14, D42, D180 and D365 to determine the rabies serum neutralizing antibody by rapid fluorescent focus inhibition test (RFFIT). Safety analyses were made by comparing the AEs in day-3, day-7, and day-(7 + 21) in Zagreb or day-(7 + 28) in Essen by gender and age cohorts. RESULTS: 617 blood samples were obtained. Two groups showed similar immunogenicity, the neutralizing antibody titer of all subjects at D14 and D42 showed >0.5 IU/ml. Under the same regimen, Subjects ≥65 y had lower GMC than those who <65 years from D7 to D365 within 2 groups. This difference was significantly shown on D7, D14, D180 in Zagreb group, and on D180 in Essen group (t = 2.38, p = 0.02; t = 3.78, p < 0.001; t = 2.30, p = 0.03; t = 4.42, p < 0.001). Subjects<65 years had higher seroconversion rate compared to ≥65 y on D7, D180 and D365 in both 2 groups, this difference was also significantly shown on D180, D365 in Zagreb group and on D180 in Essen group (χ2 = 20.66, p < 0.001; χ2 = 6.56, p = 0.02; χ2 = 10.96, p = 0.002). Two regimens all showed favorable performances with mildly or common adverse events (AEs). The incidence of local AEs after 3 d in Essen group was higher than Zagreb group (χ2 = 9.69, p = 0.002). The most common local AE was pain, the incidences (8.8%) in Zagreb group was higher than Essen group (8.4%, χ2 = 5.12, p = 0.02). All AEs for Zagreb group and 52.3% of AEs for Essen group occurred during the first 72 hours. During the first 72 hours, subjects aged <65 in Zagreb group (16.26%) had higher incidences of AEs than Essen group (8.57%, χ2 = 4.54, p = 0.03), males in Zagreb group (16.05%) had higher incidence of AEs than Essen group (5.71%, χ2 = 5.34, p = 0.02). The incidences of AEs close in during the first 7 d. CONCLUSION: The Zagreb and Essen regimens demonstrated the similar safety and efficacy of PVRV in Chinese adults aged 50 and above. People ≥65 y showed reduced immune response to both regimens. More AEs for the Zagreb regimen were observed within the first 72 hours, especially for male and people < 65 y.

A Personalized Electronic Movie Recommendation System Based on Support Vector Machine and Improved Particle Swarm Optimization.

With the rapid development of ICT and Web technologies, a large an amount of information is becoming available and this is producing, in some instances, a condition of information overload. Under these conditions, it is difficult for a person to locate and access useful information for making decisions. To address this problem, there are information filtering systems, such as the personalized recommendation system (PRS) considered in this paper, that assist a person in identifying possible products or services of interest based on his/her preferences. Among available approaches, collaborative Filtering (CF) is one of the most widely used recommendation techniques. However, CF has some limitations, e.g., the relatively simple similarity calculation, cold start problem, etc. In this context, this paper presents a new regression model based on the support vector machine (SVM) classification and an improved PSO (IPSO) for the development of an electronic movie PRS. In its implementation, a SVM classification model is first established to obtain a preliminary movie recommendation list based on which a SVM regression model is applied to predict movies' ratings. The proposed PRS not only considers the movie's content information but also integrates the users' demographic and behavioral information to better capture the users' interests and preferences. The efficiency of the proposed method is verified by a series of experiments based on the MovieLens benchmark data set.

Incidence of Co-Infections of HIV, Herpes Simplex Virus Type 2 and Syphilis in a Large Cohort of Men Who Have Sex with Men in Beijing, China.

BACKGROUND: The HIV-epidemic among MSM in China has worsened. In this key population, prevalence of HSV-2 and syphilis infection and co-infection with HIV is high. METHODS: A longitudinal study was conducted (n = 962) in Beijing, China, with three overlapping cohorts (n = 857, 757 and 760) consisting of MSM that were free from pairs of infections of concern (i.e. HIV-HSV-2, HIV-syphilis, HSV-2-syphilis) at baseline to estimate incidence of HIV, HSV-2, syphilis, and those of co-infection. RESULTS: The incidence of HIV, HSV-2 and syphilis in the overall cohort was 3.90 (95% CI = 2.37, 5.43), 7.87 (95% CI = 5.74, 10.00) and 6.06 (95% CI = 4.18, 7.94) cases per 100 person-years (PYs), respectively. The incidence of HIV-HSV-2, HIV-Syphilis and HSV-2-Syphilis co-infections was 0.30 (95% CI = 0.29, 0.88), 1.02 (95% CI = 0.13, 2.17) and 1.41 (95% CI: 0.04, 2.78) cases per 100 PYs, respectively, in the three sub-cohorts constructed for this study. CONCLUSIONS: The incidence of HIV, HSV-2 and syphilis was very high and those of their co-infections were relatively high. Such co-infections have negative impacts on the HIV/STI epidemics. Prevention practices need to take such co-infections into account.

Immunological persistence of a seasonal influenza vaccine in people more than 3 years old.

To evaluate antibody persistence of Aleph inactivated split influenza vaccine, 3308 healthy Chinese people more than 3 years old were enrolled in a hemagglutination inhibition (HI) assay before vaccination, 641 were screened by HI assay negative, 437 of which received one dose of Aleph inactivated split influenza vaccine and 204 of which received one dose of control vaccine (recombinant hepatitis B). After vaccination, the receivers were collected blood at 1st month, 3rd month, 6th month and 12th month for Aleh influenza vaccine antibody persistence assess. The antibody test were determined by hemagglutination inhibition (HI) assay. There were significant difference in antibody geometric mean titer between experimental group and control at 1st month and 3rd month after vaccination. Influenza antibody could persist at least up to 3rd month. Because of the local spring influenza epidemic, we could not analyze the results of 6th and 12th month. Aleph influenza vaccines showed good immune persistence in healthy volunteers at least in the 3 months after vaccination. Influenza viruses are important human respiratory pathogens. Immunization is widely acknowledged to currently be the most effective method of minimizing the impact of pandemic influenza. Through we have checked many references about Influenza vaccine, the duration of protective antibody for influenza vaccines are still not available. Based on this situation and our previous work, (11) Influenza vaccine antibody duration analyze are necessary. This manuscript presents data on the persistence of Hemagglutination Inhibition (HI) immune response against the A/California/7/2009(H1N1), A/Peth/16/2009(H3N2) strain and B/Brisbane/60/2008. 641 were screened from 3302 volunteers by HI test of influenza A and confirmed enrollment based on the antibodies titer less than 1:10. After administered with one dose of Aleph influenza vaccine, blood samples were collected. 437 subjects (3-10 y: 131; 11-17 y: 110; 18-54 y: 69; ≥ 55 y: 127) were vaccinated influenza vaccine as test group. 204 subjects (3-10 y: 70; 11-17 y: 47; 18-54 y: 28; ≥ 55 y: 59) were vaccinated recombinant hepatitis B vaccine as control group. Immunogenicity end points were based on the European licensure criteria for pandemic influenza vaccines. The persistence of HI immune response against the vaccine strain was assessed through GMT. The immunogenicity of the Aleph influenza vaccine induced all reached the standards at 1st month and GMTs peak could persist at least up to 3rd month. (This study has been registered at clinicaltrials.gov under registration no. NCT01758185.). Because of the local spring influenza epidemic we could not analyze the results of 6th and 12th month. Aleph influenza vaccines showed good immune persistence in healthy volunteers at least in the 3 months after vaccination.

Molecular typing of Chinese Streptococcus pyogenes isolates.

Streptococcus pyogenes causes human infections ranging from mild pharyngitis and impetigo to serious diseases including necrotizing fasciitis and streptococcal toxic shock syndrome. The objective of this study was to compare molecular emm typing and pulsed field gel electrophoresis (PFGE) with multiple-locus variable-number tandem-repeat analysis (MLVA) for genotyping of Chinese S. pyogenes isolates. Molecular emm typing and PFGE were performed using standard protocols. Seven variable number tandem repeat (VNTR) loci reported in a previous study were used to genotype 169 S. pyogenes geographically-diverse isolates from China isolated from a variety of disease syndromes. Multiple-locus variable-number tandem-repeat analysis provided greater discrimination between isolates when compared to emm typing and PFGE. Removal of a single VNTR locus (Spy2) reduced the sensitivity by only 0.7%, which suggests that Spy2 was not informative for the isolates screened. The results presented support the use of MLVA as a powerful epidemiological tool for genotyping S. pyogenes clinical isolates.

Nitrite inhalants use and HIV infection among men who have sex with men in China.

OBJECTIVE: This is the first study in China to examine the use of nitrite inhalants and its correlates among men who have sex with men (MSM) in Beijing, China. METHODS: A cross-sectional survey was conducted in 2012. Structured interviews collected data on demographics, sexual and drug use behaviors, and the use of HIV services. Blood specimens were collected and tested for HIV and syphilis. RESULTS: A total of 400 MSM eligible for the study were between 19 and 63 years of age and overall HIV prevalence was 6.0% (9.0% among nitrite inhalant users and 3.3% among nonusers). Nearly half (47.3%) of them reported ever using nitrite inhalants and 42.3% admitted using nitrite inhalants in the past year. Multivariable logistic analysis revealed that ever using nitrite inhalants in the past was independently associated with being aged ≤25 years, having higher education attainment, seeking sex via Internet, having casual partners in the past three months, and being HIV positive. CONCLUSION: The use of nitrite inhalants was alarmingly prevalent among MSM in Beijing. The independent association of the nitrite inhalant use with more casual sex partners and HIV infection underscored the need for intervention and prevention of nitrite inhalant use.

A randomized, controlled, blinded study of the safety, immunogenicity and batch consistency of Aleph inactivated split influenza vaccine made in China in Chinese people.

To evaluate the safety, immunogenicity and batch consistency of Aleph inactivated split influenza vaccine, 3308 healthy Chinese people more than 3 years old were enrolled in a randomized, controlled, blinded study and divided into four age groups: 3-10 years, 11-17 years, 18-54 years, and more than 55 years. Each age group was then randomized (2:1) to receive either influenza vaccine or control vaccine (recombinant hepatitis B) for one dose. Also each influenza vaccine group was randomized (1:1:1) to receive three different batches of influenza vaccine. Systematic and local adverse reactions for 28 days after vaccination were recorded, and influenza antibody titer was determined by hemagglutination inhibition (HI) assay at 28 days after vaccination. There were significant differences in seroconversion and seroprotection rates achieved post-immunization of three strains of influenza antibody (H1N1, H3N2, B) between experimental group and control group in all age groups (P<0.05). In addition, there were no statistically significant differences in local and systematic reaction rates after vaccination between the experimental and control group in all age groups (P>0.05), except for the systematic reaction rates in the 18-54 years and ≥ 55 years age groups (P<0.05). Thus, Aleph inactivated split influenza vaccine has good safety and immunogenicity.

Immunogenicity and safety of three 2010-2011 seasonal trivalent influenza vaccines in Chinese toddlers, children and older adults: a double-blind and randomized trial.

The 2009 influenza A(H1N1) pandemic strain was for the first time included in the 2010-2011 seasonal trivalent influenza vaccine (TIV). We conducted a double-blind, randomized trial in Chinese population to assess the immunogenicity and safety of the 2010-2011 TIV manufactured by GlaxoSmithKline and compared it with the counterpart vaccines manufactured by Sanofi Pasteur and Sinovac Biotech. Healthy toddlers (6-36 mo), children (6-12 y) and older adults (≥60 y) with 300 participants in each age group were enrolled to randomly receive two doses (toddlers, 28 d apart) or one dose (children and older adults). The immunogenicity was assessed by hemagglutination-inhibition (HI) assay. The solicited injection-site and systemic adverse events (AEs) were collected within 7 d after vaccination. All the three TIVs were well-tolerated with 15.1% of participants reporting AEs, most of which were mild. No serious AEs and unusual AEs were reported. Fever and pain were the most common systemic and injection-site AEs, respectively. The three TIVs showed good immunogenicity. The seroprotection rates against both H1N1 and H3N2 strains were more than 87% in toddlers after two doses and more than 95% in children and more than 86% in older adults after one dose. The seroprotection rates against B strain were 68-71% in toddlers after two doses, 70-74% in children and 69-72% in older adults after one dose. In conclusion, the three 2010-2011 TIVs had good immunogenicity and safety in Chinese toddlers, children and older adults and were generally comparable in immunogenicity and reactogenicity.

A randomized, controlled, blinded study of the safety and immunogenicity of Haemophilus influenzae type b conjugate vaccine injected at different intramuscular sites in Chinese infants.

To compare the safety and immunogenicity of Haemophilus influenzae type b (Hib) conjugate vaccine administered via the vastus lateralis and deltoid muscles, 320 healthy Chinese infants<12 mo of age were enrolled in a randomized, controlled, blinded study and divided into 2 age groups: 2-5 mo and 6-12 mo. Each age group was then randomized (1:1) to either the vastus lateralis (experimental) group who received Hib vaccination into this muscle 2 or 3 times at monthly intervals, or the deltoid (control) group who received Hib vaccination into this muscle either 3 times (2-5 mo group) or twice (6-12 mo group) at monthly intervals. Local and systemic adverse reactions after each vaccine dose were recorded, and Hib-PRP antibody concentrations were determined by ELISA at 28 d after completion of the immunization schedule. There were no significant differences in the proportions of subjects with post-immunization Hib-PRP antibody concentrations ≥1.0 µg/mL or ≥0.15 µg/mL with the two injection sites for either age group, or in the post-immunization Hib-PRP antibody concentrations achieved (P>0.05). In addition, there were no significant differences in the rates of local and systemic reactions after the first and second vaccinations between the 2 injection sites for either age group (P>0.05), but the rate of systemic reactions in the 2-5 mo group after the third vaccination via the vastus lateralis muscle was significantly lower than after deltoid vaccination (0% vs 8.57%; P<0.05). Thus, administration via the vastus lateralis muscle is worth considering for Hib vaccination.

Efficacy, safety, and immunology of an inactivated alum-adjuvant enterovirus 71 vaccine in children in China: a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial.

BACKGROUND: A vaccine for enterovirus 71 (EV71) is needed to address the high burden of disease associated with infection. We assessed the efficacy, safety, immunogenicity, antibody persistence, and immunological correlates of an inactivated alum-adjuvant EV71 vaccine. METHODS: We did a randomised, double-blind, placebo-controlled, phase 3 trial. Healthy children aged 6-35 months from four centres in China were randomly assigned (1:1) to receive vaccine or alum-adjuvant placebo at day 0 and 28, according to a randomisation list (block size 30) generated by an independent statistician. Investigators and participants and their guardians were masked to the assignment. Primary endpoints were EV71-associated hand, foot, and mouth disease (HFMD) and EV71-associated disease during the surveillance period from day 56 to month 14, analysed in the per-protocol population. This study is registered with ClinicalTrials.gov, number NCT01508247. FINDINGS: 10,245 participants were enrolled and assigned: 5120 to vaccine versus 5125 to placebo. 4907 (with three cases of EV71-associated HFMD and eight cases of EV71-associated disease) versus 4939 (with 30 cases of EV71-associated HFMD and 41 cases of EV71-associated disease) were included in the primary efficacy analysis. Vaccine efficacy was 90·0% (95% CI 67·1-96·9) against EV71-associated HFMD (p=0·0001) and 80·4% (95% CI 58·2-90·8) against EV71-associated disease (p<0·0001). Serious adverse events were reported by 62 of 5117 (1·2%) participants in the vaccine group versus 75 of 5123 (1·5%) in the placebo group (p=0·27). Adverse events occurred in 3644 (71·2%) versus 3603 (70·3%; p=0·33). INTERPRETATION: EV71 vaccine provides high efficacy, satisfactory safety, and sustained immunogenicity. FUNDING: China's 12-5 National Major Infectious Disease Program, Beijing Vigoo Biological.

Willingness to use the oral fluid HIV rapid test among men who have sex with men in Beijing, China.

BACKGROUND: Early detection of HIV infection enables timely care and treatment. However, many men who have sex with men (MSM) remain unaware of their HIV status because they do not or are unable to access HIV testing services. Oral fluid HIV rapid tests have the potential to increase HIV testing. This study is the first to evaluate willingness to use the oral fluid test among MSM in China. METHODS: A cross-sectional study was conducted in Beijing from July to October, 2012. Data were collected by self-administered questionnaires. RESULTS: Of 262 who participated in the survey, 223(85.1%) reported that they were willing to use the oral fluid HIV rapid test. Willingness to use the oral fluid test was associated with higher education (adjusted odds ratio (AOR): 2.40, 95% confidence interval (CI): 1.13-5.10), lack of unprotected anal intercourse (UAI) with male partners in the past one month (AOR: 2.38; 95% 95%CI: 1.15-4.95), having taken more than 4 HIV tests (AOR: 3.54; 95%CI:1.52-8.28), and having ever heard of the oral fluid HIV rapid test from gay friends or gay organizations (AOR: 3.24, 95%CI: 1.40-7.51). Among those who expressed willingness to use the oral fluid HIV rapid test, the median amount of money they were willing to pay was 8 dollars. Among the 39 participants who were unwilling to use the oral fluid test, 79.5% (31/39) expressed concerns about the accuracy of the oral fluid HIV rapid test results and 17.9%(7/39) reported that they were not familiar with the oral fluid test and did not know how to use such a test. CONCLUSIONS: A high proportion of MSM in Beijing appear to be willing to use the oral fluid HIV rapid test. Appropriate cost and education measures could help improve acceptance of the oral fluid test.

MALDI-TOF mass spectrometry-based identification of group A Streptococcus isolated from areas of the 2011 scarlet fever outbreak in china.

There was a dramatic increase in scarlet fever cases in China from March to July 2011. Group A Streptococcus (GAS) is the only pathogen known to cause scarlet fever. Matrix-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF MS) coupled to Biotyper system was used for GAS identification in 2011. A local reference database (LRD) was constructed, evaluated and used to identify GAS isolates. The 75 GAS strains used to evaluate the LRD were all identified correctly. Of the 157 suspected ß-hemolytic strains isolated from 298 throat swab samples, 127 (100%) and 120 (94.5%) of the isolates were identified as GAS by the MALDI-TOF MS system and the conventional bacitracin sensitivity test method, respectively. All 202 (100%) isolates were identified at the species level by searching the LRD, while 182 (90.1%) were identified by searching the original reference database (ORD). There were statistically significant differences with a high degree of credibility at species level (χ(2)=6.052, P<0.05 between the LRD and ORD). The test turnaround time was shortened 36-48h, and the cost of each sample is one-tenth of the cost of conventional methods. Establishing a domestic database is the most effective way to improve the identification efficiency using a MALDI-TOF MS system. MALDI-TOF MS is a viable alternative to conventional methods and may aid in the diagnosis and surveillance of GAS.

HIV incidence among men who have sex with men in Beijing: a prospective cohort study.

OBJECTIVES: (1) To assess the HIV incidence rate among men who have sex with men (MSM) in a large cohort study in Beijing, China and (2) to identify sociodemographic and behavioural risk factors of HIV seroconversion among MSM in Beijing, China. DESIGN: A prospective cohort study. SETTING: Baseline and follow-up visits were conducted among MSM in Beijing, China. PARTICIPANTS: A cohort of 797 HIV-seronegative MSM was recruited from August to December 2009, with follow-up occurring after 6 and 12 months. PRIMARY AND SECONDARY OUTCOME MEASURES: At baseline and follow-up visits, participants reported sociodemographic and sexual behaviour information, and were tested for HIV, herpes simplex virus-2 (HSV-2) and syphilis with whole blood specimens. Cox regression analysis was used to identify factors associated with HIV seroconversion. RESULTS: Most study participants (86.8%) were retained by the 12-month follow-up. The HIV, HSV-2 and syphilis incidence rates were 8.09 (95% CI 6.92 to 9.26), 5.92 (95% CI 5.44 to 6.40) and 8.06 (95% CI 7.56 to 8.56) cases per 100 person-years, respectively. HIV seroconversion was significantly associated with being <25 years old, having <12 years of education, having >1 male sex partner in the past 6 months, and being syphilis positive or HSV-2 positive. CONCLUSIONS: The HIV incidence among MSM in Beijing is serious. Interventions and treatment of sexually transmitted diseases (STD) should be combined with HIV control and prevention measures among MSM.

Draft genome sequences of two Streptococcus pyogenes strains involved in abnormal sharp raised scarlet fever in China, 2011.

A scarlet fever outbreak caused by Streptococcus pyogenes occurred in China in 2011. To determine the genomic features of the outbreak strains, we deciphered genomes of two strains isolated from the regions with the highest incidence rates. The sequences will provide valuable information for comprehensive study of mechanisms related to this outbreak.

[The sexual behavior characteristics and STD infection status of women who have sex with women in Beijing].

OBJECTIVE: To study sexual behavioral characteristics, infection status of HIV and sexually transmitted infections (STDs) among women who have sex with women (WSW) in Beijing. METHODS: A total of 150 WSWs were recruited by snowball sampling in several main types of activity sites of WSW (including NGOs, salons, bars, etc.) in Beijing during September 2010 to April 2011. Information on demographic factors, sexual behavioral characteristics, infection status of STDs, and use of medical care were collected by questionnaire investigation. Serum samples, vaginal and cervical swabs were taken for each subject to test HIV, hepatitis B (HBV), hepatitis C (HCV), syphilis, herpes simplex virus (HSV), neisseria gonorrhoeae, chlamydia trachoma, bacterial vaginosis, trichomonas vaginalis and mycotic vaginitis. RESULTS: The age range of the subjects was from 19 to 46 years old. Approximately 82.67% (124/150) of them aged 20 to 29 years old, and 54.00% (81/150) were unmarried. Approximately 76.67% (115/150) had an education level of college degree or above, and 70.67% (106/150) were migrants. Approximately 66.66% (100/150) of the subjects considered themselves as homosexual, 28.00% (42/150) as bisexual. The age at first homosexual sex ranged from 11 to 30 years old. The median of number of female sex partners in last 1 year was 1, and 33.78% (50/148) of the subjects had 2 or more female sex partners. Approximately 20.27% (30/148) of the subjects applied sex instruments, of which 66.67% (20/30) never or seldom used condoms. Hand-clitoris and hand-vagina contacts were the main types of woman-to-woman sex, accounting for 91.22% (135/148). 12.00% (18/150) of the subjects had sex with men during last year. Among them, 50.00% (9/18) used condoms at last heterosexual sex, and 66.67% (12/18) never or seldom used condoms at last heterosexual sex in past 1 year. One subject provided paid sex service for men, and used condoms every time. In the past one year, 45.33% (68/150) of the subjects had symptoms of STDs, but only 36.76% (25/68) of them sought medical care. The infection rate of STDs was 34.67% (52/150). The infection rates of NG and GV were both 16.11% (24/149), and those of mycotic vaginitis, chlamydia trachoma, and TV were 8.72% (13/149), 4.03% (6/149), and 0.67% (1/150), respectively. The numbers of subjects tested positive for HBV, HCV, and syphilis were all 1. No subjects were found HIV positive or HSV-2 positive. CONCLUSION: Multiple sexual partners and heterosexual sex behavior were common among WSW in Beijing. More than 1/3 of the subjects were infected with STD.