Search

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.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.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 %).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.ClinicalTrials.gov #NCT02559921.

Since 2007, Beijing has offered a free trivalent influenza vaccine (TIV) for residents aged ≥ 60 years and school students. The quadrivalent influenza vaccine (QIV) was administered to school children in 2018 and will be administered to elderly adults in the future. In addition, health care workers (HCWs) who are involved in the prevention and control of COVID-19 were included in the program in 2020. This study aimed to analyze the cost-effectiveness of a comprehensive list of combined strategies of TIV and QIV for school children, elderly adults, and HCWs to identify the most cost-effective strategy.A decision tree was developed to compare 1-year outcomes of TIV vs. QIV in three risk groups: school children, elderly adults, and HCWs. The outcome was incremental cost per quality-adjusted life-year (QALY). Probabilistic sensitivity analyses and scenario analyses were developed to assess the robustness of the results.From the perspective of society, this study found that the introduction of QIVs can be cost-effective for any and all targeted groups with a willingness-to-pay threshold of 3-fold GDP per capita. Among all programs, program H (all school children, elderly adults, and HCWs received the QIV) showed a 79% probability of being cost-effective with an incremental cost-effectiveness ratio (ICER) of 13,580 (95% CI: 13,294, 13,867) US$/QALY and was the preferred option in the base case scenario.The introduction of QIVs to school children, elderly adults, or HCWs is likely to be cost-effective, either separately or collectively. The introduction of QIV to school children, elderly adults, and health care workers simultaneously showed the highest probability of being cost-effective and was the preferred option.

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.

Immunization of children with special health care needs has always been one of the difficulties in community-level public health. In recent years the relevant consensus opinions on vaccination have been issued in China, but for a long time there is a lack of effective communication channels between disease prevention and clinical medical systems in China. Pediatricians play an unoccupied role in immunization, and community-level vaccinators face the difficulties including dilemma of disease identification, evidence-based evaluation and upward referral. These lead to the vaccination hesitancy, thus the multi-disciplinary management and three-level referral model of children with special health care needs should be improved urgently. It should strengthen the integration of public health and clinical care, with the active participation of pediatricians, to promote the immunization of children with special health care needs effectively.特殊健康状态儿童的疫苗接种一直是基层公共卫生工作的难点之一。尽管近年来各地出台了相关接种共识，但长期以来我国疾病预防和临床医疗两大系统之间缺乏相对有效的沟通渠道和交流机制，儿科医生在免疫接种工作中角色缺位，而基层接种人员面临疾病鉴别、科学评估和向上转诊等困境，导致疫苗接种犹豫问题凸显，特殊健康状态儿童的多学科管理和三级转诊模式亟待完善。需进一步加强医防融合，儿科医生积极参与，有效促进特殊健康状态儿童的疫苗接种。.

Green and low cost deep eutectic solvents (DESs) are promising to replace the solid acids and ionic liquids in biomass fractionation process. To enhance the lignocellulose pretreatment efficiency, an acidic DES that composed of Brønsted acid (ZnCl

Background: Psoriasis is a common immune-mediated inflammatory dermatosis. Generalized pustular psoriasis (GPP) is the severe and rare type of psoriasis. The association between tumor necrosis factor-alpha induced protein 3 interacting protein 1 ( TNIP1 ) gene and psoriasis was confirmed in people with multiple ethnicities. This study was to investigate the association between TNIP1 gene polymorphisms and pustular psoriasis in Chinese Han population. Methods: Seventy-three patients with GPP, 67 patients with palmoplantar pustulosis (PPP), and 476 healthy controls were collected from Chinese Han population. Six single nucleotide polymorphisms (SNPs) of the TNIP1 gene, namely rs3805435, rs3792798, rs3792797, rs869976, rs17728338, and rs999011 were genotyped by using polymerase chain reaction-ligase detection reaction. Statistical analyses were performed using the PLINK 1.07 package. Allele frequencies and genotyping frequencies for six SNPs were compared by using Chi-square test, odd ratio ( OR ) (including 95% confidence interval) were calculated. The haplotype analysis was conducted by Haploview software. Results: The frequencies of alleles of five SNPs were significantly different between the GPP group and the control group ( P ≤ 7.22 × 10 −3 ), especially in the GPP patients without psoriasis vulgaris (PsV). In the haplotype analysis, the most significantly different haplotype was H4: ACGAAC, with 13.1% frequency in the GPP group but only 3.4% in the control group ( OR = 4.16, P = 4.459 × 10 −7 ). However, no significant difference in the allele frequencies was found between the PPP group and control group for each of the six SNPs ( P > 0.05). Conclusions: Polymorphisms in TNIP1 are associated with GPP in Chinese Han population. However, no association with PPP was found. These findings suggest that TNIP1 might be a susceptibility gene for GPP.

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.

Background: Although psoriasis occurs worldwide, the prevalence varies considerably between different peoples and regions. In China, a questionnaire-based study was carried out in 1987 and the prevalence of psoriasis was found to be 0.12%. Since then, no large-scale, population-based study has been reported. Objectives: To obtain the accurate figures for the prevalence of psoriasis in China. Methods: A population-based survey was conducted in 6 cities. The cluster sampling method was used to select communities in each city. The subjects were required to fill out self-reporting questionnaires during a face-to-face interview and also received physical examination by dermatologists. Results: 19,974 subjects were visited and 17,345 completed the questionnaires and received dermatological examination. 102 subjects (0.59%) were found to have psoriasis. After standardization, the prevalence of psoriasis was 0.47%. The prevalence of psoriasis in males and females was 0.54% and 0.44% respectively. 97.06% of the patients had psoriasis vulgaris. 28.43% of the patients reported a family history of psoriasis. 59.80% of patients experienced a negative influence on the quality of life. Conclusions: This population-based and dermatologist-confirmed study showed that the prevalence of psoriasis in China is 0.47%, which is higher than that reported in 1987.

Polyallylamine (PAAm) was synthesized by free radical polymerization and characterized by Fourier transform infrared resonance (FT-IR) spectroscopy, hydrogen nuclear magnetic resonance ( 1 H NMR) spectroscopy and differential scanning calorimetry (DSC). The composite membranes were prepared by using PAAm–poly(vinyl alcohol) (PVA) blend polymer as the separation layer and polysulfone (PSF) ultrafiltration membranes as the support layer. The surface and cross-section morphology of the membrane was inspected by environmental scanning electron microscopy (ESEM). The gas transport property of the membranes, including gas permeance, flux and selectivity, were investigated by using pure CO 2 , N 2 , CH 4 gases and CO 2 /N 2 gas mixture (20 vol% CO 2 and 80 vol% N 2 ) and CO 2 /CH 4 gas mixture (10 vol% CO 2 and 90 vol% CH 4 ). The plots of gas permeance or flux versus feed gas pressure imply that CO 2 permeation through the membranes follows facilitated transport mechanism whereas N 2 and CH 4 permeation follows solution–diffusion mechanism. Effect of PAAm content in the separation layer on gas transport property was investigated by measuring the membranes with 0–50 wt% PAAm content. With increasing PAAm content, gas permeance increases initially, reaches a maximum, and then decreases gradually. For CO 2 /N 2 gas mixture, the membranes with 10 wt% PAAm content show the highest CO 2 permeance of about 1.80 × 10 −5 cm 3 (STP) cm −2 s −1 KPa −1 and CO 2 /N 2 selectivity of 80 at 0.1 MPa feed gas pressure. For CO 2 /CH 4 gas mixture, the membranes with 20 wt% PAAm content display the highest CO 2 permeance of about 1.95 × 10 −5 cm 3 (STP) cm −2 s −1 KPa −1 and CO 2 /CH 4 selectivity of 58 at 0.1 MPa feed gas pressure. In order to explore the possible reason of gas permeance varying with PAAm content, the crystallinity of PVA and PAAm–PVA blend polymers was measured by X-ray diffraction (XRD) spectra. The experimental results show an inverse relationship between crystallinity and gas permeance, e.g. , a minimum crystallinity and a maximum CO 2 permeance are obtained at 20 wt% PAAm content, indicating that the possibility of increasing CO 2 permeance with PAAm content due to the increase of carrier concentration could be weakened by the increase of crystallinity.

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.

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.

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.

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 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.

Vitiligo is a common skin disease, the prevalence of which varies between races and countries. In China, no population-based study has been reported, although there have been some epidemiological studies on single cities or regions. The objective of this study was to obtain the prevalence and clinical profile of vitiligo in China. The study was conducted in 6 cities. Cluster sampling was used in selecting communities. Residents were visited at home and were asked to complete questionnaires and receive dermatological examinations. A total of 19,974 residents were visited and 17,345 valid questionnaires were obtained. The overall prevalence of vitiligo was 0.56%. Men were affected more than women (0.71% vs. 0.45%, p < 0.01). The prevalence of vitiligo increased with age. The most common type was focal vitiligo (36.1%). A positive family history was found in 9.8% of patients. Thirty-two percent of patients reported a negative impact of vitiligo on their quality of life.

Acne vulgaris is a common skin condition in adolescents. The prevalence of acne is thought to vary between ethnic groups and countries. A large-scale community-based study was performed in six cities in China to determine the prevalence and possible risk factors for acne in the Chinese population. A total of 17,345 inhabitants were included in this study. Of these, 1,399 were found to have acne. No acne was found in subjects under 10 years of age, and only 1.6% in the 10-year-old group had acne. Prevalence then increased rapidly with age, up to 46.8% in the 19-year-old group. After that, it declined gradually with age. Acne was rare in people over 50 years of age. In subjects in their late teens and 20s, acne was more prevalent in males, while in those over 30 years of age it was more prevalent in females. In subjects with acne, 68.4% had mild; 26.0% had moderate and 5.6% had severe acne. In adult acne, persistent acne was much more common (83.3%) than late-onset acne (16.7%). Smoking and drinking were found to be associated with adolescent acne, while no association was found between diet and acne. These results suggest that the prevalence of acne in the Chinese population is lower than that in Caucasian populations, and that adult acne is not uncommon in Chinese subjects.