共查询到20条相似文献,搜索用时 312 毫秒
1.
Maheshi N. Ramasamy Elizabeth A. Clutterbuck Kathryn Haworth Jaclyn Bowman Omar Omar Amber J. Thompson Geraldine Blanchard-Rohner Ly-Mee Yu Matthew D. Snape Andrew J. Pollard 《Clinical and Vaccine Immunology : CVI》2014,21(8):1164-1168
Meningococcal conjugate vaccines are today successfully deployed in universal programs for children and adolescents in different geographic regions to control meningitis and septicemia. However, in adults, the advantages of these conjugates over the older polysaccharide vaccines are less clear. In this randomized clinical trial, we demonstrated that both conjugate and polysaccharide quadrivalent meningococcal vaccines elicit protective antibody responses in adults aged 18 to 70. (This study has been registered at www.clinicaltrials.gov under registration no. .) NCT00901940相似文献
2.
Young Ju Kim Hang-Rai Kim Young Hee Jung Yu Hyun Park Sang Won Seo 《Yonsei medical journal》2021,62(8):717
PurposeMuscle relaxation following electrical automatic massage (EAM) has been found to reduce fatigue, depression, stress, anxiety, and pain in individuals with various conditions. However, the effects of EAM have not been extensively explored in patients with Alzheimer''s disease (AD).Materials and MethodsHere, we conducted a randomized controlled study to evaluate the effects of EAM on the cognitive and non-cognitive functions of patients with AD spectrum disorders.ResultsWe found that EAM attenuated changes in attention-associated cognitive scores and subjective sleep quality relative to those in controls.ConclusionWhile further studies in a clinical setting are needed to support our findings, these encouraging results suggest that EAM may be an alternative therapy for the management of associated symptoms in AD (ClinicalTrials.gov ID: , 24/04/2018). NCT03507192相似文献
3.
Chen-Hua Liu Cheng-Chao Liang Chun-Jen Liu Chih-Lin Lin Tung-Hung Su Hung-Chih Yang Pei-Jer Chen Ding-Shinn Chen Jia-Horng Kao 《Journal of clinical microbiology》2015,53(5):1754-1757
Genotyping and subtyping of 225 samples with hepatitis C virus (HCV) genotype 1, 2, 3, or 6 infection were done with Versant LiPA 2.0 and Abbott RealTime HCV Genotype (GT) II by using direct sequencing of the NS5B and 5′ untranslated regions as the reference standards. The concordance rates were >99.2% for genotypes and 96.1% for subtypes 1a and 1b. Both the Abbott RealTime and Versant LiPA assays can accurately determine hepatitis C virus genotypes. (This study has been registered at ClinicalTrials.gov under registration no. .) NCT00979979相似文献
4.
Juergen Prattes Reinhard B. Raggam Kim Vanstraelen Jasmin Rabensteiner Christoph Hoegenauer Robert Krause Florian Prüller Albert W?lfler Isabel Spriet Martin Hoenigl 《Journal of clinical microbiology》2016,54(3):798-801
Blood citrulline and intestinal fatty acid binding protein were determined as biomarkers for intestinal mucositis. Biomarker levels were correlated with corresponding serum 1,3-beta-d-glucan levels in 56 samples obtained from 33 cases with underlying hematological malignancies receiving induction chemotherapy. No correlation between biomarkers of intestinal mucositis and BDG levels was observed. (This study has been registered at ClinicalTrials.gov under registration no. .) NCT01576653相似文献
5.
Geert Leroux-Roels Patricia Bourguignon Julie Willekens Michel Janssens Frédéric Clement Arnaud M. Didierlaurent Laurence Fissette Fran?ois Roman Dominique Boutriau 《Clinical and Vaccine Immunology : CVI》2014,21(3):302-311
This phase II study evaluated the effect of chloroquine on the specific CD8+ T-cell responses to and the safety of a booster dose of investigational human immunodeficiency virus type 1 (HIV-1) F4/AS01B vaccine containing 10 μg of recombinant fusion protein (F4) adjuvanted with the AS01B adjuvant system. Healthy adults aged 21 to 41 years, primed 3 years before with two F4/AS01B doses containing 10 or 30 μg of F4 (ClinicalTrials.gov registration number ), were randomized (1:1) to receive the F4/AS01B booster administered alone or 2 days after chloroquine (300 mg). F4-specific CD8+/CD4+ T-cell responses were characterized by intracellular cytokine staining and lymphoproliferation assays and anti-F4 antibodies by enzyme-linked immunosorbent assays (ELISAs). No effect of chloroquine on CD4+/CD8+ T-cell and antibody responses and no vaccine effect on CD8+ T-cell responses (cytokine secretion or proliferation) were detected following F4/AS01B booster administration. In vitro, chloroquine had a direct inhibitory effect on AS01B adjuvant properties; AS01-induced cytokine production decreased upon coincubation of cells with chloroquine. In the pooled group of participants primed with F4/AS01B containing 10 μg of F4, CD4+ T-cell and antibody responses induced by primary vaccination persisted for at least 3 years. The F4/AS01B booster induced strong F4-specific CD4+ T-cell responses, which persisted for at least 6 months with similar frequencies and polyfunctional phenotypes as following primary vaccination, and high anti-F4 antibody concentrations, reaching higher levels than those following primary vaccination. The F4/AS01B booster had a clinically acceptable safety and reactogenicity profile. An F4/AS01B booster dose, administered alone or after chloroquine, induced robust antibody and F4-specific CD4+ T-cell responses but no significant CD8+ T-cell responses (cytokine secretion or proliferation) in healthy adults. (This study has been registered at NCT00434512ClinicalTrials.gov under registration number ). NCT00972725相似文献
6.
Jiangtao Lin Wenya Wang Huaping Tang Jianmin Huo Yuhai Gu Rongyu Liu Ping Chen Yadong Yuan Xiaohong Yang Jianying Xu Dejun Sun Najia Li Shujuan Jiang Yiqiang Chen Changzheng Wang Lan Yang Xiaoju Liu Dong Yang Wei Zhang Zhuochang Chen Qichang Lin Chuntao Liu Jianying Zhou Xin Zhou Chengping Hu Ping Jiang Wei Zhou Jie Zhang Shaoxi Cai Chen Qiu Mao Huang Yijiang Huang Huiguo Liu 《Allergy, asthma & immunology research》2022,14(1):85
PurposeAs stated in the Global Initiative for Asthma, there are still some asthmatic patients who have not achieved asthma control. Mobile is a useful tool for asthma management. We aimed to compare the advantages of mobile management with traditional management in improving adherence and control of asthma.MethodsIn this prospective, multicentre, randomized, controlled and parallel-group study, we enrolled patients with poor adherence and uncontrolled asthma at 32 hospitals in 28 provinces in China. Patients were randomly assigned to the mobile management or traditional management groups for 12 months. The primary endpoint was the proportion of patients with good adherence (Medication Adherence Report Scale for Asthma [MARS-A] score ≥ 45) for 6 months. This study is registered at ClinicalTrials.gov ().ResultsBetween April 2017 and April 2018, 923 patients were eligible for randomization (mobile group, n = 461; traditional group, n = 462). Dropout was 84 (18.2%) in the mobile management group and 113 (24.4%) patients in the traditional management group. The proportion of patients with good adherence was significantly higher in the mobile management group than in the traditional management group (66.0% vs. 58.99%, P = 0.048). The mobile management group showed higher mean MARS-A score (at 1, 6, 9, and 12 months) and asthma control test scores (at 6 and 9 months), and lower total lost rate to follow-up within 12 months than the traditional management group.ConclusionsMobile asthma management can improve adherence and asthma control compared to traditional management.Trial RegistrationClinicalTrials.gov Identifier: NCT02917174 NCT02917174相似文献
7.
Elise Tu Luke C. Swenson Sally Land Sarah Pett Sean Emery Kat Marks Anthony D. Kelleher Steve Kaye Rolf Kaiser Eugene Schuelter Richard Harrigan 《Journal of clinical microbiology》2013,51(7):2063-2071
The Maraviroc Switch collaborative study (MARCH) is a study in aviremic patients on stable antiretroviral therapy and utilizes population-based sequencing of proviral DNA to determine HIV tropism and susceptibility to maraviroc. An external quality assessment (EQA) program was implemented to ensure competency in assessing the tropism of clinical samples conducted by MARCH laboratories (n = 14). The MARCH EQA has three prestudy phases assessing V3 loop sequencing and tropism determination using the bioinformatic algorithm geno2pheno, which generates a false-positive rate (FPR). DNA sequences with low FPRs are more likely to be from CXCR4-using (X4) viruses. Phase 1 of the EQA involved chromatogram interpretation. Phases 2, 2/3, and 3 involved patient and clonal samples. Clinical samples used in these phases were from treatment-experienced HIV-infected volunteers; 18/20 had viral loads of <50 copies/ml, and 10/15 were CXCR4-tropic on prior phenotyping. All samples were tested in triplicate, and any replicate with a geno2pheno FPR of <10% was designated X4. Performance was deemed adequate if ≤2 R5 and ≤1 X4 specimens were miscalled. For several clinical samples in the EQA, triplicate testing revealed marked DNA variability (FPR range, 0 to 96.7%). Therefore, a consensus-based approach was employed for each sample, i.e., a median FPR across laboratories was used to define sample tropism. Further sequencing analysis showed mixed viral populations in the clinical samples, explaining the differences in tropism predictions. All laboratories passed the EQA after achieving predefined competence thresholds in either of the phase 2 rounds. The use of clinical samples from patients resembling those who were likely to be screened in the MARCH, coupled with triplicate testing, revealed inherent DNA variability that might have been missed if single or duplicate testing and/or clonal samples alone were used. These data highlight the importance of intensive EQA of tropism laboratories before embarking on clinical studies. (This study has been registered at ClinicalTrials.gov under registration no. [http://www.clinicaltrials.gov/ct2/show/study/ NCT01384682?term= NCT01384682&rank=1].) NCT01384682相似文献
8.
Jinhyun Kim Heejung Ryu Dae-Hyun Yoo Sung-Hwan Park Gwan-Gyu Song Won Park Chul-Soo Cho Yeong-Wook Song 《Journal of Korean medical science》2013,28(12):1716-1722
Currently, infliximab is given for disease control for active rheumatoid arthritis (RA) patients despite methotrexate treatment. However, the efficacy and safety of infliximab in Korean patients has not been assessed appropriately. Therefore, we performed placebo-controlled, double-blind, randomized study and extension study. One-hundred forty-three patients with active RA were randomized to receive placebo or infliximab 3 mg/kg intravenously at week 0, 2, 6, 14, and 22 with methotrexate maintenance. Primary endpoint was American College of Rheumatology 20% improvement criteria (ACR20) at 30 week. After the clinical trial, patients on placebo (Group 1) and patients on infliximab who showed ACR20 response (Group 2) were treated with infliximab through another 84 week for evaluation of safety. During clinical trial, patients in infliximab group showed higher ACR20 at week 30 than patients in placebo group (50.1% vs 30.6%, P=0.014). A total of 92 patients participated in the extension study. The maintenance rate of infliximab was 62.0% at 84 weeks of extension study. The overall rate of adverse events was not different between Group 1 and Group 2. In Korean patients with active RA despite methotrexate treatment, infliximab in combination with methotrexate is effective and the long-term treatment with infliximab is well tolerated. (ClinicalTrials.gov No. , NCT00202852) NCT00732875相似文献
9.
Byeong-Ho Jeong Su-Young Kim Kyeongman Jeon Soo-Youn Lee Sung Jae Shin Won-Jung Koh 《Journal of clinical microbiology》2013,51(8):2747-2749
An enzyme immunoassay kit that detects serum IgA antibody reacting to glycopeptidolipid core antigen derived from Mycobacterium avium complex (MAC) was not useful for differentiating MAC pulmonary disease (PD) from Mycobacterium abscessus complex PD (MAB-PD). However, this assay could be useful for differentiating MAC- and MAB-PD from pulmonary tuberculosis. (This study has been registered at ClinicalTrials.gov under registration no. .) NCT00970801相似文献
10.
Frederike M. J. Reischies Reinhard B. Raggam Juergen Prattes Robert Krause Susanne Eigl Agnes List Franz Quehenberger Volker Strenger Albert W?lfler Martin Hoenigl 《Journal of clinical microbiology》2016,54(3):771-774
Galactomannan (GM) testing of urine specimens may provide important advantages, compared to serum testing, such as easy noninvasive sample collection. We evaluated a total of 632 serial urine samples from 71 patients with underlying hematological malignancies and found that the urine GM/creatinine ratio, i.e., (urine GM level × 100)/urine creatinine level, which takes urine dilution into account, reliably detected invasive aspergillosis and may be a promising diagnostic tool for patients with hematological malignancies. (This study has been registered at ClinicalTrials.gov under registration no. .) NCT01576653相似文献
11.
12.
Clete A Kushida Colin M Shapiro Thomas Roth Michael J Thorpy Bruce C Corser Akinyemi O Ajayi Russell Rosenberg Asim Roy David Seiden Jordan Dubow Yves Dauvilliers 《Sleep》2022,45(6)
Study ObjectivesTo assess the efficacy and safety of FT218, a novel once-nightly formulation of sodium oxybate (ON-SXB), in patients with narcolepsy in the phase 3 REST-ON trial.MethodsNarcolepsy patients aged ≥16 years were randomized 1:1 to uptitration of ON-SXB (4.5, 6, 7.5, and 9 g) or placebo. Three coprimary endpoints were change from baseline in mean sleep latency on the Maintenance of Wakefulness Test, Clinical Global Impression-Improvement rating, and weekly cataplexy attacks at 9, 7.5, and 6 g. Secondary endpoints included change from baseline on the Epworth Sleepiness Scale. Safety included adverse drug reactions and clinical laboratory assessments.ResultsIn total, 222 patients were randomized; 212 received ≥1 dose of ON-SXB (n = 107) or placebo (n = 105). For the three coprimary endpoints and Epworth Sleepiness Scale, all three doses of ON-SXB demonstrated clinically meaningful, statistically significant improvement versus placebo (all p < 0.001). For ON-SXB 9 g versus placebo, increase in mean sleep latency was 10.8 versus 4.7 min (Least squares mean difference, LSMD [95% CI], 6.13 [3.52 to 8.75]), 72.0% versus 31.6% were rated much/very much improved on Clinical Global Impression-Improvement (OR [95% CI], 5.56 [2.76 to 11.23]), change in mean weekly number of cataplexy attacks was –11.5 versus –4.9 (LSMD [95% CI], –6.65 [–9.32 to –3.98]), and change in Epworth Sleepiness Scale was –6.5 and –2.7 (LSMD [95% CI], –6.52 [–5.47 to –2.26]). Common adverse reactions included nausea, vomiting, headache, dizziness, and enuresis.ConclusionsON-SXB significantly improved narcolepsy symptoms; its safety profile was consistent with SXB. ON-SXB conferred efficacy with a clearly beneficial single nighttime dose.Clinical Trial Registration ClinicalTrials.gov: , https://clinicaltrials.gov/ct2/show/ NCT02720744. NCT02720744相似文献
13.
Yue-Mei Hu Xu Wang Jun-Zhi Wang Ling Wang Yong-Jie Zhang Lin Chang Zheng-Lun Liang Jie-Lai Xia Qi-Gang Dai Ya-Ling Hu Qun-Ying Mao Feng-Cai Zhu Yu-Fei Song Fan Gao Jiang-Ting Chen 《Clinical and Vaccine Immunology : CVI》2013,20(12):1805-1811
The determination of lot-to-lot consistency in the manufacturing process is a mandatory step in the clinical development of the novel enterovirus 71 (EV71) vaccine. A phase III, randomized, placebo-controlled, double-blind trial assessed the lot consistency, immunogenicity, and safety of the EV71 vaccine in children aged 6 to 59 months. Healthy children (n = 1,400) received one of three lots of the EV71 vaccine containing 400 U of EV71 antigen or a placebo at days 0 and 28. Blood samples were collected before dose 1 and at 28 days after dose 2 (day 56) for an anti-EV71 neutralizing antibody (NTAb) assay. The geometric mean titer (GMT) and the seropositivity rates (with titers of ≥1:8) were compared at day 56. After each dose, the solicited injection site and general adverse events (AEs) were recorded for 7 days, and unsolicited AEs were recorded for 28 days. At day 56, the seropositivity rates ranged from 99.7% to 100% for the vaccine groups. The NTAb GMTs for the vaccine were 140.3 (95% confidence interval [CI], 117.8 to 167.1), 141.5 (95% CI, 118.0 to 169.6), and 146.6 (95% CI, 122.5 to 175.3). The two-sided 95% CI of the log difference in GMTs between the pairs of lots were between −0.176 and 0.176, therefore meeting the predefined equivalence criteria. The percentages of subjects reporting any injection site AEs, general AEs, or serious AEs were similar across the four vaccination groups. In conclusion, the demonstration of consistency between the manufacturing lots confirms for the purposes of clinical development the reliability of the EV71 vaccine production process. (This study has been registered at ClinicalTrials.gov under registration no. .) NCT01636245相似文献
14.
Gerald Aichinger Barbara Grohmann-Izay Maikel V. W. van der Velden Sandor Fritsch Manuela Koska Daniel Portsmouth Mary Kate Hart Wael El-Amin Otfried Kistner P. Noel Barrett 《Clinical and Vaccine Immunology : CVI》2015,22(1):46-55
Studies on candidate pandemic vaccines against avian influenza viruses have focused on H5N1, but viruses of other subtypes, such as A/H9N2, are also considered to have pandemic potential. We investigated the safety and immunogenicity of two immunizations with one of five different antigen doses (ranging from 3.75 to 45 μg of hemagglutinin antigen) of a nonadjuvanted whole-virus G9 lineage H9N2 influenza virus vaccine in healthy adults aged 18 to 49 years. The antibody responses were measured by hemagglutination inhibition (HI), microneutralization (MN), and single radial hemolysis (SRH) assays. To investigate a hypothesis that previous exposure to H2N2 viruses in subjects born in or before 1968 might prime for more robust antibody responses to H9N2 vaccination than that in subjects born after 1968, a post hoc age-stratified analysis of antibody responses was done. Both vaccinations in all dose groups were safe and well tolerated. No vaccine-related serious adverse events were reported, and the majority of the adverse reactions were rated as mild. The rates of injection site reactions were lower in the 3.75-μg- and 7.5-μg-dose groups than those in the higher-dose groups; the rates of systemic reactions were similar across all dose groups. The seroprotection rates among the different dose groups 21 days after the second immunization ranged from 52.8% to 88.9% as measured by HI assay, from 88.7% to 98.1% or 82.7% to 96.2% as measured by MN assay (MN titer cutoffs, 1:40 and 1:80, respectively), and from 94.2% to 100% as measured by SRH assay. Higher antibody responses were not induced in subjects born in or before 1968. These data indicate that a nonadjuvanted whole-virus H9N2 vaccine is well tolerated and immunogenic in healthy adults. (This study has been registered at ClinicalTrials.gov under registration no. .) NCT01320696相似文献
15.
Study ObjectivesWe characterized vigilance deterioration with increasing time-on-task (ToT) during recurrent sleep restriction of different extents on simulated weekdays and recovery sleep on weekends, and tested the effectiveness of afternoon napping in ameliorating ToT-related deficits.MethodsIn the Need for Sleep studies, 194 adolescents (age = 15–19 years) underwent two baseline nights of 9-h time-in-bed (TIB), followed by two cycles of weekday manipulation nights and weekend recovery nights (9-h TIB). They were allocated 9 h, 8 h, 6.5 h, or 5 h of TIB for nocturnal sleep on weekdays. Three additional groups with 5 h or 6.5 h TIB were given an afternoon nap opportunity (5 h + 1 h, 5 h + 1.5 h, and 6.5 h + 1.5 h). ToT effects were quantified by performance change from the first 2 min to the last 2 min in a 10-min Psychomotor Vigilance Task administered daily.ResultsThe 9 h and the 8 h groups showed comparable ToT effects that remained at baseline levels throughout the protocol. ToT-related deficits were greater among the 5 h and the 6.5 h groups, increased prominently in the second week of sleep restriction despite partial recuperation during the intervening recovery period and diverged between these two groups from the fifth sleep-restricted night. Daytime napping attenuated ToT effects when nocturnal sleep restriction was severe (i.e. 5-h TIB/night), and held steady at baseline levels for a milder dose of nocturnal sleep restriction when total TIB across 24 h was within the age-specific recommended sleep duration (i.e. 6.5 h + 1.5 h).ConclusionsReducing TIB beyond the recommended duration significantly increases ToT-associated vigilance impairment, particularly during recurrent periods of sleep restriction. Daytime napping is effective in ameliorating such decrement.Clinical Trial Registration, NCT02838095, and NCT03333512. NCT04044885相似文献
16.
Jeffrey I. Cohen Mir A. Ali Ahmad Bayat Sharon P. Steinberg Hosun Park Anne A. Gershon Peter D. Burbelo 《Clinical and Vaccine Immunology : CVI》2014,21(9):1288-1291
A high-throughput test to detect varicella-zoster virus (VZV) antibodies in varicella vaccine recipients is not currently available. One of the most sensitive tests for detecting VZV antibodies after vaccination is the fluorescent antibody to membrane antigen (FAMA) test. Unfortunately, this test is labor-intensive, somewhat subjective to read, and not commercially available. Therefore, we developed a highly quantitative and high-throughput luciferase immunoprecipitation system (LIPS) assay to detect antibody to VZV glycoprotein E (gE). Tests of children who received the varicella vaccine showed that the gE LIPS assay had 90% sensitivity and 70% specificity, a viral capsid antigen enzyme-linked immunosorbent assay (ELISA) had 67% and 87% specificity, and a glycoprotein ELISA (not commercially available in the United States) had 94% sensitivity and 74% specificity compared with the FAMA test. The rates of antibody detection by the gE LIPS and glycoprotein ELISA were not statistically different. Therefore, the gE LIPS assay may be useful for detecting VZV antibodies in varicella vaccine recipients. (This study has been registered at ClinicalTrials.gov under registration no. .) NCT00921999相似文献
17.
18.
Background
Hypoglycemia is a major cause of morbidity and mortality among preterm infants and its management remains a challenge in resource limited settings. Use of dextrose infusion by the recommended infusion pumps is not feasible in our environment due to their high costs and yet the current use of mini dextrose boluses with syringes as adapted at Mulago national referral and tertiary teaching hospital has unknown efficacy in prevention of hypoglycemiaObjective
We determined the efficacy of dextrose infusions by burettes versus two hourly dextrose boluses in prevention of hypoglycemia among preterms admitted in the first 72 hours at Special Care Unit, Mulago Hospital.Methods
One hundred and forty preterms aged 0 to 24 hours of life were randomized to receive 10% IV dextrose either as mini boluses or by infusion using burettes in an open label clinical trial. Blood glucose was measured at 0, two hourly for next 6 hours, 6 hourly for next 12 hours and thereafter 12 hourly until end of 72 hours following admission. Primary end point was incidence of hypoglycemia (random blood sugar (RBS) < 2.6mmol/l) which was expressed as relative risk (RR). Efficacy of the dextrose infusion was computed using 1-RR.Results
From February 2012 to April 2012, 68 preterms in the bolus arm and 72 in the infusion arm were studied. Hypoglycemia was detected in 34% (48/140). The incidence of hypoglycemia in the bolus arm was 59% (40/68) compared to 11% (8/72) in the infusion arm (RR; 0.19, 95% CI; 0.09–0.37). Efficacy (1-RR) of infusion by burettes versus boluses in prevention of hypoglycemia among preterms was 0.81 (95% CI; 0.63–0.90).Conclusion
Continuous 10% dextrose infusion by burettes reduced the incidence of hypoglycemia by 81% in the first 72 hours of admission compared to two hourly 10% mini dextrose boluses among preterms admitted at Special Care Unit, Mulago Hospital. (ClinicalTrials.gov Identifier: ) NCT01688674相似文献19.
Sharon E. Frey Laurence Peiperl M. Juliana McElrath Spyros Kalams Paul A. Goepfert Michael C. Keefer Lindsey R. Baden Michelle A. Lally Kenneth Mayer William A. Blattner Clayton D. Harro Scott M. Hammer Geoffrey J. Gorse John Hural Georgia D. Tomaras Yves Levy Peter Gilbert Allan deCamp Nina D. Russell Marnie Elizaga Mary Allen Lawrence Corey 《Clinical and Vaccine Immunology : CVI》2014,21(11):1589-1599
Finding an effective human immunodeficiency virus type 1 (HIV-1) vaccine remains a major global health priority. In a phase I/II, placebo-controlled trial, healthy, HIV-1-negative adults were randomized to receive one of 5 vaccine regimens: LIPO-5 (combination of 5 lipopeptides) alone (250 μg), ALVAC-HIV (vCP1452) alone, or 3 groups of ALVAC-HIV (vCP1452) followed by ALVAC-HIV (vCP1452) plus LIPO-5 (250, 750, and 2,500 μg). Only 73/174 participants (42%) received all four vaccinations due to a study halt related to myelitis. There were no significant differences in systemic reactions between groups or in local reactogenicity between groups receiving ALVAC-HIV (vCP1452). Significant differences in local reactogenicity occurred between groups receiving LIPO-5 (P ≤ 0.05). Gag and Env antibodies were undetectable by ELISA 2 weeks after the fourth vaccination for all but one recipient. Antibodies to Gag and Env were present in 32% and 24% of recipients of ALVAC-HIV (vCP1452) alone and in 47% and 35% of ALVAC-HIV (vCP1452)+LIPO recipients, respectively. Coadministration of LIPO-5 did not significantly increase the response rate compared to ALVAC-HIV (vCP1452) alone, nor was there a significant relationship between dose and antibody responses among ALVAC-HIV (vCP1452)+LIPO groups. Over 90% of study participants had no positive gamma interferon (IFN-γ) enzyme-linked immunosorbent spot assay (ELISpot) responses to any peptide pool at any time point. The study was halted due to a case of myelitis possibly related to the LIPO-5 vaccine; this case of myelitis remains an isolated event. In general, there was no appreciable cell-mediated immunity detected in response to the vaccines used in this study, and antibody responses were limited. The clinical trial is registered on ClinicalTrials.gov with registry number . NCT00076063相似文献
20.
Jin-Ho Choi Beom Hee Lee Jung Min Ko Young Bae Sohn Jin-Sung Lee Gu-Hwan Kim Sun Hee Heo June-Young Park Yoo-Mi Kim Ja-Hye Kim Han-Wook Yoo 《Journal of Korean medical science》2015,30(4):378-384
Gaucher disease is a lysosomal storage disease for which enzyme replacement therapy has proven to be effective. A switch-over clinical trial was performed to evaluate the efficacy and safety of Abcertin® (ISU Abxis, Seoul, Korea) in subjects with type 1 Gaucher disease who were previously treated with imiglucerase. Five Korean patients with type 1 Gaucher disease were enrolled. Previous doses of imiglucerase ranged from 30 to 55 U/kg every other week. The same dose of Abcertin® was administered to all patients for 24 weeks. Primary efficacy endpoints were changes in hemoglobin levels and platelet counts, and the secondary efficacy endpoints included changes in liver and spleen volumes, serum biomarkers, skeletal status and bone mineral density (BMD). During the study period, no statistically significant changes were observed in all parameters including hemoglobin levels and platelet counts, liver and spleen volumes, skeletal status and BMD. Abcertin® administration was continued in three patients for another 24 weeks as an extension of the study. Hemoglobin levels and platelet counts were maintained in all three patients. In conclusion, the efficacy and safety of Abcertin® are similar to those of imiglucerase, and Abcertin® is an effective therapeutic agent for patients with type 1 Gaucher disease (Clinical Trial Registry No. at NCT02053896www.clinicaltrials.gov).