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Shuang-Xia Zhao,
Wei Liu,
Ming Zhan,
Zhi-Yi Song,
Shao-Ying Yang,
Li-Qiong Xue,
Chun-Ming Pan,
Zhao-Hui Gu,
Bing-Li Liu,
Hai-Ning Wang,
Liming Liang,
Jun Liang,
Xiao-Mei Zhang,
Guo-Yue Yuan, Chang-Gui Li,
Ming-Dao Chen,
Jia-Lun Chen,
Guan-Qi Gao,
Huai-Dong Song
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ABSTRACT: To pinpoint the exact location of the etiological variant/s present at 1q21.1 harboring FCRL1-5 and CD5L genes, we carried out a refined association study in the entire FCRL region in 1,536 patients with Graves' disease (GD) and 1,516 sex-matched controls by imputation analysis, logistic regression, and cis-eQTL analysis. Among 516 SNPs with P<0.05 in the initial GWAS scan, the strongest signals associated with GD and correlated to FCRL3 expression were located at a cluster of SNPs including rs7528684 and rs3761959. And the allele-specific effects for rs3761959 and rs7528684 on FCRL3 expression level revealed that the risk alleles A of rs3761959 and C of rs7528684 were correlated with the elevated expression level of FCRL3 whether in PBMCs or its subsets, especially in CD19(+) B cells and CD8(+) T subsets. Next, the combined analysis with 5,300 GD cases and 4,916 control individuals confirmed FCRL3 was a susceptibility gene of GD in Chinese Han populations, and rs3761959 and rs7528684 met the genome-wide association significance level (Pcombined = 2.27×10(-12) and 7.11×10(-13), respectively). Moreover, the haplotypes with the risk allele A of rs3761959 and risk allele C of rs7528684 were associated with GD risk. Finally, our epigenetic analysis suggested the disease-associated C allele of rs7528684 increased affinity for NF-KB transcription factor. Above data indicated that FCRL3 gene and its proxy SNP rs7528684 may be involved in the pathogenesis of GD by excessive inhibiting B cell receptor signaling and the impairment of suppressing function of Tregs.
PLoS ONE 01/2013; 8(3):e57758. · 4.09 Impact Factor
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ABSTRACT: Please cite this paper as: Li et al. (2012) Immunogenicity and safety of a 2009 pandemic influenza A (H1N1) monovalent vaccine in Chinese infants aged 6-35 months: a randomized, double-blind, controlled phase I clinical trial. Influenza and Other Respiratory Viruses DOI: 10.1111/irv.12028. Objectives The goal of this double-blind, randomized, controlled clinical trial was to assess the safety and immunogenicity of two different doses of a monovalent split-virion 2009 pandemic influenza A/H1N1 vaccine without adjuvant in Chinese infants aged 6-35 months. Design and setting Subjects were randomly assigned to receive either a 2009 pandemic (H1N1) vaccine containing 7.5 or 15 μg haemagglutinin (HA) or a seasonal influenza vaccine. 2 doses of the H1N1 vaccines or the seasonal influenza vaccine were given 21 days apart in younger infants aged 6-23 months or older infants aged 24-35 months. Sample Serum samples were collected immediately before the first injection and before and 21 days after the second injection. Main outcome measures Primary outcomes were haemagglutinin inhibition (HI) antibody responses 21 days following each vaccination. Safety was monitoring throughout the study. Results The first vaccination of 7.5 μg and 15 μg H1N1 vaccine induced seroprotective antibody titers (HI titers ≥ 1: 40) in 42.9-57.4% of younger infants and 49.1-61.0% older infants. Immune responses after completion of the two dose schedule were comparable in both age groups with seroprotective rates of 91-98% in each vaccine and age group and GMTs of 173-263. The H1N1 vaccine elicited similar rates of local and systemic adverse reactions as the seasonal influenza vaccine. Conclusions The 2009 pandemic influenza A /H1N1 vaccine were highly immunogenic in infants aged 6-35 months, and displayed a safety and reactogenicity profile similar to the seasonal influenza vaccine. Trial registration ClinicalTrial.gov identifier: NCT01047202.
Influenza and Other Respiratory Viruses 11/2012; · 4.16 Impact Factor
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Rong Cheng Li,
Feng Xiang Li,
Yan Ping Li,
Qi Ming Hou, Chang Gui Li,
Ya Nan Li,
Fu Sheng Chen,
Xue Zhong Hu,
Wen Bin Su,
Shu Min Zhang,
Han Hua Fang,
Qiang Ye,
Tian De Zeng,
Tao Xuan Liu,
Xiu Bi Li,
Yun Neng Huang,
Man Ling Deng,
Yan Ping Zhang,
Esteban Ortiz
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ABSTRACT: This study assessed the antibody persistence, and the immunogenicity and safety of a booster dose of a DTaP-IPV//PRP∼T (Pentaxim®, Sanofi Pasteur's AcXim family) combined vaccine and of standalone vaccines one year after primary vaccination in the People's Republic of China. Participants (N=719) previously primed with DTaP-IPV//PRP∼T at 2, 3, 4 months (Group A, N=255), 3, 4, 5 months (Group B, N=233), or DTaP (Wuhan Institute of Biological Products), PRP-T (Act-Hib®) and IPV (Imovax® Polio) at 3, 4, 5 months (Group C, N=231) received boosters of the same vaccines at 18-20 months of age. Seroprotection (SP) and seroconversion (SC) were determined before and 1 month after the booster. Safety was monitored from parental reports. In all groups 87.6-100% of participants had pre-booster protective anti-PRP, -diphtheria, -tetanus and -poliovirus antibody titers; post-booster, all SP rates were 100% and SC was ≥ 80.4% for anti-pertussis titers ≥ 4-fold increase. Reactogenicity was low for each group. These data support the use of the DTaP-IPV//PRP∼T vaccine in the People's Republic of China compared to separate DTaP, IPV, and PRP∼T administration in terms of both safety and immunogenicity.
Vaccine 11/2011; 29(50):9337-44. · 3.77 Impact Factor
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Xun Chu,
Chun-Ming Pan,
Shuang-Xia Zhao,
Jun Liang,
Guan-Qi Gao,
Xiao-Mei Zhang,
Guo-Yue Yuan, Chang-Gui Li,
Li-Qiong Xue,
Min Shen, [......],
Gang Chen,
Qing Su,
Yong-De Peng,
Jia-Jun Zhao,
Guang Ning,
Zhu Chen,
Jia-Lun Chen,
Sai-Juan Chen,
Wei Huang,
Huai-Dong Song
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ABSTRACT: Graves' disease is a common autoimmune disorder characterized by thyroid stimulating hormone receptor autoantibodies (TRAb) and hyperthyroidism. To investigate the genetic architecture of Graves' disease, we conducted a genome-wide association study in 1,536 individuals with Graves' disease (cases) and 1,516 controls. We further evaluated a group of associated SNPs in a second set of 3,994 cases and 3,510 controls. We confirmed four previously reported loci (in the major histocompatibility complex, TSHR, CTLA4 and FCRL3) and identified two new susceptibility loci (the RNASET2-FGFR1OP-CCR6 region at 6q27 (P(combined) = 6.85 × 10(-10) for rs9355610) and an intergenic region at 4p14 (P(combined) = 1.08 × 10(-13) for rs6832151)). These newly associated SNPs were correlated with the expression levels of RNASET2 at 6q27, of CHRNA9 and of a previously uncharacterized gene at 4p14, respectively. Moreover, we identified strong associations of TSHR and major histocompatibility complex class II variants with persistently TRAb-positive Graves' disease.
Nature Genetics 08/2011; 43(9):897-901. · 35.53 Impact Factor
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Yan-ping Li,
Feng-xiang Li,
Qi-ming Hou, Chang-gui Li,
Ya-nan Li,
Fu-sheng Chen,
Xue-zhong Hu,
Wen-bin Su,
Shu-min Zhang,
Han-hua Fang,
Qiang Ye,
Tian-de Zeng,
Tao-xuan Liu,
Xiu-bi Li,
Yun-neng Huang,
Man-ling Deng,
Rong-cheng Li,
Yan-ping Zhang,
Ortiz Esteban
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ABSTRACT: The aim of this study was to demonstrate the immunogenicity and safety of diphtheria, tetanus, pertussis (acellular, component), poliomyelitis (inactivated) vaccine (adsorbed) and Haemophilus influenzae type b conjugate vaccine (DTaP-IPV//PRP-T) combined vaccine compared with commercially available DTaP (diphtheria, tetanus and pertussis), Haemophilus influenzae type b (Hib), tetanus conjugate and IPV monovalent vaccine.
Subjects were randomly divided into three groups, Group A and Group B were DTaP-IPV//PRP-T combined vaccine (PENTAXIM(TM)) vaccinated at 2, 3, 4 months of age or 3, 4, 5 months of age respectively; Group C was commercially available DTaP. Hib tetanus conjugate (Act-HIB(TM)) and IPV (IMOVAX PolioTM(TM)) vaccines vaccinated at 3, 4, 5 months of age. All groups received booster dose at 18 to 20 months of age, with antibody titers tested. Non-inferiority analysis was demonstrated in terms of seroprotection/seroconversion rates between Group A, Group B respectively and Group C. Safety information was collected after each vaccination to assess the safety of investigational vaccines.
The non-inferiority of DTaP-IPV//PRP-T combined vaccine vaccinated at 2, 3, 4 or 3, 4, 5 months of age versus DTaP, Hib tetanus conjugate and IPV vaccine was demonstrated for all vaccine antigens in both primary and booster phases in terms of seroprotection/seroconversion rates. DTaP-IPV//PRP-T combined vaccine was well tolerated. The rate of solicited/unsoliciated severe adverse reactions was very low and similar to the control vaccines.
DTaP-IPV//PRP-T combined vaccine was highly immunogenic with good safety profile in Chinese infants, which was comparable to the commercially available control vaccines.
Zhonghua liu xing bing xue za zhi = Zhonghua liuxingbingxue zazhi 08/2011; 32(8):808-15.
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ABSTRACT: Globally, about 70% of cervical cancers are associated with human papillomavirus (HPV)-16 or HPV-18 infection. A meta-analysis of epidemiologic studies in China showed that HPV was present in 98% of cervical cancer samples. The HPV-16/18 AS04-adjuvanted vaccine Cervarix has shown a high level of protection against HPV-16/18 infections and associated cervical lesions. This phase I trial (NCT00549900) assessed the safety, tolerability, and immunogenicity of the vaccine in Chinese. Thirty healthy Chinese females, aged 15 to 45 years with a median age of 29.5 years, received three doses of Cervarix in Months 0, 1, and 6. Safety was assessed via recording solicited local and systemic symptoms within 7 days and unsolicited symptoms within 30 days after each vaccination. Serious adverse events, new onset of chronic diseases, and other medically significant conditions were recorded throughout this trial. As an exploratory objective, HPV-16/18 antibody titers were determined by enzyme-linked immunosorbent assay in serum samples collected in Months 0 and 7. Pain at the injection site was the most frequently reported local symptom. Two subjects reported medically significant adverse events. Both cases were assessed as unrelated to vaccination by the investigator. In Month 7, 100% seroconversion was observed for both anti-HPV-16 and anti-HPV-18 with high geometric mean antibody titers. HPV-16/18 AS04-adjuvanted vaccine, evaluated for the first time in Chinese females, was generally well tolerated and immunogenic, as previously shown in global studies.
Chinese journal of cancer 08/2011; 30(8):559-64.
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Rong Cheng Li,
Feng Xiang Li,
Yan Ping Li,
Qi Ming Hou, Chang Gui Li,
Ya Nan Li,
Fu Sheng Chen,
Xue Zhong Hu,
Wen Bin Su,
Shu Min Zhang,
Han Hua Fang,
Qiang Ye,
Tian De Zeng,
Tao Xuan Liu,
Xiu Bi Li,
Yun Neng Huang,
Man Ling Deng,
Yan Ping Zhang,
Esteban Ortiz
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ABSTRACT: The aim was to demonstrate the immunogenicity and safety of a DTaP-IPV//PRP-T combined vaccine (Pentaxim(®)) compared to individual vaccines in infants in the People's Republic of China. Infants (N=792) were randomly assigned to receive DTaP-IPV//PRP-T at 2, 3 and 4 months of age (Group A) or 3, 4 and 5 months of age (Group B), or DTaP (Wuhan Institute of Biological Products), PRP-T (Act-Hib(®)) and IPV (Imovax(®) Polio) at 3, 4 and 5 months of age (Group C). Antibody titers were measured pre- and 1 month after the third vaccination; non-inferiority analyses were performed for seroprotection/seroconversion (SP/SC) rates. Safety was assessed 1 month after the primary series. SP/SC rates for the DTaP-IPV//PRP-T vaccine were high and non-inferior to the controls. Reactogenicity was low for each group and no hypotonic hyporesponsive episode or seizure was reported. In conclusion, the DTaP-IPV//PRP-T vaccine was highly immunogenic, non-inferior to the commercially available control vaccines and had a good safety profile for both primary administration schedules.
Vaccine 02/2011; 29(10):1913-20. · 3.77 Impact Factor
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Jiang Wu,
Wei Li,
Hua-Qing Wang,
Jiang-Ting Chen,
Min Lv,
Ji-Chen Zhou,
Xiao-Feng Liang,
Han-Hua Fang,
Yan Liu,
Li-Ying Liu,
Xu Wang,
Wu-Li Zhang,
Xiao-Mei Zhang,
Li-Fei Song,
Yuan-Zheng Qiu, Chang-Gui Li,
Jun-Zhi Wang,
Yu Wang,
Wei-Dong Yin
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ABSTRACT: A double-blind, randomized, controlled trial involving 706 adults was conducted to evaluate the immunogenicity and safety of different dosages of whole-virion or split-virion H1N1 influenza vaccines with or without aluminum adjuvant. A rapid and strong immune response was induced at day 14 after the first injection. The seroprotection rates ranged from 72.7% (95% confidence interval [CI], 62.7%-81.1%) for 5-microg whole-virion aluminum formulation to 97.0% (95% CI, 90.9%-99.7%) for 30-microg split-virion nonaluminum formulation. All formulations were well tolerated. The incidences of mild, moderate, and severe reactions were 71 (10.1%), 15 (2.1%), and 1 (0.1%) of 706 reactions, respectively. The 15-microg split-virion formulation had the best immunogenicity and safety.
The Journal of Infectious Diseases 09/2010; 202(5):675-80. · 6.41 Impact Factor
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Jiang Wu,
Shu-Zhen Liu,
Shan-Shan Dong,
Xiao-Ping Dong,
Wu-Li Zhang,
Min Lu, Chang-Gui Li,
Ji-Chen Zhou,
Han-Hua Fang,
Yan Liu,
Li-Ying Liu,
Yuan-Zheng Qiu,
Qiang Gao,
Xiao-Mei Zhang,
Jiang-Ting Chen,
Xiang Zhong,
Wei-Dong Yin,
Zi-Jian Feng
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ABSTRACT: Highly pathogenic avian influenza A virus H5N1 has the potential to cause a pandemic. Many prototype pandemic influenza A (H5N1) vaccines had been developed and well evaluated in adults in recent years. However, data in children are limited. Herein we evaluate the safety and immunogenicity of adjuvanted split-virion and whole-virion H5N1 vaccines in children.
An open-labelled phase I trial was conducted in children aged 3-11 years to receive aluminum-adjuvated, split-virion H5N1 vaccine (5-30 microg) and in children aged 12-17 years to receive aluminum-adjuvated, whole-virion H5N1 vaccine (5-15 microg). Safety of the two formulations was assessed. Then a randomized phase II trial was conducted, in which 141 children aged 3-11 years received the split-virion vaccine (10 or 15 microg) and 280 children aged 12-17 years received the split-virion vaccine (10-30 microg) or the whole-virion vaccine (5 microg). Serum samples were collected for hemagglutination-inhibition (HI) assays.
5-15 microg adjuvated split-virion vaccines were well tolerated in children aged 3-11 years and 5-30 microg adjuvated split-virion vaccines and 5 microg adjuvated whole-virion vaccine were well tolerated in children aged 12-17 years. Most local and systemic reactions were mild or moderate. Before vaccination, all participants were immunologically naïve to H5N1 virus. Immune responses were induced after the first dose and significantly boosted after the second dose. In 3-11 years children, the 10 and 15 microg split-virion vaccine induced similar responses with 55% seroconversion and seroprotection (HI titer >or=1:40) rates. In 12-17 years children, the 30 microg split-virion vaccine induced the highest immune response with 71% seroconversion and seroprotection rates. The 5 microg whole-virion vaccine induced higher response than the 10 microg split-virion vaccine did.
The aluminum-adjuvanted, split-virion prototype pandemic influenza A (H5N1) vaccine showed good safety and immunogenicity in children and 30 microg dose induced immune response complying with European Union licensure criteria.
Vaccine 08/2010; 28(38):6221-7. · 3.77 Impact Factor
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Feng-Cai Zhu,
Hua Wang,
Han-Hua Fang,
Jian Guo Yang,
Xiao Jun Lin,
Xiao-Feng Liang,
Xue-Feng Zhang,
Hong-Xing Pan,
Fan-Yue Meng,
Yue Mei Hu,
Wen-Dong Liu, Chang-Gui Li,
Wei Li,
Xiang Zhang,
Jin Mei Hu,
Wei Bing Peng,
Bao Ping Yang,
Pei Xi,
Hua-Qing Wang,
Jing-Shan Zheng
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ABSTRACT: There is an urgent need for a vaccine that is effective against the 2009 pandemic influenza A (H1N1) virus.
A split-virus, inactivated candidate vaccine against the 2009 H1N1 virus was manufactured, and we evaluated its safety and immunogenicity in a randomized clinical trial. Subjects were between 3 and 77 years of age, stratified into four age groups. The immunization schedule consisted of two vaccinations, 21 days apart. Subjects were injected with placebo or with vaccine, with or without alum adjuvant, at doses of 7.5 microg, 15 microg, or 30 microg. Serologic analysis was performed at baseline and on days 21 and 35.
A total of 2200 subjects received one dose, and 2103 (95.6%) received the second dose, of vaccine or placebo. No severe adverse side effects associated with the vaccine were noted. In the nonadjuvanted-vaccine groups, injection-site or systemic reactions, most mild in nature, were noted in 5.5 to 15.9% of subjects. Among the subjects receiving 15 microg of nonadjuvanted vaccine, a hemagglutination-inhibition titer of 1:40 or more was achieved by day 21 in 74.5% of subjects between 3 and 11 years of age, 97.1% of subjects between 12 and 17 years, 97.1% of subjects between 18 and 60 years, and 79.1% of subjects 61 years of age or older; by day 35, the titer had been achieved in 98.1%, 100%, 97.1%, and 93.3% of subjects, respectively. The proportion with a titer of 1:40 or more was generally highest among the subjects receiving 30 microg of vaccine, with or without adjuvant. Vaccine without adjuvant was associated with fewer local reactions and greater immune responses than was vaccine with adjuvant.
These data suggest that a single dose of 15 microg of hemagglutinin antigen without alum adjuvant induces a typically protective immune response in the majority of subjects between 12 and 60 years of age. Lesser immune responses were seen after a single dose of vaccine in younger and older subjects. (ClinicalTrials.gov number, NCT00975572).
New England Journal of Medicine 10/2009; 361(25):2414-23. · 53.30 Impact Factor
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ABSTRACT: To study the immunological effectiveness of inactivated poliomyelitis vaccine (IPV) for children's primary vaccination in China and to compare with the oral poliomyelitis vaccine (OPV) used in routine vaccination.
The 2-month-old children were randomly immunized with IPV and OPV, with 208 subjects in each group. The pre- and post-vaccination blood samples were collected. Micro-neutralization method was used to measure the antibody response against 3 types of polioviruses. chi2 test was used to evaluate the statistical difference of protection rates between two groups, while the antibody titers were transformed by logarithm and analyzed by Z-test. P < 0.05 was always used to define the significance of analysis.
After 3 doses of immunization, the protection rates in IPV group reached to 100.0% (186/186), 97.3% (181/186), 98.9% (184/186) for poliovirus type 1, 2, 3, respectively, and in OPV group were 97.4% (188/193), 100.0% (193/193), 95.3% (184/193), respectively. The geometry mean titers (GMTs) were 151.2, 86.7, 211.3 for IPV group; and 1089.5, 538.2, 203.7 for OPV group. IPV showed comparable protection rates with OPV for type 1 and 2 (chi2(I) = 2.991, P = 0.084; chi2(II) = 3.512, P = 0.061), while type 3 was higher than OPV (chi2(III) = 4.143, P = 0.042). The GMT of type 1 and 2 in IPV group were lower than OPV group (Z(I) = 12.537, P = 0.000; Z(II) = 13.415, P = 0.000), while the GMT of type 3 were comparable in two groups (Z(III) = 0.067, P = 0.947).
IPV showed roughly comparable immunological effectiveness in young children. The protection rates for type 1 and 2 were similar to OPV, while type 3 was higher than in OPV group; In terms of GMT,type 1 and 2 in IPV group were lower than OPV, but type 3 were comparable to OPV group.
Zhonghua yu fang yi xue za zhi [Chinese journal of preventive medicine] 06/2009; 43(6):501-3.
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Jiang Wu,
Han-Hua Fang,
Jiang-Ting Chen,
Ji-Chen Zhou,
Zi-Jian Feng, Chang-Gui Li,
Yuan-Zheng Qiu,
Yan Liu,
Min Lu,
Li-Ying Liu,
Shan-Shan Dong,
Qiang Gao,
Xiao-Mei Zhang,
Nan Wang,
Wei-Dong Yin,
Xiao-Ping Dong
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ABSTRACT: Avian influenza A virus H5N1 has the potential to cause a pandemic. Adjuvants and whole-virion vaccines are regarded as antigen sparing for pandemic vaccines.
A double-blind, randomized trial was performed from 28 August to 22 December 2007 in 402 adults; 301 adults were randomly assigned to receive 2 doses of an inactivated, aluminum-adjuvanted, whole-virion H5N1 vaccine containing 5, 10, or 15 microg of hemagglutinin per dose 28 days apart, and 101 of them received 2 doses of 10 microg of vaccine 14 days apart. The vaccine was manufactured from the recombinant A/Vietman/1194/2004 (NIBRG14) strain. Blood samples were collected for hemagglutination inhibition and microneutralization assays.
All formulations were well tolerated, with no serious adverse events. Most local and systemic reactions were mild or moderate. Immune responses were induced after 1 dose in all vaccination groups. The highest immune response was seen after 2 doses of 15 microg of vaccine, with 90% and 100% seroconversion rates and 90% and 100% of participants having a titer of > or = 1:40 for hemagglutination inhibition and microneutralization assays, respectively. Both the 10- and 15-microg doses met or exceeded European Union licensure criteria. Generally, higher immune responses were elicited in participants vaccinated 28 days apart than those vaccinated 14 days apart. Cross-reaction assays showed that after 2 doses of 10 microg of vaccine, 98% and 87% of participants had a microneutralization titer of > or = 1:40 against heterologous Indonesia and Anhui strains, respectively.
The inactivated, aluminum-adjuvanted, whole-virion H5N1 vaccine not only showed good immunogenicity and safety but also elicited significant cross-reactivity against heterologous H5N1 strains in clade 2.
ClinicalTrials.gov identifier: NCT00535665.
Clinical Infectious Diseases 04/2009; 48(8):1087-95. · 9.15 Impact Factor
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Jiang-Tao Lin, Chang-Gui Li,
Xu Wang,
Nan Su,
Yan Liu,
Yuan-Zheng Qiu,
Meng Yang,
Jiang-Ting Chen,
Han-Hua Fang,
Xiao-Ping Dong,
Wei-Dong Yin,
Zi-Jian Feng
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ABSTRACT: An inactivated, alum-adjuvanted, whole-virion H5N1 vaccine had been evaluated previously. Hemagglutination inhibition (HI) assays showed that the antibody levels declined significantly, with 4.8%-20.8% and 0%-18.8% of participants retaining seroprotection (HI titer >or=1:40) 6 and 12 months after the second dose, respectively. A third dose of the same vaccine given 12 months after the second dose significantly boosted immune responses. Thirty days after the third dose in the 1.25-, 2.5-, 5-, and 10-microg dose groups, 29.4%, 31.3%, 78.6%, and 90.0% of participants had HI titers >or=1:40, and 52.9%, 81.2%, 92.9%, and 100% of participants had microneutralization titers >or=1:40, respectively. Both the 5-microg and 10-microg doses met European Union criteria.
The Journal of Infectious Diseases 01/2009; 199(2):184-7. · 6.41 Impact Factor
