A Randomized, Double-Blinded, Controlled, Phase I Study in Healthy Adults to Assess the Safety, Reactogenicity, and Immunogenicity of Intramuscular Subvirion Inactivated Monovalent Influenza A/H5N1 Virus Vaccine Administered With and Without AS03 Adjuvant: Standard & Systems Biology Analyses

This is a single center, randomized, double-blinded, controlled, Phase I, small targeted prospective study in healthy male and non-pregnant female subjects, 18 to 49 years old, inclusive, designed to determine the safety, reactogenicity, and immunogenicity of an intramuscular subvirion inactivated monovalent influenza A/H5N1 (HA of A/Indonesia/05/2005) virus vaccine manufactured by Sanofi Pasteur administered at 3.75 mcg per dose given with or without AS03 adjuvant manufactured by GSK. In the study, each subject will receive two doses administered 28 days apart. This study will use a systems biology approach to assess the human early gene and protein signatures expressed at Days 1, 3, 7, and 28 after the first vaccination. The systems data will be integrated with immunogenicity and reactogenicity data to develop a systems model of the human immune response to A/H5N1 vaccine with or without AS03 adjuvant.

开始日期2012-05-24

申办/合作机构

National Institute of Allergy & Infectious Diseases

NCT01032408 / Completed临床3期

A Phase 3, Randomized, Controlled, Open Label Study to Evaluate the Immunogenicity, Safety, and Tolerability of MF59-Adjuvanted Versus Non-Adjuvanted Vaccines Against Novel H1N1 Virus in Patients With Human Immunodeficiency Virus Type 1 (HIV-1) Infection

This is a phase III, randomized, controlled, open label study with two vaccine regimens. The study will assess the relative safety and immunogenicity of vaccine regimens comparing adjuvanted versus non-adjuvanted formulations of A(H1N1) inactivated influenza virus vaccine in subjects with Human Immunodeficiency Virus Type 1 (HIV-1) Infection and to compare safety and immunogenicity data with a contemporaneously enrolled control group of age-comparable, healthy subjects.
Because certain individuals may be hypo-responsive to influenza vaccination, additional studies with high-risk groups are warranted in order to determine the optimal vaccine formulation and dosing schedule for prevention of novel H1N1 virus infection.

开始日期2010-04-01

申办/合作机构

Chiltern-Pesquisa Clinica Ltda.

JPRN-jRCT2080221031 / Unknown status临床2/3期

A Multi-center, Randomized, Single-blind, Dose-Ranging Study to Evaluate Immunogenicity, Safety and Tolerability of Different Doses of Adjuvanted Cell-Derived, Inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy Japanese Adult Subjects

开始日期2010-03-02

申办/合作机构

Novartis Pharma KK

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项与 Pandemic influenza A virus vaccines(National Institute of Allergy & Infectious Diseases) 相关的文献（医药）

2013-07-01·Arthritis Care & Research2区 · 医学

High Disease Activity: An Independent Factor for Reduced Immunogenicity of the Pandemic Influenza A Vaccine in Patients With Juvenile Systemic Lupus Erythematosus

2区 · 医学

Article

作者: Bonfa, Eloisa ; Silva, Clovis A. ; Moraes, Julio C. B. ; Aikawa, Nadia E. ; Pereira, Rosa M. R. ; Bueno, Cleonice ; Ishida, Maria A. ; Jesus, Adriana A. ; Miraglia, Joao ; Campos, Lucia M. A.

ObjectiveRecent findings demonstrated a reduced immunogenicity of the influenza A H1N1/2009 vaccine in juvenile rheumatic diseases. However, a point of concern is whether the vaccine could induce disease flares. The aim of this study was to assess the disease safety of and the possible influence of disease parameters and therapy on nonadjuvant influenza A H1N1 vaccine response of juvenile systemic lupus erythematosus (SLE) patients.MethodsOne hundred eighteen juvenile SLE patients and 102 healthy controls of a comparable age were vaccinated. Seroprotection rate, seroconversion rate, and factor increase in geometric mean titer (GMT) were calculated and effective immune response was defined by the Food and Drug Administration and the European Committee for Proprietary Medicinal Products vaccine immunologic standards. Disease parameters, treatment, and adverse events were evaluated.ResultsAge was comparable in juvenile SLE patients and controls (mean ± SD 16.0 ± 3.5 versus 15.9 ± 4.5 years; P = 0.26). Three weeks after immunization, seroprotection rate (73.7% versus 95.1%; P < 0.001), seroconversion rate (63.6% versus 91.2%; P < 0.001), GMT (90.8 versus 273.3; P < 0.001), and factor increase in GMT (8.1 versus 19.9; P < 0.001) were significantly lower in juvenile SLE patients versus controls. Nonseroconversion was associated with a higher frequency of patients with a Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI‐2K) score ≥8 (48.8% versus 24%; P = 0.008) and a higher mean ± SD current glucocorticoid dosage (18 ± 21.4 versus 10.5 ± 12.5 mg/day; P = 0.018). Multivariate logistic regression including a SLEDAI‐2K score ≥8 revealed that only the SLEDAI‐2K remained a significant factor for nonseroconversion (odds ratio 0.42, 95% confidence interval 0.18–0.98; P = 0.045). Disease parameters remained stable throughout the study and no severe vaccine adverse events were observed.ConclusionThe present study demonstrated adequate disease safety and is the first to discriminate that high disease activity impairs influenza A H1N1/2009 vaccine antibody production in juvenile SLE, in spite of an overall immune response within recommended levels.

PLoS ONE3区 · 综合性期刊

Effectiveness of Non-Adjuvanted Pandemic Influenza A Vaccines for Preventing Pandemic Influenza Acute Respiratory Illness Visits in 4 U.S. Communities

3区 · 综合性期刊

ArticleOA

作者: Katz, J. ; McNabb, P. ; Zervos, M. ; Coleman, Laura A. ; Gargiullo, Paul ; Storrow, A. ; Xian, X. ; Griffin, Marie R. ; Schnabel, K. ; Johnson, E. ; Petrie, Joshua G. ; Chaves, S. ; Thompson, M. ; Bennett, N. ; Lamerato, L. ; Cross, R. ; Kieke, B. ; Waring, S. ; Wyatt, D. ; Chen, Qingxia ; Zhu, Y. ; Yoo, B.-K. ; Koptizke, S. ; Treanor, John J. ; Donahue, J. ; Vandermause, M. ; Szylagyi, P. ; Shay, David K. ; Ohmit, Suzanne E. ; Blythe, L. ; Williams, John V. ; Squires, P. ; Irving, S. ; Balish, A. ; Hall, Caroline Breese ; Kent, D. ; Chen, Jufu ; Lindstrom, S. ; Cox, N. ; Belongia, Edward A. ; Berman, LaShondra ; Falsey, A. ; Laya, L. ; Sambhara, S. ; Kjos, S. ; Monto, Arnold S. ; Edwards, K. ; Lofthus, Gerry ; Meece, Jennifer K. ; Liu, Z. ; Van Hook, S. ; Klimov, A. ; Talbot, H. Keipp

We estimated the effectiveness of four monovalent pandemic influenza A (H1N1) vaccines (three unadjuvanted inactivated, one live attenuated) available in the U.S. during the pandemic. Patients with acute respiratory illness presenting to inpatient and outpatient facilities affiliated with four collaborating institutions were prospectively recruited, consented, and tested for influenza. Analyses were restricted to October 2009 through April 2010, when pandemic vaccine was available. Patients testing positive for pandemic influenza by real-time RT-PCR were cases; those testing negative were controls. Vaccine effectiveness was estimated in logistic regression models adjusted for study community, patient age, timing of illness, insurance status, enrollment site, and presence of high-risk medical conditions. Pandemic virus was detected in 1,011 (15%) of 6,757 enrolled patients. Fifteen (1%) of 1,011 influenza positive cases and 1,042 (18%) of 5,746 test-negative controls had record-verified pandemic vaccination >14 days prior to illness onset. Adjusted effectiveness (95% confidence interval) for pandemic vaccines combined was 56% (23%, 75%). Adjusted effectiveness for inactivated vaccines alone (79% of total) was 62% (25%, 81%) overall and 32% (-92%, 76%), 89% (15%, 99%), and -6% (-231%, 66%) in those aged 0.5 to 9, 10 to 49, and 50+ years, respectively. Effectiveness for the live attenuated vaccine in those aged 2 to 49 years was only demonstrated if vaccination >7 rather than >14 days prior to illness onset was considered (61%∶ 12%, 82%). Inactivated non-adjuvanted pandemic vaccines offered significant protection against confirmed pandemic influenza-associated medical care visits in young adults.

La Medicina del lavoro4区 · 医学

Assessment of efficacy and safety of pandemic A/H1N1/2009 influenza vaccine in a group of health care workers.

4区 · 医学

Article

作者: Vicenzi, Elisa ; Mascagni, P ; Kajaste-Rudnitski, Anna ; Toffoletto, F ; Cervi, Carla ; Monti, A ; Vitalucci, Roberta ; Pellicciotta, G

INTRODUCTIONThe development in an extremely short time of an efficacious and safe vaccine against the pandemi A/H1N1 virus was a challenge that involved the entire scientific community.AIMSTo assess the immunological and clinical efficacy of the new H1N1v monovalent influenza vaccine (Focetria Novartis Vaccines, Siena, Italy) in a group of health care workers (HCWs).METHODSA total of 148 volunteer HCWs were enrolled between Mid-Novembre 2009 and December 2009. After measuring antibody titers, a single intramuscular dose of 7.5 microg of Focetria monovalent vaccine against A/H1N1/2009 influenza virus with MF59C.1 adjuvant was administered.RESULTSAntibody titers (median value) before and after a single dose of vaccine, measured by means of standard beam-agglutination inhibition test (HAI), increased from 32 to 256 (p < 0.001). After vaccination, 79.7% of the subjects showed antibody seroconversion, and in 97.3% seroprotection was achieved. The ratio between the geometric means of antibody titers (GMTR) was 6.69. For the 3 subjects who reported symptoms of ILI (Influenza-like illness), a regular nasal-pharyngeal swab sample was taken to identify the virus type by RT-PCR, the laboratory results of tests performed on these samples were negative for pandemic A/H1N1/2009 virus. During the entire follow-up period of 6 months no severe adverse events occurred.CONCLUSIONSThe vaccine against pandemic A/H1N1/2009 virus provided protection against the virus and not only contributed to a significant immunization (according to EMEA criteria), but kept all 148 subjects under study free from A/H1N1/2009 influenza illness.

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适应症	最高研发状态	国家/地区	公司	日期
糖尿病	临床3期	巴西	Chiltern-Pesquisa Clinica Ltda.	2010-03-01
心脏病	临床3期	巴西	Chiltern-Pesquisa Clinica Ltda.	2010-03-01
肺部疾病	临床3期	巴西	Chiltern-Pesquisa Clinica Ltda.	2010-03-01
流感病毒感染	临床3期	日本	Novartis Vaccines & Diagnostics, Inc.	2009-10-01
甲型流感病毒感染	临床3期	美国	National Institute of Allergy & Infectious Diseases	2006-02-01