Inactivated H5N1 whole cell vaccine(Institute Vaccines Medical Biologicals)(Inactivated H5N1 whole cell vaccine(Institute Vaccines Medical Biologicals))

概要

基本信息

药物类型

灭活疫苗、预防性疫苗

别名

IVACFLU-A

靶点-

作用机制

免疫刺激剂

治疗领域

感染呼吸系统疾病

在研适应症-

非在研适应症

H5N1流感甲型流感病毒感染禽流感+ [1]

原研机构

Institute Vaccines Medical Biologicals

在研机构-

非在研机构

Institute Of Vaccines And Medical Biologicals, VietnamInstitute Vaccines Medical Biologicals

最高研发阶段无进展临床3期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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关联

3

项与 Inactivated H5N1 whole cell vaccine(Institute Vaccines Medical Biologicals) 相关的临床试验

NCT02612909 / Completed临床2/3期

A Phase 2/3 Double Blinded, Randomized, Placebo-controlled Study in Healthy Adult Volunteers in Vietnam to Examine the Safety and Immunogenicity of an Inactivated A/H5N1 Influenza Vaccine (IVACFLU-A/H5N1) Produced by IVAC

The study hypothesis was that two 0.5 mL doses of whole virion monovalent A/H5N1 influenza vaccine (IVACFLU-A/H5N1) adjuvanted with alum would be safe and well tolerated in healthy adults, and that at least one of the two doses tested would be immunogenic in 60% or more of the subjects tested.

开始日期2017-03-07

申办/合作机构

Institute Of Vaccines And Medical Biologicals, Vietnam

[+5]

NCT02171819 / Completed临床1期

A Phase 1 Double Blinded, Randomized, Placebo-Controlled Study to Examine the Safety and Immunogenicity of an Inactivated A/H5N1 Influenza Vaccine (IVACFLU-A/H5N1) Produced by IVAC in Healthy Adult Volunteers in Vietnam

This is a first-in-human study of safety and immunogenicity of an A/H5N1 inactivated whole cell vaccine when given in two injections in two doses (low and high) compared to a placebo in 76 healthy adult subjects in Vietnam. Vaccine and placebo are manufactured by the IVAC in Vietnam.

开始日期2014-06-01

申办/合作机构

Institute Of Vaccines And Medical Biologicals, Vietnam

[+4]

NCT01507779 / Completed临床1期IIT

Evaluation of The Safety and Immunogenicity of an Influenza A/H1N1 Vaccine (IVACFLU), Produced by IVAC, in Healthy Adults in Vietnam

The study hypothesis is that two 0.5 ml doses of non-adjuvanted whole virion monovalent A/H1N1 influenza vaccine (IVACFLU)--each dose with an HA content of 15 mcg from A/California/07/2009 (H1N1)-like virus--will be safe and immunogenic in healthy adults.

开始日期2012-04-01

申办/合作机构

Program for Appropriate Technology in Health

[+2]

100 项与 Inactivated H5N1 whole cell vaccine(Institute Vaccines Medical Biologicals) 相关的临床结果

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100 项与 Inactivated H5N1 whole cell vaccine(Institute Vaccines Medical Biologicals) 相关的转化医学

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100 项与 Inactivated H5N1 whole cell vaccine(Institute Vaccines Medical Biologicals) 相关的专利（医药）

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21

项与 Inactivated H5N1 whole cell vaccine(Institute Vaccines Medical Biologicals) 相关的文献（医药）

2019-12-02·Human Vaccines & Immunotherapeutics3区 · 医学

A phase 2/3 double-blind, randomized, placebo-controlled study to evaluate the safety and immunogenicity of a seasonal trivalent inactivated split-virion influenza vaccine (IVACFLU-S) in healthy adults in Vietnam

3区 · 医学

Article

作者: Toan, Nguyen Trong ; Tewari, Tushar ; Nga, Nguyen Tuyet ; Francesco, Berlanda Scorza ; Thai, Duong Huu ; Tang, Yuxiao ; Huong, Vu Minh ; Thang, Tran Cong ; Holt, Renee ; Thang, Hoang Anh ; Lan, Phan Trong ; Flores, Jorge ; Be, Le Van

Background: Under the WHO's Global Action Plan for influenza vaccines, we conducted a phase 2-3 study of IVACFLU-S, a trivalent, seasonal inactivated influenza vaccine candidate.Methods: In the phase 2 portion of the study, 252 participants received one dose of 15 mcg hemagglutinin (HA) vaccine per strain or placebo. Following determination of safety, 636 additional participants were randomized in phase 3 to receive vaccine or placebo. Immunogenicity was assessed in a subset of the participants in the phase 3 study.Results: Higher proportion (70%) of participants in the IVACFLU-S arm reported solicited local adverse events (AEs) (p < .0001) as compared to placebo (25%). Mild injection site pain and tenderness were most common AEs seen in 55% and 60% of participants in the vaccine group. The solicited systemic AEs were comparable (p = .4149). The majority of solicited and unsolicited AEs were mild to moderate in severity. In the vaccine arm for the combined age group of 18-60 years of age, seroconversion against antigens A/H1N1, A/H3N2, and B was achieved in 70.3%, 76.1%, and 54.1% of participants respectively; seroprotection against antigens A/H1N1, A/H3N2, and B was achieved in 83.3%, 86.6%, and 60.3% of participants respectively; and the geometric mean fold rise for the hemagglutinin-inhibition (HI) antibody titers against antigen A/H1N1, A/H3N2, and B were 13.15, 11.85, and 5.87, respectively.Conclusion: This study demonstrates the local reactogenicity, other safety, and immunogenicity of IVACFLU-S, first domestically produced influenza vaccine in Vietnam.ClinicalTrials.gov number NCT03095599 (March 29, 2017).

2016-10-01·Vaccine3区 · 医学

Randomized safety and immunogenicity trial of a seasonal trivalent inactivated split virion influenza vaccine (IVACFLU-S) in healthy young Vietnamese adults

3区 · 医学

Article

作者: Nga, Nguyen Tuyet ; Thiem, Vu Dinh ; Thang, Tran Cong ; Huong, Vu Minh ; Anh, Nguyen Thi Hien ; Holt, Renee ; Berlanda Scorza, Francesco ; Anh, Dang Duc ; Chien, Vien Chinh ; Wahid, Rahnuma ; Thai, Duong Huu ; Taylor, David N ; Flores, Jorge

BACKGROUNDUnder the auspices of the World Health Organization (WHO) Global Action Plan, PATH supported evaluation of a trivalent, seasonal inactivated influenza vaccine candidate produced by the Institute of Vaccines and Medical Biologicals (IVAC), a Vietnamese manufacturer.METHODSIn 2015, 60 healthy adult subjects 18-45years of age were enrolled in a Phase 1, single center, double blind, randomized, placebo-controlled study conducted at a district health center in Thai Binh Province, Vietnam. The study evaluated the overall safety and immunogenicity of a seasonal, trivalent inactivated split virion influenza vaccine. Volunteers were given either vaccine or placebo in a randomized 1:1 ratio. After undergoing screening, eligible volunteers provided their signed consent and were enrolled in the study. On the first day of immunization, randomly chosen volunteers received IVACFLU-S 15μg (mcg) hemagglutinin of each of the three strains in 0.5mL or placebo by intramuscular injection. All volunteers were monitored for adverse events and underwent blood testing at screening and Day 8 to assess the vaccine candidate's safety. Sera obtained before and 21days after immunization were tested for influenza antibody titers using the hemagglutination-inhibition (HAI) and microneutralization tests (MNT).RESULTSVaccine was well tolerated, and there were no serious adverse events reported. HAI and MNT identified serum antibody responses against the three influenza strains in nearly all volunteers who received the vaccine. Overall, serum HAI responses of fourfold or greater were observed in 93 percent, 83 percent, and 77 percent of H1, H3, and B strains, respectively. Seroprotection rates were also very high.CONCLUSIONSIVAC's seasonal, trivalent influenza vaccine was safe and well tolerated and induced high levels of seroconversion and seroprotection rates. These clinical data are a first step towards demonstrating the feasibility of producing the vaccine locally and that seasonal vaccine production in Vietnam may be an effective strategy for enhancing the global influenza vaccine supply. ClinicalTrials.gov number NCT02598089, October 15, 2015.

2012-06-01·The International Journal of Tuberculosis and Lung Disease4区 · 医学

New vaccines for the prevention of tuberculosis in human immunodeficiency virus infection [Perspectives]

4区 · 医学

Review

作者: Ramadhani, A. ; Egwaga, S. ; Bakari, M. ; Lahey, T. ; Arbeit, R. D. ; von Reyn, C. F.

The prevention of human immunodeficiency virus (HIV) associated tuberculosis (TB) remains challenging. Several vaccines against TB have advanced to clinical trials in patients with HIV infection. The DarDar Trial, a large, randomized, placebo-controlled efficacy trial conducted in Tanzania, has demonstrated that a multiple dose series of an inactivated whole cell mycobacterial vaccine is safe in HIV and can prevent HIV-associated TB in patients with childhood bacille Calmette-Guérin vaccination and CD4 counts of ≥200 cells/mm(3). These developments offer promise that in the not too distant future immunization with an effective vaccine against TB can be added to other strategies for the prevention of HIV-associated TB. This expanded approach is referred to as the Five 'I's': intensified case finding, infection control, isoniazid preventive therapy (IPT), initiation of antiretroviral therapy (ART), and immunization against TB. We encourage additional studies of new TB vaccines in HIV, and propose a strategy to reduce the risk of TB by integrating IPT, ART and immunization into routine HIV care. At the time of HIV diagnosis, patients with CD4 counts of ≥200 cells/mm(3) could receive immunization, IPT and, as appropriate, ART. In patients presenting with lower CD4 counts or already on ART, immunization could be initiated at CD4 counts of ≥200 cells/mm(3) to add to the protection afforded by IPT and ART.

100 项与 Inactivated H5N1 whole cell vaccine(Institute Vaccines Medical Biologicals) 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
禽流感	临床3期	越南	Institute Of Vaccines And Medical Biologicals, Vietnam	2017-03-07
流感病毒感染	临床3期	越南	Institute Of Vaccines And Medical Biologicals, Vietnam	2017-03-07
H5N1流感	临床3期	越南	Institute Of Vaccines And Medical Biologicals, Vietnam	2014-06-01
甲型流感病毒感染	临床3期	-	Institute Vaccines Medical Biologicals	-

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02612909 (Pubmed) 人工标引	临床2/3期	-	930	IVACFLU-A/H5N1	憲餘選憲鹹遞網鹽製淵(蓋遞淵鑰繭選獵艱製選) = 衊獵淵膚壓製壓遞繭顧築窪願齋鬱網鹽觸構醖 (獵膚襯齋獵遞網醖壓製 ) 更多	积极	2020-02-05
NCT02612909 (CTgov)	临床2/3期	禽流感 \| 流感病毒感染	930	Placebo (Phase 2: Placebo)	繭醖鹹顧構襯夢獵構築(鑰醖築衊範願鏇淵夢夢) = 網繭艱廠衊範觸淵願窪鬱繭糧衊繭遞築醖糧夢 (製齋鬱網遞艱廠製鑰蓋, 構夢壓衊鏇醖膚鏇齋襯 ~ 築遞積願積廠製築鏇製) 更多	-	2019-04-16
				IVACFLU-A/H5N1 vaccine (Phase 2: Vaccine (15 mcg))	繭醖鹹顧構襯夢獵構築(鑰醖築衊範願鏇淵夢夢) = 鹹願蓋鏇鬱衊齋鏇鬱窪鬱繭糧衊繭遞築醖糧夢 (製齋鬱網遞艱廠製鑰蓋, 製鏇網築糧獵顧糧鏇衊 ~ 鬱襯範顧鬱網齋襯淵糧) 更多
NCT01507779 (CTgov)	临床1期	甲型流感病毒感染	48	Placebo (Placebo)	窪積獵網衊膚齋鏇製襯(簾觸襯鬱遞襯網餘糧蓋) = 遞選範築遞繭夢遞網鑰製鏇膚繭繭壓壓蓋壓繭 (淵鏇繭簾選鹽製夢衊鹽, 構獵糧夢窪觸簾鬱齋選 ~ 觸顧窪壓顧願襯廠製蓋) 更多	-	2019-02-27
				IVACFLU (Influenza Vaccine)	窪積獵網衊膚齋鏇製襯(簾觸襯鬱遞襯網餘糧蓋) = 膚鏇範願製淵簾膚衊構製鏇膚繭繭壓壓蓋壓繭 (淵鏇繭簾選鹽製夢衊鹽, 糧鏇淵構製鹽餘壓築網 ~ 夢構衊襯夢憲鬱鹹蓋鹽) 更多