HIV vaccine Ad4-EnvC150(Emergent BioSolutions, Inc.)(HIV vaccine Ad4-EnvC150(Emergent BioSolutions, Inc.))

概要

基本信息

药物类型

预防性疫苗

别名

Ad4-EnvC150 vaccine、Ad4-env Clade C、Adenovirus4 HIV EnvC150 vaccine

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靶点

gp150

作用机制

gp150抑制剂(HIV病毒gp150蛋白抑制剂)

治疗领域

免疫系统疾病感染泌尿生殖系统疾病

在研适应症-

非在研适应症

HIV感染

原研机构

Emergent BioSolutions, Inc.

在研机构-

非在研机构

Emergent BioSolutions, Inc.

Emergent Travel Health, Inc.

最高研发阶段终止临床1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

2

项与 HIV vaccine Ad4-EnvC150(Emergent BioSolutions, Inc.) 相关的临床试验

NCT02771730 / Terminated临床1期

A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of Orally-administered Replication-competent Adenovirus Type-4 HIV Vaccine Regimens in Combination With an AIDSVAX® B/E Boost in Healthy, HIV-uninfected Adult Participants

The purpose of this study is to test experimental human immunodeficiency virus (HIV) vaccines that use an adenovirus vector. The adenovirus vector may help the vaccines stimulate an immune response. Researchers want to see how the immune system will respond to these vaccines as well as if they are safe to give to people. Participants cannot get HIV from these vaccines. However, researchers also want to see if the vaccine's adenovirus is contagious. Adenoviruses cause cold symptoms or mild eye infections, therefore household and intimate contacts will be asked to participate as well.

开始日期2015-03-01

申办/合作机构

Emergent BioSolutions, Inc.

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NCT01989533 / Completed临床1期IIT

Phase I Study of Safety and Immunogenicity of Ad4-HIV Vaccine Vectors in Healthy Volunteers

Background:
- Vaccines create resistance to disease. This study tests experimental human immunodeficiency virus (HIV) vaccines that use an adenovirus as a transporter. Transporters may help vaccines stimulate an immune response against HIV. This means the body works to fight infection. Researchers want to see if different ways of giving the vaccines cause different immune responses. They also want to see if the vaccines adenovirus is contagious. Adenoviruses cause cold symptoms or mild eye infections.
Participants cannot get HIV from these vaccines. But they can get the adenovirus, so their entire household and intimate contacts must participate.
Objective:
- To test the safety of experimental HIV vaccines.
Eligibility:
- Healthy adults 18-49 years old.
Design:
Participants will be screened with medical history, physical exam, and blood and urine tests.
Participants will receive the vaccine 3 times over 6 months. Each time, they will have a physical exam and blood and urine tests. Samples will be taken from their nose, rectum, and cervix.
Some participants will receive the vaccine by swallowing 11 capsules with water. Clinic staff will observe them for 1 hour.
Some participants will receive the vaccine swabbed in their throat. They will get dose 1 at the hospital and stay there for 1 week. They will have medical tests and nose swabs. Doses 2 and 3 will not require a hospital stay.
Participants will have 7 follow-up visits over 6 months, with a physical exam and blood tests. Samples will be taken from their nose, throat, and rectum.
Household and intimate contacts will have 4 clinic visits over 8 months, with a physical exam and blood tests.

开始日期2013-11-19

申办/合作机构

National Institute of Allergy & Infectious Diseases

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100 项与 HIV vaccine Ad4-EnvC150(Emergent BioSolutions, Inc.) 相关的临床结果

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100 项与 HIV vaccine Ad4-EnvC150(Emergent BioSolutions, Inc.) 相关的转化医学

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100 项与 HIV vaccine Ad4-EnvC150(Emergent BioSolutions, Inc.) 相关的专利（医药）

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2

项与 HIV vaccine Ad4-EnvC150(Emergent BioSolutions, Inc.) 相关的文献（医药）

1992-08-15·Proceedings of the National Academy of Sciences1区 · 综合性期刊

Adenovirus-human immunodeficiency virus (HIV) envelope recombinant vaccines elicit high-titered HIV-neutralizing antibodies in the dog model.

1区 · 综合性期刊

Article

作者: Lubeck, M D ; Davis, A R ; Wade, M S ; Bhat, B M ; Natuk, R J ; Wilhelm, J ; Hjorth, R ; Lee, S ; Mizutani, S ; Chanda, P K

Recombinant human adenoviruses (Ads) (types 4, 5, and 7) expressing the HIV-1 envelope membrane glycoprotein (gp160) were tested for immunogenicity in the dog. Administration of recombinant Ad7-env by intratracheal inoculation resulted in a low serum antibody response to gp160, which developed over several weeks. A strong neutralizing antibody response to the Ad7 vector developed within 1 week of infection. A subsequent booster inoculation 12 weeks later with the heterotypic Ad4-env recombinant virus resulted in significantly enhanced humoral responses directed at the envelope antigen, as measured by both ELISA and Western blot analysis as well as high-titer type-specific neutralizing antibodies, with some animals achieving neutralization titers approaching 1000. Recombinant HIV envelope glycoprotein derived from Ad-HIV-infected cell cultures was used as a subunit booster injection for dogs that had previously received sequential immunizations with heterotypic recombinant Ads. Significant immune responses against the envelope developed as measured by ELISA, Western blot analysis, and neutralization assays. These data indicate that live recombinant Ad-HIV vaccines are capable of inducing high-titer type-specific neutralizing antibodies to gp160 in vivo. Recombinant HIV envelope glycoprotein subunit vaccines, prepared from Ad-env-infected cells, are capable of boosting these responses.

PLoS ONE3区 · 综合性期刊

Pre-Clinical Development of a Recombinant, Replication-Competent Adenovirus Serotype 4 Vector Vaccine Expressing HIV-1 Envelope 1086 Clade C

3区 · 综合性期刊

ArticleOA

作者: Jeff Alexander ; Fermin Garduno ; Ronald Swanstrom ; Jenny B. Avanzini ; David C. Montefiori ; Peggy Farness ; Celia LaBranche ; Jason Mendy ; Glenn Ishioka ; Lo Vang ; Marc Gurwith ; Tim Mayall ; Jonathan Smith ; Hua Xin Liao ; Barton F. Haynes ; Darly J. Manayani ; Li Hua Ping ; Robert Parks

BACKGROUNDThere is a well-acknowledged need for an effective AIDS vaccine that protects against HIV-1 infection or limits in vivo viral replication. The objective of these studies is to develop a replication-competent, vaccine vector based on the adenovirus serotype 4 (Ad4) virus expressing HIV-1 envelope (Env) 1086 clade C glycoprotein. Ad4 recombinant vectors expressing Env gp160 (Ad4Env160), Env gp140 (Ad4Env140), and Env gp120 (Ad4Env120) were evaluated.METHODSThe recombinant Ad4 vectors were generated with a full deletion of the E3 region of Ad4 to accommodate the env gene sequences. The vaccine candidates were assessed in vitro following infection of A549 cells for Env-specific protein expression and for posttranslational transport to the cell surface as monitored by the binding of broadly neutralizing antibodies (bNAbs). The capacity of the Ad4Env vaccines to induce humoral immunity was evaluated in rabbits for Env gp140 and V1V2-specific binding antibodies, and HIV-1 pseudovirus neutralization. Mice immunized with the Ad4Env160 vaccine were assessed for IFNγ T cell responses specific for overlapping Env peptide sets.RESULTSRobust Env protein expression was confirmed by western blot analysis and recognition of cell surface Env gp160 by multiple bNAbs. Ad4Env vaccines induced humoral immune responses in rabbits that recognized Env 1086 gp140 and V1V2 polypeptide sequences derived from 1086 clade C, A244 clade AE, and gp70 V1V2 CASE A2 clade B fusion protein. The immune sera efficiently neutralized tier 1 clade C pseudovirus MW965.26 and neutralized the homologous and heterologous tier 2 pseudoviruses to a lesser extent. Env-specific T cell responses were also induced in mice following Ad4Env160 vector immunization.CONCLUSIONSThe Ad4Env vaccine vectors express high levels of Env glycoprotein and induce both Env-specific humoral and cellular immunity thus supporting further development of this new Ad4 HIV-1 Env vaccine platform in Phase 1 clinical trials.

100 项与 HIV vaccine Ad4-EnvC150(Emergent BioSolutions, Inc.) 相关的药物交易

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