A Phase I Double-Blind, Randomized, Placebo-Controlled, Dose-Escalation Trial to Evaluate the Safety and Immunogenicity of a Sendai HIV Vaccine SeV-G(NP) Given Intranasally and Ad35-GRIN Administered Intramuscularly in Prime-Boost Regimens in HIV-Uninfected, Healthy Adult Volunteers

The purpose of this study is to evaluate the safety, tolerability and immunogenicity of Sendai HIV vaccine SeV-G(NP) given intranasally and Ad35-GRIN administered intramuscularly in prime-boost regimens in HIV-uninfected, healthy adult volunteers.

Start Date01 Mar 2013

Sponsor / Collaborator

International AIDS Vaccine Initiative, Inc.

100 Clinical Results associated with HIV vaccine SeV-G-NP(International AIDS Vaccine Initiative/Id Pharma)

100 Translational Medicine associated with HIV vaccine SeV-G-NP(International AIDS Vaccine Initiative/Id Pharma)

100 Patents (Medical) associated with HIV vaccine SeV-G-NP(International AIDS Vaccine Initiative/Id Pharma)

Literatures (Medical) associated with HIV vaccine SeV-G-NP(International AIDS Vaccine Initiative/Id Pharma)

01 Nov 2015·The Journal of Heart and Lung TransplantationQ1 · MEDICINE

Ventilatory gas exchange and early response to cardiac resynchronization therapy

Q1 · MEDICINE

Article

Author: Cha, Yong-Mei ; Kim, Chul-Ho ; Olson, Lyle J ; Johnson, Bruce D ; Shen, Win K

BACKGROUNDCardiac resynchronization therapy (CRT) is an accepted intervention for chronic heart failure (HF), although approximately 30% of patients are non-responders. The purpose of this study was to determine whether exercise respiratory gas exchange obtained before CRT implantation predicts early response to CRT.METHODSBefore CRT implantation, patients were assigned to either a mild-moderate group (Mod G, n = 33, age 67 ± 10 years) or a moderate-severe group (Sev G, n = 31, age 67 ± 10 years), based on abnormalities in exercise gas exchange. Severity of impaired gas exchange was based on a score from the measures of VE/VCO(2) slope, resting PETCO(2) and change of PETCO(2) from resting to peak. All measurements were performed before and 3 to 4 months after CRT implantation.RESULTSAlthough Mod G did not have improved gas exchange (p > 0.05), Sev G improved significantly (p < 0.05) post-CRT. In addition, Mod G did not show improved right ventricular systolic pressure (RSVP; pre vs post: 37 ± 14 vs 36 ± 11 mm Hg, p > 0.05), yet Sev G showed significantly improved RVSP, by 23% (50 ± 14 vs 42 ± 12 mm Hg, p < 0.05). Both groups had improved left ventricular ejection fraction (p < 0.05), New York Heart Association class (p < 0.05) and quality of life (p < 0.05), but no significant differences were observed between groups (p > 0.05). No significant changes were observed in brain natriuretic peptide in either group post-CRT.CONCLUSIONBased on pre-CRT implantation ventilatory gas exchange, subjects with the most impaired values appeared to have more improvement post-CRT, possibly associated with a decrease in RVSP.

01 Nov 2011·VaccineQ3 · MEDICINE

Intranasal Sendai viral vector vaccination is more immunogenic than intramuscular under pre-existing anti-vector antibodies

Q3 · MEDICINE

Article

Author: Chikaya Moriya ; Yusuke Takahara ; Tetsuro Matano ; Tsugumine Shu ; Hiroto Hara ; Mamoru Hasegawa ; Makoto Inoue ; Akihiro Iida ; Satoshi Horiba ; Kyoko Kurihara ; Takeo Kamada

Viral vectors are promising vaccine tools for eliciting potent cellular immune responses. Pre-existing anti-vector antibodies, however, can be an obstacle to their clinical use in humans. We previously developed a Sendai virus (SeV) vector vaccine and showed the potential of this vector for efficient CD8(+) T-cell induction in macaques. Here, we investigated the immunogenicity of SeV vector vaccination in the presence of anti-SeV antibodies. We compared antigen-specific CD8(+) T-cell responses after intranasal or intramuscular immunization with a lower dose (one-tenth of that in our previous studies) of SeV vector expressing simian immunodeficiency virus Gag antigen (SeV-Gag) between naive and pre-SeV-infected cynomolgus macaques. Intranasal SeV-Gag immunization efficiently elicited Gag-specific CD8(+) T-cell responses not only in naive but also in pre-SeV-infected animals. In contrast, intramuscular SeV-Gag immunization induced Gag-specific CD8(+) T-cell responses efficiently in naive but not in pre-SeV-infected animals. These results indicate that both intranasal and intramuscular SeV administrations are equivalently immunogenic in the absence of anti-SeV antibodies, whereas intranasal SeV vaccination is more immunogenic than intramuscular in the presence of anti-SeV antibodies. It is inferred from a recent report investigating the prevalence of anti-SeV antibodies in humans that SeV-specific neutralizing titers in more than 70% of people are no more than those at the SeV-Gag vaccination in pre-SeV-infected macaques in the present study. Taken together, this study implies the potential of intranasal SeV vector vaccination to induce CD8(+) T-cell responses even in humans, suggesting a rationale for proceeding to a vaccine clinical trial using this vector.

15 Nov 2007·Journal of VirologyQ2 · MEDICINE

Activation of the Beta Interferon Promoter by Unnatural Sendai Virus Infection Requires RIG-I and Is Inhibited by Viral C Proteins

Q2 · MEDICINE

Article

Author: Strähle, Laura ; Hausmann, Stéphane ; Garcin, Dominique ; Marq, Jean-Baptiste ; Kolakofsky, Daniel ; Brini, Albert

ABSTRACT As infection with wild-type (wt) Sendai virus (SeV) normally activates beta interferon (IFN-β) very poorly, two unnatural SeV infections were used to study virus-induced IFN-β activation in mouse embryonic fibroblasts: (i) SeV-DI-H4, which is composed mostly of small, copyback defective interfering (DI) genomes and whose infection overproduces short 5′-triphosphorylated trailer RNAs (pppRNAs) and underproduces viral V and C proteins, and (ii) SeV-GFP(+/−), a coinfection that produces wt amounts of viral gene products but that also produces both green fluorescent protein (GFP) mRNA and its complement, which can form double-stranded RNA (dsRNA) with capped 5′ ends. We found that (i) virus-induced signaling to IFN-β depended predominantly on RIG-I (as opposed to mda-5) for both SeV infections, i.e., that RIG-I senses both pppRNAs and dsRNA without 5′-triphosphorylated ends, and (ii) it is the viral C protein (as opposed to V) that is primarily responsible for countering RIG-I-dependent signaling to IFN-β. Nondefective SeV that cannot specifically express C proteins not only cannot prevent the effects of transfected poly(I-C) or ppp RNAs on IFN-β activation but also synergistically enhances these effects. SeV-V minus infection, in contrast, behaves mostly like wt SeV and counteracts the effects of transfected poly(I-C) or ppp RNAs.

100 Deals associated with HIV vaccine SeV-G-NP(International AIDS Vaccine Initiative/Id Pharma)

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Indication	Highest Phase	Country/Location	Organization	Date
HIV Infections	Phase 1	KE	International AIDS Vaccine Initiative, Inc.	01 Mar 2013
HIV Infections	Phase 1	RW	International AIDS Vaccine Initiative, Inc.	01 Mar 2013
HIV Infections	Phase 1	GB	International AIDS Vaccine Initiative, Inc.	01 Mar 2013

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