A Randomized, Placebo-Controlled, Dosage-Escalating Phase 2A Study, Double-Blinded With Respect to Assignment to Either Vaccine or Placebo, to Evaluate the Safety and Immunogenicity of a DNA HIV-1 Vaccine Administered Intramuscularly Followed by an MVA HIV-1 Vaccine Administered at Three Different Dosage Levels and by Three Different Routes to HIV-Uninfected, Healthy, Volunteers.

The purpose of this study is to evaluate the safety and tolerability of plasmid DNA and recombinant MVA (Modified Vaccinia Virus Ankara) in a prime-boost regimen.
Approximately 111 volunteers (90 vaccine recipients/21 placebo recipients) will be enrolled at two sites. Approximately 56 volunteers will be enrolled at each site. An over-enrolment of up to 10% (approximately 10 additional volunteers) will be permitted in the study.

开始日期2003-04-01

申办/合作机构

International AIDS Vaccine Initiative, Inc.

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100 项与 DNA HIV-1 Vaccine(International AIDS Vaccine Initiative) 相关的临床结果

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项与 DNA HIV-1 Vaccine(International AIDS Vaccine Initiative) 相关的文献（医药）

2023-10-03·Immunological investigations

The Cooperation of IL-29 and PLGA Nanoparticles Improves the Protective Immunity of the gD-1 DNA Vaccine Against Herpes Simplex Virus Type 1 in Mice

Article

作者: Karimi, Hesam ; Kokhaei, Parviz ; Rajaei, Hajar ; Ebtekar, Massoumeh ; Matloubi, Zahra ; Rahimi, Roghieh ; Kazemi-Sefat, Nazanin Atieh ; Soleimanjahi, Hoorieh ; Amir Kalvanagh, Parisa

In clinical practice, the low immunogenicity and low stability of the DNA plasmid vaccine candidates are two significant shortcomings in their application against infectious diseases. To overcome these two disadvantages, the plasmid expressing IL-29 (pIL-29) as a genetic adjuvant and polylactic-co-glycolic acid (PLGA) as a non-viral delivery system were used, respectively. In this study, the pIL-29 encapsulated in PLGA nanoparticles (nanoIL-29) and the pgD1 encapsulated in PLGA nanoparticles (nanoVac) were simultaneously applied to boost immunologic responses against HSV-1. We generated spherical nanoparticles with encapsulation efficiency of 75 ± 5% and sustained the release of plasmids from them. Then, Balb/c mice were subcutaneously immunized twice with nanoVac+nanoIL-29, Vac+IL-29, nanoVac, Vac, nanoIL-29, and/or IL-29 in addition to negative and positive control groups. Cellular immunity was evaluated via lymphocyte proliferation assay, cytotoxicity test, and IFN-γ, IL-4, and IL-2 measurements. Mice were also challenged with 50X LD50 of HSV-1. The nanoVac+nanoIL-29 candidate vaccine efficiently enhances CTL and Th1-immune responses and increases the survival rates by 100% in mice vaccinated by co-administration of nanoVac and nanoIL-29 against the HSV-1 challenge. The newly proposed vaccine is worth studying in further clinical trials, because it could effectively improve cellular immune responses and protected mice against HSV-1.

2019-02-01·Journal of virology2区 · 医学

Priming with a Potent HIV-1 DNA Vaccine Frames the Quality of Immune Responses prior to a Poxvirus and Protein Boost

2区 · 医学

Article

作者: Heeney, Jonathan L. ; Gottardo, Raphael ; Asbach, Benedikt ; Roederer, Mario ; Ding, Song ; Barnett, Susan W. ; Galmin, Lindsey ; Kao, Shing-Fen ; Perdiguero, Beatriz ; Kibler, Karen V. ; Self, Steven G. ; Tartaglia, James ; Yates, Nicole L. ; Jacobs, Bertram L. ; Köstler, Josef ; Weiss, Deborah E. ; Foulds, Kathryn E. ; Wagner, Ralf ; Ferrari, Guido ; Pantaleo, Giuseppe ; Forthal, Donald N. ; Parks, Robert ; Seaman, Michael S. ; Phogat, Sanjay ; Tomaras, Georgia D. ; Stanfield-Oakley, Sherry ; Esteban, Mariano ; Cristillo, Anthony D. ; Montefiori, David C.

The evaluation of HIV vaccine efficacy trials indicates that protection would most likely correlate with a polyfunctional immune response involving several effector functions from all arms of the immune system. Heterologous prime-boost regimens have been shown to elicit vigorous T cell and antibody responses in nonhuman primates that, however, qualitatively and quantitatively differ depending on the respective vector systems used. The present study evaluated a DNA prime and poxvirus and protein boost regimen and compared how two poxvirus vectors with various degrees of replication capacity and two different delivery modalities—conventional intramuscular delivery and percutaneous delivery by scarification—impact several immune effectors. It was found that despite the different poxvirus boosts, the overall immune responses in the three groups were similar, suggesting the potent DNA priming as the major determining factor of immune responses. These findings emphasize the importance of selecting optimal priming agents in heterologous prime-boost vaccination settings.

2016-02-01·Journal of acquired immune deficiency syndromes (1999)3区 · 医学

The Safety and Immunogenicity of an Interleukin-12–Enhanced Multiantigen DNA Vaccine Delivered by Electroporation for the Treatment of HIV-1 Infection

3区 · 医学

Article

作者: Lu Zheng ; Teresa A. Spitz ; Cara C. Wilson ; Alan L. Landay ; Jennifer Tiu ; Roy M. Matining ; Jeffrey M. Jacobson ; Nicole Frahm ; Anne F. Luetkemeyer ; David B. Clifford ; Ana L. Martinez ; Pablo Tebas ; Michael A. Egan ; Jennifer Janik ; John Eldridge ; John Hural ; Juliana McElrath

BACKGROUND:

Therapeutic vaccination is being studied in eradication and "functional cure" strategies for HIV-1. The Profectus Biosciences multiantigen (MAG) HIV-1 DNA vaccine encodes HIV-1 Gag/Pol, Nef/Tat/Vif, and Envelope, and interleukin-12 (IL-12) and is delivered by electroporation combined with intramuscular injection (IM-EP).

METHODS:

Sixty-two HIV-1-infected patients on antiretroviral therapy (plasma HIV-1 RNA levels ≤ 200 copies/mL; CD4(+) T-cell counts ≥ 500 cells/mm(3)) were randomly allocated 5:1 to receive vaccine or placebo. At weeks 0, 4, and 12, 4 consecutive cohorts received 3000 μg HIV MAG pDNA with 0, 50, 250, or 1000 μg of IL-12 pDNA by IM-EP. A fifth cohort received HIV MAG pDNA and 1000 μg of IL-12 pDNA by standard IM injection.

RESULTS:

CD4(+) T cells expressing IL-2 in response to Gag and Pol and interferon-γ responses to Gag, Pol, and Env increased from baseline to week 14 in the low-dose (50-μg) IL-12 arm vs. placebo (P < 0.05; intracellular cytokine staining). The total increase in the IL-2-expressing CD4 T-cell responses to any antigen was also higher in the low-dose IL-12 arm vs. placebo (P = 0.04). Cytokine responses by CD8 T cells to HIV antigens were not increased in any vaccine arm relative to placebo.

CONCLUSIONS:

HIV-1 MAG/low-dose IL-12 DNA vaccine delivered by IM-EP augmented CD4(+) but not CD8(+) T-cell responses to multiple HIV-1 antigens.

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适应症	最高研发状态	国家/地区	公司	日期
HIV感染	临床2期	肯尼亚	International AIDS Vaccine Initiative, Inc.	2003-04-01
HIV感染	临床2期	英国	International AIDS Vaccine Initiative, Inc.	2003-04-01