Delving into the Latest Updates on VRC-HIVDNA016-00-VP with Synapse

Overview

Basic Info

Drug Type

Prophylactic vaccine

Synonyms

HIV DNA vaccine, Plasmid DNA HIV vaccine

Target-

Action

stimulants

Mechanism

Immunostimulants

Therapeutic Areas

Immune System DiseasesInfectious DiseasesUrogenital Diseases

Active Indication-

Inactive Indication

HIV Infections

Originator Organization

National Institute of Allergy & Infectious Diseases

Active Organization-

Inactive Organization

National Institute of Allergy & Infectious Diseases

License Organization-

Drug Highest PhaseDiscontinuedPhase 2

First Approval Date-

Regulation-

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Background:
The primary focus of the Vaccine Research Center (VRC) at the NIH is to develop vaccines for HIV/AIDS. The main purpose of this study is to look in detail at the body s immune response to two experimental HIV vaccines currently in development at the VRC. One is known as the rAd5 vaccine and the other is known as the DNA vaccine. These vaccines are made with pieces of manufactured DNA. They do not contain live or killed HIV. It is impossible for study vaccines to give you HIV and they cannot cause you to give HIV to someone else. Both of these experimental vaccines have been given to people before in other research studies. They have not been approved for treating or preventing HIV infection.
Purpose:
The main purpose of this study is to look in detail at the body s immune responses after the experimental HIV vaccines are given and to assess safety of the study vaccines.
Eligibility:
Healthy volunteers between the ages of 18 and 50 who are not infected with HIV and who meet the eligibility requirements.
Design:
Participants will be screened with a medical history (including questions about sexual history and drug use), physical exam, and blood tests.
The study will have two groups:
One group will receive one injection of the rAd5 vaccine, and have 8 clinic visits over 3 months.
The second group will have three injections of the DNA vaccine, one injection of the rAd5 vaccine, and have 12 clinic visits over 6 months.
All participants will be asked to provide blood and body fluid samples for testing during the study.
Payment for participation will be provided....

Start Date17 Jun 2011

Sponsor / Collaborator

National Institute of Allergy & Infectious Diseases

NCT00955006

/ CompletedPhase 1IIT

A Phase 1b Clinical Trial to Evaluate Mucosal Immune Responses to a DNA Plasmid Vaccine Prime Followed by an HIV-1 Adenoviral Vector Boost in Healthy Adenovirus Type 5 Seronegative HIV-1-uninfected Adults

The purpose of the study is to determine the safety of mucosal immune responses to a DNA HIV vaccine followed by an adenoviral vector HIV vaccine in HIV uninfected adults.

Start Date01 May 2011

Sponsor / Collaborator

National Institute of Allergy & Infectious Diseases

NCT01054872

/ CompletedPhase 1IIT

A Phase 1B Clinical Trial to Examine the Role of Host Genetics in Determining the Immune Response to HIV Vaccination (With VRC-HIVDNA016-00-VP and VRC-HIVADV014-00-VP) in Twin Pairs

The purpose of this study is to examine the role of genetics in determining the immune response to an HIV vaccine in pairs of HIV-uninfected twins.

Start Date01 Jan 2010

Sponsor / Collaborator

National Institute of Allergy & Infectious Diseases

100 Clinical Results associated with VRC-HIVDNA016-00-VP

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100 Translational Medicine associated with VRC-HIVDNA016-00-VP

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100 Patents (Medical) associated with VRC-HIVDNA016-00-VP

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45

Literatures (Medical) associated with VRC-HIVDNA016-00-VP

03 Jun 2022·Expert Review of VaccinesQ2 · MEDICINE

Progress Towards a Therapeutic HIV DNA Vaccine

Q2 · MEDICINE

Review

Author: Munson, Paul

INTRODUCTIONAntiretroviral therapy (ART) reduces HIV replication to undetectable levels and prevents AIDS but cannot cure the infection and discontinuing ART results in viral rebound. Therefore, a primary goal of HIV therapeutic vaccine research is to induce potent HIV-specific immunity that could control viremia without ART, a so-called "functional cure" that eliminates the need for lifelong ART. DNA vaccines have several features that make them an attractive modality for an HIV therapeutic vaccine: they are easy to manufacture, induce T-cell and antibody responses without anti-vector immunity, and do not involve ex vivo manipulations of patient cells.AREAS COVEREDThis review covers the progress in developing therapeutic HIV DNA vaccines, emphasizing delivery innovations to enhance vaccine immunogenicity. A central theme is a transition from needle injection delivery to the muscle toward using more sophisticated devices to target the skin and/or increasing transfection efficiency.EXPERT OPINIONThere are multiple barriers to an effective therapeutic HIV DNA vaccine. While variables such as delivery, adjuvants, and immunogen design have been extensively explored, combining DNA vaccines with complementary approaches is underdeveloped. Complementary approaches include co-administration with latency reversal agents, immune checkpoint blockade, and targeting conserved fitness-constrained portions of the virus.

01 Feb 2018·AIDS Research and Human RetrovirusesQ4 · MEDICINE

Intradermal HIV-1 DNA Immunization Using Needle-Free Zetajet Injection Followed by HIV-Modified Vaccinia Virus Ankara Vaccination Is Safe and Immunogenic in Mozambican Young Adults: A Phase I Randomized Controlled Trial

Q4 · MEDICINE

Article

Author: Scarlatti, Gabriella ; Nilsson, Charlotta ; Robb, Merlin L. ; Stout, Richard ; Maueia, Cremildo ; Augusto, Orvalho ; the TaMoVac Study Group ; Jani, Ilesh ; Osman, Nafissa ; Wahren, Britta ; Biberfeld, Gunnel ; Andersson, Sören ; Ferrari, Guido ; Viegas, Edna Omar ; Earl, Patricia L. ; Meggi, Bindiya ; Tembe, Nelson ; Sandström, Eric

We assessed the safety and immunogenicity of HIV-DNA priming using Zetajet™, a needle-free device intradermally followed by intramuscular HIV-MVA boosts, in 24 healthy Mozambicans. Volunteers were randomized to receive three immunizations of 600 μg (n = 10; 2 × 0.1 ml) or 1,200 μg (n = 10; 2 × 0.2 ml) of HIV-DNA (3 mg/ml), followed by two boosts of 10⁸ pfu HIV-MVA. Four subjects received placebo saline injections. Vaccines and injections were safe and well tolerated with no difference between the two priming groups. After three HIV-DNA immunizations, IFN-γ ELISpot responses to Gag were detected in 9/17 (53%) vaccinees, while none responded to Envelope (Env). After the first HIV-MVA, the overall response rate to Gag and/or Env increased to 14/15 (93%); 14/15 (93%) to Gag and 13/15 (87%) to Env. There were no significant differences between the immunization groups in frequency of response to Gag and Env or magnitude of Gag responses. Env responses were significantly higher in the higher dose group (median 420 vs. 157.5 SFC/million peripheral blood mononuclear cell, p = .014). HIV-specific antibodies to subtype C gp140 and subtype B gp160 were elicited in all vaccinees after the second HIV-MVA, without differences in titers between the groups. Neutralizing antibody responses were not detected. Two (13%) of 16 vaccinees, one in each of the priming groups, exhibited antibodies mediating antibody-dependent cellular cytotoxicity to CRF01_AE. In conclusion, HIV-DNA vaccine delivered intradermally in volumes of 0.1-0.2 ml using Zetajet was safe and well tolerated. Priming with the 1,200 μg dose of HIV-DNA generated higher magnitudes of ELISpot responses to Env.

01 Apr 2016·BiomaterialsQ1 · ENGINEERING & TECHNOLOGY

Enhanced non-inflammasome mediated immune responses by mannosylated zwitterionic-based cationic liposomes for HIV DNA vaccines

Q1 · ENGINEERING & TECHNOLOGY

Article

Author: Yang, Jun ; Qiao, Chenmeng ; Weng, Jie ; Shao, Yiming ; Liu, Jiandong ; Zhang, Xin ; Li, Yan

Human immunodeficiency virus (HIV) DNA vaccine can induce cellular and humoral immunity. A safe and effective HIV DNA vaccine is urgent need to prevent the spread of acquired immune deficiency syndrome (AIDS). The major drawback of DNA vaccines is the low immunogenicity, which is caused by the poor delivery to antigen presenting cells and insufficient antigen expression. Sparked by the capability of endosomal/lysosomal escape of the zwitterionic lipid distearoyl phosphoethanol-amine-polycarboxybetaine (DSPE-PCB), we attempted to develop a zwitterionic-based cationic liposome with enhanced immunogenicity of DNA vaccines. The mannosylated zwitterionic-based cationic liposome (man-ZCL) was constructed as a DNA vaccine adjuvant for HIV vaccination. Man-ZCL could complex with DNA antigens to form a tight structure and protect them from nuclei enzyme degradation. Benefited from the capability of the specific mannose receptor mediated antigen processing cells targeting and enhanced endosomal/lysosomal escape, the man-ZCL lipoplexes were supposed to promote antigen presentation and the immunogenicity of DNA vaccines. In vitro and in vivo results revealed that man-ZCL lipoplexes showed enhanced anti-HIV immune responses and lower toxicity compared with CpG/DNA and Lipo2k/DNA, and triggered a Th1/Th2 mixed immunity. An antigen-depot effect was observed in the administration site, and this resulted in enhanced retention of DNA antigens in draining lymph nodes. Most importantly, the man-ZCL could assist to activate T cells through a non-inflammasome pathway. These findings suggested that the man-ZCL could be potentially applied as a safe and efficient DNA adjuvant for HIV vaccines.

100 Deals associated with VRC-HIVDNA016-00-VP

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
HIV Infections	Phase 2	United States	National Institute of Allergy & Infectious Diseases	01 Sep 2005
HIV Infections	Phase 2	South Africa	National Institute of Allergy & Infectious Diseases	01 Sep 2005
HIV Infections	Phase 2	Haiti	National Institute of Allergy & Infectious Diseases	01 Sep 2005
HIV Infections	Phase 2	United States	National Institute of Allergy & Infectious Diseases	01 Sep 2005
HIV Infections	Phase 2	Jamaica	National Institute of Allergy & Infectious Diseases	01 Sep 2005
HIV Infections	Phase 2	Haiti	National Institute of Allergy & Infectious Diseases	01 Sep 2005
HIV Infections	Phase 2	Brazil	National Institute of Allergy & Infectious Diseases	01 Sep 2005
HIV Infections	Phase 2	Jamaica	National Institute of Allergy & Infectious Diseases	01 Sep 2005
HIV Infections	Phase 2	Brazil	National Institute of Allergy & Infectious Diseases	01 Sep 2005
HIV Infections	Phase 2	South Africa	National Institute of Allergy & Infectious Diseases	01 Sep 2005

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00865566 (CTgov)	Phase 2	HIV Infections	2,504	recombinant DNA plasmid vaccine+DNA plasmid vaccine+Recombinant adenoviral serotype 5 (rAD5) vector vaccine (Vaccine)	djqavxjjvi(pneidynesj) = fpbktzmkgz nncljpovig (xoaskoadab, qjcovscrwz - wwtqjfnudz) View more	-	27 Feb 2019
				placebo (Placebo)	djqavxjjvi(pneidynesj) = qlgoiwzvdv nncljpovig (xoaskoadab, yxwioyqvst - sbpswmtbqn) View more