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-

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

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

NCT00865566 / TerminatedPhase 2IIT

Phase 2b, Randomized, Placebo-Controlled Test-of-Concept Trial to Evaluate the Safety and Efficacy of a Multiclade HIV-1 DNA Plasmid Vaccine Followed by a Multiclade HIV-1 Recombinant Adenoviral Vector Vaccine in HIV-Uninfected, Adenovirus Type 5 Neutralizing Antibody Negative, Circumcised Men and Male-to-Female (MTF) Transgender Persons, Who Have Sex With Men

The purpose of this study is to determine the safety and efficacy of a VRC DNA/rAd5 vaccine regimen in healthy, circumcised men and male-to-female (MTF) transgender persons who have sex with men.
NOTES:
As of April 2013, all vaccinations in this study have been stopped.
As of June 2017, this study has been closed.

Start Date01 May 2009

Sponsor / Collaborator

National Institute of Allergy & Infectious Diseases

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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

01 Mar 2015·The Lancet HIVQ1 · MEDICINE

Effect of therapeutic intensification followed by HIV DNA prime and rAd5 boost vaccination on HIV-specific immunity and HIV reservoir (EraMune 02): a multicentre randomised clinical trial

Q1 · MEDICINE

Article

Author: Timothy J Wilkin ; Brigitte Autran ; Joseph P Casazza ; Robert L Murphy ; Chad J Achenbach ; Dominique Costagliola ; Sidonie Lambert-Niclot ; Vincent Calvez ; Richard A Koup ; Lambert Assoumou ; Baiba Berzins ; Steven G Deeks ; Christine Katlama

BACKGROUNDAchievement of a cure for HIV infection might need reactivation of latent virus and improvement of HIV-specific immunity. As an initial step, in this trial we assessed the effect of antiretroviral therapy intensification and immune modulation with a DNA prime and recombinant adenovirus 5 (rAd5) boost vaccine.METHODSIn this multicentre, randomised, open-label, non-comparative, phase 2 clinical trial, we enrolled eligible adults 18-70 years of age with chronic HIV-1 infection on suppressive antiretroviral therapy with current CD4 count of at least 350 cells per μL and HIV DNA between 10 and 1000 copies per 10(6) peripheral blood mononuclear cells. After an 8 week lead-in of antiretroviral intensification therapy (standard dose raltegravir and dose-adjusted maraviroc based on baseline antiretroviral therapy), patients were randomly assigned (1:1) to receive antiretroviral therapy intensification alone or intensification plus injections of HIV DNA prime vaccine (4 mg VRC-HIVDNA016-00-VP) at weeks 8, 12, and 16, followed by HIV rAd5 boost vaccine (10(10) particle units of VRC-HIVADV014-00-VP) at week 32. Randomisation was computer generated in permuted blocks of six and was stratified by study site. The primary endpoint was a 0·5 log10 or greater decrease in HIV DNA in peripheral blood mononuclear cells at week 56. This study is registered with ClinicalTrials.gov, number NCT00976404.FINDINGSBetween Nov 29, 2010, and Oct 28, 2011, we enrolled 28 eligible patients from three academic HIV clinics in the USA. After the 8 week lead-in of antiretroviral intensification therapy, 14 patients were randomly assigned to continue antiretroviral therapy intensification alone and 14 to intensification plus vaccine. Enrolled participants had median CD4 count of 636 cells per μL, median HIV DNA 170 copies per 10(6) peripheral blood mononuclear cells, and duration of antiretroviral therapy of 13 years. The median amount of HIV DNA did not change significantly between baseline and week 56 in the antiretroviral therapy intensification plus vaccine group. One participant in the antiretroviral therapy intensification alone group reached the primary endpoint, with 0·55 log10 decrease in HIV DNA in peripheral blood mononuclear cells. Both treatments were well tolerated. No severe or systemic reactions to vaccination occurred, and five serious adverse events were recorded during the study, most of which resolved spontaneously or were judged unrelated to study treatments.INTERPRETATIONAntiretroviral therapy intensification followed by DNA prime and rAd5 boost vaccine did not significantly increase HIV expression or reduce the latent HIV reservoir. A multifaceted approach that includes stronger activators of HIV expression and novel immune modulators will probably be needed to reduce the latent HIV reservoir and allow for long-term control in patients off antiretroviral therapy.FUNDINGObjectif Recherche Vaccin SIDA (ORVACS).

01 Oct 2011·Current Opinion in VirologyQ2 · MEDICINE

Selected approaches for increasing HIV DNA vaccine immunogenicity in vivo

Q2 · MEDICINE

Review

Author: Chaoran Billie Bian ; David B Weiner ; Devin J F Myles ; Natalie A Hutnick ; Karuppiah Muthumani

The safety, stability, and ability for repeat homologous vaccination makes the DNA vaccine platform an excellent candidate for an effective HIV-1 vaccine. However, the immunogenicity of early DNA vaccines did not translate from small animal models into larger non-human primates and was markedly lower than viral vectors. In addition to improvements to the DNA vector itself, delivery with electroporation, the inclusion of molecular adjuvants, and heterologous prime-boost strategies have dramatically improved the immunogenicity of DNA vaccines for HIV and currently makes them a leading platform with many areas warranting further research and clinical development.

01 Jul 2011·VaccineQ3 · MEDICINE

Amplified antigen-specific immune responses in HIV-1 infected individuals in a double blind DNA immunization and therapy interruption trial

Q3 · MEDICINE

Article

Author: J. Lisziewicz ; D. Bernasconi ; A. Boberg ; E. Sandström ; S. Buttò ; L. Gudmundsdotter ; U. Edbäck ; B.K. Haller ; B. Wahren ; F. Gotch ; N. Imami ; F. Lori ; H. Gaines ; B. Hejdeman

Immunotherapy in patients with HIV-1 infection aims to restore and broaden immunological competence, reduce viral load and thereby permit longer periods without combined antiretroviral treatment (cART). Twelve HIV-1-infected patients on cART were immunized on the skin with DNA plasmids containing genes of several HIV-1 subtypes with or without the addition of hydroxyurea (HU), or with placebo. The mean net gain of HIV-specific CD8+ T cell responses were higher and broader in the HIV DNA vaccine groups compared to non-vaccinated individuals (p<0.05). The vaccine-induced immune responses per se had no direct effect on viral replication. In all patients combined, including placebo, the viral set point after a final structured therapy interruption (STI) was lower than prior to initiation of cART (p=0.003). Nadir CD4 levels appeared to strongly influence the post-STI viral titers. After the sixth immunization or placebo, patients could stay off cART for a median time of 15 months. The study shows that HIV DNA immunization induces broader and higher magnitudes of HIV-specific immune responses compared to structured therapy interruptions alone. Although compromised by small numbers of patients, the study also demonstrates that well-monitored STI may safely function as an immunological read out of HIV vaccine efficacy.

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	BR	National Institute of Allergy & Infectious Diseases	01 Sep 2005
HIV Infections	Phase 2	US	National Institute of Allergy & Infectious Diseases	01 Sep 2005
HIV Infections	Phase 2	ZA	National Institute of Allergy & Infectious Diseases	01 Sep 2005
HIV Infections	Phase 2	JM	National Institute of Allergy & Infectious Diseases	01 Sep 2005
HIV Infections	Phase 2	US	National Institute of Allergy & Infectious Diseases	01 Sep 2005
HIV Infections	Phase 2	BR	National Institute of Allergy & Infectious Diseases	01 Sep 2005
HIV Infections	Phase 2	HT	National Institute of Allergy & Infectious Diseases	01 Sep 2005
HIV Infections	Phase 1	ZA	National Institute of Allergy & Infectious Diseases	01 Sep 2005
HIV Infections	Discovery	HT	National Institute of Allergy & Infectious Diseases	01 Sep 2005
HIV Infections	Discovery	JM	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)	grdraltoyf(onkzzdfceb) = pigbvsrwon ciwnbchwjl (bbozqlqbix, ldkydnnasq - smdqnrkozj) View more	-	27 Feb 2019
				placebo+DNA vaccine (Placebo)	grdraltoyf(onkzzdfceb) = mzktiehrlv ciwnbchwjl (bbozqlqbix, mntkniptvr - kjauelljug) View more