VRC-HIVDNA016-00-VPOther Names: VRC DNA-HIV vaccine Drug Class: Therapeutic Vaccines Organization: NIAID Vaccine Research Center (VRC) Phase of Development: VRC-HIVDNA016-00-VP is in Phase II development as a therapeutic HIV vaccine. (VRC-HIVDNA016-00-VP has also been studied as a preventive HIV vaccine.)
(Compound details obtained from The Journal of Infectious Diseases article,1 PLoS One article,2 and New England Journal of Medicine article3)
What is an investigational vaccine?
An investigationalis one that is under study and is not approved by the U.S. (FDA) for sale in the United States. Medical research studies are conducted to evaluate the safety and effectiveness of an investigational vaccine. These research studies are also called clinical trials. Once an investigational vaccine has been proven safe and effective in clinical trials, FDA may approve the vaccine for sale in the United States.
To learn more about investigational vaccines and investigational drugs, read the What is an Investigational HIV Drug? fact sheet.
What is VRC-HIVDNA016-00-VP?
VRC-HIVDNA016-00-VP is an investigational vaccine that has been studied as a therapeutic vaccine for HIV.1,2 AHIV researchers are developing and testing therapeutic vaccines for various goals: is a type of vaccine that’s designed to improve the body’s to HIV in a person who is already infected with HIV.4
- To slow down the progression of HIV .
- To eliminate the need for (ART) while still keeping undetectable levels of HIV. (ART is the recommended treatment for HIV infection and involves using a combination of different HIV medicines to prevent HIV from replicating.)
- As part of a combination strategy that includes HIV medicines and a therapeutic vaccine to eliminate all HIV from the body.
The AIDSinfo fact sheet What is a Therapeutic HIV Vaccine? has more information on therapeutic HIV vaccines.5,6
VRC-HIVDNA016-00-VP is a DNA vaccine and is made up of parts of HIV’s genetic information. The HIV genetic information is meant to produce an immune response against HIV in the body. Besides being studied as a therapeutic HIV vaccine, VRC-HIVDNA016-00-VP has also been investigated to see if it can prevent HIV infection in people who do not have the.1,3 This vaccine record focuses on the study of VRC-HIVDNA016-00-VP as a therapeutic vaccine.
How are clinical trials of investigational vaccines conducted?
Clinical trials are conducted in phases. Each phase has a different purpose and helps researchers answer different questions.7
- Phase I trials: Researchers test an investigational vaccine in a small group of people (20–80) for the first time. The purpose is to evaluate its safety, identify side effects, and determine if the vaccine produces an immune response in the body.
- Phase II trials: The investigational vaccine is administered to a larger group of people (100–300). Researchers further evaluate the vaccine’s safety and ability to produce an immune response in the body. Some effectiveness data on the health benefits of the vaccine may also be collected.
- Phase III trials: The investigational vaccine is administered to large groups of people (1,000–3,000) to confirm its effectiveness, monitor side effects, compare it with standard or equivalent treatments, and collect information that will allow the investigational vaccine to be used safely.7,8
In most cases, an investigational vaccine must be proven effective and must show continued safety in a Phase IIIto be considered for approval by FDA for sale in the United States. Some vaccines go through FDA’s accelerated approval process and are approved before a Phase III clinical trial is complete. After a vaccine is approved by FDA and made available to the public, researchers track its safety in Phase IV trials to seek more information about the vaccine’s risks, benefits, and optimal use.7
Some clinical trials are categorized as “a” or “b,” such as “Phase Ia” or “Phase IIb.” These different subphases typically mean that a study is researching certain types of information or using a certain type of participant population.
In what phase of testing is VRC-HIVDNA016-00-VP?
As a therapeutic HIV vaccine, VRC-HIVDNA016-00-VP has been studied in a Phase II clinical trial.2,9
What are some studies on VRC-HIVDNA016-00-VP?
VRC-HIVDNA016-00-VP therapeutic vaccine
Study Names: EraMune 02; NCT00976404
Sponsor: Robert L. Murphy
Status: This study has been completed.
Location: United States
- Participants were adults with HIV who had received ART continuously for at least 3 years and who had been on an unchanged ART regimen for the past 3 months before screening.
- Participants had levels of less than 500 copies/mL for at least 3 years and had levels during the year prior to entering the study. (Viral load is the amount of HIV in a blood sample.)
- Participants had CD4 counts greater than 350/mm3 within 60 days of entering the study. (A is a laboratory test that measures the number of CD4 cells in a sample of blood and is an important indicator of immune function.)
- Within 75 days of entering the study, participants had proviral DNA between 10 and 1,000 copies/106 peripheral blood mononuclear cells (PBMCs). (Proviral DNA in PBMCs is a measure of the amount of hidden and inactive [latent] HIV in the body.)
Purpose: The purpose of the study was to find out whether intensifying an ART regimen combined with the VRC-HIVDNA016-00-VP vaccine plus another therapeutic vaccine called VRC-HIVADV014-00-VP could reduce the amount of hidden and inactive (latent) HIV in the body.9,10
VRC-HIVDNA016-00-VP has also been evaluated in a Phase I trial (VRC 101; NCT00270465). In this trial, investigators examined the VRC-HIVDNA016-00-VP vaccine’s safety and ability to generate an immune response in participants who had undetectable viral load levels while on ART.1,11
For more details on the studies listed above, see the Health Professional version.
What side effects might VRC-HIVDNA016-00-VP cause?
One goal of HIV research is to identify new drugs that have fewer side effects. In the EraMune 02 study (NCT00976404) study discussed under the previous question, 5 serious side effects were reported, although most resolved on their own or were not related to study treatments. Reactions to the vaccines used in this study were all mild and included tenderness, redness, and swelling around the injection site.9,12
Information on possible side effects of VRC-HIVDNA016-00-VP is not complete. As testing of VRC-HIVDNA016-00-VP continues, additional information on possible side effects will be gathered.
Where can I get more information about clinical trials studying VRC-HIVDNA016-00-VP?
More information about VRC-HIVDNA016-00-VP-related research studies is available from ClinicalTrials.gov.
How can I find more information about participating in a clinical trial?
Participating in a clinical trial can provide benefits. For example, a volunteer participant can benefit from new research treatments before they are widely available. Participants also receive regular and careful medical attention from a research team that includes doctors and other health professionals. However, clinical trials may also involve risks of varying degrees, such as unpleasant, serious, or even life-threatening side effects from the treatment being studied.7
Your health care provider can help you decide whether participating in a clinical trial is right for you. For more information, visit NIH Clinical Research Trials and You.
- Casazza JP, Bowman KA, Adzaku S, et al. Therapeutic vaccination expands and improves the function of the HIV-specific memory T-cell repertoire. J Infect Dis. 2013 Jun 15;207(12):1829-1840. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3654747/. Last accessed on February 20, 2018.
- Gach JS, Gorlani A, Dotsey EY, et al. HIV-1-specific antibody response and function after DNA prime and recombinant adenovirus 5 boost HIV vaccine in HIV-infected subjects. PLoS One. 2016 Aug 8;11(8):e0160341. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4976892/. Last accessed on February 20, 2018.
- Hammer SM, Sobieszczyk ME, Janes H, et al. Efficacy trial of a DNA/rAd5 HIV-1 preventive vaccine. N Engl J Med. 2013 Nov 28;369(22):2083-2092. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4030634/. Last accessed on February 20, 2018.
- The History of Vaccines website. The development of HIV vaccines. Available at: https://www.historyofvaccines.org/content/articles/development-hiv-vaccines. Last accessed on February 20, 2018. [Archived at WebCite]
- Smith PL, Tanner H, Dalgleish A. Developments in HIV-1 immunotherapy and therapeutic vaccination. F1000Prime Rep. 2014 Jun 2;6:43. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4047951/. Last accessed on February 20, 2018.
- Graziani GM, Angel JB. Evaluating the efficacy of therapeutic HIV vaccines through analytical treatment interruptions. J Int AIDS Soc. 2015 Nov 9;18:20497. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4641978/. Last accessed on February 20, 2018.
- National Institutes of Health (NIH). NIH clinical research trials and you. Available at: https://www.nih.gov/health-information/nih-clinical-research-trials-you. Last accessed on February 20, 2018.
- Hudgens MG, Gilbert PB, Self SG. Endpoints in vaccine trials. Stat Methods Med Res. 2004 Apr;13(2):89-114. Available at: http://faculty.washington.edu/peterg/Vaccine2006/articles/HudgensGilbertSelfSMMR.pdf. Last accessed on February 20, 2018. [Archived at WebCite]
- Achenbach CJ, Assoumou L, Deeks SG, et al. 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. Lancet HIV. 2015 Mar;2(3):e82-91. Available at: https://www.ncbi.nlm.nih.gov/pubmed/26424549. Last accessed on February 20, 2018.
- Robert L. Murphy. Multicenter, randomized, non-comparative, controlled study of therapeutic intensification plus immunomodulation in HIV-infected patients with long-term viral suppression. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on September 9, 2009. NLM Identifier: NCT00976404. Available at: https://clinicaltrials.gov/ct2/show/NCT00976404. Last accessed on February 20, 2018.
- National Institute of Allergy and Infectious Diseases (NIAID). VRC101: A Phase I clinical trial to evaluate the safety and immunogenicity of a prime-boost HIV-1 vaccination schedule of a 6-plasmid multiclade HIV-1 DNA vaccine, VRC-HIVDNA016-00-VP, followed by a recombinant multiclade adenoviral vector HIV vaccine. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on December 24, 2005. NLM Identifier: NCT00270465. Available at: https://clinicaltrials.gov/ct2/show/NCT00270465. Last accessed on February 20, 2018.
- Achenbach C, Deeks S, Wilkin T, et al. Impact of RAL/MVC intensification with or without HIV-rAd5 vaccination on HIV DNA: EraMune 02. Poster presented at: Conference on Retroviruses and Opportunistic Infections (CROI); March 3-6, 2014; Boston, MA. Poster 422. Available at: http://www.croiconference.org/sites/default/files/posters/422.pdf. Last accessed on February 20, 2018. [Archived at WebCite]