MVA.HIVconsvOther Names: HIVconsv vaccine vectored by modified vaccinia virus Ankara Drug Class: Therapeutic Vaccines Organization: University of Oxford Phase of Development: MVA.HIVconsv is in Phase II development as a therapeutic vaccine. (MVA.HIVconsv is also being studied for HIV prevention.)
(Compound details obtained from Treatment Action Group website,1 IrsiCaixa website,2 and ClinicalTrials.gov3)
What is MVA.HIVconsv?
MVA.HIVconsv is an investigationalbeing studied as a possible strategy to treat people living with HIV.1 MVA.HIVconsv belongs to a group of HIV vaccines called therapeutic HIV vaccines.
How do therapeutic HIV vaccines work?
There are several types of therapeutic vaccines currently being studied to treat HIV. MVA.HIVconsv belongs to a group of vaccines called viralvaccines.1,5 This type of vaccine delivers pieces of HIV’s DNA into the body’s cells. The body then uses this genetic information to produce an immune system response that can fight the .6
In addition to being studied as a therapeutic HIV vaccine, MVA.HIVconsv is also being investigated to see if it can prevent HIVin people who do not have the virus.3,7,8 This record focuses on the study of MVA.HIVconsv as a therapeutic vaccine.
Which clinical trials are studying MVA.HIVconsv?
- The purpose of the BCN01 study was to evaluate (1) the safety of both the MVA.HIVconsv vaccine and another investigational therapeutic vaccine called ChAdV63.HIVconsv, and (2) whether these vaccines could produce an immune response in people with recently diagnosed HIV infection who had while on (ART).
- The purpose of the BCN02-Romi study was to evaluate additional doses of MVA.HIVconsv given along with the investigational latency-reversing agent romidepsin in participants who had completed the BCN01 trial. The study looked at whether this combination of treatments could reduce the size of the and control during a treatment interruption of ART.9,10 A treatment interruption of ART is a planned break from HIV medicines to evaluate how well an can maintain control of a participant’s during a .
Study Names: RIVER; NCT02336074
Status: This study is ongoing, but not recruiting participants.
Location: United Kingdom
Purpose: The purpose of this study in participants with recently diagnosed HIV infection is to determine whether using ART plus the ChAdV63.HIVconsv and MVA.HIVconsv vaccines plus the investigational latency-reversing agent vorinostat can lead to a greater reduction in the size of the latent HIV reservoir when compared to taking only ART.11
For more details on the studies listed above, see the Health Professional version of this drug summary.
A Phase I trial (HIV-CORE 001; NCT01024842) of MVA.HIVconsv in adults on ART who were virologically suppressed was also completed. This study looked at the safety of MVA.HIVconsv, its ability to produce an immune response in the body, and its ability to reduce the size of the latent HIV reservoir.12,13
What side effects might MVA.HIVconsv cause?
One goal of HIV research is to identify new drugs that have fewer side effects. The following side effects were observed in some of the studies of MVA.HIVconsv listed above.BCN01 (NCT01712425); BCN02-Romi (NCT02616874):
In the BCN01 study, the majority of participants experienced side effects, ranging from mild to moderate in intensity. Pain at or near the injection site was more commonly reported with MVA.HIVconsv than with ChAdV63.HIVconsv.14
The BCN02-Romi study enrolled a subset of participants who had completed the BCN01 study and evaluated additional doses of MVA.HIVconsv along with romidepsin. The types of side effects that occurred with MVA.HIVconsv were similar to what was seen in the BCN01 study.10,15RIVER (NCT02336074):
In this Phase II study, 97% of participants who received ART along with ChAdV63.HIVconsv, MVA.HIVconsv, and vorinostat experienced side effects. Seventy percent of these side effects were mild, 23% were moderate, and 3% were severe in intensity. In comparison, in the group that received ART only, 73% of participants experienced a side effect, of which 33% were mild, 20% were moderate, and 20% were severe. No serious side effects related to the study vaccines were reported.11,16,17
Because MVA.HIVconsv is still being studied, information on possible side effects of the vaccine is not complete. As testing of MVA.HIVconsv continues, additional information on possible side effects will be gathered.
Where can I get more information about clinical trials studying MVA.HIVconsv?
More information about MVA.HIVconsv-related research studies is available from the AIDSinfo database of study summaries. Click on the title of any trial in the list to see the ClinicalTrials.gov trial summary and more information about the study.
Some clinical trials may be looking for volunteer participants. Your health care provider can help you decide whether participating in a clinical trial is right for you. For information, visit NIH Clinical Research Trials and You.
- Treatment Action Group website. Research toward a cure trials. http://www.treatmentactiongroup.org/cure/trials. Accessed October 18, 2018.
- IrsiCaixa website. Safety and immunogenicity of ChAdV63.HIVconsv and MVA.HIVconsv vaccines in individuals with documented acute/recent HIV-1 infection initiating early antiretroviral treatment | BCN01. http://www.irsicaixa.es/en/safety-and-immunogenicity-chadv63hivconsv-and-mvahivconsv-vaccines-individuals-documented. Accessed October 18, 2018.
- University of Oxford. A Phase I study to evaluate the safety and immunogenicity of simultaneous prime-boost immunisations with candidate HCV and HIV-1 vaccines, AdCh3NSmut1 / ChAdV63.HIVconsv and MVA-NSmut / MVA.HIVconsv, in healthy volunteers. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered November 6, 2014. NLM Identifier: NCT02362217. https://clinicaltrials.gov/ct2/show/NCT02362217. Accessed October 18, 2018.
- The History of Vaccines website. The development of HIV vaccines. https://www.historyofvaccines.org/content/articles/development-hiv-vaccines. Accessed October 18, 2018.
- The Joint Research Centre of the European Commission. GMO Register: B/ES/12/10. MVA.HIVconsv – Summary notification information format for the release of genetically modified organisms other than higher plants in accordance with article 11 of directive 2001/18/ec; 01/12/2012. http://gmoinfo.jrc.ec.europa.eu/bsnifs-gmo/B-ES-12-10.pdf. Accessed October 18, 2018.
- HIV Vaccine Trials Network website. Types of vaccines. https://www.hvtn.org/en/science/hiv-vaccine-basics/types-vaccines.html. Accessed October 18, 2018.
- University of Oxford. A randomized single-blind placebo-controlled study to evaluate the safety and immunogenicity of three candidate HIV-1 vaccines, pSG2.HIVconsv DNA, ChAdV63.HIVconsv and MVA.HIVconsv, administered in combination to healthy HIV 1 uninfected adults. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered June 24, 2010. NLM Identifier: NCT01151319. https://clinicaltrials.gov/ct2/show/NCT01151319. Accessed October 18, 2018.
- University College, London. A randomised double-blind, placebo-controlled Phase I/IIa trial to investigate the effect of depletion of serum amyloid P component (SAP) on the immune response to DNA vaccination in healthy male volunteers. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered April 29, 2013. NLM Identifier: NCT02425241. https://clinicaltrials.gov/ct2/show/NCT02425241. Accessed October 18, 2018.
- IrsiCaixa. Safety and immunogenicity of ChAdV63.HIVconsv and MVA.HIVconsv candidate HIV-1 vaccines in recently HIV-1 infected individuals with early viral suppression after initiation of antiretroviral therapy (HAART). In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered October 4, 2012. NLM Identifier: NCT01712425. https://clinicaltrials.gov/ct2/show/NCT01712425. Accessed October 18, 2018.
- IrsiCaixa. An open label Phase I trial to evaluate the safety and effect of HIVconsv vaccines in combination with histone deacetylase inhibitor romidepsin on the viral rebound kinetic after treatment interruption in early treated HIV-1 infected individuals (BCN02-Romi). In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered November 9, 2015. NLM Identifier: NCT02616874. https://clinicaltrials.gov/ct2/show/NCT02616874. Accessed October 18, 2018.
- Imperial College London. Research in viral eradication of HIV reservoirs. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on October 23, 2014. NLM Identifier: NCT02336074. https://www.clinicaltrials.gov/ct2/show/NCT02336074. Accessed October 18, 2018.
- University of Oxford. HIV-CORE 001 - a randomised placebo-controlled study to evaluate the safety and immunogenicity of a candidate HIV-1 vaccine, MVA.HIVconsv, delivered by intramuscular needle injection to HIV-1 seropositive adult subjects receiving antiretroviral therapy (ART). In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered December 1, 2009. NLM Identifier: NCT01024842. https://clinicaltrials.gov/ct2/show/NCT01024842. Accessed October 18, 2018.
- Hancock G, Morón-López S, Kopycinski J, et al. Evaluation of the immunogenicity and impact on the latent HIV-1 reservoir of a conserved region vaccine, MVA.HIVconsv, in antiretroviral therapy-treated subjects. J Int AIDS Soc. 2017;20(1). doi:10.7448/IAS.20.1.21171
- Mothe B, Manzardo C, Coll P, et al. Shaping CTL immunodominance with conserved HIV vaccines after early treatment (BCN01). Poster presented at: Conference on Retroviruses and Opportunistic Infections (CROI); February 22-25, 2016; Boston, MA. Poster 320. http://www.croiconference.org/sites/default/files/posters-2016/320.pdf. Accessed October 18, 2018.
- Mothe B. Viral control induced by HIVconsv vaccines & romidepsin in early treated individuals. Webcast presented at: Conference on Retroviruses and Opportunistic Infections (CROI); February 13-16, 2017; Seattle, Washington. http://www.croiwebcasts.org/console/player/33576?mediaType=slideVideo&. Accessed October 18, 2018.
- Fidler S, Stohr W, Pace M, et al. A randomised controlled trial comparing the impact of antiretroviral therapy (ART) with a “Kick-and-Kill” approach to ART alone on HIV reservoirs in individuals with primary HIV infection (PHI); RIVER trial. Abstract presented at: International AIDS Conference; July 23-27, 2018; Amsterdam, Netherlands. Abstract TUAA0202LB. http://programme.aids2018.org/Abstract/Abstract/12977. Accessed October 18, 2018.
- Fidler S. RIVER research in viral eradication of HIV reservoirs: a two-arm (proof of concept) randomised Phase II trial vorinostat plus a prime boost vaccine. Slides presented at: International AIDS Conference; July 23-27, 2018; Amsterdam, Netherlands. https://programme.aids2018.org/PAGMaterial/PPT/6106_3214/RIVER%20presentation%20at%20IAS%2024.7.2018%20final%20draft.pptx. Accessed October 18, 2018.
Last Reviewed: November 5, 2018