Drugs

MVA.HIVconsv

MVA.HIVconsv

Other 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 2 development as a therapeutic vaccine. (MVA.HIVconsv has also been studied for HIV prevention.)

(Compound details obtained from Treatment Action Group website1 and ClinicalTrials.gov2)

What is MVA.HIVconsv?

What is MVA.HIVconsv?

MVA.HIVconsv is an investigational vaccine that is being 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.

To learn how investigational vaccines and drugs are tested during clinical trials, read the AIDSinfo What is an Investigational HIV Drug? and HIV/AIDS Clinical Trials fact sheets.

How do therapeutic HIV vaccines work?

How do therapeutic HIV vaccines work?

A therapeutic HIV vaccine is a type of vaccine that’s designed to improve the body’s immune response to HIV in a person living with HIV.3 Therapeutic vaccines may be able to reduce the amount of HIV in the body and help keep HIV at undetectable levels without the need for the regular use of antiretroviral therapy (ART).4 To learn more, read the AIDSinfo What is a Therapeutic HIV Vaccine? fact sheet.

There are several types of therapeutic vaccines that are currently being studied to treat HIV. MVA.HIVconsv belongs to a group of vaccines called viral vector vaccines.1 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 virus.5

In addition to being studied as a therapeutic HIV vaccine, MVA.HIVconsv has also been investigated to see if it can prevent HIV infection in people who do not have the virus.2,6,7 This record focuses on the study of MVA.HIVconsv as a therapeutic vaccine.

Which clinical trials are studying MVA.HIVconsv?

Which clinical trials are studying MVA.HIVconsv?

Study Names: (1) BCN01; NCT01712425 and (2) BCN02-Romi; NCT02616874
Phase: 1
Status: BCN01 and BCN02-Romi have both been completed.
Location: Spain
Purpose:

  • The purpose of the BCN01 study was to (1) evaluate the safety of both the MVA.HIVconsv vaccine and another investigational therapeutic HIV vaccine called ChAdV63.HIVconsv, and (2) investigate whether these vaccines could produce an immune response in people with recently diagnosed HIV infection who were on ART and who were virally suppressed.
  • The purpose of the BCN02-Romi study was to evaluate booster doses of MVA.HIVconsv in participants who had completed the BCN01 trial. MVA.HIVconsv was administered in combination with another investigational drug called romidepsin. The study looked at whether this combination of treatments could reduce the size of the latent HIV reservoir and control viral rebound during a structured treatment interruption of ART.8,9

Study Names: RIVER; NCT02336074
Phase: 2
Status: This study is ongoing, but not recruiting participants.
Location: United Kingdom
Purpose: The purpose of this study is to determine whether using a combination of ART, the ChAdV63.HIVconsv and MVA.HIVconsv vaccines, and another investigational drug (vorinostat) can lead to a greater reduction in the size of the latent HIV reservoir than using ART alone.10

For more details on the studies listed above, see the Health Professional version of this drug summary.

A Phase 1 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.11,12

What side effects might MVA.HIVconsv cause?

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, which ranged from mild to moderate in intensity. Pain at or near the injection site was more commonly reported with MVA.HIVconsv than with ChAdV63.HIVconsv.13

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.9,14

RIVER (NCT02336074):

In this Phase 2 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 the group that only received ART, 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.10,15,16

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?

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 ClinicalTrials.gov 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 more information, visit NIH Clinical Research Trials and You.

References

References

  1. Treatment Action Group website. Research toward a cure trials. http://www.treatmentactiongroup.org/cure/trials. Accessed August 23, 2019
  2. 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 August 23, 2019
  3. The History of Vaccines website. The development of HIV vaccines. https://www.historyofvaccines.org/content/articles/development-hiv-vaccines. Accessed August 23, 2019
  4. Graziani GM, Angel JB. Evaluating the efficacy of therapeutic HIV vaccines through analytical treatment interruptions. J Int AIDS Soc. 2015;18(1):20497.
  5. HIV Vaccine Trials Network website. Types of vaccines. https://www.hvtn.org/en/science/hiv-vaccine-basics/types-vaccines.html. Accessed August 23, 2019
  6. 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 August 23, 2019
  7. 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 August 23, 2019
  8. 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 August 23, 2019
  9. 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 August 23, 2019
  10. 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 August 23, 2019
  11. 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 August 23, 2019
  12. 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
  13. 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 August 23, 2019
  14. 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 August 23, 2019
  15. 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 August 23, 2019
  16. 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 August 23, 2019

Last Reviewed: August 23, 2019

Print