Drugs

ChAdV63.HIVconsv

ChAdV63.HIVconsv

Other Names: HIVconsv vaccine vectored by ChAdV63 Drug Class: Therapeutic Vaccines Organization: University of Oxford Phase of Development: ChAdV63.HIVconsv is in Phase II development as a therapeutic vaccine. (ChAdV63.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 ChAdV63.HIVconsv?

What is ChAdV63.HIVconsv?

ChAdV63.HIVconsv is an investigational vaccine being studied as a possible strategy to treat people living with HIV.1 ChAdV63.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.4 Therapeutic vaccines work by strengthening the immune system to recognize and eliminate HIV from the body. To learn more, read the AIDSinfo fact sheet What is a Therapeutic HIV Vaccine?.

There are several types of therapeutic vaccines currently being studied to treat HIV. ChAdV63.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, ChAdV63.HIVconsv is also being investigated to see if it can prevent HIV infection in people who do not have the virus.3,6,7 This record focuses on the study of ChAdV63.HIVconsv as a therapeutic vaccine.

Which clinical trials are studying ChAdV63.HIVconsv?

Which clinical trials are studying ChAdV63.HIVconsv?

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

  • The purpose of the BCN01 study was to evaluate (1) the safety of both the ChAdV63.HIVconsv vaccine and another investigational therapeutic HIV vaccine called MVA.HIVconsv, and (2) whether these vaccines could produce an immune response in people with recently diagnosed HIV infection who had viral suppression while on antiretroviral therapy (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 latent HIV reservoir and control viral rebound during a treatment interruption of ART.8,9 A treatment interruption of ART is a planned break from HIV medicines to evaluate how well an investigational drug can maintain control of a participant’s viral load during a clinical trial.

Study Names: RIVER; NCT02336074
Phase: II
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.10

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

What side effects might ChAdV63.HIVconsv cause?

What side effects might ChAdV63.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 ChAdV63.HIVconsv listed above.

BCN01 (NCT01712425):

In this Phase I 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.11

RIVER (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.10,12,13

Because ChAdV63.HIVconsv is still being studied, information on possible side effects of the vaccine is not complete. As testing of ChAdV63.HIVconsv continues, additional information on possible side effects will be gathered.

Where can I get more information about clinical trials studying ChAdV63.HIVconsv?

Where can I get more information about clinical trials studying ChAdV63.HIVconsv?

More information about ChAdV63.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 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 October 6, 2018.
  2. 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 6, 2018.
  3. 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 6, 2018.
  4. The History of Vaccines website. The development of HIV vaccines. https://www.historyofvaccines.org/content/articles/development-hiv-vaccines. Accessed October 6, 2018.
  5. HIV Vaccine Trials Network website. Types of vaccines. https://www.hvtn.org/en/science/hiv-vaccine-basics/types-vaccines.html. Accessed October 6, 2018.
  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 October 6, 2018.
  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 October 6, 2018.
  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 October 6, 2018.
  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 October 6, 2018.
  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 October 6, 2018.
  11. 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 6, 2018.
  12. 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 6, 2018.
  13. 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 6, 2018.

Last Reviewed: October 6, 2018