Drugs

Vacc-C5

Vacc-C5

Other Names: HIV Env C5/gp41 vaccine Drug Class: Therapeutic Vaccines Organization: Bionor Holding AS Phase of Development: I/II

(Compound details obtained from Treatment Action Group website1 and Bionor Holding AS website2)

What is an investigational vaccine?

What is an investigational vaccine?

An investigational vaccine is one that is under study and is not approved by the U.S. Food and Drug Administration (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 AIDSinfo What is an Investigational HIV Drug? fact sheet.

What is Vacc-C5?

What is Vacc-C5?

Vacc-C5 is an investigational vaccine that has been studied as a therapeutic vaccine for HIV.1,2 A therapeutic HIV vaccine is a type of vaccine that’s designed to improve the body’s immune response to HIV in a person who is already infected with HIV.3

HIV researchers are developing and testing therapeutic vaccines for various goals:
  • To slow down the progression of HIV infection.
  • To eliminate the need for antiretroviral therapy (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.4,5

Vacc-C5 is made up of HIV peptides (pieces of HIV proteins). The HIV peptides in the Vacc-C5 vaccine are used to help the body generate an immune response against HIV.6,7

How are clinical trials of investigational vaccines conducted?

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.8

  • 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.8,9

In most cases, an investigational vaccine must be proven effective and must show continued safety in a Phase III clinical trial to 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.8

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 Vacc-C5?

In what phase of testing is Vacc-C5?

Vacc-C5 has been studied in a Phase I/II clinical trial.1,6

What are some studies on Vacc-C5?

What are some studies on Vacc-C5?

Study Identifiers: NCT01627678
Sponsor: Bionor Immuno AS
Phase: I/II
Status: This study has been completed.
Location: Norway
Participants:

  • Participants were adults who had HIV for at least 1 year.
  • Participants had been on ART and had viral load levels of less than 50 copies/mL during the 6 months prior to the start of the study. (Viral load is the amount of HIV in a blood sample.)
  • Participants had CD4 counts greater than 400 cells/mm3 during the 6 months prior to the start of the study. Participants’ lowest ever CD4 counts were above 200 cells/mm3. (A CD4 count is a laboratory test that measures the number of CD4 cells in a sample of blood and is an important indicator of immune function.)

Purpose: The purpose of this study was to evaluate the safety of Vacc-C5 when given by injection, either into the skin or in the muscle, with 2 different adjuvants. (An adjuvant is a substance added to a drug or vaccine to enhance its effectiveness.) The study also evaluated the impact of Vacc-C5 on the body’s immune response.6,10

For more details on the study listed above, see the Health Professional version.

What side effects might Vacc-C5 cause?

What side effects might Vacc-C5 cause?

One goal of HIV research is to identify new drugs that have fewer side effects. In the Phase I/II study (NCT01627678) discussed under the previous question, many participants who received injections into the skin reported temporary pain or discomfort at the injection site. No serious side effects related to Vacc-C5 were reported.11

Information on possible side effects of Vacc-C5 is not complete. As testing of Vacc-C5 continues, additional information on possible side effects will be gathered.

Where can I get more information about clinical trials studying Vacc-C5?

Where can I get more information about clinical trials studying Vacc-C5?

More information about research studies related to Vacc-C5 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.

How can I find more information about participating in a clinical trial?

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.8

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. Available at: http://www.treatmentactiongroup.org/cure/trials. Last accessed on May 29, 2018. [Archived at WebCite]
  2. Bionor Holding AS. About us. Available at: https://bionorholding.com/about-us/. Last accessed on May 29, 2018. [Archived at WebCite]
  3. The History of Vaccines website. The development of HIV vaccines. Available at: https://www.historyofvaccines.org/content/articles/development-hiv-vaccines. Last accessed on May 29, 2018. [Archived at WebCite ]
  4. 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 May 29, 2018.
  5. 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 May 29, 2018.
  6. Brekke K, Sommerfelt M, Ökvist M, Dyrhol-Riise AM, Kvale D. The therapeutic HIV Env C5/gp41 vaccine candidate Vacc-C5 induces specific T cell regulation in a phase I/II clinical study. BMC Infect Dis. 2017; 17: 228. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5366104/. Last accessed on May 29, 2018.
  7. Bionor Holding AS. About Vacc-C5. Available at https://bionorholding.com/functional-hiv-cure/vacc-c5/. Last accessed on May 29, 2018. [Archived at WebCite]
  8. 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 May 29, 2018.
  9. 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 May 29, 2018. [Archived at WebCite]
  10. Bionor Immuno AS. Immunotherapy of HIV-infected patients an open, dose-escalating assessment of Vacc-C5 with either GM-CSF or Alhydrogel as adjuvant in HIV-1-infected subjects on antiretroviral therapy (ART). In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on June 21, 2012. Available at: https://clinicaltrials.gov/ct2/show/NCT01627678. Last accessed on May 29, 2018.

Last Reviewed: May 29, 2018