Drugs

VAC-3S

VAC-3S

Drug Class: Therapeutic Vaccines Registry Number: 1502828-53-6 (CAS) Organization: InnaVirVax Phase of Development: IIa

(Compound details obtained from ChemIDplus Advanced,1 Treatment Action Group website,2 InnaVirVax website,3 and IAS Towards an HIV Cure 2015 Poster MOPEA0384)

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 VAC-3S?

What is VAC-3S?

VAC-3S is an investigational vaccine that is being studied as a therapeutic vaccine for HIV.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.5

HIV researchers are developing and testing therapeutic vaccines (1) to slow down the progression of HIV infection, (2) to eliminate the need for antiretroviral therapy (ART) while still keeping undetectable levels of HIV, and (3) as part of a combination strategy that includes HIV medicines and a therapeutic vaccine to eliminate all HIV from the body. (ART is the recommended treatment for HIV infection and involves using a combination of different HIV medicines to prevent HIV from replicating.) The AIDSinfo fact sheet What is a Therapeutic HIV Vaccine? has more information on therapeutic HIV vaccines.6,7

The VAC-3S vaccine is made up of an HIV peptide (a piece of HIV protein). The HIV peptide in the VAC-3S vaccine is used to help the body generate an immune response against HIV.8,9

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.10

  • 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.10,11

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.10 (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 VAC-3S?

In what phase of testing is VAC-3S?

VAC-3S is currently being studied in a Phase IIa clinical trial.4

What are some studies on VAC-3S?

What are some studies on VAC-3S?

Study Name: IVVAC-3S/P1; NCT01549119 
Sponsor: InnaVirVax
Phase: I/IIa
Location: France
Participants:

  • Participants were HIV-infected adults who were receiving ART when they started the study. They had been on ART for at least 1 year before the study.
  • Participants had viral load levels of less than 50 copies/mL when they started the study and in the prior year. (Viral load is the amount of HIV in a blood sample.)
  • Participants had CD4 counts of at least 200 cells/mm3 at the start of the study. A participant’s lowest ever CD4 count was 100 cells/mm3 or above. (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 look at the safety of VAC-3S and its ability to produce an immune response in the body.8,12

 

Study Name: IVVAC-3S/P2; NCT02390466 
Sponsor: InnaVirVax
Phase: I/IIa
Location: France
Participants:

  • Participants are HIV-infected adults who have been on ART for at least 1 year before the study. Participants have completed the IVVAC-3S/P1 study.
  • Participants have had viral load levels of 200 copies/mL or less in the 12 months before the study and a viral load level of 50 copies/mL or less at the start of the study.
  • Participants have CD4 counts of at least 200 cells/mm3. A participant’s lowest ever CD4 count has been 100 cells/mm3 or above.

Purpose: The purpose of this study is to look at the safety and tolerability of VAC-3S in participants who had an immune response to VAC-3S in the IVVAC-3S/P1 study.13

*This study is ongoing, but not recruiting participants.

 

Study Name: IPROTECT1; NCT02041247 
Sponsor: InnaVirVax
Phase: IIa
Location: France, Germany, Spain
Participants:

  • Participants are HIV-infected adults who have been on ART for at least 1 year before the study.
  • Participants have had viral load levels of less than 50 copies/mL in the year before the study.
  • Participants have CD4 counts above 200 cells/mm3 but below 500 cells/mm3.

Purpose: The purpose of this study is to evaluate the treatment benefits of VAC-3S.4,14

 *This study is ongoing, but not recruiting participants.


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

 

What side effects might VAC-3S cause?

What side effects might VAC-3S cause?

Researchers from the IVVAC-3S/P1 study (NCT01549119) reported that VAC-3S was safe.12,15 Side effects that occurred during the study included local injection site reactions, such as reddening of skin, hardening of tissue, and pain. Other side effects that occurred included weakness, fever, muscle pain, and headache. There were no serious side effects related to VAC-3S and no side effects that caused participants to stop the study early.8,16

In the IPROTECT1 study (NCT02041247), early results showed that the most common side effects related to VAC-3S included the following: weakness, headache, fever, nausea, muscle pain, vertigo, general pain, and local injection site reactions (such as pain, sensitivity, hardening of tissue, and reddening of skin). Most of these side effects were of mild to moderate intensity.4,14

Because VAC-3S is still being studied, information on possible side effects of the vaccine is not complete. As testing of VAC-3S continues, additional information on possible side effects will be gathered.

 

Where can I get more information about clinical trials studying VAC-3S?

Where can I get more information about clinical trials studying VAC-3S?

More information about research studies related to VAC-3S 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.10 

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. United States National Library of Medicine. ChemIDplus Advanced. Available at: https://chem.nlm.nih.gov/chemidplus/rn/1502828-53-6. Last accessed on March 15, 2017.
  2. Treatment Action Group website. Research toward a cure trials. Available at: http://www.treatmentactiongroup.org/cure/trials. Last accessed on March 15, 2017.
  3. InnaVirVax website. Products pipeline. Available at: http://www.innavirvax.fr/en/translational-medicine/infectious-diseases/products-pipeline. Last accessed on February 8, 2017.
  4. Katlama C, Rockstroh JK, Gatell JM, et al. VAC-3S immunotherapeutic HIV vaccine combined with ART is immunogenic and safe. Phase II initial analysis of the IPROTECT1 multicenter European study. Poster presented at: International AIDS Society (IAS) Conference on HIV Pathogenesis, Treatment & Prevention; July 19-22, 2015; Vancouver, Canada. Poster MOPEA038. Available at: http://pag.ias2015.org/PAGMaterial/eposters/3071.pdf. Last accessed on March 15, 2017.
  5. The History of Vaccines website. The development of HIV vaccines. Available at: http://www.historyofvaccines.org/content/articles/development-hiv-vaccines. Last accessed on March 15, 2017.
  6. Smith PL, Tanner H, Dalgleish A. Developments in HIV-1 immunotherapy and therapeutic vaccination. F1000Prime Rep. 2014 Jun 2;6:43. Available at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4047951/. Last accessed on March 15, 2017.
  7. Graziani GM and Angel JB. Evaluating the efficacy of therapeutic HIV vaccines through analytical treatment interruptions. J Int AIDS Soc. 2015 Nov 9;18: 20497. Available at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4641978/. Last accessed on March 15, 2017.
  8. Katlama C, Launay O, Gharakhanian S, et al. Experimental evidence and potential immunotherapeutic applications of vaccine-induced antibodies against 3S, a highly conserved motif of gp41, in HIV-1-infected patients treated with antiretroviral therapy. Poster presented at: 30 Years of HIV Science: Imagine the Future; May 21-23, 2013; Paris, France. Poster 145. Available at: http://www.sgmdconsultingllc.com/wp-content/uploads/2013/06/2013-VAC3S-Poster-no-145-Institut-Pasteur-Paris-May.pdf. Last accessed on March 15, 2017.
  9. InnaVirVax website. Our innovative products: VAC-3S. Available at: http://www.innavirvax.fr/en/translational-medicine/infectious-diseases/innovations. Last accessed on February 8, 2017.
  10. 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 March 15, 2017.
  11. 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 March 15, 2017.
  12. InnaVirVax. Multicentre, randomized, placebo-controlled, double-blind, Phase I/IIa dose-escalation clinical study of a therapeutic vaccine (VAC-3S) intended to confer protection against immunopathological effects of HIV-1 in infected patients. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on March 2, 2012. NLM Identifier: NCT01549119. Available at: https://clinicaltrials.gov/ct2/show/NCT01549119. Last accessed on March 15, 2017.
  13. InnaVirVax. Multicentre, open-label, Phase I/IIa clinical study of an immunoprotective therapeutic vaccine candidate (VAC-3S) in human immunodeficiency virus type 1 (HIV-1) chronically infected patients virologically controlled on antiretroviral therapy (ART) who rose an immune response to VAC-3S during IVVAC-3S/P1. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on January 30, 2015. NLM Identifier: NCT02390466. Available at: https://clinicaltrials.gov/ct2/show/NCT02390466. Last accessed on March 15, 2017.
  14. InnaVirVax. Assessment of VAC-3S therapeutic properties when combined with standard antiretroviral therapy (ART) in the course of HIV-1 infection. A European, randomized, double blind placebo-controlled Phase II study. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on November 27, 2013. NLM Identifier: NCT02041247. Available at: https://clinicaltrials.gov/ct2/show/NCT02041247. Last accessed on March 15, 2017.
  15. Ho Tsong Fang R, Launay O, Rouzioux C, et al. VAC-3S, a safe immunotherapeutic HIV vaccine decreased total HIV DNA and increased CD4/CD8 ratio: Phase I final results. Poster presented at: International AIDS Society (IAS) Towards an HIV Cure Symposium; July 18-19, 2015; Vancouver, Canada. Poster PE67 LB. Available at: https://www.iasociety.org/Web/WebContent/File/HIV_Cure_Symposium_2015/Posters2/PE67_Fang.pdf. Last accessed on March 15, 2017.
  16. Gharakhanian S, Katlama CH, Launay O, et al. VAC-3S, an immunoprotective HIV vaccine directed to the 3S motif of gp41, in patients receiving ART: safety, dose & immunization schedule assessment. Poster presented at: AIDS Vaccine; October 7-10, 2013; Barcelona, Spain. Poster P13.57. Available at: http://epostersonline.com/aidsvax2013/?q=node/4860&posterview=true. Last accessed on March 15, 2017.

Last Reviewed: March 15, 2017