Clinical Trials

Date: 2013-12-01

Type of information: Initiation of the trial

phase: 2

Announcement: initiation of the trial

Company: Innavirvax (France)

Product: VAC-3S immunotherapy

Action mechanism:

immunotherapy product. The VAC-3S vaccine is intented to induce sustainable levels of anti-3S peptide antibodies in patients, therefore blocking the 3S peptide-mediated pathway of CD4+ T lymphocyte depletion. 3S is a short and conserved peptide from the gp41 envelope protein of the HIV-1 and was shown to be responsible for the loss of CD4+ T lymphocytes in HIV infected patients. The VAC-3S vaccine will not have a direct effect on the virus replication and propagation itself. It will protect the CD4+ T lymphocytes from being depleted and also reduce immune activation. Basically it will protect the immune against deleterious effects of the virus. These effects will be synergistic to that of antiretroviral therapies. This immunotherapy will be used in poor and non immune responders patients under antiretroviral therapy, allowing their CD4+ T lymphocyte count to get to a value above 500/mm3. The poor and non immune responder patients represent a significant proportion of patients under antiretroviral therapies. This therapy will also be used in asymptomatic patients delaying/preventing the patients to be subjected to a decrease of CD4+ T lymphocytes, therefore keeping such patients in the asymptomatic phase, for which there is no associated morbidity.

Disease: HIV/Aids

Therapeutic area: Infectious diseases

Country: France, Germany, Spain

Trial details:

The Phase 2 study is a randomized, double-blind, placebo-controlled study among HIV-1 infected adults with viral load less than or equal to 50 copies/mm3 treated with ART, whose CD4+ T-cell count at screening is between 200 and 500 cells/mm3. A total of 90 patients will be studied in France, Germany and Spain. Three VAC-3S doses will be compared. First a 3 months base vaccination will be performed; then 3-maintenance injections in two of three dosage groups and a 6-month follow-up period.
Coordinating principal investigators for the three countries are Professors Christine Katlama, Paris, France, Juergen Rockstroh in Bonn, Germany and José Gatell in Barcelona, Spain (co-chair of 2013 AIDS vaccine conference).
*This phase I/IIa clinical trial is being carried out in two major clinical reference centers in Paris, France: the Pitié-Salpêtrière and Cochin Hospitals, and involves 24 patients infected with HIV-1 whose viral load is controlled under antiretroviral therapy, who will receive of escalating doses of treatment.The primary endpoint is the safety of this immunotherapy. The immunogenicity of the candidate drug is also being studied, as are its effects on laboratory markers of HIV infection (notably the CD4 count, viral load and markers of cellular activation). Patients will be immunized and then followed for one year. The primary endpoint of the study will be reviewed one month after the last treatment of each patient. Innavirvax has received the clinical trial authorization from the French drug agency (ANSM) last October.

Latest news:

* On December 1, 2013, InnaVirVax has announced the initiation of a Phase 2 clinical trial assessing the therapeutic properties of the VAC-3C vaccine when combined with standard antiretroviral therapy (ART) in the course of HIV-1 infection. The primary objective of the Phase 2 study is to assess antibody response to the VAC-3S vaccine.Secondary objectives include overall general and local tolerance as well as clinical safety, comprehensive evaluation of the immunological endpoints, inflammatory biomarkers, and identifying the vaccine’s immunogenic characteristics.

A phase I dose escalation study of VAC-3S previously performed in 33 patients living with HIV whose CD4 T-lymphocyte levels were higher than 200 mm3 and who were on ART, demonstrated safety and provided data for dose selection.
* On November 29, 2012, InnaVirVax, a biopharmaceutical company specialized in research and development on therapeutic and diagnostic solutions for diseases linked to immune dysregulation, has just announced successful completion of the first clinical development phase for VAC-3S immunotherapy in the treatment of HIV infections. This phase I/IIa dose escalation study was performed in 24 patients living with HIV whose CD4 Tlymphocyte levels were higher than 200/mm3 and who were under antiretroviral therapy. The treatment was administered in 3 injections at 4-week intervals. The primary endpoint of this study was to assess the safety and tolerability of VAC-3S, four weeks after the third injection. Secondary endpoints included an evaluation of the immune response, the long-term safety of the treatment and the monitoring of different biological markers of infection (including viral load and the CD4 Tlymphocyte count). The study was carried out under double-blinded conditions in two AP-HP (Paris Public Hospitals System) reference clinical centers at Hôpital de la Pitié Salpêtrière and Hôpital Cochin. The results showed that VAC-3S was well tolerated, thus meeting the primary endpoint of the study. Full results of this study will be presented at an international medical conference. InnaVirVax is now looking forward to analyzing these results in detail in terms of the full set of endpoints. The company is also actively preparing the next stage, which will involve submission of an application for a Phase II clinical study.
* On March 5, 2012, InnaVirVax has initiated a Phase I/IIa clinical trial on its VAC-3S immunotherapy agent for the treatment of HIV infections. This " first-in-class " therapy seeks to protect the immune system of patients infected with HIV-1, and this trial is starting only a little more than three years since InnaVirVax started its operations. This clinical trial has been awarded a grant of €600,000 from OSEO, the French government-backed agency that supports innovation. Professor Christine Katlama, Department of Infectious and Tropical Diseases at Pitié-Salpêtrière Hospital, and Principal Investigator for the Phase I/IIa trial, explained: "The preclinical findings on this immunotherapy suggest that we may be able to protect CD4 T-cells from being destroyed during the disease and reduce cell activation and inflammation. If these results can be replicated in patients, then the therapeutic armementarium of antiretroviral drugs will be significantly enhanced."
* On October 13, 2011, InnaVirVax has announced that it has received a clinical trial authorization (CTA) from the French drug agency (AFSSAPS) to run a phase 1/2a clinical trial of its VAC-3S vaccine candidate.This vaccine is designed to preserve the immune system of patients infected with HIV-1. It aims to combat the pathogenicity of the virus by blocking the loss of CD4 + T cells and by protecting the immune system, including reducing immune activation and inflammation. This vaccine approach is the result of original work at the Pitié Salpêtrière (AP-HP) by Professor Patrice Debré and Dr. Vincent Vieillard (UMR INSERM and Pierre and Marie Curie University UMRS 946).
* On June 22, 2011, InnaVirVax has announced promising preclinical results of its therapeutic vaccine VAC-3S, which aims at preserving the immune system of patients infected with HIV-1. The VAC-3S project was supported by the French National Research Agency, as part of a collaborative project with the UMRS 946 and the 'Commissariat à l'Energie Atomique'. This support has enabled the consolidation of the proof of concept of the vaccine approach developed by InnaVirVax, specifically the protection of CD4 + T lymphocytes cells during the disease. In addition, InnaVirVax has developed a manufacturing process of the vaccine candidate, compatible with subsequent industrial use. Studies of toxicity and local tolerance of the vaccine candidate VAC-3S have just been completed. Conducted under Good Laboratory Practice (GLP) at the CIT (Evreux, France), the results showed the absence of toxicity of the vaccine. The company intends to start Phase I / IIa clinical studies in that the main objective of the trial will focus on the safety and immunogenicity of VAC-3S in patients infected with HIV-1. Based on the obtained results, InnaVirVax will file to the AFSSAPS, the French drug agency, a request for a Phase I / IIa clinical trial authorization. The main objective of this trial, which will be carried out in France will focus on the safety and immunogenicity of VAC-3S in patients infected with HIV-1. Some efficacy parameters such as CD4 count, viral load and cellular activation will be studied during as secondary objective.

Is general: Yes