Date: 2013-02-21
Type of information:
phase: 1
Announcement: publication of phase 1 results in PLOS ONE (Randomized Phase I: Safety, Immunogenicity and Mucosal Antiviral Activity in Young Healthy Women Vaccinated with HIV-1 Gp41 P1 Peptide on Virosomes)
Company: Mymetics (Switzerland)
Product: MYM-V101
Action
mechanism: vaccine formulation developed to induce the production of IgA antibodies (antibodies found at the mucosal level). This prophylactic vaccine candidate has been designed for blocking early HIV-1 transmission across mucosal membranes and early infection underneath the mucosa. With its vaccine, Mymetics aims to provide a first line of defense through mucosal protection as well as a second line of defense against infection through the generation of blood antibodies. Today, there is evidence in favor of multiple separate immune compartments with local mucosal cells producing mucosal IgG and IgA that may circulate or not to other compartments. Each immune compartment can be partially or totally complementary to the others. A sub-group of women and men who produce mucosal IgA antibodies against the HIV-1 gp41 protein in their mucosal secretions have been found to display resistance to HIV-1 transmission and infection. Mymetics has used its technology and expertise to design a vaccine specifically intended to induce a mucosal antibody response against HIV-1, while also inducing blood antibodies.
Disease: HIV/Aids
Therapeutic area: Infectious diseases
Country: Belgium
Trial
details: The placebo-controlled Phase I trial involved 24 healthy women randomized in two groups to monitor the safety and immunogenicity of the HIV-1 vaccine. A low dose group received 10mg/dose and a high dose group received 50mg/dose. In each group, eight subjects received the vaccine MYM-V101 and four subjects received the placebo. Two doses were given intramuscularly at week 0 and week 8 followed by two doses given intranasally at week 16 and week 24. The study was conducted at a single site, the Center for Vaccinology (CEVAC) at the University of Ghent (Belgium) with Prof. Dr. G. Leroux-Roels as principal investigator. The clinical study was managed by Kinesis-Pharma, the CRO of Mymetics. The functional antiviral activity of these mucosal antibodies was demonstrated by the inhibition of HIV-1 transcytosis, as reported by Dr. Morgane Bomsel (INSERM/Cochin Institute, France), a key academic partner. (NCT01084343)
Latest
news: * On February 21, 2013, Mymetics Corporation has announced that results from a randomized study with its HIV-1 (Human Immunodeficiency Virus type 1) vaccine MYM-V101 have been published in PLOS ONE. These date indicate that the vaccine is safe and well tolerated and demonstrates a high level of immunogenicity in a Phase I trial involving 24 healthy women. The publication highlights that vaccine-induced mucosal antibodies may contribute to reduce sexually transmitted HIV-1.
All vaccinated women rapidly developed lipopeptide P1-specific serum antibodies, confirming the high efficacy of the influenza virosome as carrier/adjuvant for inducing a Th2 (T helper type 2) response. This antibody concentration represents billions of molecules of antibodies in the vaginal secretion and it is believed to be sufficient for preventing sexually transmitted HIV-1 within the first minutes or hours following the virus entry in the vaginal cavity.
Until the completion of this double blind, randomized, placebo controlled Phase I trial, the capacity of an HIV-1 vaccine to induce mucosal antibodies in the genital and rectal tracts of women after intramuscular and intranasal administrations was unknown. This Phase I study confirms Mymetics’ previous pre-clinical study conducted on non-human primates, which was published in February 2011 in the journal Immunity.
Providing Mymetics obtains additional sources of financing for this project, the company plans to test its prophylactic HIV-1 vaccine candidate in a combined Phase I and II trial to investigate an additional HIV-1 antigen and a further optimized vaccine formulation.
* On May 26, 2011, Mymetics Corporation has announced that the phase I study of its anti-VIH-1 vaccine MYM-V101 has confirmed the safety profile of virosomes and the anti-HIV-1 mucosal responses elicited by the product. The vaccine was well tolerated and highly immunogenic. All vaccinated women rapidly developed lipopeptide P1-specific serum antibodies, confirming the efficacy of the influenza virosomes as carriers/adjuvants for inducing a Th2 (T helper type 2) response. Every woman involved in the trial has developed serum antibodies but also mucosal antibodies in the genital and intestinal tracts. The company now plan the next phase I/II trial to test an additional HIV-1 antigen and a further optimized vaccine formulation. MYM-V101 has been co-developed with Pevion Biotech, using proprietary virosome technology. The next trial will also involve the industrial partner Px-Therapeutics for its expertise in recombinant protein production and GMP grade for clinical trials.
Mymetics Corporation has announced that the phase I study of its anti-VIH-1 vaccine MYM-V101 has confirmed the safety profile of virosomes and the anti-HIV-1 mucosal responses elicited by the product. The vaccine was well tolerated and highly immunogenic. All vaccinated women rapidly developed lipopeptide P1-specific serum antibodies, confirming the efficacy of the influenza virosomes as carriers/adjuvants for inducing a Th2 (T helper type 2) response. Every woman involved in the trial has developed serum antibodies but also mucosal antibodies in the genital and intestinal tracts. The company now plan the next phase I/II trial to test an additional HIV-1 antigen and a further optimized vaccine formulation. MYM-V101 has been co-developed with Pevion Biotech, using proprietary virosome technology. The next trial will also involve the industrial partner Px-Therapeutics for its expertise in recombinant protein production and GMP grade for clinical trials.
