Investigation of the Safety of an HIV-1 Vaccine Given Intra-muscularly and Intra-nasally to Healthy Female Subjects
Condition: HIV-1
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to investigate the safety and efficacy of a newly developed vaccine
      against HIV-1 in female healthy subjects. Safety will be assessed by local and systemic
      adverse reactions, investigations of blood and urine, and physical exam including vital sign
      measurements. Efficacy will be assessed in blood, and in vaginal and rectal mucosal samples.
    

Detailed description: 
      The current treatment of HIV is aimed at delaying the disease process after the body has been
      infected with the virus. HIV treatment does not prevent the spreading of the virus to
      uninfected people. Prevention of HIV infection could be realized by a vaccine. An effective
      vaccine could slow down the world wide epidemic. None of the potential vaccines investigated
      in the past 20 years could provide protection to HIV. All these vaccines were aimed at
      stimulating an immune reaction in the blood. A new theory has been raised that protection
      against HIV should take place at the site where the virus in most cases enters the body after
      sexual contacts, in the vagina and rectum. Mymetics Corporation, sponsor of this clinical
      trial, has developed a new vaccine, based on the so-called virosome technique. This vaccine
      should be able to induce a local immune reaction in the mucosa of vagina and rectum.
      Investigations in laboratory animals showed that the newly developed vaccine was safe and
      well tolerated and a local immune reaction in the mucosa could be established. The next step
      is to investigate if the concept of mucosal immunity does also apply in the human being.
      Therefore this trial is being designed to investigate if the newly developed vaccine is also
      safe and well tolerated in healthy subjects. In addition, it will be investigated if the
      vaccine can induce an immune response in the mucosa of vagina and rectum. The vaccine will be
      investigated for the first time in man. The vaccine consists of a very small part of the HIV
      1 virus, coupled to a carrier, the virosome. The vaccine also contains two proteins of the
      influenza virus. These are needed for stability of the vaccine and activation of the immune
      system in general. There will be two groups of 12 healthy female subjects. In total 24
      subjects will participate in this study. The first group will be vaccinated with a low dose
      of the vaccine (10 microgram of peptide). If the vaccine is assessed as safe during the
      safety reviews, the second group will be vaccinated with a high dose of vaccine (50 microgram
      of peptide). Safety and tolerability of the high dose will also be assessed during two safety
      reviews. Each subject will be vaccinated on four occasions, separated by eight weeks. The
      first two vaccinations will be given in the muscles and the third and fourth vaccination will
      be given in the nose in order to enhance the immune response in the mucosa. In both groups,
      eight subjects will be vaccinated with the real vaccine and four subjects will be vaccinated
      with the carrier only (placebo). Nor the investigator neither the subject will know which
      vaccination they receive. It will be a so-called double-blinded study. Safety and
      tolerability will be assessed by the local and systemic adverse reactions. In addition, blood
      and urine will be investigated and subjects will have a physical examination including vital
      signs measurements. At home, subjects will complete a diary card for the registration of
      local and systemic adverse events. The immune response in blood will be measured. For the
      investigation of the mucosal immune response, a smear from the mucosa of vagina and rectum
      will be taken and investigated at four visits. This will be performed with special sponges
      and it is a painless procedure. Total duration of the study for each subject will be 32-34
      weeks. HIV infection due to this vaccination is not possible.
    

Intervention name(s): MYM-V101
Intervention type(s): Biological
Intervention description(s): Panel 1: 2 vaccinations in the muscles followed by 2 vaccinations in the nose, 10 microgram or placebo each, every 8 weeks.
Panel 2: 2 vaccinations in the muscles followed by 2 vaccinations in the nose, 50 microgram or placebo each, every 8 weeks.
Other intervention name(s): MYM-V101.1: low dose intramuscular; MYM-V101.2: high dose intramuscular; MYM-V101.3: high dose intranasal; MYM-V101.4: low dose intranasal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: vaccination; prophylaxis