A Safety Study Of A Single Vaginal Administration Of P2G12 Antibody In Healthy Female Subjects
Condition: Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Immunologic Deficiency Syndromes
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety and tolerability of intravaginal
      administration of P2G12. 11 subjects will receive P2G12/placebo. Three subjects in Group 1
      will receive up to 7mg of P2G12, or placebo. Three subjects in Group 2 will receive up to
      14mg of P2G12, or placebo and five subjects in Group 3 will receive up to 28mg of P2G12, or
      placebo. A safety review will take place before subjects in Groups 2 and 3 receive study drug
      to determine if it is safe to proceed to the next dose of P2G12. Vaginal and cervical
      inspections will be performed to determine what effect, if any, the study drug has had on the
      site of administration. Adverse event data will be collected throughout the trial.
    

Detailed description: 
      This is a phase I study in healthy women aged 18 to 50 years, which involves vaginal
      application of study drug P2G12 or placebo.

      P2G12 is a monoclonal antibody (MAb) (a kind of protein), and belongs to a group of MAbs that
      can help to prevent and protect from HIV infection. Most of these MAbs have been produced
      using a system called Chinese Hamster Ovary cell (CHO-Cell) fermentation, e.g. C2G12. This
      method of production is very expensive and cannot produce enough MAbs on a scale required for
      the global market.

      Unlike C2G12, P2G12 is manufactured from plants. It is hoped that plant manufacture of such
      MAbs may offer some solutions to the high cost and low output of CHO-cell fermentation.

      This study is designed to confirm the safety of a vaginally delivered MAb (P2G12) derived
      from plants and manufactured to Good Manufacturing Practice (a quality standard used for the
      manufacture of medicinal products).

      11 subjects will be enrolled consecutively in cohorts (groups); in each successive cohort a
      higher dose of study drug will be administered, as well as placebo. The dose range is from up
      to 7 to up to 28mg of P2G12 in saline.

      Subjects attend 7 visits over 13 weeks. At visit 3 subjects receive a single administration
      of study drug/placebo. Study visits include the following procedures: physical exam, vital
      signs, blood and urine samples, cervical smear test and colposcopy (medical examination of
      the cervix).

      The relationship of adverse events (AEs) and serious adverse events (SAEs) to P2G12
      administration, and abnormal laboratory test results as compared to baseline (pre-dose)
      values, will determine the safety of P2G12 in the study.

      Levels of P2G12 in vaginal and serum samples will be measured at particular time-points in
      order to understand how quickly P2G12 is broken down by the body (pharmacokinetics) and
      whether any P2G12 is absorbed into the systemic circulation.
    

Intervention name(s): P2G12
Intervention type(s): Drug
Intervention description(s): A single intravaginal administration of 1ml P2G12/placebo.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Human Immunodeficiency Virus; Neutralising monoclonal antibody