Measuring Responses to Sublingual Antigens
Condition: Sexually Transmitted Diseases, Viral
MeSH terms: Sexually Transmitted Diseases; Virus Diseases; Sexually Transmitted Diseases, Viral
Study type: Interventional

Summary: 
      This study is a preliminary investigation of immune responses, in the blood and in cervical &
      vaginal secretions, to proteins ("antigens") taken up across the undersurface of the tongue.
    

Detailed description: 
      Animal studies have shown that this "sublingual" surface can take up antigens and stimulate
      immune responses, which may have a different character to responses induced by injecting the
      same antigens. In previous studies of nasal and oral delivery, we used licensed vaccine
      preparations as pure and well-characterised model antigens safe for use in humans. We will
      use a licensed "HPV" vaccine as the source of antigens in this study. The quantity and
      character of responses (lymphocyte number and pattern of surface proteins, concentration and
      type of antibodies in fluids) will be measured in detail in various anatomical sites (blood,
      vaginal secretions) before and after delivery of antigens on three occasions. As well as
      using established immune assays to characterise the responses, we will develop new research
      assays to detect populations of lymphocytes and antibodies present in secretions. To ensure
      we have positive samples to include in our assays and validate new techniques, we will
      recruit some subjects to receive a standard intramuscular injection, as this is known to be
      nearly 100% reliable in inducing measurable immune responses. As this is a preliminary study
      we will recruit enough subjects (based on our previous experience with nasal, oral and
      injected delivery) to ensure we generate sufficient responses we can measure. We may be able
      to draw some tentative conclusions about differences in character of immune responses
      following sublingual or injected delivery, but it is not the intention of this initial study
      to formally compare these two routes. If we observe that sublingual delivery in humans can
      induce immune responses, we can select assays to test any differences more formally in
      subsequent bigger and more focused studies.
    

Intervention name(s): Human Papillomavirus 6,11,16,18 Vaccine Recombinant alum ads; Human Papillomavirus 6,11,16,18 Vaccine Recombinant alum ads
Intervention type(s): Biological; Biological
Intervention description(s): 1 intramuscular dose (0.5 ml) on month 0, 1 and 4 containing approximately: Human Papillomavirus Type 6 L1 protein 20 micrograms Human Papillomavirus Type 11 L1 protein 40 micrograms Human Papillomavirus Type 16 L1 protein 40 micrograms Human Papillomavirus Type 18 L1 protein 20 micrograms; 1 sublingual application on month 0, 1 and 4 of 0.5 ml containing approximately: Human Papillomavirus Type 6 L1 protein 20 micrograms Human Papillomavirus Type 11 L1 protein 40 micrograms Human Papillomavirus Type 16 L1 protein 40 micrograms Human Papillomavirus Type 18 L1 protein 20 micrograms
Other intervention name(s): Gardasil; Gardasil
Intervention MeSH terms: Vaccines; Aluminum sulfate
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: mucosal immunity; immunization; sublingual