P40.22
Background: HIV infection is mostly acquired through mucosal surfaces and an efficacious HIV vaccine would ideally elicit an immune response at these surfaces. This study presents acceptability of the mucosal sampling procedures among study volunteers enrolled in a phase 1 HIV vaccine trial in Kigali, Rwanda.
Methods: Since January 2013, Project San Francisco (PSF) has been participating in a multicenter phase 1 clinical trial to assess the safety and immunogenicity of a Sendai HIV vaccine given intra-nasally and an Ad35-GRIN HIV vaccine administered intra-muscularly in prime-boost regimens. The study was discussed extensively with volunteers during education and consenting sessions. Mucosal sampling included saliva from parotid glands (Salimetrics Oral Swabs), oral fluids (Falcon tubes), nasal secretions (FloQ swabs), cervico-vaginal secretions (Softcup or Merocel sponge), and rectal secretions (Merocel sponge). Samples were collected at baseline before vaccination and at 5 subsequent time points during follow-up to date. The study is ongoing and will have 9 mucosal sampling time points in total. Consent for mucosal sampling was reassessed at each collection visit.
Results: A total of 20 participants were enrolled (8 women and 12 men), and all 20 participants (100%) consented to each type of mucosal secretion collection. As of April 2014, the 20 study volunteers have completed the 6 mucosal collection visits each. All study participants provided all protocol required specimens, both at baseline and at the 5 subsequent follow-up visits, resulting in a 100% acceptability rate.
Conclusions: This study confirms that multiple collection sites and repeated mucosal specimen collection in HIV vaccine trials is highly acceptable in Rwanda. The high acceptability of these procedures may be a reflection of extensive counseling and mutual trust between study participants and study staff.
