Immunogenicity, follow-up study for patients infected with HIV-1

• Research type

  Research Study

• Full title

  Re-boosting of Subjects Previously Included in the CT BI-Vacc-4x 2007/1 Study. An Open, Multicentre, Immunogenicity, Follow-up Re-boosting Study with Vacc-4x in Subjects Infected with HIV-1 Who Have Maintained an Adequate Response to ART (Anti-Retroviral Therapy)

• IRAS ID

  111233

• Contact name

  Barry Peters

• Sponsor organisation

  Bionor Immuno AS

• Eudract number

  2012-002281-12

• Research summary

  This study is a follow-up, re-boosting study of the CT-BI Vacc-4x 2007/1 Study, which was performed in US and Europe (UK, Germany, Spain and Italy). During the CT-BI Vacc-4x 2007/1 study a reduction in the viral load set-point was seen in the Vacc-4x group compared to placebo group. Further stimulation of the immune system by re-boosting with Vacc-4x could reduce the viral load set-point further. This is the rationale for conducting this study (CT-BI Vacc-4x 2007/1). Vacc-4x is a peptide-based HIV therapeutic vaccine. The primary objective of Vacc-4x therapeutic vaccine is to strengthen the immune system??s response to HIV. ART (Anti-Retroviral Therapy) dramatically reduces the level of virus in circulation in the body, thereby allowing the immune system to focus on the therapeutic vaccine that is administered. ART also allows for the generation of new naÇîve CD4 cells that can be triggered by the therapeutic vaccine to generate new immune responses to HIV-1. Subjects are therefore immunized with Vacc-4x in the presence of ART to generate new HIV-specific immune responses that can sustain immunological fitness for prolonged periods when patients are removed from ART. All subjects to be included will have participated in the CT-BI Vacc-4x 2007/1 study, completed the immunization regimen with active Vacc-4x and stopped ART at Week 28. The study is ??open-label?? because the number of subjects available is limited (only subjects having participated in the initial study are eligible for inclusion). Eighty-eight subjects completed the initial study CT-BI Vacc-4x 2007/1. It is estimated that approximately 30 to 40 of these subjects will be eligible for this follow-up, re-boosting study.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  12/LO/1252

• Date of REC Opinion

  14 Nov 2012

• REC opinion

  Further Information Favourable Opinion