A Randomised Double-blind, Placebo-controlled Phase I/IIa Trial to Investigate the Effect of Depletion of Serum Amyloid P Component (SAP) on the Immune Response to DNA Vaccination in Healthy Male Volunteers (HIV-CORE003)

NCT02425241 Phase 1/Phase 2 COMPLETED

This is a clinical proof-of-concept (PoC) study of DNA vaccination after SAP depletion. The investigators will measure the immune responses to DNA vaccination against HIV-1 in healthy adult male volunteers, comparing a group in whom SAP has been completely depleted at the time of DNA vaccination and a control group vaccinated without SAP depletion.

Details

Lead sponsor	University College, London
Phase	Phase 1/Phase 2
Status	COMPLETED
Enrolment	41
Start date	2013-10
Completion	2016-09

Conditions

• HIV

Interventions

• pSG2.HIVconsv DNA vaccine
• ChAdV63.HIVconsv booster vaccine
• MVA.HIVconsv booster vaccine
• CPHPC
• Placebo

Primary outcomes

• vaccine safety (Proportion of volunteers who develop a grade 3 or grade 4 local reaction/ grade 3 or 4 systemic reaction) — 20 weeks
  Proportion of volunteers who develop a grade 3 or grade 4 local reaction. Proportion of volunteers who develop a grade 3 or grade 4 systemic reaction.
• vaccine immunogenicity (T cell responses will be determined initially by interferon-gamma enzyme-linked immunospot assay) — 20 weeks
  T cell responses will be determined initially by interferon-gamma enzyme-linked immunospot assay.

Countries

United Kingdom