Depletion of Serum Amyloid P Component to Enhance the Immune Response to DNA Vaccination

• Status: Completed
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University College, London
• Collaborators: GlaxoSmithKline; Medical Research Council; University of Oxford
• Treatments: Vaccines

Criteria

Inclusion Criteria:

• Healthy males, as assessed by a medical history, physical examination and laboratory tests.

• Aged at least 18 years on the day of screening and no greater than 50 years on the day of the first vaccination.

• Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study.

• In the opinion of the Chief Investigator (CI) or designee, the volunteer has understood the information provided and is able to provide written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.

• Willing to undergo HIV-1 testing, HIV-1 counselling and receive HIV-1 test results.

• If heterosexually active male; willing to use an effective method of contraception from the day of the first vaccination until six weeks after the last vaccination.

• Willing to forgo donating blood during the study.

Exclusion Criteria:

• None.