Depletion of Serum Amyloid P Component to Enhance the Immune Response to DNA Vaccination
HIV-CORE003
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
2 other identifiers
interventional
41
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 hiv
Started Oct 2013
Longer than P75 for phase_1 hiv
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 29, 2013
CompletedStudy Start
First participant enrolled
October 1, 2013
CompletedFirst Posted
Study publicly available on registry
April 23, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedMarch 26, 2020
March 1, 2020
2.3 years
April 29, 2013
March 25, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
vaccine safety (Proportion of volunteers who develop a grade 3 or grade 4 local reaction/ grade 3 or 4 systemic reaction)
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.
20 weeks
vaccine immunogenicity (T cell responses will be determined initially by interferon-gamma enzyme-linked immunospot assay)
T cell responses will be determined initially by interferon-gamma enzyme-linked immunospot assay.
20 weeks
Study Arms (2)
CPHPC
EXPERIMENTALCPHPC infusion over 26 hours to deplete SAP at weeks 0,4 and 8. pSG2.HIVconsv DNA vaccine 4 mg at weeks 0, 4 and 8 after 24 hours of CPHPC infusion. ChAdV63.HIVconsv booster vaccine 5 x 10\^10 vp at week 12. MVA.HIVconsv booster vaccine 2 x 10\^8 pfu at week 20
0.9% w/v saline solution
PLACEBO COMPARATORPlacebo (normal saline) infusion over 26 hours at weeks 0,4 and 8. pSG2.HIVconsv DNA vaccine 4 mg at weeks 0, 4 and 8 after 24 hours of placebo infusion. ChAdV63.HIVconsv booster vaccine 5 x 10\^10 vp at week 12. MVA.HIVconsv booster vaccine 2 x 10\^8 pfu at week 20
Interventions
pSG2.HIVconsv DNA 4 mg at weeks 0, 4 and 8.
ChAdV63.HIVconsv 5 x 10\^10 vp at week 12.
MVA.HIVconsv 2 x 10\^8 pfu at week 20
40 mg CPHPC IV infusion for 26 hours at weeks 0, 4 and 8 during which pSG2.HIVconsv is administered after 24 hours.
Placebo IV infusion for 26 hours at weeks 0, 4 and 8 during which pSG2.HIVconsv is administered after 24 hours.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- None.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University College, Londonlead
- Medical Research Councilcollaborator
- University of Oxfordcollaborator
- GlaxoSmithKlinecollaborator
Study Sites (1)
National Amyloidosis Centre
London, England, NW3 2PF, United Kingdom
Related Publications (1)
Borthwick NJ, Lane T, Moyo N, Crook A, Shim JM, Baines I, Wee EG, Hawkins PN, Gillmore JD, Hanke T, Pepys MB. Randomized phase I trial HIV-CORE 003: Depletion of serum amyloid P component and immunogenicity of DNA vaccination against HIV-1. PLoS One. 2018 May 17;13(5):e0197299. doi: 10.1371/journal.pone.0197299. eCollection 2018.
PMID: 29772028DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Julian D Gillmore, MBBS
University College, London
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 29, 2013
First Posted
April 23, 2015
Study Start
October 1, 2013
Primary Completion
February 1, 2016
Study Completion
September 1, 2016
Last Updated
March 26, 2020
Record last verified: 2020-03