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Trial record 15 of 29 for:    " April 07, 2013":" May 07, 2013"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

Depletion of Serum Amyloid P Component to Enhance the Immune Response to DNA Vaccination (HIV-CORE003)

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ClinicalTrials.gov Identifier: NCT02425241
Recruitment Status : Unknown
Verified April 2015 by University College, London.
Recruitment status was:  Recruiting
First Posted : April 23, 2015
Last Update Posted : April 23, 2015
Sponsor:
Collaborators:
Medical Research Council
University of Oxford
GlaxoSmithKline
Information provided by (Responsible Party):
University College, London

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.

Condition or disease Intervention/treatment Phase
HIV Biological: pSG2.HIVconsv DNA vaccine Biological: ChAdV63.HIVconsv booster vaccine Biological: MVA.HIVconsv booster vaccine Drug: CPHPC Other: Placebo Phase 1 Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : October 2013
Estimated Primary Completion Date : October 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Amyloidosis HIV/AIDS

Arm Intervention/treatment
Experimental: CPHPC

CPHPC 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

Biological: pSG2.HIVconsv DNA vaccine
pSG2.HIVconsv DNA 4 mg at weeks 0, 4 and 8.

Biological: ChAdV63.HIVconsv booster vaccine
ChAdV63.HIVconsv 5 x 10^10 vp at week 12.

Biological: MVA.HIVconsv booster vaccine
MVA.HIVconsv 2 x 10^8 pfu at week 20

Drug: CPHPC
40 mg CPHPC IV infusion for 26 hours at weeks 0, 4 and 8 during which pSG2.HIVconsv is administered after 24 hours.
Other Name: (R)-1-[6-[(R)-2-carboxy-pyrrolidin-1-yl]-6-oxohexanoyl] pyrrolidine-2-carboxylic acid

Placebo Comparator: 0.9% w/v saline solution

Placebo (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

Biological: pSG2.HIVconsv DNA vaccine
pSG2.HIVconsv DNA 4 mg at weeks 0, 4 and 8.

Biological: ChAdV63.HIVconsv booster vaccine
ChAdV63.HIVconsv 5 x 10^10 vp at week 12.

Biological: MVA.HIVconsv booster vaccine
MVA.HIVconsv 2 x 10^8 pfu at week 20

Other: Placebo
Placebo IV infusion for 26 hours at weeks 0, 4 and 8 during which pSG2.HIVconsv is administered after 24 hours.
Other Name: 0.9% saline




Primary Outcome Measures :
  1. vaccine safety (Proportion of volunteers who develop a grade 3 or grade 4 local reaction/ grade 3 or 4 systemic reaction) [ Time Frame: 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.

  2. vaccine immunogenicity (T cell responses will be determined initially by interferon-gamma enzyme-linked immunospot assay) [ Time Frame: 20 weeks ]
    T cell responses will be determined initially by interferon-gamma enzyme-linked immunospot assay.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02425241


Contacts
Contact: Julian D Gillmore, MBBS +44 20 7433 2726 j.gillmore@ucl.ac.uk
Contact: Thirusha Lane, MSc +44 20 7433 2759 t.lane@ucl.ac.uk

Locations
United Kingdom
National Amyloidosis Centre Recruiting
London, England, United Kingdom, NW3 2PF
Contact: Thirusha Lane, MSc    +44 20 7433 2759    t.lane@ucl.ac.uk   
Principal Investigator: Julian D Gillmore, MBBS         
Sponsors and Collaborators
University College, London
Medical Research Council
University of Oxford
GlaxoSmithKline
Investigators
Principal Investigator: Julian D Gillmore, MBBS University College, London

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT02425241     History of Changes
Other Study ID Numbers: HIV-CORE003
2012-004052-11 ( EudraCT Number )
First Posted: April 23, 2015    Key Record Dates
Last Update Posted: April 23, 2015
Last Verified: April 2015

Keywords provided by University College, London:
Vaccine
DNA
HIV-1
Serum amyloid P component (SAP)
Clinical trial
Vaccination
Prophylaxis
Adult male

Additional relevant MeSH terms:
Vaccines
Immunologic Factors
Physiological Effects of Drugs