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 :
Completed
First Posted : April 23, 2015
Last Update Posted : March 26, 2020
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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 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 41 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 |
Actual Primary Completion Date : | February 2016 |
Actual Study Completion Date : | September 2016 |

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 |
- 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.
- 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 |
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.

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
United Kingdom | |
National Amyloidosis Centre | |
London, England, United Kingdom, NW3 2PF |
Principal Investigator: | Julian D Gillmore, MBBS | University College, London |
Responsible Party: | University College, London |
ClinicalTrials.gov Identifier: | NCT02425241 |
Other Study ID Numbers: |
HIV-CORE003 2012-004052-11 ( EudraCT Number ) |
First Posted: | April 23, 2015 Key Record Dates |
Last Update Posted: | March 26, 2020 |
Last Verified: | March 2020 |
Vaccine DNA HIV-1 Serum amyloid P component (SAP) |
Clinical trial Vaccination Prophylaxis Adult male |
Amyloidosis Proteostasis Deficiencies Metabolic Diseases |
Vaccines Immunologic Factors Physiological Effects of Drugs |