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

NCT02425241 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2020-03-26

No results posted yet for this study

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.

Conditions

Interventions

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

Placebo

Placebo IV infusion for 26 hours at weeks 0, 4 and 8 during which pSG2.HIVconsv is administered after 24 hours.

Sponsors & Collaborators

Principal Investigators

  • Julian D Gillmore, MBBS · University College, London

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2016-02-29
Completion
2016-09-30

Countries

  • United Kingdom

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02425241 on ClinicalTrials.gov