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Safety and Immunogenicity of HIV DNA-C CN54ENV and Recombinant HIV CN54gp140 Vaccines in Healthy Volunteers

NCT02589795 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2025-01-31

Study results available
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Summary

CUTHIVAC002 is a randomised Phase I study aimed at exploring the safety and immunogenicity of two different modes of delivery of a deoxyribonucleic acid (DNA) vaccine (DNA-C CN54ENV) via combined intramuscular and intradermal methods with and without electroporation, and boosted with recombinant HIV CN54gp140 administered by intradermal injection in healthy volunteers.

The aim of this study is to identify optimal DNA delivery conditions for promoting enhanced antibody responses to boosting with recombinant protein by the intradermal method.

Conditions

Interventions

BIOLOGICAL

DNA-C CN54ENV

DNA plasmid containing the Clade C gp140 envelope gene from HIV-1 isolate CN54

BIOLOGICAL

CN54gp140

Recombinant protein expressed from the Clade C gp140 envelope gene from HIV-1 isolate CN54

DEVICE

Trigrid Delivery System - Intramuscular

Electroporation

DEVICE

Trigrid Delivery System - Intradermal

Electroporation

Sponsors & Collaborators

Principal Investigators

  • David Lewis, MD · Imperial College London

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-08-11
Primary Completion
2017-12-22
Completion
2017-12-22

Countries

  • United Kingdom

Study Locations

More Related Trials

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 NCT02589795 on ClinicalTrials.gov