HIV Clinical Trial - Safety & Immunogenicity of HIV DNA-C CN54ENV &

Status Completed

Clinical Trial 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.

Clinical Trial Description

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

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 route. Healthy male and female volunteers aged 18 to 50 years old, who are at low risk of HIV infection, are to be recruited. The participants will be divided into 3 groups:

Group 1:

Participants will receive 1 x 0.15 ml (0.6 mg) DNA intradermal injections into the upper arm with EP and 1 x 0.5 ml (2 mg) intramuscular injection into the upper thigh without EP at Weeks 0, 4 & 8. And also 1 x 0.1 ml (50 μg) HIV recombinant protein by intradermal injection into the upper arm at Week 20 (final vaccination).

Group 2:

Participants will receive 1 x 0.15 ml (0.6 mg) DNA intradermal injections into the upper arm without EP and 1 x 0.5 ml (2 mg) intramuscular injection into the upper thigh with EP at weeks 0, 4 & 8. And also 1 x 0.1 ml (50 μg) HIV recombinant protein by intradermal injection into the upper arm at Week 20 (final vaccination).

Group 3:

Participants will receive 1 x 0.15 ml (0.6 mg) of DNA of intradermal injections into the upper arm with EP and 1 x 0.5 ml (2 mg) intramuscular injection into the upper thigh with EP at weeks 0, 4 & 8. And also 1 x 0.1 ml (50 μg) HIV recombinant protein by intradermal injection into the upper arm at Week 20 (final vaccination).

The investigators aim to have 8 participants complete the study in each group. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02589795
Study type	Interventional
Source	Imperial College London
Contact
Status	Completed
Phase	Phase 1
Start date	August 11, 2016
Completion date	December 22, 2017

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms