NCT02589795

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

A Phase I Clinical Trial to Assess the Safety and Immunogenicity of HIV DNA-C CN54ENV Immunisations Administered Via the IM and ID Methods With and Without Electroporation Followed by Boosting With Recombinant HIV CN54gp140 in Healthy Male and Female Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Imperial College London · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• HIV

Interventions

Type	Name	Description
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

Timeline

• Start date: 2016-08-11
• Primary completion: 2017-12-22
• Completion: 2017-12-22
• First posted: 2015-10-28
• Last updated: 2025-01-31
• Results posted: 2025-01-31

Locations

1 site across 1 country: United Kingdom