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Safety and Immunogenicity of HIV DNA-C CN54ENV and Recombinant HIV CN54gp140 Vaccines in Healthy Volunteers | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

NCT02589795•Imperial College London

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 50 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Men and women aged between 18 and 50 years on the day of screening
•2. BMI between 18-30
•3. Available for follow-up for the duration of the study (\~5 months from screening)
•4. Willing and able to give written informed consent
•5. At low risk of HIV and willing to remain so for the duration of the study defined as:
•* no history of injecting drug use in the previous ten years
•* no gonorrhoea or syphilis in the last six months
•* no high risk partner (e.g. injecting drug use, HIV positive partner) either currently or within the past six months
•* no unprotected anal intercourse in the last six months, outside a relationship with a regular partner known to be HIV negative
•* no unprotected vaginal intercourse in the last six months outside a relationship with a regular known/presumed HIV negative partner
+7 more criteria

Exclusion Criteria

•1. Pregnant or lactating
•2. History of cardiac arrhythmia or palpitations \[e.g., supraventricular tachycardia, atrial fibrillation, frequent ectopy, or sinus bradycardia prior to study entry (sinus arrhythmia is not excluded)
•3. History of syncope or fainting episodes within 1 year of study entry
•4. History of grand-mal epilepsy, seizure disorder or any history of prior seizure
•5. Individuals in which a skin-fold measurement (cutaneous and subcutaneous tissue) of the upper right or left thigh exceeds 40 mm
•6. Clinically relevant abnormality on history or examination
•7. Known hypersensitivity to any component of the vaccine formulations used in this trial, or have severe or multiple allergies to drugs or pharmaceutical agents
•8. History of severe local or general reaction to vaccination defined as
•* local: extensive, indurated redness and swelling involving most of the antero-lateral thigh or the major circumference of the arm, not resolving within 72 hours
•* general: fever ≥39.5 °C within 48 hours; anaphylaxis; bronchospasm; laryngeal oedema; collapse; convulsions or encephalopathy within 72 hours
+13 more criteria

Locations (1)

NIHR/Wellcome Trust Imperial Clinical Research Facility, Hammersmith Hospital, Imperial College Healthcare NHS Trust

London, United Kingdom

Key Dates

Start Date

August 11, 2016

Primary Completion Date

December 22, 2017

Completion Date

December 22, 2017

Last Updated

January 31, 2025

Enrollment

ACTUAL participants

Conditions

HIV

Interventions

DNA-C CN54ENV

BIOLOGICAL

CN54gp140

BIOLOGICAL

Trigrid Delivery System - Intramuscular

DEVICE

Trigrid Delivery System - Intradermal

DEVICE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 31, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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