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

NCT02589795 | Completed Phase 1 Results

• 1 other identifier: CUTHIVAC002
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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

HIV

Keywords

safety; immunogenicity; HIV vaccine

Outcome Measures

Primary Outcomes (2)

• Primary Safety Endpoint

  Number of participants experiencing a Grade 3 or above solicited local, systemic or laboratory adverse event, or any grade of adverse event leading to a clinical decision to discontinue immunizations, or any grade of unsolicited adverse event with onset within 7 days of immunization

  From first dose until up to Week 22

• Primary Immunogenicity

  Magnitude of antigen-specific systemic IgG antibody binding responses (ng/mL) to CN54gp140

  Week 22

Secondary Outcomes (1)

• Adverse Event Local to the Injection Sites, Starting Within 7 Days of Injection

  7 days after injection

Study Arms (3)

Group 1: ID/EP + IM

EXPERIMENTAL

0.6 mg DNA-C CN54ENV, intradermally with electroporation, at Weeks 0, 4 and 8. 2 mg DNA-C CN54ENV, intramuscularly without electroporation, at Weeks 0, 4 and 8. 50 µg CN54gp140, intradermally without electroporation, at Week 20.

Biological: DNA-C CN54ENV; Biological: CN54gp140; Device: Trigrid Delivery System - Intradermal

Group 2: ID + IM/EP

EXPERIMENTAL

0.6 mg DNA-C CN54ENV, intradermally without electroporation, at Weeks 0, 4 and 8. 2 mg DNA-C CN54ENV, intramuscularly with electroporation, at Weeks 0, 4 and 8. 50 µg CN54gp140, intradermally without electroporation, at Week 20.

Biological: DNA-C CN54ENV; Biological: CN54gp140; Device: Trigrid Delivery System - Intramuscular

Group 3: ID/EP + IM/EP

EXPERIMENTAL

0.6 mg DNA-C CN54ENV, intradermally with electroporation, at Weeks 0, 4 and 8. 2 mg DNA-C CN54ENV, intramuscularly with electroporation, at Weeks 0, 4 and 8. 50 µg CN54gp140, intradermally without electroporation, at Week 20.

Biological: DNA-C CN54ENV; Biological: CN54gp140; Device: Trigrid Delivery System - Intramuscular; Device: Trigrid Delivery System - Intradermal

Interventions

DNA-C CN54ENV BIOLOGICAL

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

Group 1: ID/EP + IM; Group 2: ID + IM/EP; Group 3: ID/EP + IM/EP

CN54gp140 BIOLOGICAL

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

Group 1: ID/EP + IM; Group 2: ID + IM/EP; Group 3: ID/EP + IM/EP

Trigrid Delivery System - Intramuscular DEVICE

Electroporation

Also known as: TDS-IM

Group 2: ID + IM/EP; Group 3: ID/EP + IM/EP

Trigrid Delivery System - Intradermal DEVICE

Electroporation

Also known as: TDS-ID

Group 1: ID/EP + IM; Group 3: ID/EP + IM/EP

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Men and women aged between 18 and 50 years on the day of screening
• BMI between 18-30
• Available for follow-up for the duration of the study (\~5 months from screening)
• Willing and able to give written informed consent
• 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
• Willing to undergo a HIV test
• Willing to undergo a genital infection screen
• Must agree to require male sexual partner to use condoms, from at least 14 days before the first vaccination until at least 14 days after the last
• If heterosexually active female capable of becoming pregnant, must (in addition to requiring male partner to use condoms) agree to use hormonal contraception, or to complete abstinence, from at least 14 days before the first vaccination until at least 14 days after the last. \[Note: Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal, and IUD/IUS, are not acceptable methods of contraception.\] If sexually active male, must agree to use condoms from the day of first vaccination until at least 14 days after the last. \[Note: Additional use of an effective method of contraception is recommended for any non-pregnant female partner over the same period.\]
• Agree to abstain from donating blood for three months after the end of their participation in the trial, or longer if necessary

You may not qualify if:

• Pregnant or lactating
• 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)
• History of syncope or fainting episodes within 1 year of study entry
• History of grand-mal epilepsy, seizure disorder or any history of prior seizure
• Individuals in which a skin-fold measurement (cutaneous and subcutaneous tissue) of the upper right or left thigh exceeds 40 mm
• Clinically relevant abnormality on history or examination
• Known hypersensitivity to any component of the vaccine formulations used in this trial, or have severe or multiple allergies to drugs or pharmaceutical agents
• 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
• Receipt of live attenuated vaccine or HIV envelope components within 60 days or other vaccines within 14 days of enrolment
• Receipt of an experimental vaccine containing HIV envelope components at any time in the past
• Receipt of blood products or immunoglobulin within 4 months of screening
• Participation in another trial of a medicinal product, completed less than 30 days prior to enrolment.
• HIV 1 or 2 positive or indeterminate on screening.

Sponsors & Collaborators

• Imperial College London: lead
• Medical Research Council: collaborator

Study Sites (1)

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

London, W12 0HS, United Kingdom

Location

Results Point of Contact

• Title: Research Integrity Officer
• Organization: Imperial College London

rgit@imperial.ac.uk

020 7594 1872

Study Officials

• David Lewis, MD

  Imperial College London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2015
• First Posted: October 28, 2015
• Study Start: August 11, 2016
• Primary Completion: December 22, 2017
• Study Completion: December 22, 2017
• Last Updated: January 31, 2025
• Results First Posted: January 31, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)