HIVPhase 1NCT02589795
Safety and Immunogenicity of HIV DNA-C CN54ENV and Recombinant HIV CN54gp140 Vaccines in Healthy Volunteers
A Phase 1 study testing DNA-C CN54ENV, CN54gp140 and Trigrid Delivery System - Intramuscular in people with HIV, run by Imperial College London at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- DNA-C CN54ENV, CN54gp140 and Trigrid Delivery System - Intramuscular
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Aug 2016to 22 Dec 2017
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 17Show fewer
- 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
- Registered with a GP for at least the past three months
- Entered and clearance obtained from The Over-volunteering Prevention System (TOPS) database.
Who cannot join
- 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
Show all 23Show fewer
- 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.
- Positive for hepatitis B surface antigen, hepatitis C antibody or serology indicating active syphilis requiring treatment
- Grade 1 or above routine laboratory parameters. Hyperbilirubinaemia to be considered an exclusion criterion only when confirmed to be conjugated bilirubinaemia
- Current use of any electronic stimulation device, such as cardiac demand pacemakers, automatic implantable cardiac defibrillator, nerve stimulators, or deep brain stimulators.
- Presence of any surgical or traumatic metal implants at the sites of administration
- Unable to read and speak English to a fluency level adequate for the full comprehension of procedures required in participation and consent.
- Women with a history of toxic shock syndrome.
- Women using an intrauterine device for contraception (as incompatible with softcup sampling)
- Unlikely to comply with protocol.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
NIHR/Wellcome Trust Imperial Clinical Research Facility, Hammersmith Hospital, Imperial College Healthcare NHS Trust
London, W12 0HS
About this study
Official title: 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
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.
Read the 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
- Being tested
- DNA-C CN54ENV, CN54gp140, Trigrid Delivery System - Intramuscular, Trigrid Delivery System - Intradermal
- Keywords
- safety, immunogenicity, HIV vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNA-C CN54ENVBiological
DNA plasmid containing the Clade C gp140 envelope gene from HIV-1 isolate CN54
CN54gp140Biological
Recombinant protein expressed from the Clade C gp140 envelope gene from HIV-1 isolate CN54
Trigrid Delivery System - IntramuscularDevice
Also called TDS-IM
Electroporation
Trigrid Delivery System - IntradermalDevice
Also called TDS-ID
Electroporation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Biological: DNA-C CN54ENV; Biological: CN54gp140; Device: Trigrid Delivery System - Intramuscular; Device: Trigrid Delivery System - Intradermal |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From first dose until up to Week 22
Primary Immunogenicity
Magnitude of antigen-specific systemic IgG antibody binding responses (ng/mL) to CN54gp140
Measured: Week 22
Secondary outcomes (1)
Adverse Event Local to the Injection Sites, Starting Within 7 Days of Injection
Number of participants experiencing an adverse event local to the injection sites, starting within 7 days of injection
Measured: 7 days after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2015 (estimated)
- Study start11 Aug 2016
- Primary completion22 Dec 2017
- Study completion22 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council
- Responsible party
- Sponsor
- Investigators
- David Lewis, MD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02589795
- Sponsor's protocol ID
- CUTHIVAC002
- Status last verified
- Jan 2025
- First submitted
- 21 Oct 2015
- Last updated
- 31 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02589795
- Acronym / sponsor ID
- CUTHIVAC002
- Conditions
- HIV
- Keywords
- safety, immunogenicity, HIV vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Medical Research Council
- Study start
- 11 Aug 2016 (actual)
- Primary completion
- 22 Dec 2017 (actual)
- Study completion
- 22 Dec 2017 (actual)
- First posted
- 28 Oct 2015 (estimated)
- Results
- Posted 31 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: ID/EP + IM | Experimental | Biological: DNA-C CN54ENV, Biological: CN54gp140, Device: Trigrid Delivery System - Intradermal0.6 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. |
| Group 2: ID + IM/EP | Experimental | Biological: DNA-C CN54ENV, Biological: CN54gp140, Device: Trigrid Delivery System - Intramuscular0.6 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. |
| Group 3: ID/EP + IM/EP | Experimental | Biological: DNA-C CN54ENV, Biological: CN54gp140, Device: Trigrid Delivery System - Intramuscular, Device: Trigrid Delivery System - Intradermal0.6 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- 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:
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DNA-C CN54ENVDNA plasmid containing the Clade C gp140 envelope gene from HIV-1 isolate CN54 | Biological | Group 1: ID/EP + IM, Group 2: ID + IM/EP, Group 3: ID/EP + IM/EP |
| CN54gp140Recombinant protein expressed from the Clade C gp140 envelope gene from HIV-1 isolate CN54 | Biological | Group 1: ID/EP + IM, Group 2: ID + IM/EP, Group 3: ID/EP + IM/EP |
| Trigrid Delivery System - IntramuscularAlso: TDS-IMElectroporation | Device | Group 2: ID + IM/EP, Group 3: ID/EP + IM/EP |
| Trigrid Delivery System - IntradermalAlso: TDS-IDElectroporation | Device | Group 1: ID/EP + IM, Group 3: ID/EP + IM/EP |
Primary outcome
Primary Safety Endpoint
Time frame: From first dose until up to Week 22
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
Primary Immunogenicity
Time frame: Week 22
Magnitude of antigen-specific systemic IgG antibody binding responses (ng/mL) to CN54gp140
1 secondary outcome
Adverse Event Local to the Injection Sites, Starting Within 7 Days of Injection
Time frame: 7 days after injection
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for HIV
RecruitingPhase 4
A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments
HIV-1-infection
Not yet recruitingPhase 4
NOTRE: Optimizing Long-Acting Pre-Exposure Prophylaxis and Medications for Opioid Use Disorder Interventions in Carceral Settings
HIV Infections, Opioid Use Disorder
Enrolling by invitation
Effect of Omega-3 Supplementation on Pregnant Outcomes and Inflammation Markers of Women Infected With HIV Using Antiretroviral Therapy
Pregnant HIV Positive Women
Not yet recruiting
Smoking Cessation Program for Lao People With HIV
Smoking Cessation, HIV
Enrolling by invitation
Promoting Aging and Thriving With HIV
HIV (Human Immunodeficiency Virus), Geriatric
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Lewis, MD principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DNA-C CN54ENV, CN54gp140 and Trigrid Delivery System - Intramuscular in people with HIV, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety Endpoint (time frame: From first dose until up to Week 22). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2025; AzTrials last refreshed its copy on 8 Nov 2026.