Safety and Immunogenicity of HIV DNA-C CN54ENV and Recombinant HIV CN54gp140 Vaccines in Healthy Volunteers
NCT ID: NCT02589795
Last Updated: 2025-01-31
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
28 participants
INTERVENTIONAL
2016-08-11
2017-12-22
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Group 1: ID/EP + IM
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.
DNA-C CN54ENV
DNA plasmid containing the Clade C gp140 envelope gene from HIV-1 isolate CN54
CN54gp140
Recombinant protein expressed from the Clade C gp140 envelope gene from HIV-1 isolate CN54
Trigrid Delivery System - Intradermal
Electroporation
Group 2: ID + IM/EP
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.
DNA-C CN54ENV
DNA plasmid containing the Clade C gp140 envelope gene from HIV-1 isolate CN54
CN54gp140
Recombinant protein expressed from the Clade C gp140 envelope gene from HIV-1 isolate CN54
Trigrid Delivery System - Intramuscular
Electroporation
Group 3: ID/EP + IM/EP
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.
DNA-C CN54ENV
DNA plasmid containing the Clade C gp140 envelope gene from HIV-1 isolate CN54
CN54gp140
Recombinant protein expressed from the Clade C gp140 envelope gene from HIV-1 isolate CN54
Trigrid Delivery System - Intramuscular
Electroporation
Trigrid Delivery System - Intradermal
Electroporation
Interventions
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DNA-C CN54ENV
DNA plasmid containing the Clade C gp140 envelope gene from HIV-1 isolate CN54
CN54gp140
Recombinant protein expressed from the Clade C gp140 envelope gene from HIV-1 isolate CN54
Trigrid Delivery System - Intramuscular
Electroporation
Trigrid Delivery System - Intradermal
Electroporation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
6. Willing to undergo a HIV test
7. Willing to undergo a genital infection screen
8. 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
9. 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. \[Note: Additional use of an effective method of contraception is recommended for any non-pregnant female partner over the same period.\]
10. Agree to abstain from donating blood for three months after the end of their participation in the trial, or longer if necessary
11. Registered with a GP for at least the past three months
12. Entered and clearance obtained from The Over-volunteering Prevention System (TOPS) database.
Exclusion Criteria
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
9. Receipt of live attenuated vaccine or HIV envelope components within 60 days or other vaccines within 14 days of enrolment
10. Receipt of an experimental vaccine containing HIV envelope components at any time in the past
11. Receipt of blood products or immunoglobulin within 4 months of screening
12. Participation in another trial of a medicinal product, completed less than 30 days prior to enrolment.
13. HIV 1 or 2 positive or indeterminate on screening.
14. Positive for hepatitis B surface antigen, hepatitis C antibody or serology indicating active syphilis requiring treatment
15. Grade 1 or above routine laboratory parameters. Hyperbilirubinaemia to be considered an exclusion criterion only when confirmed to be conjugated bilirubinaemia
16. Current use of any electronic stimulation device, such as cardiac demand pacemakers, automatic implantable cardiac defibrillator, nerve stimulators, or deep brain stimulators.
17. Presence of any surgical or traumatic metal implants at the sites of administration
18. Unable to read and speak English to a fluency level adequate for the full comprehension of procedures required in participation and consent.
19. Women with a history of toxic shock syndrome.
20. Women using an intrauterine device for contraception (as incompatible with softcup sampling)
21. Unlikely to comply with protocol.
18 Years
50 Years
ALL
Yes
Sponsors
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Medical Research Council
OTHER_GOV
Imperial College London
OTHER
Responsible Party
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Principal Investigators
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David Lewis, MD
Role: PRINCIPAL_INVESTIGATOR
Imperial College London
Locations
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NIHR/Wellcome Trust Imperial Clinical Research Facility, Hammersmith Hospital, Imperial College Healthcare NHS Trust
London, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CUTHIVAC002
Identifier Type: -
Identifier Source: org_study_id
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