HIV prophylaxis MedDRA version: 18.0 Level: PT Classification code 10020161 Term: HIV infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: DNA-C CN54ENV
Pharmaceutical Form: Solution for injection
Other descriptive name: DNA-C CN54ENV
Concentration unit: mg/ml milligram(s)/mil
Sponsors
Imperial College London
Eligibility
Sex/Gender
All
Inclusion criteria
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 6. Willing to undergo a HIV test 7. Willing to undergo a genital infection screen 8. If heterosexually active female, using an effective method of contraception with partner: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral and transdermal); progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable); bilateral tubual occlusion, vasectomised partner (if sole partner); sexual abstinence (based on historical preferred and usual lifestyle), from 30 days prior to the first vaccination until 30 days after the last, and willing to undergo urine pregnancy tests prior to each vaccination 9. If heterosexually active male, using male contraception (condom) with their partner from the first day of vaccination until 4 months after the last vaccination. Furthermore additional use of an effective method of contraception (as listed above) should be 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 Overvolunteering Prevention System (TOPS) database. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 24 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion 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 =39.5oC within 48 hours; anaphylaxis; bronchospasm; laryngeal oedema; collapse; convulsions or encephalopathy within 72 hours 9. Receipt of live attenuated vaccine within 30 days or other vaccine 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 (see appendix 2 for definitions). 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: We aim to assess the safety of the HIV vaccines, and also to assess how well they stimulate responses by the body's immune system, when they are given by intradermal and intramuscular injection with or without electroporation.;Secondary Objective: We aim to assess the safety of the electroporation devices.; Primary end point(s): Primary Endpoints Safety • The primary safety endpoint is the presence of a grade 3 or above local or systemic solicited adverse event or any adverse event that results in a clinical decision to discontinue further immunisations. • The primary safety endpoint will compare the safety of the Electroporation device to standard Intramuscular and Intradermal injections Immunogenicity • The primary immunogenicity endpoint is the presence of a detectable antigen specific IgG antibody response (relative to a predefined cut off based on assay internal controls) and in those which are positive, the titre (?g/ml) according to a quantitative EIA assay collected 2 weeks after the final vaccination. ; Timepoint(s) of evaluation of this end point: Adverse events will be recorded from first dose until the final safety visit at Week 22. The primary immunogenicity endpoint will be evaluated at Week 22. Follow up to assess those responders will be evaluated at Weeks 24 and 44. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Endpoints Safety • Any grade of adverse event, local to the ID and IM injection sites that start within 7 days after Doses 1-3. Comparisons will be made against groups for example: ID+EP vs ID (Groups 1 and 3 vs Group 2) and IM+EP vs IM (Groups 2 and 3 vs Group 1). ;Timepoint(s) of evaluation of this end point: Adverse events will be recorded from first dose until the final safety visit at Week 22. | — |
Countries
United Kingdom
Outcome results
None listed