A Phase I clinical trial to assess the safety and immunogenicity of HIV DNA-C CN54ENV immunisations administered via the Intramuscular and Intradermal methods with and without electroporation followed by boosting with recombinant HIV CN54gp140 in healthy male and female volunteers - CUTHIVAC002

Imperial College London0 sites28 target enrollmentJuly 20, 2015

Overview

No summary available.

Registry

who.int

Start Date

July 20, 2015

End Date

December 22, 2017

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

•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

•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