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

Phase 1

• Conditions: HIV prophylaxis; MedDRA version: 18.0 Level: PT Classification code 10020161 Term: HIV infection System Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2015-001023-23-GB
• Lead Sponsor: Imperial College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-07-20
• Study Completion: 2017-12-22
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 28

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified