Status:
COMPLETED
Safety & Immunogenicity of Immunisations With EN41-UGR7C HIV Vaccine
Lead Sponsor:
PX'Therapeutics
Collaborating Sponsors:
European Commission
Conditions:
- HIV
Eligibility:
FEMALE
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of the clinical trial is to evaluate the safety and immunogenicity in female volunteers of EN41-UGR7C vaccine candidate adjuvanted with Alum using IM administration. The objective of the i...
Eligibility Criteria
Inclusion
- Women aged between 18 and 55 years on the day of screening
- Available for a maximal study duration of 8 months from screening
- Willing and able to give written informed consent
- At low risk of HIV infection 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 infected sexual partner) either currently or within the past six months
- no unprotected vaginal or anal intercourse in the last six months outside a relationship with a regular partner known to be HIV negative
- no unprotected sex with someone from a high HIV prevalence region where HIV is more common than in the UK (e.g. Sub-Saharan Africa, Caribbean, South-East Asia)
- Negative HIV1/2 antibody/antigen test result at screening
- If heterosexually active female, using an effective method of contraception using a double barrier method of contraception (combined oral contraceptive pill, injectable or implanted contraceptive and use of condoms incorporating spermicide; physiological or anatomical sterility) from 14 days prior to the first vaccine administration until 3 months after the last administration, and willing to undergo urine pregnancy tests prior to each vaccine administration and blood pregnancy test at screening and final follow-up visits. Heterosexual females who become sexually active during the trial should also follow the same guidance
- Agree to abstain from donating blood during their participation in the trial
- Registered with a General Practitioner and medical history available for 12 months before dosing
- Satisfactory response received from General Practitioner relating to medical history before randomization
Exclusion
- Pregnant or lactating or planning to get pregnant within the next year
- Clinically relevant abnormality on history or examination:
- central nervous system disorder or disease, including history of grand-mal epilepsy
- severe eczema
- clinically significant haematological, cardio-pulmonary, metabolic, gastrointestinal, renal, psychiatric or ophthalmological disorders
- acute infection or illness
- autoimmune disease, immunodeficiency or use of immunosuppressive agents in preceding 3 months prior to dosing
- Known hypersensitivity to any component of the vaccine formulation used in this trial, or have severe or multiple allergies
- History of severe local or general reaction to previous 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 within 60 days or other vaccine within 14 days of schedules study vaccine dosing
- Receipt of an experimental vaccine containing HIV envelope proteins 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 90 days prior to Visit 2 and planned participation in another clinical trial during the present trial
- HIV 1/2 antibody/antigen positive or indeterminate on screening
- Positive for hepatitis B surface antigen, hepatitis C antibody or serology indicating active syphilis requiring treatment
- Clinically significant abnormal result in routine laboratory parameters.
- Unable to read and speak English to a fluency level adequate for the full comprehension of study and procedures required in participation and consent
- Unlikely to comply with protocol
- History of drug or alcohol abuse or regular use of drugs, or who test positive for alcohol test at screening
- On regular medication which in the opinion of the investigator makes volunteer unsuitable for participation in the study
- Any local vaginal, cervical or gynaecological condition which may interfere with collection or interpretation of data collected through vaginal samples
- Using any Intra Uterine Contraceptive Device as there is a risk of dislodging, displacing or removing the device when pulling or removing Softcup used for vaginal sampling
- Clinically significant abnormality on ECG performed at the screening visit
- Any condition that, in the investigator's opinion, compromises the volunteer's ability to meet protocol requirements or to complete the study
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01827397
Start Date
April 1 2013
End Date
February 1 2014
Last Update
May 21 2014
Active Locations (1)
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1
Royal Free Hospital; Royal Free London NHS Foundation Trust Pond Street
London, United Kingdom, NW3 2QG