Status:
COMPLETED
EuroNeut41: Safety & Immunogenicity of Immunisations With HIV Vaccine
Lead Sponsor:
PX'Therapeutics
Collaborating Sponsors:
European Commission
Conditions:
HIV
Eligibility:
FEMALE
18-55 years
Phase:
PHASE1
Brief Summary
Objectives: * To assess the safety of three priming immunisations by nasal route followed by two booster immunisations by intramuscular route * To assess immunogenicity responses induced by the vacci...
Eligibility Criteria
Inclusion
- Women aged between 18 and 55 years on the day of screening
- Available for a maximal study duration of 12/13 months from the inclusion
- 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 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 HIV negative partner
- not had unprotected sex with someone from a region where HIV is more common (e.g Sub-Saharan African, Caribbean, South East Asia) outside a relationship with a regular known HIV negative partner
- Negative HIV 1/2 antibody/antigen test at screening
- If heterosexually active female, using an effective method of contraception with partner (combined oral contraceptive pill; injectable or implanted contraceptive; use of condoms incorporating spermicide if using these; physiological or anatomical sterility) from 14 days prior to the first vaccination until 6 months after the last, and willing to undergo urine pregnancy tests prior to each vaccination and blood pregnancy test at screening and final follow up.
- Agree, to abstain from medications or other agents that are applied via the nasal route from 24 hours prior to each nasal vaccine dosing through to the safety assessment 1week later
- Agree to abstain from donating blood during their participation in the trial
- Registered with GP 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
- Positive alcohol test
- Positive drugs of abuse test
- Clinically relevant abnormality on history or examination:
- central nervous system disorder or disease, including
- history of grand-mal epilepsy
- cranial nerve palsies
- severe eczema
- severe epistaxis requiring surgical intervention or blood transfusion
- clinically significant liver disease
- clinically significant haematological, metabolic, gastrointestinal, renal, psychiatric or cardio-pulmonary disorders
- ongoing infection;
- autoimmune disease, immunodeficiency or use of immunosuppressive agents in preceding 3 months prior to dosing
- using inhaled cortico-steroids and intranasal medications
- Known or suspected history of clinically relevant nasal surgery, injury, nasal polyps or cleft palate, or a condition likely to require regular intranasal medication, which in the opinion of the investigator might interfere with intranasal vaccine administration
- Known hypersensitivity to any component of the vaccine formulations used in this trial or have severe or multiple allergies
- 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
- Receipt of live attenuated vaccine within 60 days or other vaccine within 14 days of scheduled study vaccine dosing
- Receipt of an experimental vaccine containing HIV envelope proteins at any time in the past
- Receipt of blood products or immunoglobin 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 routine laboratory parameters.
- Unable to read and speak English to a fluency level adequate for the full comprehension of procedures required in participation and consent.
- Unlikely to comply with protocol
- History of drug or alcohol abuse or regular using of drugs, or who test positive in drugs of abuse and alcohol test at screening or admission
- Has a condition, or is on regular medication (other than paracetamol, multivitamin, E45, or over the counter remedies) which in the opinion of the investigator is not suitable 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 :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT01509144
Start Date
January 1 2012
End Date
October 1 2013
Last Update
May 21 2014
Active Locations (1)
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1
Surrey Clinical Research Centre University of Surrey
Guildford, Surrey, United Kingdom, GU2 7XP