Status:
TERMINATED
Safety Study Of Nasal HIV Vaccine Adjuvanted With LTK63
Lead Sponsor:
St George's, University of London
Collaborating Sponsors:
Richmond Pharmacology Limited
Novartis Vaccines
Conditions:
HIV Infections
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine whether an HIV vaccine given as three nasal immunisations with a protein from HIV virus mixed with a toxoid adjuvant, followed by two intramuscular immunisati...
Detailed Description
The purpose of this study is to determine whether an HIV vaccine given as three nasal immunisations with a protein from HIV virus mixed with a toxoid adjuvant, followed by two intramuscular immunisati...
Eligibility Criteria
Inclusion
- They are adult volunteers, 18 to 45 years of age, who have signed an informed consent form following a detailed written explanation of participation in the protocol.
- They are volunteers who are in good health as determined by medical history, physical examination and clinical judgement.
- They are available for the duration of the study
- They are women who, if capable of becoming pregnant during the study, have agreed to have a pregnancy test immediately before immunisation, and to use appropriate contraception methods during the whole study period.
Exclusion
- They have hypersensitivity to any component of the vaccines used in this study.
- They are found to be HIV antibody positive at the time of initial screening
- They have a known or suspected history of nasal disease, malignancy or abnormality, or any nasal disease, malignancy or abnormality discovered at time of screening.
- They have a known or suspected history of severe seasonal allergies and allergic rhinitis (requiring medication), recurrent nose bleeds, asthma, or cardio-pulmonary disease, or any of these conditions discovered at time of screening.
- They present in the samples obtained at the screening visit:
- a clinically significant amount of protein or haemoglobin in the urine sample, determined by urine dipstick:
- a clinically significant abnormality in the haematological or biochemical assays
- An abnormal value will be defined by the ranges quoted in the St George's Pathology Services Handbook.
- They have a known impairment of immune function or are receiving immunosuppressive therapy (including systemic or inhaled steroids, but excluding topical).
- They are receiving any medications via nasal route.
- They have any acute infections (including fever greater than or equal to 38°C) or any chronic disease.
- They are women capable of becoming pregnant who do not agree to have pregnancy testing before application of study products, or who do not agree to take appropriate contraception measures during the whole study period. Appropriate contraception shall include physician-prescribed oral, injected or implanted hormonal agents; barrier contraceptives used in conjunction with spermicidal agents; or intrauterine devices only.
- They present a current problem with substance abuse or with a history of substance abuse which, in the opinion of the investigator, might interfere with participation in the study.
- They have any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
- They have received an investigational agent within 3 months prior to study entry.
- They cannot speak fluent English, or are planning to leave the area of the study site prior to the end of the study period, or are likely not to complete the study.
- They have a weight (W)/height (H) index (WHI) less than 18.5 or greater than 40
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00369031
Start Date
September 1 2006
End Date
March 1 2008
Last Update
April 15 2008
Active Locations (1)
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1
St George's Vaccine Institute
London, England, United Kingdom, SW17 0RE