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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00637962 |
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Date of registration:
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11/03/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Reactogenicity and Immunogenicity of Vaginal CNgp140
SG06RS02 |
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Scientific title:
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Phase I Clinical Trial in Healthy Female Volunteers of Reactogenicity and Immunogenicity of Nine Vaginal Immunisations With HIV CN54gp140 Glycoprotein |
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Date of first enrolment:
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September 2007 |
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Target sample size:
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23 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00637962 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
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Phase:
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Phase 1
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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David JM Lewis, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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St George's, University of London, UK |
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Name:
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Charles Lacey, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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York Hospitals |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- They are adult female 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. Appropriate contraception shall
include physician-prescribed oral hormonal agents, barrier contraceptives, regular
and consistent use of condoms without spermicidal agents, or intrauterine devices
only. Progesterone-only contraceptives are not suitable due to the lack of a regular
menstrual cycle.
- They have agreed not to undertake any vaginal practices other than receptive
intercourse with a male or use of sanitary tampons during menses. Use of condoms
without spermicidal agents is encouraged.
- They have not donated blood during 3 months prior to study entry and agree to not
donate for 3 months after the end of their participation in the study.
Exclusion Criteria:
- They have hypersensitivity to any component of the vaccine used in this study.
- They are found to be HIV antibody or HIV proviral DNA positive at the time of initial
screening.
- They have a known or suspected history of cervico-vaginal disease, malignancy or
abnormality 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.
- Positive tests for Hepatitis B and/or C infection An abnormal value will be
defined by the ranges quoted by The Doctors Laboratory for the Vaccine Institute
site and Pathology Department, York Hospital for the York site.
- They have a known or suspected impairment of lung, heart, liver, kidney, diseases,
blood disorders or immune dysfunction.
- They are receiving immunosuppressive therapy (including systemic steroids).
- They are receiving any medications via vaginal route.
- They have any acute infections (including fever greater than or equal to 38°C) or any
chronic disease.
- 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.
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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HIV Infections
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Acquired Immune Deficiency Syndrome
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Intervention(s)
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Biological: HIV glycoprotein CN54gp140 (vaccine)
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Biological: Carbopol 974
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Primary Outcome(s)
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To determine the local and systemic safety of vaginal immunisation with CN54gp140 glycoprotein administered 9 times over a 3 week period.
[Time Frame: 13 weeks]
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Secondary Outcome(s)
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frequency of cellular responses to gp140 in cervical cells after a cycle of 9 vaginal immunisations
[Time Frame: 13 wks]
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frequency of subjects with a T-cell response to gp140 in blood after a cycle of 9 vaginal immunisations
[Time Frame: 13 wks]
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frequency of subjects mounting a cervico-vaginal IgA and IgG response to gp140 after a cycle of 9 vaginal immunisations
[Time Frame: 13 wks]
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frequency of subjects mounting a serum IgG and IgA response to gp140 after a cycle of 9 vaginal immunisations
[Time Frame: 13 wks]
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Secondary ID(s)
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07/Q0803/29
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2007-000781-20
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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