Reactogenicity and Immunogenicity of Vaginal CNgp140 (SG06RS02)
|HIV Infections Acquired Immune Deficiency Syndrome||Biological: HIV glycoprotein CN54gp140 (vaccine) Biological: Carbopol 974||Phase 1|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
|Official Title:||Phase I Clinical Trial in Healthy Female Volunteers of Reactogenicity and Immunogenicity of Nine Vaginal Immunisations With HIV CN54gp140 Glycoprotein|
- 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 ]
- frequency of subjects mounting a cervico-vaginal IgA and IgG response to gp140 after a cycle of 9 vaginal immunisations [ Time Frame: 13 wks ]
- frequency of subjects mounting a serum IgG and IgA response to gp140 after a cycle of 9 vaginal immunisations [ Time Frame: 13 wks ]
- frequency of subjects with a T-cell response to gp140 in blood after a cycle of 9 vaginal immunisations [ Time Frame: 13 wks ]
- frequency of cellular responses to gp140 in cervical cells after a cycle of 9 vaginal immunisations [ Time Frame: 13 wks ]
|Study Start Date:||September 2007|
|Study Completion Date:||January 2009|
|Primary Completion Date:||October 2008 (Final data collection date for primary outcome measure)|
Experimental: Active product
CN54gp140 + gel
Biological: HIV glycoprotein CN54gp140 (vaccine)
vaginal immunisation with 100ug CN54gp140 antigen in gel on 9 occasions in one menstrual cycle
Other Name: Previously designated ZM96gp140
Placebo Comparator: Gel alone
Biological: Carbopol 974
vaginal immunisation with Carbopol 974 P 0.924%; benzyl alcohol 1.09%; sodium hydroxide 0.176%; and purified water 97.81%. alone on 9 occasions in one menstrual cycle
Other Name: Carbapol gel
Hide Detailed Description
This randomised, placebo-controlled, double-blind study will primarily assess the local and systemic safety and tolerability of CN54gp140 vaccine. We will also assess whether CN54gp140 vaccine is effective at inducing systemic and/or local specific immune responses.
Thirty healthy women volunteers will be enrolled in this study, at 2 clinical sites. Twenty will receive active CN54gp140 vaccine, and 10 will receive placebo. The placebo group will help us identify side effects caused by CN54gp140. The study is double-blind to eliminate any possibility of researcher or subject bias.
Before administration, CN54gp140 or placebo will be mixed into an aqueous gel vehicle. The treatments will be administered intravaginally in a regimen of 9 immunisations over 3 weeks. Each immunisation of CN54gp140 vaccine will contain 100 µg of CN54gp140 protein, meaning that a total dose of 900 µg will be given to subjects in the active treatment group.
Subjects will be required to make a total of 15 outpatient visits to their local clinical site, over 4 successive menstrual cycles.
Menstrual cycle 1: Screening visits There will be 2 screening visits, at about 4 and 2 weeks before the first immunisation. During these visits the volunteers will be asked questions about their health history and to give permission for us to contact their General Practitioner. Blood and urine samples will be taken for routine laboratory safety tests, and tests for HIV and hepatitis, sexual health, and pregnancy. Blood will also be collected for immunology tests to establish the pre-immunisation state of the immune system. The volunteers will also have a cervico-vaginal examination, and sampling of cervico-vaginal secretions and cells will be done for immunology tests. A photograph of the cervix will be taken to help identify any changes that might occur during the trial. Also, a full medical history and examination will be done.
The volunteers will be given a diary card to take home. They'll be asked to record in the diary any symptoms they have, and medication they take, during the course of the trial. The diaries be regularly checked by the trial staff, who will also make a symptom enquiry at each visit.
Menstrual cycle 2: Immunisation visits There will be 9 immunisation visits, on successive Mondays, Wednesdays and Fridays. The 1st of these visits will be about 7 days after the start of menses. At the 1st, 4th and 9th immunisation visits, blood and urine will be collected for routine laboratory safety and pregnancy tests, and blood collected for immunology tests. Subjects will also have a cervico-vaginal examination, and their temperature, blood pressure and heart rate measured, before self-administering the vaccine.
At the rest of the immunisation visits, subjects will self-administer the vaccine. No other procedures will be done.
Menstrual cycle 3: Sampling visits There will be 3 sampling visits, at about 9, 14 and 21 days after the start of menses. At each visit, subjects will have a cervico-vaginal examination, during which sampling of secretions and cells will be done for immunology tests. Also, blood will be collected for immunology tests, and subjects will have their temperature, blood pressure and heart rate measured. At the 1st and 3rd sampling visits only, blood and urine will be collected for routine laboratory safety tests also.
Menstrual cycle 4: End-of-study visit This visit will be about 10 days after the start of menses. Blood and urine will be collected for routine laboratory safety and pregnancy tests, tests for HIV, and immunology tests. The volunteers will also have a cervico-vaginal examination, during which sampling of secretions and cells will be done for immunology tests, and a full medical examination. A photograph of the cervix will be taken. This visit concludes the subject's participation in the study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00637962
|St George's Vaccine Institute|
|London, England, United Kingdom, SW17 0RE|
|York, England, United Kingdom, YO31 7WA|
|Principal Investigator:||David JM Lewis, MD||St George's, University of London, UK|
|Principal Investigator:||Charles Lacey, MD||York Hospitals|
|Study Director:||David JM Lewis, MD||St George's, University of London, UK|