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Sponsors and Collaborators: |
St George's, University of London Bill and Melinda Gates Foundation York Hospitals |
---|---|
Information provided by: | St George's, University of London |
ClinicalTrials.gov Identifier: | NCT00637962 |
To determine the local (cervico-vaginal) and systemic (whole body) safety of vaginal immunisation with ZM96gp140 glycoprotein administered 9 times over a 3 week period.
Condition | Intervention | Phase |
---|---|---|
HIV Infections Human Immunodeficiency Virus Acquired Immune Deficiency Syndrome |
Biological: HIV glycoprotein 140 ZM96 (vaccine) Biological: Carbopol 974 |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety Study |
Official Title: | Phase I Clinical Trial in Healthy Female Volunteers of Reactogenicity and Immunogenicity of Nine Vaginal Immunisations With HIV ZM96gp140 Glycoprotein |
Enrollment: | 23 |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | January 2009 |
Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
gp140ZM96 + gel
|
Biological: HIV glycoprotein 140 ZM96 (vaccine)
vaginal immunisation with 100ug gp140ZM96 antigen in gel on 9 occasions in one menstrual cycle
|
2: 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
|
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
They present in the samples obtained at the screening visit:
United Kingdom, England | |
St George's Vaccine Institute | |
London, England, United Kingdom, SW17 0RE | |
York Hospital | |
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 |
Responsible Party: | St George's University of London ( Dr David JM Lewis, Chief Investigator ) |
Study ID Numbers: | 2007-000781-20, 07/Q0803/29, SG06RS02 |
Study First Received: | March 11, 2008 |
Last Updated: | December 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00637962 |
Health Authority: | United Kingdom: Research Ethics Committee; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
HIV AIDS Vaccine |
intravaginal mucosal HIV Seronegativity |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Interferons Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome |
Healthy PS-K Retroviridae Infections Immunologic Deficiency Syndromes Ethanol |
Interferon Inducers Anti-Infective Agents Radiation-Protective Agents RNA Virus Infections Slow Virus Diseases Disease Immune System Diseases Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs |
Adjuvants, Immunologic Infection Antibiotics, Antineoplastic Protective Agents Antiviral Agents Pharmacologic Actions Pathologic Processes Therapeutic Uses Syndrome Lentivirus Infections |