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Main
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Note: This record shows only the 20 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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PACTR |
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Last refreshed on:
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29 April 2013 |
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Main ID: |
PACTR2009040001075080 |
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Date of registration:
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26/11/2008 |
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Primary sponsor: |
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Public title:
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HIVIS03
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Scientific title:
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A phase I/II trial to assess safety & immunogenicity of a plasmid DNA-MVA prime boost HIV-1 vaccine candidate among volunteers in DaresSalaam, Tanzani |
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Date of first enrolment:
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Target sample size:
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Recruitment status: |
Closed to recruitment: follow up continuing |
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URL:
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HTTP://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?da=true&tno=PACTR2009040001075080 |
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Study type:
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interventional |
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Study design:
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Factorial: participants randomly allocated to either no,one,some or all interventions simultaneously,
Randomised,
Simple randomisation using envelopes,
Sealed opaque envelopes,
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Countries of recruitment
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South Africa
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Contacts
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Name:
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Muhammad
Bakari |
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Address:
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MUHAS, United Nations Road
P.O. Box 65001
Dar es Salaam
United Republic of Tanzania |
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Telephone:
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+255 754 387328 |
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Email:
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mbakari@muhas.ac.tz |
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Affiliation:
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Senior Lecturer, Department of Internal Medicine, School of Medicine, MUHAS |
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Name:
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Eric
Sandstrom |
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Address:
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Sjukhusbacke 10
S 118 83
Stockholm
Sweden |
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Telephone:
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+46 8 616 2571 |
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Email:
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eric.sandstrom@sodersjukhuset.se |
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Affiliation:
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Professor at the Institute of Clinical Research and Education, KI, at Sodersjukhuset |
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Key inclusion & exclusion criteria
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Inclusion criteria: 18-40 years
Willing to be counseled & HIV tested
Negative HIV Ag/Ab ELISA
Informed consent
Minimum 7 years of 1? Education.
Resident in Dar es Salaam
At low risk of HIV, (absence of: sexual partner with HIV, partner with unknown HIV serostatus and unwilling to use protection in sexual relations, partner known to be at high risk for HIV, b1 sexual partner in last 6 months, alcoholic (b35 units/week), STI in past 6 months).
Assurances for birth control measures till 4 months after last vaccination
Negative UPT
Willingness for safe sex practice
Good health by clinical & lab parameters: (FBG `7.8 mmol/l, Hb b10.5g/dl, WBC count b1,300/mm3, Granulocytes b6.4/ mm3, Lymphocytes b1.0/ mm3, Platelets b120,000/ mm3, CD4 b400cells/mm3, RBG 2.5-7.0 mmol/L; if elevated, then a FBG `7.8 mmol/l, Bilirubin `1.25 x uln, ALT `1.25 x uln, Creatinine `1.25 x uln, -ve/trace urine dipstick for protein and blood)
Exclusion criteria: Active TB/other systemic infection
Positive HBsAg
Active syphilis
Immunodeficiency/chronic illness
Autoimmune disease
Severe eczema
Psychiatric/substance abuse problem in past 6 months
Grand-mal epilepsy, or current use of anti-epileptics
Blood/Blood products/immunoglobulins use in past 3 months
Immunosuppressive therapy.
Experimental therapeutic agents within 30 days of study entry
Any live, attenuated vaccination within 60 days of study entry
Receipt of an HIV candidate vaccine.
Severe local or general reaction to vaccination
Lactating mothers
Study site employees
Protocol non-compliance
Age minimum:
18 null
Age maximum:
40 null
Gender:
Both
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Health Condition(s) or Problem(s) studied
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HIV/AIDS
null
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Primary Outcome(s)
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Immunogenicity, cellular & Humoral
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Safety of Immunization
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Source(s) of Monetary Support
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European Union
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Swedish Embassy through Treasury & Ministry of Health, Tanzania
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EDCTP
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Sida/SAREC, Lusaka Office
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