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Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834     Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za     Website: www.pactr.org

Trial no.: PACTR2009040001075080 Date registered: 2008/11/26
TRIAL DESCRIPTION
Public title HIVIS03
Official scientific title 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
Brief summary describing the background
and objectives of the trial
Following work in TANSWED Programme funded by Sida/SAREC, in 2001 a EU funded HIVIS project was initiated to develop and evaluate a candidate multi-gene, DNA (A, B, C) prime with MVA {CRF01 A_E}) boost vaccine. A Phase I trial showed excellent safety & immunogenicity in Sweden. Objectives HIVIS03 are to assess safety & immunogenicity; and build capacity in evaluating HIV vaccines in Tanzania.
Type of trial CCT
Acronym (If the trial has an acronym then please provide) HIVIS03
Disease(s) or condition(s) being studied HIV/AIDS ,
Purpose of the trial Prevention
Anticipated trial start date
Actual trial start date
Anticipated date of last follow up
Actual date of last follow up
Anticipated target sample size (number of participants)   
Actual target sample size (number of participants) 60   
Recruitment status Closed to recruitment: follow up continuing
Secondary Ids Issuing authority/Trial register Links to Secondary ID
ISRCTN90063831 International Standard Randomised Controlled Trial Register (ISRCTN)

STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person
allocating the participants to the intervention arms
Masking If masking / blinding was used
Factorial: participants randomly allocated to either no,one,some or all interventions simultaneously Randomised Simple randomisation using envelopes Sealed opaque envelopes Masking/blinding used

INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental group Priming with intramuscular DNA, Boosting with intramuscular MVA DNA at 3.8mg IM by Bioject® device, MVA at 10^8 pfu IM by needle & syringe DNA at months 0,1 & 3. MVA at months 9 & 21 DNA has 7 plasmids containing HIV-1 env subtype A, B and C, gag subtype A and B, RTmut and rev subtype B. MVA contains analogous HIV-1 genes from subtype A/E. 20
Control group Saline Saline IM by Bioject® device, Saline IM by needle & syringe Saline at months 0,1 & 3. and then Saline at months 9 & 21 Normal saline as DNA and MVA placebo respectively 10 Placebo
Experimental group Priming with intradermal DNA, Boosting with intradermal MVA DNA at 1.0mg ID by Bioject® device, MVA at 10^8 pfu IM by needle & syringe DNA at months 0,1 & 3. MVA at months 9 & 21 DNA has 7 plasmids containing HIV-1 env subtype A, B and C, gag subtype A and B, RTmut and rev subtype B. MVA contains analogous HIV-1 genes from subtype A/E. 20
Control group Saline Saline ID by Bioject® device, Saline IM by needle & syringe Saline at months 0,1 & 3. and then Saline at months 9 & 21 Normal saline as DNA and MVA placebo respectively 10 Placebo

ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Min age Max age Gender
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, >1 sexual partner in last 6 months, alcoholic (>35 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 >10.5g/dl, WBC count >1,300/mm3, Granulocytes >6.4/ mm3, Lymphocytes >1.0/ mm3, Platelets >120,000/ mm3, CD4 >400cells/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) 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 18 nulls 40 nulls Both

ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval
Name of the ethics committee
Yes 2006/01/30 National Ethics Committee at the National Institute for Medical Research (NIMR). The study was approved on 30/01/2006 (ref: NIMR/HQ/R.8a Vol.IX/410). As of 19/08/2008, the last amendments were approved on 19/06/2008 (ref: MU/DRP/PA/ Vol.I/37)
Ethics Committee Address
Street address City Postal code Country
Ocean Road Dar es Salaam P.O. Box 9653 United Republic of Tanzania
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval
Name of the ethics committee
Yes 2006/01/30 National Ethics Committee at the National Institute for Medical Research (NIMR). The study was approved on 30/01/2006 (ref: NIMR/HQ/R.8a Vol.IX/410). As of 19/08/2008, the last amendments were approved on 19/06/2008 (ref: MU/DRP/PA/ Vol.I/37)
Ethics Committee Address
Street address City Postal code Country
Ocean Road Dar es Salaam P.O. Box 9653 United Republic of Tanzania

OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Immunogenicity, cellular & Humoral 2 weeks post vaccination
Primary Outcome Safety of Immunization within 7 days of vaccination

RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Muhimbili Upanga Dar es Salaam P.O. Box 65001 United Republic of Tanzania

FUNDING SOURCES
Name of source Street address City Postal code Country
EDCTP Laan Van Nieuw Oost Indie 300 Den Haag 2593 CE Netherlands
Sida/SAREC, Lusaka Office Lusaka Zambia
Swedish Embassy through Treasury & Ministry of Health, Tanzania Dar es Salaam United Republic of Tanzania
European Union Brussels Belgium
EDCTP Laan Van Nieuw Oost Indie 300 Den Haag 2593 CE Netherlands
Sida/SAREC, Lusaka Office Lusaka Zambia
Swedish Embassy through Treasury & Ministry of Health, Tanzania Dar es Salaam United Republic of Tanzania
European Union Brussels Belgium

SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Muhimbili University of Health and Allied Sciences (MUHAS) United Nations Road, Upanga Dar es Salaam P.O. Box 65001 United Republic of Tanzania University
Primary Sponsor Swedish Institute for Infectious Disease Control (SMI) Nobels Vag 18171 82 Solna 18171 82 Sweden University
Secondary Sponsor Muhimbili University of Health and Allied Sciences (MUHAS) United Nations Road, Upanga Dar es Salaam P.O. Box 65001 United Republic of Tanzania University
Primary Sponsor Swedish Institute for Infectious Disease Control (SMI) Nobels Vag 18171 82 Solna 18171 82 Sweden University

COLLABORATORS
Name Street address City Postal code Country
Karolinska Institutet at Sodersjukhuset Sjukhusbacke 10 Stockholm S 118 83 Sweden
Tanzania Police Force, Minstry of Home Affairs Luthuli Road Dar es Salaam P.O. Box 9141 United Republic of Tanzania
Muhimbili University of Health and Allied Sciences (MUHAS) United Nations Road, Upanga Dar es Salaam P.O. Box 65001 United Republic of Tanzania
Muhimbili National Hospital (MNH) United Nations Road, Upanga Dar es Salaam P.O. Box 65000 United Republic of Tanzania
Swedish Institute for Infectious Disease Control (SMI) Nobels Vag Solna 18171 82 Sweden
Karolinska Institutet at Sodersjukhuset Sjukhusbacke 10 Stockholm S 118 83 Sweden
Tanzania Police Force, Minstry of Home Affairs Luthuli Road Dar es Salaam P.O. Box 9141 United Republic of Tanzania
Muhimbili University of Health and Allied Sciences (MUHAS) United Nations Road, Upanga Dar es Salaam P.O. Box 65001 United Republic of Tanzania
Muhimbili National Hospital (MNH) United Nations Road, Upanga Dar es Salaam P.O. Box 65000 United Republic of Tanzania
Swedish Institute for Infectious Disease Control (SMI) Nobels Vag Solna 18171 82 Sweden

CONTACT PEOPLE
Role Name Email Phone Fax
Scientific Enquiries Prof Eric Sandstrom eric.sandstrom@ sodersjukhuset.se +46 8 616 2571 +46 8 616 2509
Street address City Postal code Country Position / Affiliation
Sjukhusbacke 10 Stockholm S 118 83 Sweden Professor at the Institute of Clinical Research and Education, KI, at Sodersjukhuset
Role Name Email Phone Fax
Public Enquiries Dr Muhammad Bakari mbakari@muhas.ac.tz +255 754 387328 +255 222153027
Street address City Postal code Country Position / Affiliation
MUHAS, United Nations Road Dar es Salaam P.O. Box 65001 United Republic of Tanzania Senior Lecturer, Department of Internal Medicine, School of Medicine, MUHAS
Role Name Email Phone Fax
Principal Investigator Prof Fred Mhalu fmhalu@muhas.ac.tz +255 713 227944 +255 222153027
Street address City Postal code Country Position / Affiliation
MUHAS, United Nations Road Dar es Salaam P.O. Box 65001 United Republic of Tanzania Professor, Department of Microbiology/Immunology, School of Medicine, MUHAS