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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.: PACTR201106000304583 Date registered: 2011/06/17
TRIAL DESCRIPTION
Public title A Phase I trial to assess safety and immunogenicity of i.d. DNA priming and i.m. MVA boosting in healthy volunteers in Mozambique
Official scientific title A Phase I trial to assess safety and immunogenicity of i.d. DNA priming and i.m. MVA boosting in healthy volunteers in Mozambique and to develop further HIV vaccine trial capacity building in Mozambique
Brief summary describing the background
and objectives of the trial
While antiretroviral drugs have shown great promise in reducing HIV replication and thus in reducing HIV/AIDS associated morbi-mortality and HIV transmission, the cost is substantial and side effects are a potentially limiting factor. Development of an effective safe-affordable vaccine is likely to be the best way to stop further virus spread. The study aims to determine safety and immunogenicity of the DNA-vaccine at a dose of 600µg and 1200µg delivered id in combination with MVA-CMDR boost im.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) TaMoVac I
Disease(s) or condition(s) being studied HIV/AIDS ,
Purpose of the trial Prevention
Anticipated trial start date 2011-07-18
Actual trial start date 2011-08-14
Anticipated date of last follow up 2012-12-18
Actual date of last follow up
Anticipated target sample size (number of participants) 24   
Actual target sample size (number of participants) 0   
Recruitment status Open to recruitment: actively recruiting participants
Secondary Ids Issuing authority/Trial register Links to Secondary ID

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
Parallel: different groups receive different interventions at same time during study Randomised Block randomization in blocks of 12 with a ratio of 10 vaccine recipients to two placebos Sealed opaque envelopes Masking/blinding used

INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental group IA 600 micrograms of DNA i.d. at weeks 0, 4 and 12; then MVA at 10^8 i.m. at weeks 24 and 36 48 weeks Low dose, combined plasmids pools DNA 10
Experimental group IIA 1,200 micrgrams of DNA i.d. at weeks 0, 4 and 12; then MVA at 10^8 i.m. at weeks 24 and 36 48 weeks High dose, combined plasmids pools DNA 10
Control group IB Saline 2 x 0.1ml i.d. at 0, 4 and 12 weeks, then saline i.m. at 24 and 36 weeks 48 weeks Saline Placebo 2 Placebo
Control group IIB Saline 2 x 0.2ml i.d. at 0, 4 and 12 weeks, then saline i.m. at 24 and 36 weeks 48 weeks Saline placebo 2 Placebo

ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Min age Max age Gender
1. Age: 18 to 26 years 2. Willing to undergo HIV counseling and testing 3. Have a negative antigen/antibody or antibody ELISA for HIV infection 4. Able to give informed consent 5. Satisfactory completion of an assessment of understanding prior to enrolment defined as 89% correct answers after three opportunities to take the test 6. Basic abilities to read and write 7. Resident in Maputo, and willing to remain so for the duration of the study 8. At low risk of HIV infection, defined as the absence of an identifiable risk factor/ behavior (their presence is therefore an exclusion criteria): sexual partner with HIV sexual partner with unknown HIV serostatus who is also unwilling to use protective condoms consistently in all sexual relations sexual partner is known to be at high risk for HIV more than one sexual partner in the last 6 months history of being an alcoholic [as medically defined or more than 35 units /week] history of STI within past 6 months 9. Verbal assurances that adequate birth control methods are used not to conceive/father a child during the study and up to 3 months after the last vaccine injection. 10. Women shall have a negative urine pregnancy test 11. Be willing to practice safe sex for the duration of the study to avoid sexually transmitted infections including HIV 12. Good health as determined by medical history, physical examination, clinical judgment and by key laboratory parameters as judged by the study physician. 13. Laboratory criteria: Hb >10.5g/dl White blood cell count <13,000/mm3 Neutrophils >1,300/mm3 Lymphocytes >1.000/ mm3 Platelets >120,000/ mm3 Random Blood Glucose < 6.44 mmol/L; if elevated, then a Fasting Blood Glucose < 6.11mmol/L (according to DAIDS Table for Lab Criteria) Bilirubin <1.25 x uln ALT <1.25 x uln Creatinine <1.25 x uln Urine dipstick for protein and blood: negative or trace. (If either is ¿ 1+, complete urinalysis (UA) will be performed. 1. At risk of HIV infection as mentioned above in the inclusion criteria 2. Active tuberculosis or other systemic infectious process elicited by review of systems, physical examination and laboratory detection 3. A history of immunodeficiency, chronic illness requiring continuous or frequent medical intervention 4. Autoimmune disease by history and physical examination 5. Hives or recurrent hives and severe eczema 6. A history of psychiatric, medical (including traditional medicine) and/or substance abuse problems during the past 6 months that the investigator believes would adversely affect the volunteer's ability to participate in the trial 7. History of epilepsy, or currently taking anti-epileptics 8. Received blood or blood products or immunoglobulins in the past 3 months 9. Receiving immunosuppressive therapy such as systemic corticosteroids or cancer chemotherapy 10. Use of experimental therapeutic agents within 30 days of study entry 11. Reception of any live, attenuated vaccine within 60 days of study entry. 12. Abnormality in ECG that could indicate risk or make interpretation of vaccine effects difficult according to the study operating procedures 13. Previously received an HIV vaccine candidate 14. History of severe local or general reaction to vaccination defined as: Local: Extensive, indurate redness and swelling involving most of the major circumference of the arm, not resolving within 72 hours General: Fever >= 39.5 0C within 48 hours; anaphylaxis; bronchospasm; laryngeal edema; collapse; convulsions or encephalopathy within 72 hours 15. Being a lactating mother 16. Study site employees who are involved in the protocol and may have direct access to the immunogenicity results 17. Unlikely to comply with protocol as judged by the principal investigator or his designate. 18 Years 26 Years 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 2011/03/28 Comite Nacional de Bioetica para a Saude
Ethics Committee Address
Street address City Postal code Country
Avenida Eduardo Mondlane/Salvador Allende Maputo 264 Mozambique

OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Immunogenicity by IFN-gamma ELISPOT 2 weeks post vaccination
Primary Outcome Safety 7 days following each vaccination
Secondary Outcome Immunogenicity by intracellular cytokine staining (ICS) 2 weeks post vaccination
Secondary Outcome Immunogenicity by Lymphoproliferation Assay (LPA) 2 weeks post vaccination

RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Centro de Investigacao e Treino em Saude da Polana Canico Rua da Costa de Sol, number 178 Maputo 264 Mozambique

FUNDING SOURCES
Name of source Street address City Postal code Country
European and Developing Countries Clinical Trials Partnership (EDCTP) 334 Laan van Nieuw Osst Indie, 2593 CE The Hague 2509 AA Netherlands

SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Swedish Institute for Infectious Disease Control Nobels vag 18 Solna 171 82 Sweden Funding Agency
Secondary Sponsor Instituto Nacional de Saude Av. Eduardo Mondlane/Salvador Allende Maputo 264 Mozambique Funding Agency

COLLABORATORS
Name Street address City Postal code Country
Swedish Institute for Communicable Diseases Control Nobels vag 18 Solna 171 82 Sweden
Instituto Nacional de Saude Av. Eduardo Mondlane/Salvador Allende Maputo 264 Mozambique
University of Munich Geschwister-Scholl-Platz 1, 80539 Munchen Munich 80802 Germany
Imperial College of Science, Technology and Medicine Exhibition Road London SW7 2AZ United Kingdom
Hospital Central de Maputo Av. Agostinho Neto, number 1164 Maputo Mozambique
Walter Read Army Institute of Research (WRAIR) 503 Robert Grant Avenue Silver Spring, MD 20910 United States of America
Muhimbili University of Health and Allied Sciences United Nations Road, Upanga West Dar es Salaam 65001 Tanzania

CONTACT PEOPLE
Role Name Email Phone Fax
Principal Investigator Dr Ilesh Jani ilesh.jani@gmail.com +25821431103 +25821431103
Street address City Postal code Country Position / Affiliation
Av. Eduardo Mondlane/Salvador Allende, number 1008 Maputo 264 Mozambique Director of Instituto Nacional de Saude
Role Name Email Phone Fax
Public Enquiries Dr Ilesh Jani ilesh.jani@gmail.com +25821431103 +25821431103
Street address City Postal code Country Position / Affiliation
Av. Eduardo Mondlane/Salvador Allende, number 1008 Maputo 264 Mozambique Director of Instituto Nacional de Saude
Role Name Email Phone Fax
Public Enquiries Dr Ilesh Jani ilesh.jani@gmail.com +25821431103 +25821431103
Street address City Postal code Country Position / Affiliation
Av. Eduardo Mondlane/Salvador Allende, number 1008 Maputo 264 Mozambique Director of Instituto Nacional de Saude
Role Name Email Phone Fax
Scientific Enquiries Dr Ilesh Jani ilesh.jani@gmail.com +25821431103 +25821431103
Street address City Postal code Country Position / Affiliation
Av. Eduardo Mondlane/Salvador Allende, number 1008 Maputo 264 Mozambique Director of Instituto Nacional de Saude