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: pactr.samrc.ac.za
Trial no.: PACTR2010050002122368 Date of Approval: 23/05/2010
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title TaMoVac-01
Official scientific title A Phase I/II trial to assess safety and immunogenicity of i.d. DNA priming, i.m. MVA and i.m. rgp140/GLA-AF boosting in healthy volunteers in Tanzania and to develop further HIV vaccine trial capacity building in Tanzania
Brief summary describing the background and objectives of the trial Availability of safe and efficacious vaccine is an important desired goal. Participation of developing countries in this effort is crucial. Following earlier investments through Swedish and EU support, a phase I/II trial has been concluded in Tanzania. The DNA-prime, MVA-boost was safe and induced strong cellular immune responses. We intend to further explore the safety and immunogenicity of boosting with two doses of rgp140 in the adjuvant GLA-AF, administered IM among the TaMoVac01 volunteers
Type of trial RCT
Acronym (If the trial has an acronym then please provide) TAMOVAC 01
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Prevention: Vaccines
Anticipated trial start date 26/05/2010
Actual trial start date 26/05/2010
Anticipated date of last follow up 30/11/2012
Actual Last follow-up date 30/11/2012
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants) 120
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
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 Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomisation Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomisation Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomisation Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Group IA 600 micrograms of DNA i.d. at weeks 0, 4 and 12; then MVA at 10^8 i.m. at weeks 36 and 60 60 weeks Low dose, combined plasmids pools DNA 36
Experimental Group Group IIA 600 micrograms of DNA i.d. at weeks 0, 4 and 12; then MVA at 10^8 i.m. at weeks 36 and 60 60 weeks Low dose, combined plasmids pools DNA 36
Experimental Group Group IIIA 1,000 micrgrams of DNA i.d. at weeks 0, 4 and 12; then MVA at 10^8 i.m. at weeks 36 and 60 60 weeks High dose, combined plasmids pools DNA 36
Control Group Group IB Saline 2 x 0.1ml i.d. at 0, 4 and 12 weeks, then saline i.m. at 36 and 60 weeks 60 weeks Saline Placebo 4 Placebo
Control Group Group IIB Saline 2 x 0.1ml i.d. at 0, 4 and 12 weeks, then saline i.m. at 36 and 60 weeks 60 weeks Saline Placebo 4 Placebo
Control Group Group IIIB Saline 5 x 0.1ml i.d. at 0, 4 and 12 weeks, then saline i.m. at 36 and 60 weeks 60 weeks Saline placebo 4 Placebo
Experimental Group rgp140/GLA-AF 100 ¿g rgp140/5 ¿g GLA-AF x2 40
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Age: 18 to 40 years 2. Willing to undergo counseling and HIV testing 3. Have a negative antigen/antibody ELISA for HIV infection 4. Able to give informed consent 5. Satisfactory completion of an assessment of understanding prior to enrolment defined as 90% correct answers after three opportunities to take test. 6. Basic abilities to read and write. 7. Resident in Dar es Salaam or Mbeya, 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 9. Verbal assurances that adequate birth control measures 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 urinary 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. 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 (for example detection of Hepatitis B surface antigen, or active syphilis). 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 grand-mal 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. {NOTE: Medically indicated subunit or killed vaccines (e.g., Hepatitis A or Hepatitis B) are not exclusionary but should be given at least 2 weeks before or after HIV immunization to avoid potential confusion of adverse reactions}. 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 candidate vaccine. 14. History of severe local or general reaction to vaccination in the past 15. Lactating mother 16. Study site employees who are involved in the protocol 17. Ulikeliness of protocol compliance 18 Year(s) 40 Year(s) 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 16/11/2009 MUHAS IRB
Ethics Committee Address
Street address City Postal code Country
Upanga West, United Nations Road Dar es Salaam P.O. Box 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 31/12/2009 National Ethics Committee (NIMR)
Ethics Committee Address
Street address City Postal code Country
Ocean Road Dar es Salaam P.O. Box 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 22/03/2010 Mbeya IRB
Ethics Committee Address
Street address City Postal code Country
Mbeya Consultant Hospital Mbeya P.O. Box 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 08/05/2012 National Ethics Committee (NIMR)
Ethics Committee Address
Street address City Postal code Country
OCean Road Dar es Salaam P.O Box United Republic of Tanzania
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Safety 7 days following each vaccination
Primary Outcome Immunogenicity by IFN-gamma ELISPOT 2 weeks post 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
Muhimbili University of Health and Allied Sciences (MUHAS) Upanga West, United Nations Road Dar es Salaam P.O. Box United Republic of Tanzania
Mbeya Medical Research Programme (MMRP) Top Hill Mbeya P.O. Box United Republic of Tanzania
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
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 University
Primary Sponsor Swedish Institute for Infectious Disease Control Nobels vag 18 Solna 171 82 Sweden University
Secondary Sponsor Muhimbili University of Health and Allied Sciences United Nations Road, Upanga West Dar es Salaam P.O. Box 65001 United Republic of Tanzania University
Secondary Sponsor Muhimbili University of Health and Allied Sciences United Nations Road, Upanga West Dar es Salaam P.O. Box 65001 United Republic of Tanzania University
COLLABORATORS
Name Street address City Postal code Country
National Institute for Medical Research (NIMR) Muhimbili, Upanga West Dar es Salaam P.O. Box United Republic of Tanzania
National Institute for Medical Research (NIMR) Muhimbili, Upanga West Dar es Salaam P.O. Box United Republic of Tanzania
Mbeya Medical Research Programme Top Hill Mbeya P.O. Box United Republic of Tanzania
Mbeya Medical Research Programme Top Hill Mbeya P.O. Box United Republic of Tanzania
Swedish Institute for Medical Research Nobels vag 18 Solna 171 82 Sweden
Swedish Institute for Medical Research Nobels vag 18 Solna 171 82 Sweden
Karolinska Institutet Sjukhusbacke 10 Stockholm S118 83 Sweden
Karolinska Institutet Sjukhusbacke 10 Stockholm S118 83 Sweden
University of Munich Geschwister-Scholl-Platz 1, 80539 Munchen Munich 80802 Germany
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
Imperial College of Science, Technology and Medicine Exhibition Road London SW7 2AZ United Kingdom
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Muhammad Bakari drbakari@muhas.ac.tz +255 754 387 328 United Nations Road, Upanga West
City Postal code Country Position/Affiliation
Dar es Salaam P.O. Box 65001 United Republic of Tanzania Senior Lecturer at MUHAS
Role Name Email Phone Street address
Public Enquiries Muhammad Bakari drbakari@yahoo.com +255 754 387328 United Nations Road, Upanga West
City Postal code Country Position/Affiliation
Dar es Salaam P.O. Box 65001 United Republic of Tanzania Senior Lecturer at MUHAS
Role Name Email Phone Street address
Scientific Enquiries Muhammad Bakari drbakari@yahoo.com +255 754 387328 United Nations Road, Upanga West
City Postal code Country Position/Affiliation
Dar es Salaam P.O. Box 65001 United Republic of Tanzania Senior Lecturer at MUHAS
REPORTING
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