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.: PACTR201211000435126 Date of Approval: 15/10/2012
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title TaMoVaC II
Official scientific title A Phase II trial to assess the safety and immunogenicity of DNA priming
Brief summary describing the background and objectives of the trial This is a randomised, double blinded HIV vaccine trial with the HIVIS DNA prime administered ID by the ZetajetR device with or without the Derma Vax¿ electroporation, followed by IM MVA-CMDR 108pfu per ml. 1.To compare the safety and immunogenicity of 600¿g HIVIS-DNA (3mg/ml) administered ID, followed by MVA-CMDR given IM to healthy HIV-uninfected sujects. 2. To compare the safety and immunogenicity of 600¿g HIVIS-DNA administered ID via ZetajetR followed by ID Derma Vax¿ electroporation boost
Type of trial RCT
Acronym (If the trial has an acronym then please provide) TaMoVaC II
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
Anticipated trial start date 03/12/2012
Actual trial start date
Anticipated date of last follow up 05/09/2014
Actual Last follow-up date
Anticipated target sample size (number of participants) 198
Actual target sample size (number of participants) 198
Recruitment status Recruiting
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 Stratified allocation where factors such as age, gender, centre, or previous treatment are used in the stratification (MUHAS 80, MMRP 80, CISPOC 38) Sealed opaque envelopes. 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 I HIVIS DNA (Zetajet 2x 0.1ml 3mg/ml [300g] ID of combined Pools (env/gag) in left (1x 0.1 ml) and right (1x 0.1 ml) arm) at 0, 4 12 weeks, MVA (1x 1ml of 108 pfu IM in left arm) at 24 and 40 weeks 40 weeks Participnats will be primed with HIVIS DNA followed with boosting with MVA 60
Experimental Group Group II HIVIS DNA (Zetajet+DermaVax 2x 0.1ml 3mg/ml [300]g] ID of combined Pools (env/gag) in left (1x 0.1 ml) and right (1x 0.1 ml) arm at 0, 4 12 weeks,MVA (1x 1ml of 108 pfu IM in left arm) at 24 and 40 w 40 weeks Participnats will be primed with HIVIS DNA followed with boosting with MVA 60
Experimental Group Group III HIVIS DNA (Zetajet+DermaVax 1x 0.1ml 6mg/ml [600]g] ID of combined Pools (env/gag) in left arm at 0, 4 12 weeks, MVA (1x 1ml of 108 pfu IM in left arm) at 24 and 40 weeks 40 weeks Participnats will be primed with HIVIS DNA followed with boosting with MVA 60
Control Group Placebo/Saline HIVIS DNA/Placebo and MVA/Placebo volume similar the active products. 40 weeks HIVIS DNA/Placebo followed by MVA/Placebo 18 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Age: 18 to 40 years Willing to undergo counselling and HIV testing Have a negative antigen/antibody ELISA for HIV infection Able to give informed consent Basic abilities to read and write. Satisfactory completion of an assessment of understanding prior to enrolment defined as 90% correct answers after three opportunities to take test. Resident in Dar es Salaam, Mbeya or Maputo catchment areas, and willing to remain so for the duration of the study At low risk of HIV infection, defined as the absence of an identifiable risk factor/ behaviour according to a risk assessment questionniare. 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. Women shall have a negative urinary pregnancy test Be willing to practice safe sex for the duration of the study to avoid sexually transmitted infections including HIV Good health as determined by medical history, physical examination, clinical judgment and by key laboratory parameters as judged by the study physician. Laboratory criteria within 8 weeks prior to enrollment At risk of HIV infection as mentioned above in the inclusion criteria 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). A history of immunodeficiency, ongoing medical and/or psychiatric condition and/or chronic illness requiring continuous or frequent medical intervention Autoimmune disease by history and physical examination. Hives or recurrent hives and severe eczema Substance abuse problems (including traditional medicine) during the past 12 months that in the opinion of the investigator would preclude participation History of grand-mal epilepsy, or currently taking anti-epileptics Received blood or blood products or immunoglobulins in the past 3 months. Receiving immunosuppressive therapy such as systemic corticosteroids or cancer chemotherapy. Use of experimental therapeutic agents within 30 days of study entry. Reception of any live, attenuated vaccine within 60 days of study entry. 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 immunisation to avoid potential confusion of adverse reactions. History of cardiac disease 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 13/09/2012 National Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
OCean Road Dar es Salaam 255 United Republic of Tanzania
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Immunogenicity a positive response in the HIV peptide-specific ¿-IFN Elispot assay using freshly isolated PBMCs collected 2 weeks after the final vaccination
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mbeya Medical Research Programme (MMRP) Hospital Area Mbeya 255 United Republic of Tanzania
Centro de Investigação e Treino em Saúde da Polana Caniço (CISPOC) Instituto Nacional de Saúde Maputo 258 Mozambique
MUHAS Off United Nations Road Dar es Salaam 255 United Republic of Tanzania
FUNDING SOURCES
Name of source Street address City Postal code Country
European and Developing Countries Clinical Trials Partnership Programme Laan van Nieuw Oost Indië 334 The Hague 31 Netherlands
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Swedish Institute for Infectious Disease Control Smittskyddsinstitutet (SMI), 171 82 Solna Stockholm 46 Sweden University
Secondary Sponsor Muhimbili University of Health & Allied sciences Off United Nations Road Dar es Salaam 255 United Republic of Tanzania University
COLLABORATORS
Name Street address City Postal code Country
Swedish Institute for Communicable Disease Control Smittskyddsinstitutet (SMI), 171 82 Solna Stockholm 46 Sweden
Muhimbili University of Health and Allied Sciences Off United Nations Road Dar es Salaam 255 United Republic of Tanzania
Mbeya Medical Research Programme Hospital Area Mbeya 255 United Republic of Tanzania
Centro de Investigação e Treino em Saúde da Polana Caniço Instituto Nacional de Saúde Maputo 258 Mozambique
Klinikum der Universität München Leopoldstrasse 5 Munich 49 Germany
Imperial College, Chelsea & Westminisster Hospital 369 Fulham Road London 44 United Kingdom
Military HIV Research Program (MHRP) 6720-A Rockledge Drive, Suite 400 Bethesda, MD 20817 1 United States of America
Walter Reed Army Institute of Research (WRAIR) 6720-A Rockledge Drive, Suite 400 Bethesda, MD 20817 1 United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Muhammad Bakari drbakari@yahoo.com 255 713 702211 Off United Nations Road
City Postal code Country Position/Affiliation
Dar es Salaam 255 United Republic of Tanzania Principal Investigator
Role Name Email Phone Street address
Principal Investigator Leonard Maboko lmaboko@mmrp.org 258 827453820 Hospital Area
City Postal code Country Position/Affiliation
Mbeya 255 Principal Investigator
Role Name Email Phone Street address
Principal Investigator Ilesh Jani ilesh.jani@gmail.com 258 827453820 Instituto Nacional de Saúde
City Postal code Country Position/Affiliation
Maputo 258 Mozambique Principal Investigator
Role Name Email Phone Street address
Public Enquiries Eligius Lyamuya eligius_lyamuya@yahoo.com +255 (754) 495933 Off United Nations Road
City Postal code Country Position/Affiliation
Dar es Salaam 255 United Republic of Tanzania Chief Investigator
REPORTING
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Result URL Hyperlinks
Changes to trial information