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.: PACTR201110000274327 Date of Registration: 02/02/2011
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Immunization with peptide-mix and adjuvant. A vaccine to induce cellular immunity against HIV-1 [retrospectively registered]
Official scientific title Immunization with peptide-mix and adjuvant. A vaccine to induce cellular immunity against HIV-1
Brief summary describing the background and objectives of the trial The primary purpose is to evaluate tolerability and safety of the vaccine. Secondary purpose is to evaluate the clinical effect of the vaccine as measured by induction of immunity, lowering viral load, induction of escape mutations in the virus and improvement in patient CD4 lymphocyte blood counts. Third is to evaluate feasibility of conducting a therapuetic HIV immunization study in a poorly resourced AFrican setting
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/08/2009
Actual trial start date 17/08/2010
Anticipated date of last follow up 03/12/2012
Actual Last follow-up date
Anticipated target sample size (number of participants) 20
Actual target sample size (number of participants) 19
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation by using procedures such as coin-tossing (notes drawn from a hat) Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Placebo comparaotr 1.2 ml 8 weeks 1.2ml saling intrsmuscularly 5 Placebo
Experimental Group Peptides in CAF01 (AFO18) 5.6 mg peptides in CAF adjuvant injected i.m. week 0, 2,4,8 8 weeks terapeutic vaccination with peptides in adjuvant 15
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. HIV - 1 seropositive with measurable viral load > 10e3 copies/ml and CD4+Tcell count > 400 CD4+cell/ul 2. Not in Antiretroviral therapy (>1year) 3. male or female aged between 18 - 50 years 4. Normal values for the area of liver and kidney enzymes, blood cell count with differential counts (eg white blood cells, lymphocytes, platelets/thrombocytes) and Hemoglobin 5. Expected to follow instructions 6. Written informed consent after oral and written information 1. Vaccinated with other vaccines within 3 months before the first vaccination 2. Treated with immune modulating medicine within 3 months before the first immunization 3. Other important active chronic infectious diseases likely to influence the HIV-1 infection, like HIV-2,HBV, HCV adn TB 4. Significant medical disease as judged by the investigators, for example, severe asthma/COLD, badly regulated heart disease, insulin dependent diabete mellitus 5. Severe allergy or earlier analphylactic reactions 6. Active autoimmune disease 7. Simultaneous treatment with other experimental drugs 8. Laboratory parameters outside the 'normal' range for teh area and which are considered clinically significant 9. Pregnancy 18 Year(s) 50 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 11/08/2010 Comité Nacional deÈtica na Saúde
Ethics Committee Address
Street address City Postal code Country
Av Combatente da Liberdade de Pátria, Hospital "3 de Agosta", Apartado 861 Bissau 1004 Bissau Codex Guinea-Bisseu
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 09/06/2009 Ministerio da Saude Publica
Ethics Committee Address
Street address City Postal code Country
Av Combatente da Liberdade de Pátria, Hospital "3 de Agosta". Aparto 861 Bissau 1004 Bissau Codex Guinea-Bisseu
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 27/04/2009 The Danish National Committee on Biomedical Research Ethics
Ethics Committee Address
Street address City Postal code Country
Slotsholmsgade 12 Copenhagen DK1216K Denmark
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Evaluate tolerability and safety of treatment up to 6 months after treatment
Secondary Outcome evaluate the clinical effect measured as induction of new T-cell immune response, lowering of viral load, and increase in the CD4 cell count up to six months after last immunisation
Primary Outcome Safety and tolerability At each injection
Secondary Outcome immunogenicity 1-2 weeks after laset immunisation 3 months after last immunisation 6 months after last immunisation
Secondary Outcome Lowering of HIV RNA viral load 1-2 weeks after last immunisation 3 month after last immunisation 6 months after last immunisation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Hospital Nacional Simao Mendes Av Unite Africaine Bissau 50-1013 Guinea-Bisseu
FUNDING SOURCES
Name of source Street address City Postal code Country
EDCTP Laan van Nieuw Oost Indie 300 Haag 2593 CE Den Haag Netherlands
DANIDA Roal Danish Ministry of Foreign Affairs Asiatisk Plads 2 Copenhagen DK1448K Denmark
Statens Serum Institut Artillerivej 5 Copenhagen DK2300S Denmark
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Statens Serum Institut (Helle Bossen Konradsen) 5, Artillerivej Copenhagen DK-2300 Denmark Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Anders Fomsgaard, SSI Artillerivej 5 Copenhagen DK2300S Denmark
Zacarias José da Silva Projecto de Saúde Bandim, Apartado 861 Bissau 1004 Bissau Codex Guinea-Bisseu
David da Silva Te Hospital Simao Mendes Bissau 50-1013 Guinea-Bisseu
Peter Aaby Projecto de Saude Bandim Bissau 1004 Bissau Codex Guinea-Bisseu
Gitte Kronborg, Hvidovre University Hospital Kettegaards Alle Copenhagen DK2650 Denmark
Helle Bossen Konradsen, SSI Artillerivej 5 Copenhagen DK2300S Denmark
Raul Gomez Roman, SSI Artillerivej 5 Copenhagen DK2300S Denmark
Raul Gomez Roman, SSI Artillerivej 5 Copenhagen DK2300S Denmark
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator David Da Silva daciddasilvate@gmail.com 00 (245) 6618972 Hospital Nacional Simao Mendes
City Postal code Country Position/Affiliation
Bissau 50-1013 Guinea-Bisseu Chief Physisian
Role Name Email Phone Street address
Public Enquiries Anders Fomsgaard afo@ssi.dk +45-32683460 Artillerivej 5
City Postal code Country Position/Affiliation
Copenhagen DK2300S Denmark MD, Chielf of Lab / Statens Serum Institut
Role Name Email Phone Street address
Scientific Enquiries Anders Fomsgaard AFO@ssi.dk 45 326 834 60 5 Artillerivej
City Postal code Country Position/Affiliation
Copenhagen DK2300 Copenhagen S Denmark Chief of Molecular Virology Laboratory
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information