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.: PACTR201503001038304 Date of Approval: 17/02/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title GMZ2CAF01
Official scientific title A randomized, controlled, double-blind, single-center phase 1 clinical trial to evaluate safety, tolerability, immunogenicity and efficacy of CAF01 and aluminum hydroxide as adjuvants for the malaria vaccine candidate GMZ2 in health adult African volunteer
Brief summary describing the background and objectives of the trial GMZ2 is a vaccine candidate targeting the asexual blood stage of the malaria parasite life cycle. This candidate shows excellent safety and tolerability, and modest immunogenicity when adjuvanted with aluminum in phase 1 and 2 trials. In order to improve the immune response to the vaccine and induce better protection, this trial is proposing to combine GMZ2 with a novel adjuvant. CAF01 has demonstrated good safety, tolerability and immunogenicity when combined with various vaccines in previous trials. This trial plans to compare GMZ2 adjuvanted with Alum, CAF01 and a placebo in varying doses with and without subsequent Controlled Human Malaria Infection (CHMI) to assess efficacy. Primary Objective: Establish a regimen of GMZ2-CAF01, which is safe and well tolerated. Secondary Objective: Establish a regimen of GMZ2-CAF01 that reduces parasite multiplication upon CHMI. Establish a regimen of GMZ2-CAF01 that induces a superior anti-GMZ2 antibody-response compared to GMZ2-alum and a control vaccine (Rabies).
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 Malaria
Purpose of the trial Prevention: Vaccines
Anticipated trial start date 30/03/2015
Actual trial start date 20/04/2015
Anticipated date of last follow up 31/01/2016
Actual Last follow-up date
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants)
Recruitment status Closed to recruitment,follow-up continuing
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 Computer generated Envelopes Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Group A Three times Rabies vaccine 8
Experimental Group Group B Three times 100ug GMZ2 in alum 12
Experimental Group Group C Three times 30ug GMZ2 in CAF01 8
Experimental Group Group D Three times 100ug GMZ2 in CAF01, with CHMI 12
Experimental Group Group E Three times 100ug GMZ2 in CAF01, no CHMI 10
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
¿ Healthy adults aged 18 to 40 years. ¿ Able and willing (in the Investigator¿s opinion) to comply with all study requirements. ¿ Agreement to refrain from blood donation during the course of the study and after the end of their involvement in the study according to the local blood banking eligibility criteria ¿ Residence in Lambaréné or surroundings for the period of the trial. ¿ History of long term residence (>10 years) in area known to have significant transmission of P. falciparum ¿ Written informed consent to receive GMZ2 for immunization and PfSPZ Challenge for CHMI. ¿ Answer all questions on the informed consent quiz correctly. ¿ Willingness to take two curative anti-malarial regimens. ¿ Reachable (24/7) by mobile phone during the immunization, CHMI and follow-up. ¿ A body mass index <35. ¿ Receipt of an investigational product in the 30 days preceding enrollment, or planned receipt during the study period. ¿ Prior receipt of an investigational malaria vaccine. ¿ Immunization with more than 3 other vaccines within the past month. ¿ Positive HIV test. ¿ Any confirmed or suspected immunosuppressive or immunodeficient state, asplenia, recurrent, severe and chronic (more than 14 days) infections, immunosuppressant medication within the past 6 months (inhaled and topical steroids are allowed). ¿ Use of immunoglobulins or blood products within 3 months prior to enrolment. ¿ Sickle cell disease or any clinically relevant blood disorder. ¿ A history of allergic disease or reactions likely to be exacerbated by vaccine administration. ¿ History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ). ¿ History of serious psychiatric condition that may affect participation in the study. ¿ Any other serious chronic illness requiring hospital specialist supervision. ¿ Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 60 g per day. ¿ Suspected or known injecting drug abuse in the 5 years preceding enrollment. ¿ Contraindications to the use of the first-line anti-malarial medications: artemether/lumefantrine or atovaquone/proguanil. ¿ Positive for hepatitis B surface antigen (HBs-antigen). ¿ Seropositive for hepatitis C virus (antibodies to HCV). ¿ Subjects unable to be closely followed for social, geographic or psychological reasons. ¿ Any clinically significant abnormal finding on biochemistry or hematology blood tests, urine analysis or clinical examination. ¿ History of seizure. ¿ Subjects unable to be closely followed for social, geographic or psychological reasons. ¿ Abnormal electrocardiogram on screening: pathologic Q wave and significant ST-T wave changes, left ventricular hypertrophy, non-sinus rhythm except isolated premature atrial contractions, right of left bundle branch block, advanced A-V heart block (secondary or tertiary). ¿ A QT/QTc interval > 450 ms. ¿ Any other significant disease, disorder or finding which, in the opinion of the Investigator, may significantly increase the risk to the volunteer because of participation in the study, affect the ability 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 07/02/2015 National Ethics Committee of Gabon
Ethics Committee Address
Street address City Postal code Country
B.P. 2.217 Libreville 217 Gabon
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Establish a regimen of GMZ2-CAF01, which is safe and well tolerated. After vaccination During follow up visits During CHMI
Secondary Outcome Establish a regimen of GMZ2-CAF01 that reduces parasite multiplication upon controlled human malaria infection (CHMI) During CHMI
Secondary Outcome Establish a regimen of GMZ2-CAF01 that induces a superior anti-GMZ2 antibody-response compared to GMZ2-alum and a control vaccine (Rabies). At follow up visits
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Centre de Recherches Medicales de Lambarene (CERMEL) Hopital Albert Schweitzer Lambarene BP118 Gabon
FUNDING SOURCES
Name of source Street address City Postal code Country
German Centre for Infection Research Braunschweig Germany
Bundesministerium für Bildung und Forschung Germany
Bundesministerium für Bildung und Forschung Heinemannstraße 2 Bonn 53175 Germany
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Centre de Recherches Medicales Lambarene Hopital Albert Schweitzer Lambarene BP118 Gabon Hospital
COLLABORATORS
Name Street address City Postal code Country
Institut für Tropenmedizin, Universitätsklinikum Tübingen Wilhelmstraße 27 Tübingen 72070 Germany
Sans Serums Institute 5 Artillerivej Copenhagen DK-2300 Denmark
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ulysse Ateba Ngoa ulyssus700@yahoo.fr 004970712982929 Hopital Albert Schweizer
City Postal code Country Position/Affiliation
Lambarene BP118 Gabon
Role Name Email Phone Street address
Public Enquiries Jessica Brosnahan jessica.brosnahan@medizin.uni-tuebingen.de 004970712982929 Wilhelmstraße 27
City Postal code Country Position/Affiliation
Tübingen 72070 Germany Project Manager
Role Name Email Phone Street address
Scientific Enquiries Jessica Brosnahan jessica.brosnahan@medizin.uni-tuebingen.de +4970712982929 Wilhelmstraße 27
City Postal code Country Position/Affiliation
Tübingen 72070 Germany Project Manager
REPORTING
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