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.: PACTR201310000683408 Date of Approval: 21/10/2013
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Safety And Immunogenicity Of Novel Candidate Blood-Stage Malaria Vaccine P27A : Phase Ia/Ib
Official scientific title Safety And Immunogenicity Of Novel Candidate Blood-Stage Malaria Vaccine P27A With Alhydrogel® Or GLA-SE As Adjuvant: A Staggered, Antigen And Adjuvant Dose-Finding, Randomized, Multi-Centre Phase Ia/Ib Trial
Brief summary describing the background and objectives of the trial The malaria vaccine candidate P27A is based on a long synthetic peptide (104 amino acids) representing a region of the Plasmodium falciparum antigen PFF0165c. This blood-stage antigen was found to be the target of human antibodies inhibiting in-vitro parasite growth. Antibodies acquired by natural exposure were also associated with clinical protection in endemic areas. The vaccine candidate was shown to be immunogenic in animals. The objectives of the clinical trial is i) To demonstrate the safety and immunogenicity of P27A with Alhydrogel or GLA-SE in healthy non-exposed European adults and exposed African adults, and ii) To conduct an antigen and adjuvant dose finding in African adults. It will be a phase Ia/Ib clinical trial with a rapid assessment of safety in Switzerland as go criterion to proceed with a more detailed investigation of the best antigen and adjuvant dose in a population living in endemic areas. The clinical trial proposed follows the new momentum of having African scientists involved early in the clinical development process, with study findings relevant for the populations that should benefit from this malaria vaccine.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) P27A CT
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 01/01/2014
Actual trial start date 17/03/2014
Anticipated date of last follow up 27/02/2015
Actual Last follow-up date 17/07/2015
Anticipated target sample size (number of participants) 56
Actual target sample size (number of participants) 56
Recruitment status Stopped early/ terminated
Publication URL
Secondary Ids Issuing authority/Trial register
P27A_1_13 Sponsor CHUV
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 using a randomisation table created by a computer software program -Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a randomisation table created by a computer software program -Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a randomisation table created by a computer software program -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
Experimental Group P27A Alhydrogel 1a 50µg P27A, 0.85mg Alhydrogel 3 times Week 0, 4 and 8 50µg P27a formulated with Alhydrogel (0.85 mg Al3+) will be given to healthy European adults not previously exposed to the parasite Plasmodium falciparum 8
Experimental Group P27A GLA-SE 1a 50µg P27A, 2.5µg GLA-SE 3 times Week 0, 4 and 8 50µg P27A formulated with GLA-SE (2.5µg) will be given to healthy European adults not previously exposed to the parasite Plasmodium falciparum 8
Experimental Group P27A Alhydrogel 1b 50µg P27A, 0.85mg Alhydrogel 3 times Week 0, 4 and 8 50µg P27A formulated with Alhydrogel (0.85 mg Al3+ ) will be given to healthy African adults previously exposed to the parasite Plasmodium falciparum 8
Experimental Group P27A 10µg GLA-SE 2.5µg 1b 10µg P27A, 2.5µg GLA-SE 3 times Week 0, 4 and 8 10µg P27A formulated with GLA-SE (2.5µg) will be given to healthy African adults previously exposed to the parasite Plasmodium falciparum 8
Experimental Group P27A 50µg GLA-SE 2.5µg 1b 50µg P27A, GLA-SE 2.5µg 3 times Week 0, 4 and 8 50µg P27A formulated with GLA-SE (2.5µg) will be given to healthy African adults previously exposed to the parasite Plasmodium falciparum 8
Experimental Group P27A 50µg GLA-SE 5µg 1b 50µg P27A, GLA-SE 5µg 3 times Week 0, 4 and 8 50µg P27A formulated with GLA-SE (5µg) will be given to healthy African adults previously exposed to the parasite Plasmodium falciparum 8
Control Group Commercial control rabies vaccine Ib no less than 2.5IU of inactivated rabies virus, 3 times Week 0, 4 and 8 Commercial control rabies vaccine will be given to healthy African adults previously exposed to the parasite Plasmodium falciparum 8 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Phase Ia Inclusion criteria: Healthy volunteers aged 18-45 years General good health based on history and clinical examinationWritten informed consent obtained before any study procedure Female volunteers practicing contraception before and up to 13 weeks after the last immunisation Available to participate in follow-up for the duration of study (34 weeks) Reachable by phone during the whole study period Phase Ib inclusion criteria Healthy male volunteers aged 18-45 years General good health based on history and clinical examination Written informed consent obtained before any study procedure Available to participate in follow-up for the duration of study (34 weeks) Reachable by phone during the whole study period Having always lived in an area of low malaria transmission Previous participation in any malaria vaccine trial Symptoms, physical signs or laboratory values suggestive of systemic disorders which could interfere with the interpretation of the trial results or compromise the health of the volunteers Any clinically significant laboratory abnormalities on screened blood samples Enrolment in any other clinical trial during the whole trial period Intake of chronic medication, especially immunosuppressive agents during the 13 weeks preceding the screening visit or during the trial period except topical and inhaled steroids Volunteers unable to be closely followed for social, geographic or psychological reasons Previous history of drug or alcohol abuse interfering with normal social function during a period of one year prior to enrolment in the study Known hypersensitivity to any of the vaccine components Vaccination or infusion of gammaglobulin from 4 weeks prior to the first vaccination and up to 6 weeks after the third vaccination Additional Phase Ia exclusion criteria Positive pregnancy test for females Actively breast feeding females Any history of malaria History of living in a malaria endemic area for more than five (5) years OR living in a malaria endemic area in early childhood. Known exposure to malaria in the previous six (6) months P27A ELISA positive OR parasite ELISA antibody positive AND Known exposure to malaria in a malaria endemic area P27A ELISA positive AND parasite ELISA antibody positive (with or without history of stay in a malaria endemic area) Intention to travel to malaria endemic countries during the study period Positive HIV, HBV or HCV tests Additional Phase Ib exclusion criteria Previous vaccination with the control vaccine Positive HIV, HCV test or HBVsAg positive Malaria parasite positivity by microscopy and/or RDT Having had a history of confirmed malaria episode in the last five year 18 Year(s) 45 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 03/07/2013 Commission Cantonale Ethique de la recherche sur être humain du canton de Vaud
Ethics Committee Address
Street address City Postal code Country
Avenue de Chailly 23 Lausanne 1012 Switzerland
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 23/10/2013 Ifakara health Institute institutional review board
Ethics Committee Address
Street address City Postal code Country
P O BOX 78373 DAR ES SALAAM Tanzania
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To evaluate the safety of P27A with Alhydrogel or GLA-SE as adjuvant, in healthy European adults not previously exposed to the parasite Plasmodium falciparum and in healthy African adults previously exposed to the parasite. The safety profile will be assessed on the basis of immediate local and systemic reactogenicity measured from Day 0 to Day 28 after each vaccination. week 0 week 4 week 8
Secondary Outcome Assessment of the humoral immune response to the vaccine antigen day 0 week 4 week 8 week 12 week 26 week 34
Secondary Outcome Assessment of the cellular immune response to the vaccine antigen day 0 week 4 week 8 week 12 week 26 week 34
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Bagamoyo Clinical Trial Unit Ifakara Health Institute Kingani Estate Bagamoyo Tanzania
Centre Hospitalier Universitaire Vaudois, Centre de Recherche Clinique Rue du Bugnon 44 Lausanne 1011 Switzerland
FUNDING SOURCES
Name of source Street address City Postal code Country
European Vaccine Initiative UniversitätsKlinikum Heidelberg Im Neuenheimer Feld ¿ 326 Heidelberg 69120 Germany
European and Developing Countries Clinical Trials Partnership Laan van Nieuw Oost Indië 334 The Hague 2593 CE Netherlands
BundesMinisterium für Bildung und Forschung Dienstsitz Bonn Heinemannstraße 2 Bonn 53175 Germany
Irish Aid Ireland
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Centre Hospitalier Universitaire Vaudois Rue du Bugnon 21 Lausanne 1011 Switzerland Hospital
Secondary Sponsor Centre Hospitalier Universitaire Vaudois Rue du Bugnon 21 Lausanne 1011 Switzerland Hospital
COLLABORATORS
Name Street address City Postal code Country
François SPERTINI Division of Immunology & Allergy, Centre Hospitalier Universitaire Vaudois CHUV BH19-610 Rue du Bugnon 46 Lausanne 1011 Switzerland
Blaise GENTON CHUV & Policlinique Médicale Universitaire Rue du Bugnon 44 Lausanne 1005 Switzerland
Régine AUDRAN Division of Immunology & Allergy, Centre Hospitalier Universitaire Vaudois CHUV BH19-610 Rue du Bugnon 46 Lausanne 1011 Switzerland
Giampietro CORRADIN Department of Biochemistry, UNIL Chemin des Boveresses 155 Epalinges 1066 Switzerland
Seif SHEKALAGHE Ifakara Health Institute Bagamoyo Research and Training Center Bagamoyo Tanzania
Salim ABDULLA Ifakara Health Institute Bagamoyo Research and Training Center Bagamoyo Tanzania
Claudia DAUBENBERGER Swiss Tropical and Public Health Institute Socinstr. 57 Basel 4051 Switzerland
Mastidia RUTAIHWA Ifakara Health Institute Bagamoyo Research and Training Center Bagamoyo Tanzania
Said Abdallah JONGO Ifakara Health Institute Bagamoyo Research and Training Center Bagamoyo Tanzania
Philip SASI Muhimbili University of Health and Allied Sciences Dar es Salaam Tanzania
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Seif SHEKALAGHE sshekalaghe@ihi.or.tz +255 686 997 713 Ifakara Health Institute Bagamoyo Research and Training Center
City Postal code Country Position/Affiliation
Bagamoyo Tanzania Senior Research Scientists at Ifakara Health Institute
Role Name Email Phone Street address
Principal Investigator Seif Shekalaghe sshekalaghe@ihi.or.tz +255 686 997 713 Ifakara Health Institute Bagamoyo Research and Training Center
City Postal code Country Position/Affiliation
Bagamoyo Tanzania Senior Research Scientists at Ifakara Health Institute
Role Name Email Phone Street address
Public Enquiries Samuel Roethlisberger Samuel.Roethlisberger@chuv.ch +41 213 14 08 58 Service d'immunologie et allergie CHUV BH19-610 Rue du Bugnon 46
City Postal code Country Position/Affiliation
Lausanne 1011 Switzerland
Role Name Email Phone Street address
Scientific Enquiries François SPERTINI Francois.Spertini@chuv.hospvd.ch +41 21 314 07 99 Service d'immunologie et allergie CHUV BH19-610 Rue du Bugnon 46
City Postal code Country Position/Affiliation
Lausanne 1011 Switzerland Médecin-Chef du Service d'immunologie et allergie
REPORTING
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