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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: www.pactr.org
Trial no.:
PACTR2010060002033537
Date registered:
2010/04/07
TRIAL DESCRIPTION
Public title
Phase II multi-centre study to evaluate efficacy, safety, and immunogenicity of GMZ2 candidate malaria vaccine in children aged 12 to 60 months
Official scientific title
A phase II, randomized, controlled, double-blind, multi-centre study to evaluate the efficacy, safety, and immunogenicity of GMZ2 candidate malaria vaccine in Gabonese, Bukinabe, Ghanaian, and Ugandan children aged 12 to 60 months
Brief summary describing the background
and objectives of the trial
GMZ2 candidate malaria vaccine; phase IIb multicentred trial enrolling 1840 children aged 12 - 60 months in Gabon; Burkina Faso; Ghana and Uganda. This trial will primarily assess efficacy of the GMZ2 experimental vaccine and secondarily safety and immunogenicity. Humoral and cellular immune responses(quality and functionality)will be explored. GMZ2 experimental vaccine has successfuly undergone phase I safety testing in adults and children. (clintrial.gov NCT00397449,NCT00424944 & NCT00703066)
Type of trial
RCT
Acronym (If the trial has an acronym then please provide)
GMZ2_4_10
Disease(s) or condition(s) being studied
Malaria ,
Purpose of the trial
Prevention
Anticipated trial start date
2010-07-01
Actual trial start date
2010-11-01
Anticipated date of last follow up
2012-09-30
Actual date of last follow up
2014-03-30
Anticipated target sample size (number of participants)
1840
Actual target sample size (number of participants)
1849
Recruitment status
Completed: recruitment & data analysis complete
Secondary Ids
Issuing authority/Trial register
Links to Secondary ID
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
Independent Statistician (LSHTM); Simple randomization using Computer software
Sealed opaque envelopes
Masking/blinding used
INTERVENTIONS
Intervention type
Intervention name
Dose
Duration
Intervention description
Group size
Nature of control
Experimental group
Lyophilized recombinant Lactococcus lactis Hybrid GMZ2 [GLURP+MSP3]
Three (3) doses of 100µg administered 28 days apart
Day 0, 28 & 56
Intramuscular vaccine
920
Control group
Human diploid cell (HDC) rabies vaccine
0.5mls on Day 0, 28 & 56 and booster and cross vaccination of GMZ2 at end of study
24 months
Intramuscular injection one month apart
920
Active
ELIGIBILITY CRITERIA
List inclusion criteria
List exclusion criteria
Min age
Max age
Gender
1. Children aged 12 - 60 months inclusive at the time of the first dose 2. Healthy by medical history and physical examination 3. Signed or thumb-printed Informed Consent by guardian/parent. Where guardian/parent cannot sign, a witness will be asked to sign to indicate that the procedures were understood and consent was given. 4. Resident in the study villages during the whole clinical trial period
1. Symptoms, physical signs of disease that could interfere with the interpretation of the clinical trial results or compromise the health of the subjects if they were vaccinated 2. Immunosuppressive therapy (steroids, immune modulators or immune suppressors) within three (3) months prior recruitment. (for corticosteroids, this will mean prednisone, or equivalent, ¿ 0.5 mg/kg/day. Inhaled and topical steroids are allowed.) 3. Cannot be followed for any social, psychological or geographical reasons. 4. Use of any investigational drug or vaccine other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use up to the end of the child¿s participation in this clinical trial. 5. Suspected or known hypersensitivity to any of the vaccine components or to any vaccine. 6. Acute or chronic, clinically significant hepatic or renal functional abnormality. 7. Anaemia associated with clinical signs or symptoms of decompensation or haemoglobin < 7.0 g/dL. 8. Planned administration of a vaccine not foreseen by the trial protocol within 30 days of the first dose of vaccine. An exception, is the receipt of an EPI or licensed vaccine (measles, oral polio, Hib, meningococcal and combined diphtheria/ pertussis/ tetanus vaccines) which may be given 14 days or more before or after vaccination 9. Presence of chronic illness that, in the judgement of the investigator, would interfere with the study outcomes or pose a threat to the participant¿s health. 10. Administration of immunoglobulin and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period 11. History of surgical splenectomy. 12. Severe malnutrition at screening defined as weight for age Z-score less than 3
12 Months
60 Months
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
2010/05/20
Comite d'ethique pour la recherche en sante
Ethics Committee Address
Street address
City
Postal code
Country
Centre National de rechereche et de Formation sur le Paludisme (CNRFP), Burkina Faso
Ouagadougou
BP668
Burkina Faso
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
2010/05/20
Albert Schweitzer Hospital, MRU
Ethics Committee Address
Street address
City
Postal code
Country
Lambaréné
B.P.13901
Gabon
Has the study received appropriate ethics committee approval
Date the study will be submitted for approval
Date of approval
Name of the ethics committee
No
2010/05/20
Navrongo Health Research Center Institutional Review Board
Ethics Committee Address
Street address
City
Postal code
Country
PO Box 114
Navrongo, Upper East Region
Ghana
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
Faculty of Medicine and Ethics committee
Ethics Committee Address
Street address
City
Postal code
Country
Makerere University
Kampala
PO Box 7072
Uganda
OUTCOMES
Type of outcome
Outcome
Timepoint(s) at which outcome measured
Primary Outcome
Efficacy
Primary analysis will be done as soon after 6 months of follow-up have elapsed if at least 330 children have had an episode of malaria. In case the target number is not reached by 12 months, analysis will be carried out at 12 months.
Secondary Outcome
Efficacy on anemia and severe anemia
6 months after full vaccination (D252)
Secondary Outcome
safety and reactogenicity
monitored
Secondary Outcome
Efficacy on clinical malaria by other case definitions
as soon after 6 months of follow-up have elapsed if at least 330 children have had an episode of malaria. In case the target number is not carried out at 12 months
Secondary Outcome
EXPLORATORY: Humoral and cellular responses
Days 0, 28, 56, 84, 168, 252, 365, 588 and 730 as appropriate
Secondary Outcome
EXPLORATORY: Functionality of immune responses
Days 0 and 84, 252, 365, 730
Secondary Outcome
EXPLORATORY: Effect of other infections on immune response and vaccine efficacy
Days 0, 28, 56, 84, 168, 252, 365, 588 and 730 as appropriate
Secondary Outcome
EXPLORATORY: Assess changes in parasite population
Days 0, 28, 56, 84, 168, 252, 365, 588 and 730 as appropriate
Secondary Outcome
EXPLORATORY: Investigate evidence for waning of efficacy
Days 0, 28, 56, 84, 168, 252, 365, 588 and 730 as appropriate
RECRUITMENT CENTRES
Name of recruitment centre
Street address
City
Postal code
Country
Banfora (CNRFP)
Banfora, Burkina Faso
Burkina Faso
Navrongo Health Research Center (NHRC)
Navrongo
Ghana
Lambarene
Lambarene
Gabon
Inganga Mayuge
Mayuge district, Uganda
Uganda
FUNDING SOURCES
Name of source
Street address
City
Postal code
Country
EDCTP
Laan van Nieuw Oost Indië 334
The Hague
Netherlands
SPONSORS
Sponsor level
Name
Street address
City
Postal code
Country
Nature of sponsor
Primary Sponsor
Statens Serum Intitute
85/117 5 Artillerivej
Openhagen
DK-2300
Denmark
Foundation
COLLABORATORS
Name
Street address
City
Postal code
Country
Makarere University
PO Box 4687
Kampala
Uganda
Albert Schweitzer Hospital, Medical Research Unit
Box BP 13901
Libreville
Gabon
MRC Laboratories
PO Box 273
Banjul
Gambia
Projet de Development de Vaccins Anti-Paludique - Centre
01 BP 2208
Ouagadougou 01
oq BP 2208
Burkina Faso
CONTACT PEOPLE
Role
Name
Email
Phone
Fax
Public Enquiries
Dr Dawit Ejigu
daejigu@gmail.com
251911405540
Street address
City
Postal code
Country
Position / Affiliation
Addis Ababa
PO Box 329
Ethiopia
Staten Serum Institute
Role
Name
Email
Phone
Fax
Scientific Enquiries
Dr Thomas L Richie, MD PhD
thomas.richie@med.navy.mil
001 301 319 7584
001 301 319 7545
Street address
City
Postal code
Country
Position / Affiliation
503 Robert Grant Ave, Room 3A40
Silver Springs, Maryland
20910 - 7500
United States of America
Director, Malaria Program, Navy Component
Role
Name
Email
Phone
Fax
Principal Investigator
Dr Sodiomon Bienvenu SIRIMA, BA, MD, PHD
s.sirima.cnlp@fasonet.bf
+22650324695
+22650305220
Street address
City
Postal code
Country
Position / Affiliation
Projet de developpment de Vaccins Anti-Paludique, Centre National de Recherche et de Formation sur le Paludisme (PDVAP-CNRFP) 01BP2208
Ougadougou
01BP 2208
Burkina Faso
Role
Name
Email
Phone
Fax
Principal Investigator
Dr Saadou Issifou, MD MSC, PhD
isaadou2002@yahoo.fr
+241 07457813
Street address
City
Postal code
Country
Position / Affiliation
Albert Schweitzer Hosp, Medical Research Unit
Libreville
BP 13901
Gabon
Role
Name
Email
Phone
Fax
Principal Investigator
Mr Fred Kironde PhD
kironde@starcom.co.ug
+256 782989930
+256 782989930
Street address
City
Postal code
Country
Position / Affiliation
PO BOx 4687
Kampala
Uganda
Role
Name
Email
Phone
Fax
Principal Investigator
Mr Atuguba Frank
fatuguba@ navrongo.mimcom.org
+23374222380
+23374222320
Street address
City
Postal code
Country
Position / Affiliation
PO Box 114
Navrongo, Upper East Region
Ghana
Navrongo Health Research Center