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.: PACTR201712002879427 Date of Approval: 15/12/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title ESMAVAC - 1
Official scientific title Randomized, placebo-controlled, double-blind, three-arm, clinical trial to assess safety, tolerability and protective efficacy of PfSPZ-CVac and PfSPZ Vaccine in 1-12 years old African children naturally exposed to malaria parasites
Brief summary describing the background and objectives of the trial Malaria is the most important parasitic disease and a major cause for child death in highly endemic regions of sub-Saharan Africa. Vaccines would be an essential tool to control and eliminate malaria as well as to contain drug-resistant parasite strains. So far, only whole sporozoite-based immunization has shown high-grade and prolonged protective efficacy. To transform this concept into a vaccine, Sanaria Inc. developed methods to produce aseptic, purified, cryopreserved Plasmodium falciparum sporozoites (PfSPZ) in compliance with current good manufacturing practices (cGMP) for immunisation and for assessment of antimalarial interventions using highly standardized controlled human malaria infection (CHMI). PfSPZ can be used for immunization using two major approaches: 1) immunization with fully viable PfSPZ (PfSPZ Challenge) under chemoprophylaxis (together termed PfSPZ Chemoprophylaxis Vaccine ¿ PfSPZ-CVac approach), 2) immunization with radiation-attenuated PfSPZ (PfSPZ Vaccine). They are the only two malaria vaccine approaches which have ever shown >90% protection against CHMI. ESMAVAC.1 will directly compare, for the first time in children, PfSPZ-CVac with PfSPZ Vaccine against placebo in the most malaria-affected population: African children under high-level exposure to P. falciparum malaria.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) ESMAVAC.1
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 01/03/2018
Actual trial start date
Anticipated date of last follow up 03/02/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 0
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
BONNECHANCE, BONNECHANCEmini DZIF
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 Computer generated 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
Control Group PfSPZ placebo and chloroquine placebo PfSPZ placebo: 3 times 0.5 mL, 4 week intervals; chloroquine placebo: weekly 10 weeks Normal saline: direct venous inoculation; chloroquine placebo: oral 67 Placebo
Control Group PfSPZ placebo and chloroquine PfSPZ placebo: 3 times 0.5 mL, 4 week intervals; chloroquine: weekly 5mg/kg 10 weeks Normal saline: direct venous inoculation; chloroquine: oral 67 Placebo
Experimental Group PfSPZ Vaccine PfSPZ Vaccine: 3 times 900,000 PfSPZ, 4 week intervals; chloroquine placebo: weekly 10 weeks PfSPZ Vaccine: direct venous inoculation; chloroquine placebo: oral 133
Experimental Group PfSPZ-CVac PfSPZ Challenge: 3 times up to 100,000 PfSPZ, 4 week intervals; chloroquine: weekly 5mg/kg 10 weeks PfSPZ Challenge: direct venous inoculation; chloroquine: oral 133
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Recruited children will be healthy population with the following inclusion criteria: -Healthy children aged 1 to 12 years -Provision of written informed consent of a legal representative of age 18 or above and provision of informed assent by underage participants in concordance with Gabonese national guidelines. -Able and willing to comply with all study requirements -Residence in the area throughout the study period -Household member reachable by mobile phone during the immunization phase -Correct answers on the informed consent quiz for legal representatives Children will not enter the study if any of the following apply: -Receipt of an investigational product in the 30 days preceding enrollment -Immunization with more than 3 other vaccines or at least one live vaccine within the past four weeks -Use of immunoglobulins or blood products within 3 months prior to enrolment -Known intolerance to, or contraindications to the use of chloroquine or clindamycin -Known or suspected HIV infection or any other immunosuppressive state -Positive for hepatitis B surface antigen (HBs­antigen) -Seropositive for hepatitis C virus (antibodies to HCV) -A hemoglobin concentration <9 g/dl -History of non-febrile or atypical febrile seizures -Pregnancy or lactation -Any other significant disease, disorder or finding which, in the opinion of the investigator, may significantly increase the risk to the child because of participation in the study or impair interpretation of the study data In case of inconclusive results in laboratory tests or other diagnostic procedures, the test will be repeated. If doubts about the results persist, volunteers will be considered ineligible. 1 Year(s) 12 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
No 01/02/2018 Comité National d'Ethique pour la Recherche (CNER)
Ethics Committee Address
Street address City Postal code Country
Libreville B.P. 2217 Gabon
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Occurrence of Grade 3 adverse events and serious adverse events First dose of chemoprophylaxis or placebo until 28 days after the last vaccine dose
Secondary Outcome Occurrence of Grade 1-3 adverse events and serious adverse events First dose of chemoprophylaxis or placebo until 28 days after the last vaccine dose
Secondary Outcome Proportion of volunteers who develop P. falciparum parasitemia From day 28 until 26 weeks after the last vaccine dose
Secondary Outcome Proportion of volunteers who develop P. falciparum parasitemia 104 weeks after the last vaccine dose
Secondary Outcome Time to P. falciparum parasitemia From day of last vaccine dose until end of trial
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Centre de Recherches Médicales de Lambaréné Lambaréné BP 242 Gabon
FUNDING SOURCES
Name of source Street address City Postal code Country
Deutsches Zentrum für Infektionsforschung e.V. Inhoffenstraße 7 Braunschweig 38124 Germany
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Centre de Recherches Médicale de Lambaréné Lambaréné B.P : 242 Gabon Hospital
COLLABORATORS
Name Street address City Postal code Country
Institut of Tropical Medicin, University Clinic Tübingen 27 Wilhelmstr. Tübingen 72074 Germany
Institut of Tropical Medicine, University Clinic Tübingen 27 Wilhelmstr. Tübingen 72074 Germany
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Selidji Agnandji agnandjis@cermel.org +241 07353114 BP242, Lambarènè
City Postal code Country Position/Affiliation
Lambaréné B.P: 242 Gabon Centre de Recherches Médicale de Lambaréné
Role Name Email Phone Street address
Public Enquiries Bertrand Lell bertrand.lell@cermel.org +241 07877557 BP242, Lambarènè
City Postal code Country Position/Affiliation
Lambaréné B.P: 242 Gabon Centre de Recherches Médicale de Lambaréné
Role Name Email Phone Street address
Scientific Enquiries Matthew McCall matthew.mccall@cermel.org +241 06942023 BP242, Lambarènè
City Postal code Country Position/Affiliation
Lambaréné B.P: 242 Gabon Centre de Recherches Médicale de Lambaréné
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
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