Prevention of P.falciparum malaria
Conditions
Interventions
Intervention type:VACCINE
Name of intervention:Injection of BK-SE36/CpG
Dose form / Japanese Medical Device Nomenclature:INJECTION
Route of administration / Site of application:INTRAMUSCULAR
Dose per
0.5mL/dose, twice Stage2
1.0 mL/dose, twice
mL/dose
Dosing frequency / Frequency of use:OTHER, SPECIFY
twice with three weeks interval
Planned duration of intervention:
Intended dose regimen:
detailes of teratment arms:
Compa
0.5mL/dose Stage2
1.0mL/dose
mL/dose
Dosing frequency / Frequency of use:OTHER, SPECIFY
twice with three weeks interval
Planned duration of intervention:
Intended dose regimen:
Sponsors
MYOI, Akira; the principal investigator of this clinical trial
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Age between 20 years and 35 years old when the informed consent be taken. 2) Those who are able to understand the contents of informed consent form based on the explanation by the principle investigator or clinical investigators, are able to agree by writing, comply with matters to be observed during participation in the trial, undergo consultation/examination, as described in this protocol, and report symptom. 3) Persons whose Body Mass Index be between 18.5 and 25.0. 4) Those who are considered to be eligible to participate in this trial based on screening tests.
Exclusion criteria
Exclusion criteria: 1)Persons with cardiovascular, renal, hepatic, hematological, autoimmune or developmental condition, which in the opinion of the investigator may increase the risk of the subject from participating in the trial 2)Persons with a past history of fever within 2 days after preventive administration with other types of vaccine, or those in whom symptoms have suggested systemic allergy 3)Persons with food/drug/metal-related allergic reactions, especially that of ampicillin, chloramphenicol. 4)Persons with a history of convulsion 5)Persons with any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection. Persons whose close relatives are diagnosed as congenital immunodeficiency. 6)Persons who use medicines/drugs that the clinical trial defines as contraindication (steroids that are neither external nor inhalation usage, immunosuppressant, antimalarials) during the trial period 7)Persons with drug/ alcohol dependency 8)Persons to whom any live vaccine was administered within 4 weeks before the first administration of the investigational product, or inactivated vaccine/toxoid was administered within 1 week 9)Persons who participated in another trial within 4 months before the first administration of this test vaccine 10)Persons who have a past history of clinical malaria (no matter of which species of Plasmodium spp.) 11)Persons who have stayed longer than three months of the last three years in the endemic area of Plasmodium falciparum, or who have visited during the last one year or have a plan of visit to the endemic area of Plasmodium falciparum during the trial period 12)Persons who have used ani-malarial agents within 12 weeks before the first administration of the investigational product 13)Persons with a history of splenectomy 14)Persons in whom 200 ml of blood was collected (donation) within 1 month before the first administration of the investigational product, or more than 400 ml of blood was collected within 3 months 15)Others who are not considered to be eligible by the investigator or those whose medical condition would, in the opinion of the investigator, make the subject unsuitable for the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety of BK-SE36/CpG | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunogenicity of BK-SE36/CpG | — |
Countries
Japan
Contacts
Public ContactEZOE, Sachiko
Osaka University
Outcome results
None listed