NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JMACCT ID: JMA-IIA00109

Registered date:11/01/2013

First-in-human trial of BK-SE36/CpG tropical malaria vaccine

Basic Information

Recruitment status Other
Health condition(s) or Problem(s) studiedPrevention of P.falciparum malaria
Date of first enrollment06/08/2013
Target sample size26
Countries of recruitmentJapan
Study typeINTERVENTIONAL
Intervention(s)Intervention type:VACCINE. Intervention1:Injection of BK-SE36/CpG, Dose form:INJECTION, Route of administration:INTRAMUSCULAR. Control intervention1:normal saline, Dose form:INJECTION, Route of administration:INTRAMUSCULAR.

Outcome(s)

Primary OutcomeSafety of BK-SE36/CpG. Timepoint:Whole period of the trial after 1st injection .
Secondary OutcomeImmunogenicity of BK-SE36/CpG. Timepoint: 21days and 42days after the 1st injection.

Key inclusion & exclusion criteria

Age minimum>=20 YEARS
Age maximum<=35 YEARS
GenderMale
Include criteria1) 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.
Exclude criteria1)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.

Related Information

Contact

public contact
Name EZOE, Sachiko
Address Medical Center for Translational Research Department of Medical Innovation,2-2, Yamadaoka, Suita, Osaka, JAPAN
Telephone +81-6-6210-8289
E-mail sezoe@bldon.med.osaka-u.ac.jp
Affiliation Osaka University
scientific contact
Name MYOI, Akira
Address Medical Center for Translational Research,2-15, Yamadaoka, Suita, Osaka, JAPAN
Telephone +81-6-6210-8289
E-mail
Affiliation Osaka University Hospital