BK-SE36 phase 1a vaccine trial for falciparum malaria
- Conditions
- Falciparum malariaInfections and InfestationsPlasmodium falciparum malaria
- Registration Number
- ISRCTN78679862
- Lead Sponsor
- The Research Foundation for Microbial Diseases of Osaka University (BIKEN) (Japan)
- Brief Summary
2010 results in https://pubmed.ncbi.nlm.nih.gov/20493274/ (added 29/12/2020)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 40
1. Healthy adult Japanese males aged 20 to 35 years (age on informed consent)
2. Those whose body mass index (BMI) is 18.5 to 25.0 kg/m^2
3. Those who are able to agree, comply with matters to be observed during participation in the trial, undergo consultation/examination, as described in this protocol, and report symptoms
4. Those who are considered to be eligible to participate in this trial based on screening:
4.1. Vital signs and physical examination are within baseline range
4.2. Haematology: within 15% deviations from the upper and lower limits of the baseline range. The differential white blood count is not questioned when the white blood cell count is within the baseline range.
4.3. Blood chemistry:
4.3.1. Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and creatinine within the baseline range
4.3.2. Total bilirubin, triglyceride (TG) within 50% deviation from the upper limit
4.3.3. Serum electrolytes within the baseline range
4.3.4. Other blood chemistry items within 15% deviation from the upper and lower limits of the baseline range
4.4. Urinalysis within the normal range
4.5. Infectious disease tests within the normal ranges
1. Persons with fever (37.5°C or higher) on administration of the test vaccine
2. Persons with clear symptoms of serious acute disorders
3. Persons with a clear history of food/drug-related anaphylaxis
4. Persons with a clear history of malaria, or those with anti-plasmodium falciparum (SE36 antigen) antibody
5. Persons with a history or present illness of disorders requiring gastrointestinal surgery, serious cardiovascular/blood system/respiratory/liver/kidney/digestive tract/neuropsychiatric disorders, or developmental anomalies
6. Persons with a history of fever within 2 days after preventive administration with other types of vaccine, or those in whom symptoms have suggested systemic allergy
7. Persons with a history of convulsion
8. Persons under a diagnosis of immunodeficiency
9. Persons with a history or tentative diagnosis of drug allergy
10. Persons with a history of or present drug/ alcohol dependency
11. Persons who took any medication within 1 week before administration of this test vaccine
12. Persons to whom any live vaccine was administered within 4 weeks before administration of this test vaccine, or inactivated vaccine/toxoid was administered within 1 week
13. Persons who participated in another trial within 4 months before administration of this test vaccine
14. Persons in whom 200 ml of blood was collected (donation) within 1 month before administration of this test vaccine, or more than 400 ml of blood was collected within 3 months
15. Persons consuming excessive alcohol or cigarettes
16. Persons with a positive reaction on drug abuse screening
17. Others who are not considered to be eligible by the chief principal investigator or sub-investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> The safety of BK-SE36 is assessed by the presence or absence of adverse events evaluated from test results, subjective/objective symptoms, laboratory data, blood pressure/pulse rate and body temperature.<br><br> Subjects were visited once a week. At every subjects' visit to the hospital, doctors did health interview for finding some symptoms and blood/serum examination and measurement of blood pressure etc were conducted at the time.<br>
- Secondary Outcome Measures
Name Time Method <br> Changes in the anti-SE36 protein antibody titre at each time point.<br><br> Subjects were visited once a week. At every subjects' visit to the hospital, doctors did health interview for finding some symptoms and blood/serum examination and measurement of blood pressure etc were conducted at the time.<br>