BK-SE36 two-stage phase 1b vaccine trial for falciparum malaria
- Conditions
- MalariaInfections and InfestationsPlasmodium falciparum malaria
- Registration Number
- ISRCTN71619711
- Lead Sponsor
- The Research Foundation for Microbial Diseases of Osaka University (BIKEN) (Japan)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 140
1. Inclusion criteria for Stage 1: 21 to 40 years old
Healthy subjects are specified, and the inclusion criteria of malnutrition index and laboratory test values were included to reduce individual variation.
1.1. Healthy adults; Ugandan males and females aged 21 to 40 years (age on informed consent)
1.2. Those who do not suffer from severe malnutrition (defined as an adult whose weight-for-height is below -3 standard deviation or less than 70% of the median of the National Center for Health Statistics [NCHS]/World Health Organization [WHO] normalised reference values)
1.3. 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
1.4. Those who are considered to be eligible to participate in this trial based on screening:
1.4.1. Vital signs and physical examination are within baseline range
1.4.2. Haematology within 25% 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.
1.4.3. Blood chemistry:
i. Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and creatinine within the baseline range
ii. Total bilirubin within 50% deviation from the upper limit
iii. Serum electrolytes within the baseline range
iv. Other blood chemistry items within 25% deviation from the upper and lower limits of the baseline range
1.4.4. Urinalysis within the normal range
2. Inclusion criteria for Stage 2: 6 to 20 years old
2.1. Healthy volunteers, irrespective of gender, aged 6 to 20 years (age on informed consent)
2.2. Those who do not suffer from severe malnutrition (defined as a child or adult whose weight-for-height is below -3 standard deviation or less than 70% of the median of the NCHS/WHO normalised reference values)
2.3. Those who can give affirmative agreement to participate in the trial. For children between 8 to 17 years, the child's assent takes precedence over the parent(s)/guardian(s) consent
2.4. 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
2.5. Those who are considered to be eligible to participate in this trial based on screening:
2.5.1. Vital signs and physical examination are within baseline range
2.5.2. Hematology within 25% 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.
2.5.3. Blood chemistry:
i. AST, ALT, and creatinine within the baseline range
ii. Total bilirubin within 50% deviation from the upper limit
iii. Serum electrolytes within the baseline range
iv. Other blood chemistry items within 25% deviation from the upper and lower limits of the baseline range
2.5.4. Urinalysis within the normal range
Exclusion criteria for Stages 1 and 2:
1. Persons with fever (37.5°C or higher) on administration of the test vaccine
2. Persons with a clear history of food/drug-related anaphylaxis
3. Females (adolescents/adults) who are pregnant or have a positive urine beta-human chorionic gonadotrophin [beta-hCG] on the day of, or prior to, administration
4. Females currently lactating or breast-feeding
5. Persons with acute or chronic cardiovascular, pulmonary, hepatic, renal, or neurological condition, which in the opinion of the investigator may increase the risk of the subject from participating in the trial
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 with any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection. (No infectious disease testing will be conducted. HIV testing will not be done. Severe, suspected infectious diseases will be ruled out by investigators during physical examination/consultation, blood haematology/chemistry tests; although not conclusive of the causative agent). Additional oral confirmation: Subject informed the investigator that he/she has been tested positive for HIV/acquired immune deficiency virus (AIDS).
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 (except for artemether/lumefantrine and dihydroartemisinin-piperaquine)
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. 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The safety of BK-SE36 will be assessed by the presence or absence of adverse events. This information will be gathered from patient symptoms, vital signs and laboratory test results obtained 1 hour after administration and 1, 7, 14 and 21 ±1 days after each administration.
- Secondary Outcome Measures
Name Time Method Changes in the anti-SE36 protein antibody titre at each time point: screening, before each administration and 21 +/- 1 day post-administration (final visit).