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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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28 March 2022 |
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Main ID: |
EUCTR2006-002095-18-BE |
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Date of registration:
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14/02/2007 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A phase II randomized, double-blind (observer blind), adjuvant justification study of RTS,S/AS01B and RTS,S/AS02A, candidate malaria vaccines, administered according to a 0, 1, 2 months schedule in malaria-naive adults aged 18 to 45 years. - Malaria-048
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Scientific title:
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A phase II randomized, double-blind (observer blind), adjuvant justification study of RTS,S/AS01B and RTS,S/AS02A, candidate malaria vaccines, administered according to a 0, 1, 2 months schedule in malaria-naive adults aged 18 to 45 years. - Malaria-048 |
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Date of first enrolment:
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20/03/2007 |
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Target sample size:
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36 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-002095-18 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: yes
Other specify the comparator: RTS,S/Saline
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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Belgium
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Key inclusion & exclusion criteria
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Inclusion criteria:
• A male or female between, and including, 18 and 45 years of age at the time of the first vaccination.
• Written informed consent obtained from the subject.
• Free of obvious health problems as established by medical history and clinical examination before entering into the study.
• Have clinically normal laboratory values for creatinine, alanine aminotransferase (ALT), aspartate aminotransferase (AST), complete blood count (CBC) and differential at screening.
• Be seronegative for human immunodeficiency virus 1 and 2 (HIV 1/2) antibodies, hepatitis B surface antigen (HBsAg) and hepatitis C virus (HCV) antibodies.
• Have anti HBs titre >=10mIU/ml at screening.
• If the subject is female, she must be of non-childbearing potential, i.e. have a current tubal ligation, hysterectomy, ovariectomy or be post-menopausal, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. (For corticosteroids, this will mean prednisone, or equivalent, >= 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
• Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine.
• Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
• Any history of clinical malaria.
• Known exposure to malaria parasites within the previous 12 months.
• Planned travel to a malaria endemic region during the study period.
• History of allergic reactions (significant Immunoglobulin [IgE]-mediated events) or anaphylaxis to previous immunizations.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
• Personal history of autoimmune disease or subjects who describe a first-degree relative with clearly documented autoimmune disease. Exclusionary medical histories will include the following diagnoses: systemic lupus erythmatosus, rheumatoid arthritis, mixed connective tissue disease, scleroderma, vasculitis, and multiple sclerosis.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
• Major congenital defects or serious chronic illness(es).
• History of any neurologic disorders or seizures.
• Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. Oral temperature <37.5°C (99.5°F) / axillary temperature <37.5°C (99.5°F).
• Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
• Hepatomegaly, right upper quadrant abdominal pain or tenderness.
• Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
• History of previous exposure to experimental products containing AS02A, AS01B or related products containing MPL and QS21.
• Pregnant or lactating female.
• History of chronic alcohol consumption and/or drug abuse.
• Female planning to become pregnant or planning to discontinue contraceptive precautions.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Malaria disease
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Intervention(s)
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Product Name: Active control
Product Code: RTS,S/saline diluent
Pharmaceutical Form: Powder and solvent for suspension for injection
Current Sponsor code: RTS,S
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: range
Concentration number: 80-120
Product Name: Candidate Plasmodium falciparum malaria vaccine
Product Code: RTS,S/AS01B
Pharmaceutical Form: Powder and solvent for suspension for injection
Current Sponsor code: RTS,S
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: range
Concentration number: 80-120
Product Name: Candidate Plasmodium falciparum malaria vaccine
Product Code: RTS,S/AS02A
Pharmaceutical Form: Powder and solvent for solution for injection
Current Sponsor code: RTS,S
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: range
Concentration number: 80-120
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Primary Outcome(s)
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Secondary Objective: Safety
• To assess the safety and reactogenicity of RTS,S/AS01B and RTS,S/AS02A vaccine formulations as well as that of RTS,S reconstituted with saline diluent, following a three-dose vaccination regimen according to a 0, 1, 2-month schedule to malaria-naïve adults aged 18 to 45 years.
Immunogenicity
• To describe the humoral and cellular immunogenicity of RTS,S/AS01B and RTS,S/AS02A vaccine formulations as well as that of RTS,S vaccine antigen reconstituted with saline diluent when administered according to a 0, 1, 2-month schedule to malaria-naïve adults aged 18 to 45 years by:
? assessing the antibody responses to CS and HBs antigens.
? assessing the cellular immune responses to the CS and HBs antigens by flow cytometry using intracellular cytokine staining (ICS) analyses on frozen peripheral blood mononuclear cells (PBMCs).
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Main Objective: Immunogenicity
• To demonstrate the superiority of anti-CS antibody response at 1 month post Dose 3 induced by RTS,S vaccine antigen formulated with AS01B adjuvant compared to RTS,S vaccine antigen reconstituted with saline.
• To demonstrate the superiority of the anti-CS antibody response at 1 month post Dose 3 induced by RTS,S vaccine antigen formulated with AS02A adjuvant compared to RTS,S vaccine antigen reconstituted with saline.
The primary objective of the trial is considered reached if 1 of the 2 co-primary objectives is met.
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Primary end point(s): Immunogenicity
Anti-CS antibody titers one month post Dose 3 for RTS,S/AS01B, RTS,S/AS02A and RTS,S/Saline Groups.
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 23/02/2007
Contact:
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