Last updated: 11/07/2018 02:04:34
Characterisation of the immune responses of 2 experimental malaria vaccines
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Adjuvant justification study of candidate malaria vaccines (257049), administered according to a 0, 1, 2 months schedule .
Trial description: In this study, two experimental malaria vaccines (with adjuvants) are tested to evaluate and characterise how the vaccine exactly works on the immune system by comparing it to a control (without adjuvant). The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Anti-CS antibody titers.
Timeframe: One month post Dose 3.
Secondary outcomes:
Occurrence, intensity and relationship to vaccination of solicited local and general symptoms.
Timeframe: During the 7-day follow-up period following vaccination after each vaccine dose.
Occurrence, intensity and relationship to vaccination of unsolicited symptoms.
Timeframe: During the 30-day follow-up period following vaccination after each vaccine dose.
Occurrence of serious adverse events.
Timeframe: Up until 1 month post dose 3.
Antibody responses to the P. falciparum circumsporozoite (CS) antigen.
Timeframe: At Day 0, prior to dose 2, prior to dose 3 and 1 month post-dose 3.
Antibody responses to HBs antigen.
Timeframe: At Day 0, prior to dose 2, prior to dose 3 and 1 month post-dose 3
Frequency of CS and Hepatitis B surface agent (HBs)-specific CD4+ and CD8+ T cells expressing Th1 specific activation markers and cytokines.
Timeframe: At Day 0, prior to dose 2, prior to dose 3 and 1 month post-dose 3
Interventions:
Biological/vaccine: GSK Malaria vaccine 257049
Enrollment:
36
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Leroux-Roels G et al. (2014) Evaluation of the immune response to RTS,S/AS01 and RTS,S/AS02 adjuvanted vaccines: randomized, double-blind study in malaria-naïve adults. Hum Vaccin Immunother. 10(8):2211-2219.
Medical condition
Malaria
Product
SB257049
Collaborators
Not applicable
Study date(s)
March 2007 to July 2007
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18 - 45 years
Accepts healthy volunteers
Yes
- Subjects who the investigator believes can and will comply with the requirements of the protocol.
- A male or female between, and including, 18 and 45 years of age at the time of the first vaccination.
- 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 6 months prior to the first vaccine dose.
Inclusion and exclusion criteria
Inclusion criteria:
- Subjects who the investigator believes can and will comply with the requirements of the protocol.
- 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, 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 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.
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 6 months prior to the first vaccine dose.
- 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 or anaphylaxis to previous immunizations.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- Personal history of autoimmune disease or subjects who describe a first-degree relative with clearly documented autoimmune disease.
- 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).
- Acute disease at the time of enrolment.
- History of any neurologic disorders or seizures.
- 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 any component of the vaccines used in this study.
- Pregnant or lactating female.
- History of chronic alcohol consumption and/or drug abuse.
- Female planning to become pregnant or planning to discontinue contraceptive precautions.
Trial location(s)
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2007-13-07
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
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