characterisation of the immune responses of 2 experimental malaria vaccines

Conditions: Malaria

Summary: 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.


Eligibility 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.

Keywords: adjuvant malaria safety immunogenicity