Study of VMP001 and AS01B (Adjuvant Formulation) in Healthy Malaria-Naïve Adults

This is an interventional prevention trial for Malaria focused on measuring Malaria, Plasmodium Vivax, Vaccine Read More

Inclusion Criteria:

• Subjects who meet all of the following criteria may participate in this study:
• Healthy adults (male or non-pregnant, non-lactating female) 18 to 55 years of age (inclusive) at the time of enrollment
• If the subject is female, she must be of non-childbearing potential (either surgically sterilized or one year post-menopausal) or, if of childbearing potential, she must be capable of preventing pregnancy, have a negative pregnancy test at the time of each vaccination, and must agree to continue such precautions until completion of the last study visit.
• Free of significant health problems as established by medical history, laboratory and clinical examination before entering the study
• Duffy positive phenotype (homozygous or heterozygous)
• Normal (non-deficient) Glucose 6-phosphate dehydrogenase (G6PD) phenotype (range: 4.6 to 13.5 units/gm hemoglobin)
• Volunteers must have low cardiac risk factors according to the NHANES I criteria and a non-significant electrocardiogram (EKG)
• Available to participate and reachable by phone for duration of study (approximately 9 months)
• No plans to travel to outside the Washington, District of Columbia (DC) area up until treatment course has been completed (post challenge)
• No plans to travel to a malaria endemic area during the course of the study
• Written informed consent must be obtained from the subject before screening procedures
• Volunteers must score at least 80% correct on a 10 or 14 question multiple-choice quiz (control and immunization groups, respectively) that assesses their understanding of this study
• If a subject is active duty military he or she must obtain approval from his or her supervisor per Walter Reed Army Institute of Research (WRAIR) Policy 06-15

Exclusion Criteria:

• Subjects meeting any of the following criteria will be excluded from the study:
• Any history of malaria infection
• History of travel to P. vivax endemic areas in the last three months, and travel to Republic of Korea or China in the last 18 months
• Any history of receiving malaria vaccine or any licensed vaccine within 7 days prior to first immunization
• History of receipt of malaria prophylaxis during the previous 2 months or the use of any drugs with significant anti-malarial activity during the study period one month prior to challenge (for control volunteers). Examples include tetracycline, doxycycline, clindamycin, azithromycin or sulfa drugs
• Use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of study vaccine or planned use during the study period.
• Any history of allergic reaction or anaphylaxis to previous vaccination

Allergy to kanamycin, nickel, or imidazole

• Pregnant (positive β-HCG) or nursing at screening or plans to become pregnant or nurse from the time of enrollment until study completion.
• Allergy to antimalarial drugs or use of medications known to cause drug reactions with chloroquine and/or primaquine
• Significant (e.g. systemic) hypersensitivity reactions to mosquito bites (local hypersensitivity reactions at the site of mosquito bites are not an exclusion criterion)
• History of sickle cell disease
• History of psoriasis or porphyria
• History of splenectomy
• Any confirmed or suspected immunodeficiency, including HIV infection
• Administration of chronic (defined as more than 14 days) immunosuppressive drugs or other immune-modifying drugs within 6 months of immunization. For corticosteroids, this is defined as >20 mg/day prednisone or equivalent. -Inhaled and topical steroids are allowed
• A family history of congenital or hereditary immunodeficiency
• Acute or chronic, clinically significant, pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by history, physical examination, and laboratory evaluation
• History of diabetes or hypertension even if well controlled on medication
• An abnormal baseline screening electrocardiogram (EKG) suggestive of cardiac disease as determined by a clinical investigator
• Chronic or active neurologic disease including seizure disorder and chronic migraine headaches
• Any abnormal baseline laboratory screening tests: Alanine Aminotransferase (ALT) above normal range, -Creatinine above normal range, Hemoglobin out of normal range, Platelet count out of normal range, Total white blood cell count out of normal range
• Hepatomegaly, right upper quadrant abdominal pain or tenderness
• Seropositive for HIV or hepatitis C virus, or HBsAg positive
• Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or any planned administration during the study period
• Suspected or known current alcohol or drug abuse as determined from the medical history or by physical examination
• Any other significant finding that in the opinion of the investigator would increase the risk of having an adverse outcome from participating in this study