Status:
COMPLETED
Study of VMP001 and AS01B (Adjuvant Formulation) in Healthy Malaria-Naïve Adults
Lead Sponsor:
U.S. Army Medical Research and Development Command
Collaborating Sponsors:
The PATH Malaria Vaccine Initiative (MVI)
Walter Reed Army Institute of Research (WRAIR)
Conditions:
Malaria
Plasmodium Vivax
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
PHASE2
Brief Summary
This is a first-in-humans safety, immunogenicity and efficacy study with recombinant protein VMP001, a Plasmodium vivax circumsporozoite (CS) protein based vaccine. This open label study will be perfo...
Detailed Description
This is a Phase 1/2a, non-randomized, open label, dose escalation study in healthy, malaria-naïve adults aged 18 to 55 years (inclusive). The vaccine will be administered with GlaxoSmithKline Biologic...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT01157897
Start Date
July 1 2010
End Date
January 1 2012
Last Update
May 29 2019
Active Locations (1)
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1
Clinical Trials Center, Walter Reed Army Institute of Reserach
Silver Spring, Maryland, United States, 20910