Status:
COMPLETED
Safety and Immunogenicity of EBA-175 RII-NG Malaria Vaccine Administered Intramuscularly
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Plasmodium Falciparum Malaria
Eligibility:
All Genders
18-40 years
Phase:
PHASE1
Brief Summary
Malaria is an illness caused by a parasite (an animal or plant that lives in or on a host) that enters the human body through the bite of an infected mosquito. The purpose of this study is to find out...
Detailed Description
This study is a phase I, double-blinded, placebo-controlled, dosage-escalation study of the safety and immunogenicity of EBA-175 RII-NG malaria vaccine administered intramuscularly. The vaccine is a r...
Eligibility Criteria
Inclusion
- Healthy males and healthy nonpregnant females between the ages of 18 and 40 years.
- Females of childbearing potential must agree to practice adequate contraception for the entire study period (including abstinence; hormonal contraception; condoms with spermicidal agents; surgical sterilization; or vasectomized partner).
- Good health as determined by screening medical history, physical examination, and routine laboratory assessments.
- Willingness to comply with protocol requirements.
- Ability to provide informed consent before any protocol procedures are performed.
- Availability for follow up for 12 months after the first immunization dose.
Exclusion
- Regular use of medications other than vitamins and contraceptives.
- Current or recent (within the last 4 weeks) treatment with parenteral, inhaled, or oral corticosteroids (intranasal steroids are acceptable), or other immunosuppressive agents, or chemotherapy.
- History of splenectomy.
- Abnormal screening laboratory values. Any abnormal screening value for any screening test, except reticulocyte count (even if in subsequent tests the value is within normal range) will exclude the subject from the study. An exception to this rule is the glucose measurement. Random plasma glucose will be measured on all subjects during the screening visit. Values higher than 109 mg/dl will be confirmed by a repeat fasting glucose measurement.
- History of or current medical, occupational, social or family problems as a result of alcohol or illicit drug use.
- History of moderate to severe mental illness, as defined by symptoms interfering with social or occupational function or suicidal thoughts/attempts.
- History of receiving blood or blood products (such as blood transfusion, platelet transfusion, immunoglobulins, hyperimmune serum) in the previous 6 months.
- Vaccination with a live vaccine within the past 30 days or with a nonreplicating, inactivated, or subunit vaccine within the last 14 days.
- Known hypersensitivity to components of the vaccine (EBA-175 RII-NG, sucrose, or aluminum adjuvant).
- History of acute or chronic medical conditions including, but not limited to, disorders of the liver, kidney, lung, heart, or nervous system, or other metabolic and autoimmune/inflammatory conditions.
- History of anaphylaxis or severe hypersensitivity reaction.
- Severe asthma, as defined by an emergency room visit or hospitalization within the last 12 months.
- Pregnant or breastfeeding women, or women unwilling to use effective contraception during the study period.
- Acute illness, including temperature \>100 degrees F within one week of vaccination.
- Positive serology for human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B surface antigen (HBsAg).
- Concurrent participation in other investigational protocols or receipt of an investigational product within the previous 30 days.
- Identification of any condition that, in the opinion of the investigator, would affect the ability of the subject to understand or comply with the study protocol or would jeopardize the safety or rights of a subject participating in the study.
- History of malignancy, including hematologic and skin cancers, or known immunodeficiency syndrome.
- History of malaria infection or receipt of a malaria vaccine.
- History of travel to malaria-endemic area or receipt of antimalarial prophylaxis in the past 12 months.
- Planned travel to a malaria-endemic area during the course of the study.
- Pre-medication with analgesic or antipyretic in the 6 hours prior to vaccination, or planned medication with analgesic or antipyretic in the 24 hours following vaccination. This should not preclude subjects receiving such medication if the need arises.
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00347555
Start Date
May 1 2006
End Date
April 1 2008
Last Update
April 12 2013
Active Locations (1)
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1
Baylor College of Medicine - Molecular Virology and Microbiology
Houston, Texas, United States, 77030