EBA-175 RII-NG Malaria Vaccine Administered Intramuscularly in Semi-immune Adults

• Status: Completed
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Malaria is caused by a germ that people get from the bites of some mosquitoes. It kills over 2 million people each year. Many of the drugs used to treat malaria do not work as well as they used to and researchers are exploring other vaccines to prevent malaria. The purpose of this study is to learn if the vaccine, called EBA-175 RII-NG, is safe and if it strengthens the body's defenses against malaria. Participants will include 60 healthy adults, ages 18-40, recruited from Accra, Ghana. Several dosages of the vaccine will be tested for safety. The lowest dosages of the vaccine will be tested before the next higher dose is tested. There will be two groups for each dose, one group will receive the vaccine and the other group will receive a placebo (salt water solution). Participants may be involved in study related procedures for up to 398 days.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Aluminum phosphate; Vaccines

Criteria

Inclusion Criteria:

• Healthy males and healthy non-pregnant and non breastfeeding females between the ages of 18 and 40 years.

• Females of childbearing potential must agree to practice adequate contraception through out the study and for 3 months after the third vaccination (including abstinence; hormonal contraception; condoms with spermicidal agents); males with female partners of childbearing age must agree to use condoms or other birth control.

• Good health as determined by screening medical history, physical examination (PE), 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 Criteria:

• Regular use of medications other than vitamins and contraceptives.

• Current or recent (within the last 4 weeks prior to vaccination) 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, 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 110 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 by the volunteer.

• 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 non-replicating, inactivated, or subunit vaccine within the last 14 days.

• Known hypersensitivity to components of the vaccine [Erythrocyte-Binding Antigen 175 kDa Region II-Nonglycosylated (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, sickle cell disease.

• 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 > 37.8 degrees Celsius within one week prior to 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.

• 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 criterion should not preclude subjects receiving such medication after vaccination if the need arises.