Safety and Immunogenicity of EBA-175 RII-NG Malaria Vaccine Administered Intramuscularly
Phase I, Double-Blinded, Placebo-Controlled Dosage-Escalation Study of the Safety and Immunogenicity of EBA-175 RII-NG Malaria Vaccine Administered Intramuscularly
2 other identifiers
interventional
80
1 country
1
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 about the safety of an experimental malaria vaccine and whether the vaccine causes humans to produce antibodies (proteins made by the body's immune system to help control or prevent infection). Four strengths of the vaccine will be tested. The lowest strength of the vaccine will be tested before the next higher strength is tested. Each dosage (shot) of vaccine will be given to 18 people in 4 dosage groups on Day 0, at 1 month and at 6 months. Two people in each dosage group will receive injections of a placebo (contains no medication). Participants will include 80 healthy adults between 18 and 40 years of age. Multiple blood draws will occur over the duration of the study. Participants will be involved in study related procedures for approximately 13 months.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started May 2006
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2006
CompletedFirst Submitted
Initial submission to the registry
June 29, 2006
CompletedFirst Posted
Study publicly available on registry
July 4, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2008
CompletedApril 12, 2013
May 1, 2012
1.9 years
June 29, 2006
April 11, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Frequency and severity of injection site and systemic adverse events (AEs).
Duration of study.
Secondary Outcomes (4)
Relative binding inhibition of recombinant EBA-175 RII-NG to human RBCs in vitro in the presence of serum from immunized individuals.
Days 0, 14, 28, 42, 180, and 194.
Anti-parasite antibodies by indirect fluorescence antibody test (IFAT).
Days 0, 14, 28, 42, 180, and 194.
Anti-EBA-175 RII-NG antibody level by ELISA.
Days 0, 14, 28, 42, 180, and 194.
Relative growth inhibition of Pf in human RBCs cultured in vitro in the presence of serum from immunized individuals.
Days 0, 14, 28, 42, 180, and 194.
Study Arms (4)
Group D
EXPERIMENTAL18 subjects 160 micrograms EBA-175+500 micrograms aluminum adjuvant; 2 subjects placebo.
Group A
EXPERIMENTAL18 subjects 5 micrograms EBA-175+500 micrograms aluminum adjuvant; 2 subjects placebo.
Group B
EXPERIMENTAL18 subjects 20 micrograms EBA-175+500 micrograms aluminum adjuvant; 2 subjects placebo.
Group C
EXPERIMENTAL18 subjects 80 micrograms EBA-175+500 micrograms aluminum adjuvant; 2 subjects placebo.
Interventions
1.0 mg/mL (0.5 mg/0.5 mL per dose) aluminum as aluminum phosphate adjuvant; dosage 500 micrograms.
0.5 mL normal saline placebo. Sodium phosphate buffer (10 mM sodium phosphate and 150 mM sodium chloride).
White, translucent, cloudy, nonparticulate liquid suspension. Recombinant Plasmodium falciparum erythrocyte-binding antigen 175 kDa Region II-nonglycosylated (EBA-175 RII-NG) absorbed to aluminum phosphate adjuvant; dosage levels 5, 20, 80, and 160 micrograms.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Baylor College of Medicine - Molecular Virology and Microbiology
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 29, 2006
First Posted
July 4, 2006
Study Start
May 1, 2006
Primary Completion
April 1, 2008
Study Completion
April 1, 2008
Last Updated
April 12, 2013
Record last verified: 2012-05