Status:
COMPLETED
FMP2.1/AS02A: Rabies Vaccine Malaria-Experienced Adults in Bandiagara, Mali
Lead Sponsor:
U.S. Army Medical Research and Development Command
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Walter Reed Army Institute of Research (WRAIR)
Conditions:
Malaria
Plasmodium Falciparum Malaria
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
Malaria is a disease that affects many people in Africa and in Mali. It is caused by germs that are spread by mosquito bites. This study will look at the safety, effectiveness, and best dose of an exp...
Detailed Description
The primary objective of this study is to evaluate the safety and reactogenicity of two dose levels of WRAIR's AMA1 malaria antigen (FMP2.1) adjuvanted in GlaxoSmithKline Biologicals' AS02A compared t...
Eligibility Criteria
Inclusion
- A male or non-pregnant female aged 18-55 years inclusive at the time of screening
- For women, willingness not to become pregnant until 1 month after the last immunization (pre-menopausal female participants will be referred to the local family planning clinic in Bandiagara, which offers several means of contraception that are approved and recommended by the Malian Ministry of Health)
- Separate written informed consent obtained from the participant before screening and study start, respectively
- Available and willing to participate in follow-up for the duration of study (12 months)
Exclusion
- Previous vaccination with any investigational vaccine or with any rabies vaccine
- Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first study immunization, or planned use up to 30 days after the third immunization
- Chronic administration (defined as more than 14 days) of immuno-suppressants or other immune-modifying drugs within six months prior to the first immunization. This will include any dose level of oral steroids or inhaled steroids, but not topical steroids
- Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before the first study immunization with the exception of tetanus toxoid
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
- Any confirmed or suspected autoimmune disease
- History of allergic reactions or anaphylaxis to immunizations or to any vaccine component
- History of serious allergic reactions to any substance, requiring hospitalization or emergent medical care
- History of allergy to tetracycline, doxycycline, nickel, Imidazole, chicken eggs, processed bovine gelatin, chicken protein, neomycin, or amphotericin B
- History of splenectomy
- Serum ALT \>/=43 IU/L
- Serum creatinine level \>113 µmol /L for males and 70 µmol /L for females
- Hgb \<11 g/dL for males and \<10 g/dL for females
- WBC \<4.0 x 1000/cubic mm or \>13 x 1000/cubic mm
- Absolute lymphocyte count \</=1.4 x 1000 /µl
- Thrombocytopenia \< 108,000/µl
- More than trace protein, more than trace hemoglobin or positive glucose in urine
- Administration of immunoglobulins and/or any blood products within the three months preceding the first study immunization or planned administration during the study period
- Suspected or known current alcohol or illicit drug abuse
- Pregnancy or positive urine beta-HCG on the day of or prior to immunization
- Breastfeeding
- Simultaneous participation in any other interventional clinical trial
- Acute or chronic pulmonary, cardiovascular, hepatic, renal or neurological condition, or any other findings that in the opinion of the Principal Investigator (PI) may increase the risk of participating in the study
- Other condition that in the opinion of the PI would jeopardize the safety or rights of a participant in the trial or would render the participant unable to comply with the protocol
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00349713
Start Date
November 1 2004
End Date
December 1 2006
Last Update
July 24 2017
Active Locations (1)
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1
University of Bamako, Malaria Research and Training Center
Bamako, Mali