Initial Study of Malaria Vaccine Pfs25-EPA/Alhydrogel(Registered Trademark)

This is an interventional prevention trial for Malaria focused on measuring Recombinant, Proteins, Antigen, Membrane, Assay, Malaria Read More

• INCLUSION CRITERIA:

All of the following criteria must be fulfilled for a volunteer to participate in this trial:

• Age between 18 and 50 years.
• Good general health as a result of review of medical history and/or clinical testing at the time of screening.
• Available for the duration of the trial.
• Willingness to participate in the study as evidenced by signing the informed consent document.
• If female: subject is willing to use reliable contraception methods for the period of at least 1month (2 months for oral contraceptive pills) prior to first vaccination to 3 months after last vaccination. Reliable methods of birth control include: pharmacologic contraceptives including oral, parenteral, and transcutaneous delivery; condoms with spermicide; diaphragm with spermicide; surgical sterilization; vaginal ring; transdermal patch; intrauterine device; abstinence; and post-menopause.

EXCLUSION CRITERIA:

A volunteer will be excluded from participating in this trial if any one of the following criteria is fulfilled:

• Pregnancy as determined by a positive urine or serum human choriogonadotropin (Beta-hCG) test at any point during the study (if female).
• Currently is lactating and breast-feeding (if female).
• Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the participant to understand and cooperate with the study protocol.
• Neutropenia as defined by an absolute neutrophil count < 1500/mm(3).
• Alanine transaminase (ALT) level above the laboratory-defined upper limit of normal.
• Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, endocrine, rheumatologic, autoimmune, hematological, or renal disease by history, physical examination, and/or laboratory studies including urinalysis.
• Other condition that in the opinion of the investigator would jeopardize the safety or rights of a participant participating in the trial or would render the subject unable to comply with the protocol.
• History of receiving any investigational product within the past 30 days.
• Receipt of antimalarial prophylaxis during the past 12 months, or planned travel to a destination which would require malaria prophylaxis during the period of participation.
• Prior malaria infection by history.
• Participant has had medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months.
• History of a severe allergic reaction or anaphylaxis.

• Severe asthma. This will be defined as:

  • Asthma that is unstable or required emergent care, urgent care, hospitalization or intubation during the past 2 years, or that requires the use of oral or parenteral corticosteroids.
  • Clinically significant reactive airway disease that does not respond to bronchodilators.
• Positive ELISA and confirmatory Western blot tests for HIV-1.
• Positive ELISA and confirmatory tests for hepatitis C virus (HCV).
• Positive hepatitis B surface antigen (HBsAg) by ELISA.
• Pre-existing autoimmune or antibody-mediated diseases including but not limited to: systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren's syndrome, or autoimmune thrombocytopenia.
• Known immunodeficiency syndrome.
• Use of chronic (greater than or equal to 14 days) oral or intravenous corticosteroids (excluding topical or nasal) at immunosuppressive doses (i.e. prednisone > 10 mg/ day) or immunosuppressive drugs within 30 days of starting this study.
• Receipt of a live vaccine within past 4 weeks or a killed vaccine within past 2 weeks prior to entry into the study.
• History of a surgical splenectomy.
• Receipt of blood products within the past 6 months.
• Previous receipt of an investigational malaria vaccine.
• Refusal to allow storage of samples for future research.
• Any medical, psychiatric, social, or occupational condition or other responsibility that, in the judgment of the Principal Investigator (PI), would interfere with the evaluation of study objectives.