A Phase I Clinical Trial Immunizing Healthy Adults With the NMRC-M3V-Ad-PfCA Vaccine to Generate Biologic Reagents (AdBa)

This is an interventional health services research trial for Healthy Read More

Inclusion Criteria:

• Healthy adults (male or non-pregnant, non-lactating female) 18 - 50 years of age (inclusive)
• Available and willing to participate for duration of study
• Able and willing to provide written informed consent
• Able to complete an Assessment of Understanding with a score of at least 75% correct
• In good general health with no clinically significant health problems as established by medical history, physical exam, and laboratory screening
• Men, and women of childbearing potential must agree to use effective means of birth control from time of enrollment through the duration of the active phase of the study (3 months following immunization)
• Women: Sexually active females, unless surgically sterile or at least one year post-menopausal, must use an effective method of avoiding pregnancy (including oral or implanted contraceptives, IUD, female condom, diaphragm with spermicide, cervical cap, abstinence, use of a condom by the sexual partner or sterile sexual partner) prior to dosing of study vaccine, and must agree to continue using such precautions for at least 3 months after immunization. Female subjects unable to bear children must have a note from a Primary Care Provider as proof of her documentation (e.g. tubal ligation or hysterectomy) or must be post-menopausal as appropriate by age with at least one year of amenorrhea.
• Men must agree to use of effective means of birth control. If a male subject has had a vasectomy this will be considered an adequate means of birth control.
• Agree to refrain from blood donation for one year after immunization
• Agree not to travel to a malaria endemic region during the active phase of the study
• Good peripheral venous access

Exclusion Criteria:

• Females who are pregnant (positive urine β-HCG) or nursing at screening or plan on becoming pregnant or plan to nurse from time of screening through the duration of the active phase of the study (3 months following immunization)
• Positive HIV, HBsAg or HCV serology
• An abnormal EKG, defined as one showing pathologic Q waves and significant ST-T wave changes; left ventricular hypertrophy; any non-sinus rhythm excluding isolated premature atrial contractions; right or left bundle branch block; or advanced (secondary or tertiary) A-V heart block.
• Weight less than 110 pounds
• Use of systemic immunosuppressant pharmacotherapy (inhaled and topical steroids are allowed) within 60 days of scheduled leukapheresis/60 mL blood draw or immunization
• Current significant medical condition (cardiovascular, pulmonary, hepatic, renal, or hematological) or evidence of any other serious underlying medical condition identified by medical history, physical examination, or laboratory examination (includes bleeding disorders)
• Plan for surgery between screening visit and second (final) leukapheresis
• Known allergy to any component of the vaccine formulation
• Participation in any study involving another investigational vaccine or drug within 30 days prior to the first scheduled leukapheresis/60 mL blood draw or plan to participate in another investigational vaccine/drug research study during participation in the active phase of this study
• Receipt of immunoglobulin and/or any blood products within 90 days of scheduled leukapheresis/60 mL blood draw or immunization
• Any other significant finding which, in the investigator's judgment, may substantially increase the risk associated with the subject's participation in the study or compromise the scientific objectives
• Risk factors for HIV exposure: unsafe sex and injectable drug use