Status:
TERMINATED
B-19 Parvovirus Vaccine Study
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Parvovirus B19 Infection
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
PHASE2
Brief Summary
This study investigates the safety and effectiveness of a preventative vaccine for parvovirus B-19 infection. Eighty-nine healthy adults ages 18-49, whose blood tests negative for B-19, will be enroll...
Detailed Description
This study is a Phase I/II randomized, placebo-controlled, double-blind clinical trial of the immunogenicity and safety of 2 dose levels of a recombinant human parvovirus B-19 vaccine (VAI-VP705). The...
Eligibility Criteria
Inclusion
- Must be able to provide informed consent;
- Must be between the ages of 18 to 45 at time of randomization;
- Must be in good health, as determined by vital signs (heart rate, blood pressure, respiration, and oral temperature), medical history, and a targeted physical examination based on medical history;
- Must have a negative serum pregnancy test at screening and negative urine pregnancy test prior to each vaccination (females);
- Must be medically or surgically sterile or agree to practice effective contraception (egg, oral contraceptives, diaphragm in combination with contraceptive jelly, cream, or foam; intrauterine contraceptive device; Depo-Provera; skin patch; vaginal ring or cervical cap) through 30 days after the final dose of study drug. Oral and hormonal contraceptives must be initiated at least 30 days prior to first dose of study drug and must continue through 30 days after the final dose of study drug;
- Must have a negative hepatitis B surface antigen (HBsAg) and hepatitis C virus (HCV) and HIV antibodies \[by Enzyme-Linked Immunosorbent Assay (ELISA) and confirmed if positive by Western blot analysis \[WBA\]) prior to randomization);
- Must be seronegative for parvovirus B-19 by enzyme-linked immunosorbent assay \[ELISA\] prior to randomization.
Exclusion
- Acute febrile illness (greater than or equal to 37.8 degrees Celcius/100 degrees Fahrenheit) within the 72 hours preceding the vaccination (vaccine may be deferred until resolved);
- Known exposure to persons with parvovirus B-19 (egg, fifth disease) within 6 weeks prior to randomization;
- Illness associated with parvovirus B-19 infection within 6 weeks prior to randomization;
- History of severe adverse reaction or allergy to any vaccine;
- Known or suspected allergies to vaccine constituents (egg, MF59);
- History of treatment with immunosuppressive drugs in the 30 days prior to enrollment (inhaled or topical corticosteroids are permitted) or for 28 days following last dose of vaccine;
- Treatment with blood or blood products within 3 months prior to enrollment or throughout the duration of the study;
- History of polyarthritis;
- A history or clinical manifestation of significant immunodeficiency, metabolic, pulmonary, cardiovascular, hepatic, renal, hematologic (including hereditary and hemolytic anemias), or gastrointestinal disorders;
- Clinically significant abnormal laboratory values at Screening including the following:
- Hgb \<11.5 g/dL (females) or 12.5 g/dL (males); white blood cell (WBC) \<4000/microliters; platelet count \<135000/microliters;
- Alanine aminotransferase (ALT) or creatinine above the upper limits of normal.
- Any acute or chronic condition (including alcohol or drug abuse) that in the principal investigator's (PIs) opinion would limit the volunteer's ability to complete the study;
- Pregnant or breastfeeding;
- Receipt or planned receipt of any investigational drug, vaccine (exclusive of the vaccine under study), device or intervention within 30 days prior to randomization or through the 6 months following the last dose of study vaccine;
- Receipt of any licensed killed vaccine within 2 weeks before or after any dose of study vaccine;
- Receipt of any licensed, live, attenuated vaccine within 4 weeks before or after any dose of study vaccine;
- Any other condition that, in the opinion of the investigators, would place the subject at an unacceptable risk for participation in the study.
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT00379938
Start Date
August 1 2006
End Date
October 1 2008
Last Update
August 15 2011
Active Locations (3)
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1
University of Maryland School of Medicine
Baltimore, Maryland, United States, 21201
2
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229-3039
3
Baylor College of Medicine
Houston, Texas, United States, 77030