Parvovirus B19 Infection Clinical Trial
Official title:
A Phase I/II Study of the Safety and Immunogenicity of a Recombinant Human Parvovirus B-19 Vaccine
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 enrolled. Participants will be randomly chosen to receive 1 of 4 possible vaccine types: low dose of the vaccine and an adjuvant (substance which assists with transfer of medication to body); high dose of the vaccine alone; high dose of the vaccine and an adjuvant; or saline (substance containing no medication). Participants will receive 3 vaccinations over a 6 month period and will be followed for 6 additional months. Blood samples will be taken at months 1, 2, 6, 7 and 12 to determine if antibody, protein produced by the body's immune system that recognizes and helps fight infections, has been formed to the vaccine. These tests measure vaccine efficacy, i.e., determine if the vaccine induces immunity. All participants will be followed closely for safety throughout the study.
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 vaccine is composed of viral capsids that incorporate 2 B-19 proteins (VP-1 and VP-2). There will be 3 sites participating in this study: Cincinnati Children's Hospital Medical Center, Baylor College of Medicine, and the University of Maryland School of Medicine. Eighty-nine parvovirus B-19 seronegative healthy adults 18-45 years old will be randomized to 1 of 4 groups: 2.5 mcg VAI-VP705 with the adjuvant MF59, 25 mcg with the adjuvant MF59, 25 mcg without the adjuvant MF59, or placebo (saline control). Each participant will receive 3 separate vaccinations (Months 0, 1, and 6) and will continue in the study for up to approximately 14 months. Study participants will be followed to evaluate safety and immune response. The primary study objective is to evaluate the safety of VAI-VP705 administered with and without MF59 adjuvant in healthy parvovirus B-19 seronegative adults. The secondary study objectives are to: evaluate the immunogenicity of primary and booster immunizations of 25 mcg of VAI VP705 with and without MF59 and 2.5 mcg with MF59; compare the antibody response of vaccine administered with MF59 at each of 2 doses, 2.5 and 25 mcg versus 25 mcg of vaccine administered without MF59; and evaluate the duration of the immune response 12 months after primary immunization. The primary endpoint is the number and percentage of study participants who experience any vaccine-associated adverse events or serious adverse events. The secondary endpoints include: the percentage of study participants who develop neutralizing antibody responses against parvovirus B-19 28 days following the last dose of vaccine; the percentage of study participants who maintain a neutralizing antibody titer at 12 months after primary immunization; the geometric mean antibody titers (as measured by enzyme-linked immunosorbent assay) by treatment group at 28 days and at 12 months after primary immunization; and the geometric mean neutralizing titers per treatment group at 28 days and at 12 months after primary immunization. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT04822090 -
Parvovirus B19 Infection in Hereditary Hemolytic Anemias Patients
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