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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00379938
Other study ID # 05-0078
Secondary ID
Status Terminated
Phase Phase 1/Phase 2
First received September 21, 2006
Last updated August 11, 2011
Start date August 2006
Est. completion date October 2008

Study information

Verified date February 2009
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority United States: Federal GovernmentUnited States: Food and Drug AdministrationUnited States: Institutional Review Board
Study type Interventional

Clinical Trial 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 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.


Description:

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Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Biological:
VAI-VP705 (parvovirus B-19 vaccine)
Recombinant human parvovirus B-19 capsids at dose levels: 25 micrograms of VAI-VP705 with and without MF59 adjuvant and 2.5 micrograms with MF59 adjuvant.
Drug:
Placebo
Saline control
Biological:
MF-59
Adjuvant

Locations

Country Name City State
United States University of Maryland School of Medicine Baltimore Maryland
United States Cincinnati Children's Hospital Medical Center Cincinnati Ohio
United States Baylor College of Medicine Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number and percentage of study participants who experience any vaccine-associated AEs or SAEs. Duration of study Yes
Secondary Geometric mean antibody titers (measured by Enzyme-Linked Immunosorbent Assay) by treatment group. 28 days and 12 months after the primary immunization No
Secondary Percentage of study participants who develop neutralizing antibody responses against parvovirus B-19. 28 days following the last dose of vaccine No
Secondary Percentage of study participants who maintain a neutralizing antibody titer. 12 months after the primary immunization No
Secondary Geometric mean neutralizing titer per treatment group. 28 days and 12 months after the primary immunization No
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04822090 - Parvovirus B19 Infection in Hereditary Hemolytic Anemias Patients