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B-19 Parvovirus Vaccine Study

NCT00379938 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2011-08-15

No results posted yet for this study

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.

Conditions

  • Parvovirus B19 Infection

Interventions

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

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-08-31
Primary Completion
2008-10-31
Completion
2008-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00379938 on ClinicalTrials.gov