B-19 Parvovirus Vaccine Study

NCT00379938 | Terminated Phase 1

• 1 other identifier: 05-0078
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 3

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 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

Keywords

Parvovirus B-19, Parvoviridae, vaccine

Outcome Measures

Primary Outcomes (1)

• Number and percentage of study participants who experience any vaccine-associated AEs or SAEs.

  Duration of study

Secondary Outcomes (4)

• Geometric mean antibody titers (measured by Enzyme-Linked Immunosorbent Assay) by treatment group.

  28 days and 12 months after the primary immunization

• Percentage of study participants who develop neutralizing antibody responses against parvovirus B-19.

  28 days following the last dose of vaccine

• Percentage of study participants who maintain a neutralizing antibody titer.

  12 months after the primary immunization

• Geometric mean neutralizing titer per treatment group.

  28 days and 12 months after the primary immunization

Study Arms (4)

1

EXPERIMENTAL

25 micrograms + MF59 (n=26)

Biological: VAI-VP705 (parvovirus B-19 vaccine); Biological: MF-59

3

EXPERIMENTAL

2.5 micrograms + MF59 (n=26)

Biological: VAI-VP705 (parvovirus B-19 vaccine); Biological: MF-59

4

PLACEBO COMPARATOR

saline (n=11)

Drug: Placebo

2

EXPERIMENTAL

25 micrograms alone (n=26)

Biological: VAI-VP705 (parvovirus B-19 vaccine)

Interventions

VAI-VP705 (parvovirus B-19 vaccine) BIOLOGICAL

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.

1; 2; 3

Placebo DRUG

Saline control

4

MF-59 BIOLOGICAL

Adjuvant

1; 3

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (3)

University of Maryland School of Medicine

Baltimore, Maryland, 21201, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229-3039, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Erythema Infectiosum; Parvoviridae Infections

Condition Hierarchy (Ancestors)

DNA Virus Infections; Virus Diseases; Infections; Skin Diseases, Viral; Erythema; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Infectious

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: September 21, 2006
• First Posted: September 25, 2006
• Study Start: August 1, 2006
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: August 15, 2011

Record last verified: 2009-02

Locations

US (3)