Parvovirus B19 InfectionPhase 1/2NCT00379938
B-19 Parvovirus Vaccine Study
A Phase 1/2 study testing VAI-VP705 (parvovirus B-19 vaccine) and MF-59 in people with Parvovirus B19 Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Parvovirus B19 Infection
- What is being tested?
- VAI-VP705 (parvovirus B-19 vaccine) and MF-59
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 2006to Oct 2008
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Maryland School of Medicine
Baltimore, Maryland, 21201
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229-3039
Baylor College of Medicine
Houston, Texas, 77030
About this study
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.
Read the 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 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.
- Conditions
- Parvovirus B19 Infection
- Being tested
- VAI-VP705 (parvovirus B-19 vaccine), Placebo, MF-59
- Keywords
- Parvovirus B-19, Parvoviridae, vaccine
- Medical subject headings
- Erythema Infectiosum, Parvoviridae Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
PlaceboDrug
Saline control
MF-59Biological
Adjuvant
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 25 micrograms + MF59 (n=26) Receives: Biological: VAI-VP705 (parvovirus B-19 vaccine); Biological: MF-59 |
| 3 | Experimental | 2.5 micrograms + MF59 (n=26) Receives: Biological: VAI-VP705 (parvovirus B-19 vaccine); Biological: MF-59 |
| 4 | Placebo comparator | saline (n=11) Receives: Drug: Placebo |
| 2 | Experimental | 25 micrograms alone (n=26) Receives: Biological: VAI-VP705 (parvovirus B-19 vaccine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and percentage of study participants who experience any vaccine-associated AEs or SAEs.
Measured: Duration of study
Secondary outcomes (4)
Geometric mean antibody titers (measured by Enzyme-Linked Immunosorbent Assay) by treatment group.
Measured: 28 days and 12 months after the primary immunization
Percentage of study participants who develop neutralizing antibody responses against parvovirus B-19.
Measured: 28 days following the last dose of vaccine
Percentage of study participants who maintain a neutralizing antibody titer.
Measured: 12 months after the primary immunization
Geometric mean neutralizing titer per treatment group.
Measured: 28 days and 12 months after the primary immunization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2006 (estimated)
- Study startAug 2006
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parvovirus B19 InfectionStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00379938
- Sponsor's protocol ID
- 05-0078
- Status last verified
- Feb 2009
- First submitted
- 21 Sep 2006
- Last updated
- 15 Aug 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of the Safety and Immunogenicity of a Recombinant Human Parvovirus B-19 Vaccine
- ClinicalTrials.gov ID
- NCT00379938
- Acronym / sponsor ID
- 05-0078
- Conditions
- Parvovirus B19 Infection
- Keywords
- Parvovirus B-19, Parvoviridae, vaccine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 43 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Aug 2006
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 25 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: VAI-VP705 (parvovirus B-19 vaccine), Biological: MF-5925 micrograms + MF59 (n=26) |
| 3 | Experimental | Biological: VAI-VP705 (parvovirus B-19 vaccine), Biological: MF-592.5 micrograms + MF59 (n=26) |
| 4 | Placebo comparator | Drug: Placebosaline (n=11) |
| 2 | Experimental | Biological: VAI-VP705 (parvovirus B-19 vaccine)25 micrograms alone (n=26) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (18 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Biological | 1, 2, 3 |
| PlaceboSaline control | Drug | 4 |
| MF-59Adjuvant | Biological | 1, 3 |
Primary outcome
Number and percentage of study participants who experience any vaccine-associated AEs or SAEs.
Time frame: Duration of study
4 secondary outcomes
Geometric mean antibody titers (measured by Enzyme-Linked Immunosorbent Assay) by treatment group.
Time frame: 28 days and 12 months after the primary immunization
Percentage of study participants who develop neutralizing antibody responses against parvovirus B-19.
Time frame: 28 days following the last dose of vaccine
Percentage of study participants who maintain a neutralizing antibody titer.
Time frame: 12 months after the primary immunization
Geometric mean neutralizing titer per treatment group.
Time frame: 28 days and 12 months after the primary immunization
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2011.
Related trials for Parvovirus B19 Infection
RecruitingObservational study
Parvovirus B19 Infection in Pregnancy: Clinical Manifestations and Fetus/Newborn Outcome
Parvovirus B19 Infection, Pregnancy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing VAI-VP705 (parvovirus B-19 vaccine) and MF-59 in people with Parvovirus B19 Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and percentage of study participants who experience any vaccine-associated AEs or SAEs. (time frame: Duration of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2011.