Accelerated Immunization to Induce Cytomegalovirus Immunity in Stem Cell Donors
A Pilot Trial of an Accelerated Immunization Schedule With ALVAC-pp65 (vCP260) for Inducing CMV-Specific Immunity in Stem Cell Allotransplant Donors and Healthy Volunteers
2 other identifiers
interventional
38
1 country
1
Brief Summary
This study will evaluate the safety and effectiveness of a new vaccine, ALVAC-pp65, in boosting immunity to cytomegalovirus (CMV) infection in stem cell transplant donors. CMV is a member of the herpesvirus group, which includes herpes simplex virus types 1 and 2, varicella-zoster virus (which causes chickenpox), and Epstein-Barr virus (which causes infectious mononucleosis). Most adults are infected with CMV, but a healthy immune system keeps the virus in check, so that it does not cause harm. In people with a weakened immune system, such as transplant recipients, the virus can become reactivated. Medications for treating the infection may cause low blood counts and kidney damage, and, in some cases, the virus may cause death. The ALVAC-pp65 vaccine is intended to improve immunity against CMV in stem cell donors and thereby prevent its reactivation in recipients. It is made from a virus that ordinarily infects canaries. The virus is weakened so that it cannot infect the person who receives it, and it is modified to carry a copy of a CMV gene called pp65. This gene instructs cells to make CMV proteins that the vaccine recipient's immune system can produce antibodies to, thus conferring immunity to the disease. Persons 18 years of age or older who are scheduled to donate stem cells for a patient in an NIH protocol and who are not allergic to eggs, egg products, or other vaccines, may be eligible for this study. Candidates are screened with a medical history, physical examination, and blood tests. Participants receive three vaccinations one week apart beginning at least 3 weeks before the scheduled stem cell donation. They are observed for 30 minutes after each vaccination to look for any immediate side effects of the vaccine. Approximately 3 tablespoons of blood are drawn before each vaccination and 1 week after the last vaccination to evaluate vaccine safety. Blood samples are also collected at the screening evaluation, 3 weeks after the start of vaccination, and 3 months after the last vaccination to check for CMV immunity. Participants keep a diary, recording any reactions to the vaccine and any change in medications. They are contacted by telephone for follow-up 3 months after the last vaccination to report any additional symptoms.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started May 2004
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2004
CompletedFirst Submitted
Initial submission to the registry
July 18, 2006
CompletedFirst Posted
Study publicly available on registry
July 19, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2008
CompletedResults Posted
Study results publicly available
July 8, 2014
CompletedJuly 8, 2014
June 1, 2014
3.8 years
July 18, 2006
April 30, 2013
June 5, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cellular Immune Response in Vaccine Recipients
Evaluate the efficacy of an accelerated ALVAC-pp65 immunization schedule in generating cytomegalovirus (CMV)-specific immunity in seronegative transplant donors and healthy volunteers (HV) and augmenting CMV-specific immunity in seropositive transplant donors.
Day 45
Study Arms (1)
ALVAC-CMV (vCP260) Vaccinated group
EXPERIMENTALPatients who were vaccinated with ALVAC-CMV (vCP260)
Interventions
ALVAC-pp65 (vCP260), an attenuated canary pox-based vaccine (Aventis Sanofi Pasteur, Lyon, France), 3 doses (1.0 ml each) delivered intramuscularly in the deltoid muscle. Sero-negative subjects will receive a total of 3 immunizations to be given day 0, 5 and 10. Sero-positive subjects will receive a total of 2 immunizations to be given day 0 and 5. (Protocol amendment after findings from the 9/6/2006 interim analysis demonstrated that in the sero-positive group, only 2 vaccinations were required to generate maximum immune response.)
Eligibility Criteria
You may qualify if:
- Under evaluation for enrollment as a donor on a stem cell transplant protocol at the NIH Clinical Center, Or
- CMV sero-negative or sero-positive healthy volunteer
- Age greater than or equal to 18 years, but less than or equal to 80 years
- Ability to comprehend the investigational nature of the study and provide informed consent
- All subjects (men and women) must agree to practice abstinence or effective contraception during the study period
- Baseline laboratory evaluations are within normal limits
- For woman, negative urinary pregnancy test
- Informed consent from transplant recipients obtained
- STEM CELL TRANSPLANT RECIPIENT
- Under evaluation for enrollment as a recipient on a stem cell transplant protocol at the NIH
- Age greater than or equal to 18 years, and less than or equal to 75 years
- Ability to comprehend the investigational nature of the study and provide informed consent
You may not qualify if:
- VACCINE RECIPIENT
- History of severe adverse reaction or allergy to any vaccine
- Known or suspected allergies to vaccine constituents - eggs, mono-sodium glutamate or neomycin
- Acute febrile illness within the 72 hours preceding the vaccination
- History of any immunosuppressive disease or major chronic disorder
- History of treatment with immunosuppressive medications in the past 6 months
- Pregnant or breast feeding
- Enrolled or planning to enroll in another drug or vaccine clinical trial during the study period (other than the stem cell transplant when applicable)
- STEM CELL TRANSPLANT RECIPIENT
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892, United States
Related Publications (3)
Gerberding JL. Incidence and prevalence of human immunodeficiency virus, hepatitis B virus, hepatitis C virus, and cytomegalovirus among health care personnel at risk for blood exposure: final report from a longitudinal study. J Infect Dis. 1994 Dec;170(6):1410-7. doi: 10.1093/infdis/170.6.1410.
PMID: 7995979BACKGROUNDBevan IS, Daw RA, Day PJ, Ala FA, Walker MR. Polymerase chain reaction for detection of human cytomegalovirus infection in a blood donor population. Br J Haematol. 1991 May;78(1):94-9. doi: 10.1111/j.1365-2141.1991.tb04388.x.
PMID: 1645986BACKGROUNDBolovan-Fritts CA, Mocarski ES, Wiedeman JA. Peripheral blood CD14(+) cells from healthy subjects carry a circular conformation of latent cytomegalovirus genome. Blood. 1999 Jan 1;93(1):394-8.
PMID: 9864186BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Minoo Battiwalla, MD
- Organization
- Hematology Branch, NHLBI
Study Officials
- PRINCIPAL INVESTIGATOR
Minocher Battiwalla, MD
National Institutes of Health- NHLBI
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 18, 2006
First Posted
July 19, 2006
Study Start
May 1, 2004
Primary Completion
March 1, 2008
Study Completion
March 1, 2008
Last Updated
July 8, 2014
Results First Posted
July 8, 2014
Record last verified: 2014-06