CompletedPhase 2

Accelerated Immunization to Induce Cytomegalovirus Immunity in Stem Cell Donors

United States38 participantsStarted 2004-05

Plain-language 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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

\- INCLUSION CRITERIA: VACCINE RECIPIENT * 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 * INCLUSION CRITERIA: 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 * EXCLUSION CRITERIA: 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 durin…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Cellular Immune Response in Vaccine Recipients

Timeframe: Day 45

Trial details

NCT IDNCT00353977

SponsorNational Heart, Lung, and Blood Institute (NHLBI)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2008-03

Results submitted2013-04-30

View on ClinicalTrials.gov More Cytomegalovirus Infections trials