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Efficacy, Safety, And Immunogenicity of Herpes Zoster Vaccine


Title Supportive Care: Efficacy, Safety, And Immunogenicity of Herpes Zoster Vaccine after Autologous Transplantation
Therapeutic Area Herpes Zoster, Transplant
Principal Investigator Andreas Klein, MD
Min Age 18 Years
Gender Both
Contact Liz Kendricken
617-636-5558
More Information https://clinicaltrials.gov/ct2/show/NCT01610414

Overview

This study is to test whether or not an investigational vaccine works to protect against a condition called “shingles,” which is caused by the Herpes Zoster virus. The vaccine will be tested in people who have received a transplant with their own blood stem cells. Subjects are either planning to receive this type of transplant or just received the transplant. Shingles is caused by the same virus that causes chickenpox. After that, the virus stays in the body but is asleep. A person can get shingles when the virus wakes up. If a person's immune system (resistance to disease) is weakened, the risk of getting shingles increases. This can happen after an autologous transplant with blood stem cells, so the researchers for this study are trying to find new ways to protect against this condition.

Study Details

Inclusion Criteria

  • People who have had or will have a stem cell transplant with their own stem cells within 50-70 days before they would receive the study vaccine
  • People who have not had a vaccine for chickenpox or herpes zoster within 12 months of receiving vaccine

Exclusion Criteria

  • People who have a history of allergic reaction to any part of the vaccine. (The study team can ask you questions to determine this.)
  • People who are taking any medicine to prevent or treat herpes zoster or chickenpox before or during their transplant
  • For questions about the above criteria and additional criteria for the study, please contact a member of the study team

Study Requirements

There will be two groups in this study. One group will get 2 injections of the active study vaccine. The other group will get 2 injections of a solution without active ingredients. Subjects will be “randomized” to receive either the study vaccine or the placebo. This mean a computer will be used to put subjects into one of the 2 groups at random, like flipping a coin. There will be 5 study visits in total. Some participants will be asked to donate blood samples during the trial for testing. For more detail, please contact the study team.