Poxvirus Vectored Cytomegalovirus Vaccine to Prevent Cytomegalovirus Viremia in Transplant Recipients: A Phase 2, Randomized Clinical Trial.

ABSTRACT:

Background

Triplex vaccine was developed to enhance cytomegalovirus (CMV)-specific T cells and prevent CMV reactivation early after hematopoietic stem cell transplant (HCT).

Objective

To determine the safety and efficacy of Triplex.

Design

First-in-patient, phase 2 trial. (ClinicalTrials.gov: NCT02506933).

Setting

3 U.S. HCT centers.

Participants

102 CMV-seropositive HCT recipients at high risk for CMV reactivation.

Intervention

Intramuscular injections of Triplex or placebo were given on days 28 and 56 after HCT. Triplex is a recombinant attenuated poxvirus (modified vaccinia Ankara) expressing immunodominant CMV antigens.

Measurements

The primary outcomes were CMV events (CMV DNA level ≥1250 IU/mL, CMV viremia requiring antiviral treatmen

SUBMITTER: Aldoss I 

PROVIDER: S-EPMC9074089 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature