1531. A CMV Vaccine Based on Non-Replicating Lymphocytic Choriomeningitis Virus Vectors Expressing gB and pp65 Is Safe and Immunogenic in Healthy Volunteers, Allowing for Development of a Phase II Clinical Trial in Living Donor Kidney Transplant Recipients

ABSTRACT: Abstract

Background

Cytomegalovirus (CMV) is a major pathogen in pregnancy and immunocompromised patients. Antiviral prophylaxis is limited by toxicities, recurrent infection, and antiviral resistance. A safe and protective CMV vaccine is highly desirable.

Methods

HB-101 is a CMV vaccine consisting of two nonreplicating lymphocytic choriomeningitis virus vectors, one expressing the human CMV antigen pp65 and the other a truncated, more antigenic isoform of the CMV fusion protein gB. The safety and immunogenicity of HB-101 were evaluated in a randomized, placebo-controlled, double-blind phase I dose-escalating trial (NCT02798692). Three dosing cohorts (1: 2.6 × 106; 2: 2.6 × 107 and 3: 2.6 × 108 FFU) of 18 subjects each were enrolled. On Day 0, Month 1, and Month 3, HB-101

SUBMITTER: Kotton C 

PROVIDER: S-EPMC6253627 | biostudies-literature | 2018 Nov

REPOSITORIES: biostudies-literature