Immunogenicity and safety of subunit plague vaccine: A randomized phase 2a clinical trial.

ABSTRACT:

Background

Although the killed whole-cell and live attenuated plague vaccine have been licensed, they are rarely used today because of toxicities, limited evidence of efficacy against plague, poor immune persistence required booster immunization every year, and limited commercial availability. This study was a randomized phase 2a clinical trial aimed to evaluating the immunogenicity and safety of a novel subunit plague vaccine.

Methods

240 healthy adults aged 18-55 y were enrolled and randomly assigned at a ratio of 1:1 to receive 2 doses of 15 or 30 mcg vaccine at a 28-day interval between doses. Blood samples were collected at day 0, 28 and 56. Adverse events were collected during the first 28 d after each vaccination. Serious Adverse Event was observed throughout the stud

SUBMITTER: Chu K 

PROVIDER: S-EPMC5027722 | biostudies-literature | 2016 Sep

REPOSITORIES: biostudies-literature