Preliminary aggregate safety and immunogenicity results from three trials of a purified inactivated Zika virus vaccine candidate: phase 1, randomised, double-blind, placebo-controlled clinical trials

Publication date: Available online 5 December 2017 Source:The Lancet Author(s): Kayvon Modjarrad, Leyi Lin, Sarah L George, Kathryn E Stephenson, Kenneth H Eckels, Rafael A De La Barrera, Richard G Jarman, Erica Sondergaard, Janice Tennant, Jessica L Ansel, Kristin Mills, Michael Koren, Merlin L Robb, Jill Barrett, Jason Thompson, Alison E Kosel, Peter Dawson, Andrew Hale, C Sabrina Tan, Stephen R Walsh, Keith E Meyer, James Brien, Trevor A Crowell, Azra Blazevic, Karla Mosby, Rafael A Larocca, Peter Abbink, Michael Boyd, Christine A Bricault, Michael S Seaman, Anne Basil, Melissa Walsh, Veronica Tonwe, Daniel F Hoft, Stephen J Thomas, Dan H Barouch, Nelson L Michael Background A safe, effective, and rapidly scalable vaccine against Zika virus infection is needed. We developed a purified formalin-inactivated Zika virus vaccine (ZPIV) candidate that showed protection in mice and non-human primates against viraemia after Zika virus challenge. Here we present the preliminary results in human beings. Methods We did three phase 1, placebo-controlled, double-blind trials of ZPIV with aluminium hydroxide adjuvant. In all three studies, healthy adults were randomly assigned by a computer-generated list to receive 5 μg ZPIV or saline placebo, in a ratio of 4:1 at Walter Reed Army Institute of Research, Silver Spring, MD, USA, or of 5:1 at Saint Louis University, Saint Louis, MO, USA, and Beth Israel Deaconess Medical Center, Boston, MA, USA. Va...
Source: The Lancet - Category: General Medicine Source Type: research