This dataset is the result of a phase 3, randomized, double-blind, placebo-controlled efficacy trial of a single dose live oral cholera vaccine. PXVX0200 was developed to rapidly confer protection to humanitarian relief workers and other travelers visiting cholera-endemic areas as well as residents in regions experiencing outbreaks. Existing licensed vaccines require 2 or 3 (children) doses weeks apart. The trial consisted of 3 groups of volunteers each of which were randomly split into receiving either the PXVX0200 vaccine or a placebo. One group was challenged with virulent V. cholera O1 El Tor Inaba strain N16961 inoculum 10 days post-vaccination. A second group was challenged 3 months post-vaccination, while individuals in the third group remained unchallenged. A total of 197 volunteers participated in the trial. This dataset includes demographics and clinical and immunology measures from the 3 study sites: University of Maryland, Baltimore School of Medicine, Cincinnati Children’s Hospital Medical Center, Ohio, and the Vaccine Testing Center, University of Vermont College of Medicine. (National clinical trial registry number: NCT01895855; Research funded by: PaxVax, Inc.)

This multicenter randomized, controlled, double-blind Phase 1 trial investigated the safety, tolerability, immunogenicity, and feasibility of adding an adjuvant to an influenza vaccine at point-of-use (commonly referred to as the Mix-N-Match study). Inactivated influenza A/Indonesia/05/2005 virus vaccine and the adjuvant, AS03, were provided by the US Department of Health and Human Services (HHS) Biomedical Advanced Research and Development Authority (BARDA) from the National Prepandemic Influenza Vaccine Stockpile. 225 subjects completed the regimen of receiving 2 intramuscular doses of vaccine spaced 21 days apart at either 3.75, 7.5, or 15 mcg of hemagglutinin. The AS03 adjuvant or a phosphate-buffered saline diluent was added immediately prior to injection. This dataset includes: a) serum hemagglutination inhibition (HAI) and microneutrilization (MN) antibody assessment values taken on days 0 (prevaccination), 8, 21 (before second dose), and 42; b) clinical safety hematology and chemistry laboratory values collected before and 8 days subsequent to each vaccination; and, c) clinical reactogenicity and adverse event data.

The research associated with this dataset is an extension of a multicenter randomized, controlled, double-blind phase 1 trial that investigated combining an adjuvant (AS03) with an influenza (A/H5N1) vaccine at point-of-use (see “Related Datasets” below). In the original study adult volunteers were given 2 intramuscular doses of vaccine containing 3.75, 7.5, or 15 mcg of hemagglutinin (HA) with or without adjuvant spaced 21 days apart. Serum samples were taken at 4 intervals ending with day 42 after vaccination. This research assessed the kinetics of antibody responses by analyzing samples taken at day 201 (6 months) and 386 (12 months) postvaccination. Hemagglutination inhibition (HAI) and microneutrilization (MN) responses were evaluated for the homologous virus (A/Indonesia/05/2005) as well as the heterologous virus strains A/Vietnam/1203/2004, A/Anhui/01/2005, A/turkey/Turkey/01/2005, and A/Hubei/1/2010. This dataset includes HAI and MN antibody assessment values for the 3 different doses with and without adjuvant for the homologous virus as well as the 4 drift virus strains.