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.

Non-typhoidal Salmonella (NTS) is responsible for approximately 93 million cases of gastroenteritis annually. Little research has been directed towards a development of vaccines against Salmonella serogroups O:6,7 or O:8. Researchers constructed a live attenuated serogroup O:8 vaccine, CVS 1979, by deleting guaBA, htrA, and aroA from the genome of S. Newport. Over the course of 6 weeks, 6 to 8-week-old female BALB/c mice were immunized with live attenuated S. Newport vaccine CVD 1979 or sterile phosphate buffered saline (PBS) three times. Four weeks after the last immunization, mice were challenged intraperitoneally (i.p.) with wild-type Salmonella strains to assess the homologous and heterologous protection elicited by the live attenuated S. Newport vaccine CVD 1979.

An adapted version of the Brighton Collaboration priority list was used to evaluate serious adverse events (SAE) of special interest observed in mRNA Covid-19 vaccine trials. In December of 2020, reviewers searched journal publications and trial data on the FDA’s and Health Canada’s websites to locate SAE results tables for these trials. For each trial, blinded SAE tables were prepared. Using these blinded SAE tables, two clinician reviewers judged whether each SAE type was an adverse event of special interest (AESI). Risk ratios and risk differences between vaccine and placebo groups were calculated for the incidence of AESIs and SAEs.

This study investigates multiple vaccine strategies to enhance immunogenicity and protection against SARS-CoV-2 in aged mice. The study aims to determine the effect of a booster dose, with an emphasis on older age. Female three and eleven-month-old BALB/c mice were studied over the course of 38 weeks. Mice received BNT162b2 SARS-CoV-2 spike mRNA vaccine series, primary vaccination series, and mock Phosphate-buffered saline (PBS) injections. Single mouse experiments aimed to include 20 mice per group. Sample size and age criteria were chosen empirically based on the results of previous studies. Mice were randomly assigned to different treatment groups.

Due to constraints in vaccine supply, this agent-based model of COVID-19 transmission was developed to compare the impact of two vaccination strategies: 1) vaccinate more individuals with the first dose of available vaccines and delay the second dose or 2) to continue with the recommended 2-dose series as tested in clinical trials. Model population was stratified into 6 age groups of 0 to 4, 5 to 19, 20 to 49, 50 to 64, 65 to 79, and 80+ years based on United States census data.