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 age-stratified agent-based model of COVID-19 was used to simulate outbreaks in states within two U. S. regions. The northeastern region consisted of Connecticut, Massachusetts, Maine, New Hampshire, New Jersey, New York, Pennsylvania, Rhode Island and Vermont. The southern region consisted of Alabama, Arkansas, Delaware, District of Columbia, Florida, Georgia, Kentucky, Louisiana, Maryland, Mississippi, North Carolina, Oklahoma, South Carolina, Tennessee, Texas, Virginia and West Virginia. The model was calibrated using reported incidence of COVID-19 in each state from October 1, 2020 to August 31, 2021. It then projected the number of infections, hospitalizations, and deaths that would be averted between September 2021 and the end of March 2022, if states increased their daily vaccination rate.

"Data from 205 adolescent and early adult girls in Jos, Nigeria was collected to assess risk factors for vaginal human papillomavirus (HPV) infection, knowledge about HPV vaccines, and assess willingness to receive the HPV vaccine. Data on prevalence and patterns of HPV infections was also collected. Participants, age 9 to 20 years old, were recruited from 10 randomly selected schools. Research nurses from the Jos University Teaching Hospital interviewed each participant using a structured questionnaire. Data on sexual history and information on sexual partners was used to assess the risk factors for HPV infections. Data on knowledge related to HPV infections, vaccines, and willingness to receive the vaccine was collected through a questionnaire. Principal component analysis (PCA) was used to compute wealth index using data on ownership of household items and availability of household facilities. To assess the prevalence of HPV infections, participants were trained to self-collect vaginal samples which were tested for HPV infection using DEIA/LIPA25. "

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.

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.

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.)

Randomised, placebo-controlled clinical trials are considered the gold standard for evaluating new vaccines. To assess its efficacy and safety, the manufacturer of quadrivalent human papillomavirus (qHPV) vaccine conducted multiple clinical trials involving approximately 30,000 volunteers. The trials of the qHPV vaccine are reported as ‘placebo-controlled.’ However, participants in the ‘placebo’ arms received an injection-containing amorphous aluminium hydroxyphosphate sulfate (AAHS), a proprietary adjuvant. AAHS is used in the qHPV vaccine to boost immune response, but the rationale for adding it to the ‘placebo’ is not reported in publications of these trials and is contrary to the advice of the public health bodies and regulators. Standard recommendations for control recipients in trials testing an unlicensed, experimental vaccine include using either an inert substance or an approved efficacious vaccine. However, several pivotal trial publications incompletely reported important methodological details and inaccurately described the formulation that the control arms received. Under the Restoring Invisible and Abandoned Trials Initiative (RIAT), the primary objective of this study was to characterize the reporting of the methodology with respect to the rationale for the choice of standalone aluminum-containing adjuvanted controls. Clinical study reports (CSRs) from five randomized controlled trials described as placebo-controlled were obtained from the European Medicines Agency (EMA). Content and rationale for the choice of control used in each trial was extracted across six data sources: trial publications, register records, CSR synopses, CSR main bodies, protocols and informed consent forms. For each source within each trial, the following was recorded: (1) the phrases used to describe the comparator to qHPV vaccine; (2) the rationale for using aluminum-containing adjuvant as a control, if present and (3) all listed contents (ingredients) of formulation received by intervention and control arms. This dataset includes data extraction sheets and RIAT protocol documentation publicly accessible via the Open Science Framework with the CSRs available upon request.

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.

Dataset consists of 107 full clinical study reports (CSRs) of published and unpublished randomized, placebo-controlled clinical trials of two neuraminidase inhibitors. A systematic review of the CSRs and other regulatory documents was conducted to determine the potential benefits and harms of oseltamivir (Tamiflu) and zanamivir (Relenza). Outcome measures included time to first alleviation of symptoms, influenza outcomes, complications, admissions to hospital, and adverse events in the intention to treat population. Completeness of relevant parts of the CSRs was determined via an extraction form based on the CONSORT statement checklist. Authors have provided the full set of clinical study reports for both medications provided to the Cochrane collaboration by Roche, GlaxoSmithKline, and the European Medicines Agency (EMA) for use in the systematic review of these neuraminidase inhibitors for treating/preventing influenza in healthy adults and children. A guest post on the "Dryad News and Views" site regarding the dataset of clinical study reports and the resulting Cochrane systematic review is available at: https://blog.datadryad.org/2014/04/17/tamiflu-data/