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Current Studies

SwabCurrently Enrolling Studies

To learn more, call 319-356-4848 or e-mail recruit-vaccine-research@uiowa.edu.

Ongoing Studies (Closed to Enrollment)

Smallpox Vaccine POX-MVA-031

The main purpose of this clinical trial is to show that three lots, or batches, of an investigational vaccine called MVA-BN, produced at different times, have the same quality. In addition, blood will be drawn for basic lab tests and health will be monitored for any side effects. Blood will also be collected and analyzed for the amount of antibodies produced, which is how protection against smallpox is measured.

Smallpox was an infectious disease caused by a virus called variola. In 1980, after years of vaccination campaigns throughout the 19th and 20th centuries, the world was considered free of smallpox and mass vaccinations against smallpox stopped. Routine vaccinations for smallpox in the US were stopped in 1971. Today, the majority of the world’s population does not have existing protection against smallpox.

There is recent concern over the use of the smallpox virus as a biological weapon for terrorism. In response to this concern, the United States government is making efforts to improve its ability to protect its citizens in the event of a bioterrorist attack.

Smallpox vaccine supplies worldwide are no longer sufficient, and the currently approved US smallpox vaccine can sometimes cause severe side effects. Also, the vaccine cannot be used by people with weakened immune systems such as HIV-positive and transplant patients. Therefore, efforts are being made to develop new and safer smallpox vaccines.

Pharmacokinetics of Antibacterials in Critically Ill Adults 16-0077

This study is evaluating patients in the intensive care unit (ICU) that are on an antibiotic (cefepime, meropenem and/or piperacillin-tazobactam) as part of their care.

The overall goal of this study is to evaluate how the body absorbs these antibiotics when people are very ill and being cared for in an intensive care setting. We will also try to understand how different factors such as weight, kidney function, severe infection and other medical conditions affect these antibiotics.

H7N9 Flu Trial 17-0078

The main purpose of this study is to find ways to improve immune responses to H7N9 vaccines.

This study is evaluating two different H7N9 vaccines that do and do not contain an adjuvant called AS03. This study will compare immune responses of the two different H7N9 vaccines given with or without the AS03 adjuvant including the timing of the second study vaccination. This study will also look at the safety of the H7N9 vaccines and AS03 adjuvant.

H7N9 Flu Study 17-0090 

The purpose of this research study is to find ways to improve the immune responses to H7N9 flu vaccines, because previous studies have found that H7 influenza strains generally do not lead to strong immune responses in people. H7N9 influenza is a type of “bird flu” that can infect humans and frequently causes death or severe disease. One way to improve the response to vaccines or to allow for the use of smaller amounts of vaccine is to include a substance that can stimulate the immune system. This type of substance is called an adjuvant. An adjuvant may cause the body to produce more antibodies when it is given with a vaccine.

This study will look at an A/H7N9 Inactivated Influenza Vaccine (IIV) that does or does not contain an adjuvant called AS03. The trial will compare the study vaccine with or without AS03 as a boost in volunteers who received an H7N9 flu vaccine in a previous study and in volunteers who have never received an H7N9 flu vaccine. The study will also look at the safety of the study vaccine and AS03 adjuvant.

Quadrivalent Flu 18-0011

The purpose of this research study is to assess the safety, reactogenicity (reactions at the injection site and overall side effects) and effectiveness of the 2018-2019 seasonal Fluzone or Flublok given without or with one of two adjuvant formulations. An adjuvant is a substance that may cause the body to produce more antibodies when it is given with a vaccine. The two adjuvants being evaluated in this study are AF03 and Advax-CpG55.2. The adjuvants are investigational and have not been approved or licensed by the US Food and Drug Administration (FDA). Fluzone and Flublok are quadrivalent influenza vaccines (QIV) for the 2018-2019 season and are licensed and approved by the FDA.

Pharmacokinetics of Beta-Lactams in Cystic Fibrosis 16-0078

This study is evaluating hospitalized patients with cystic fibrosis on one of the following antibiotics: cefepime, meropenem, or piperacillin-tazobactam. Each of these antibiotics is approved by the Food and Drug Administration (FDA) to treat bacterial infections and are commonly used in children and adults with cystic fibrosis.

It is known how these antibiotics move around the body and how they are removed from the body in healthy volunteers. Patients with CF usually have less fat in their bodies, have other health problems, and take other medicines, which may affect how these antibiotics work and move in the body in ways we do not yet know.

This study is being done to help understand how these 3 antibiotics move around the body and how they are removed from the body in children and adults with CF. We want to understand whether we need to give more or less of the drug, or potentially give it more frequently for CF patients than we do for other patients.