Currently Funded Projects:

SERVE – Optimal Strategies to Estimate the Relative Effectiveness of Influenza Vaccines 
There are many different influenza vaccine products available for use in the United States, but most have not been directly compared to determine if one product might work better than another. This information is needed to inform policymakers, healthcare providers, and the public on how influenza vaccines should be best used. In addition, new influenza vaccine products are expected in the coming years given rapid technology advancements during the COVID-19 pandemic, and ongoing efforts to develop a universal influenza vaccine. Therefore, the goal of this project is to develop strategies for comparing the effectiveness of current and novel influenza vaccines. 

Funding Source: Centers for Disease Control and Prevention 
PI: Joshua Petrie, PhD, MPH and Huong Nguyen, PhD, MPH 


First Influenza Infection and Immunization (FI3)
 
A persons first exposures to influenza during their life by infection or vaccination can affect how their immune system responds to future exposures. In this study we are studying how the immune response to influenza differs among children who are vaccinated against or infected with influenza for the first or second time in their lives. The information learned in this study could help improve how well future influenza vaccines work.  

Funding Source: Centers for Disease Control and Prevention 
PI: Joshua Petrie, PhD, MPH and Huong Nguyen, PhD, MPH 


Rapid Cycle Analysis (RCA) to Monitor the Safety of COVID-19 Vaccines in Near Real-Time
Multiple COVID-19 vaccines have been authorized or approved by the Food and Drug Administration and recommended by the Centers for Disease Control and Prevention (CDC); all have been subject to intensive safety evaluation. The Vaccine Safety Datalink (VSD) is a collaborative project between the CDC and nine integrated healthcare organizations; it is one of several systems monitoring the safety of COVID-19 vaccines in the U.S. As one of the VSD sites, Marshfield Clinic Research Institute (MCRI) has received three years of funding from the CDC to co-lead a project that evaluates the safety of COVID-19 vaccines using near real-time surveillance of adverse events potentially associated with COVID-19 vaccines in the VSD population. This surveillance system provides an opportunity to identify potential vaccine safety issues in weeks or months rather than years. The Marshfield team works closely with investigators at all VSD sites, and in particular with those at the CDC and Kaiser Permanente Northern California. The results of this surveillance have been thus far reassuring. The VSD surveillance did confirm results reported by others that two adverse events, myocarditis/pericarditis and Guillain-Barré Syndrome, were found to be associated with specific vaccines in certain subgroups, although their occurrence was very rare.


The project was begun in late 2020 and interim results have been published in several journals:

Funding Source: Centers for Disease Control and Prevention
PI: James Donahue, PhD, DVM

Monitoring for Vaccine-Associated Enhanced Disease following COVID-19 Vaccines in the Vaccine Safety Datalink
The Marshfield Clinic Research Institute (MCRI) has received a 3 year award from the Centers for Disease Control and Prevention (CDC) to lead a study to assess vaccine-mediated enhanced disease (VMED) in the Vaccine Safety Datalink network. There is a theoretical risk that a COVID-19 vaccine could trigger an immune system response that increases the severity of a subsequent infection with SARS-CoV-2. Multiple studies of COVID-19 vaccines have found no evidence for VMED, but this study will monitor risk over time to ensure vaccine safety. It will also provide an estimate of COVID-19 vaccine effectiveness for preventing hospital admission.

Funding Source
: Centers for Disease Control and Prevention
PI: Edward Belongia, MD

Vaccine Safety Datalink

Post-licensure monitoring of vaccine safety is critical to identify vaccine-related adverse events and maintain public confidence. Marshfield Clinic Research Institute (MCRI) is one of 9 organizations participating in the Vaccine Safety Datalink (VSD) Project in collaboration with the Centers for Disease Control and Prevention (CDC). The VSD uses electronic health data from each participating site to conduct post-licensure vaccine safety research. Overall, the VSD sites have access to outpatient, inpatient, emergency department, and immunization data for more than 12 million children and adults in the United States. VSD can identify new safety signals and confirm safety signals from other sources such as the Vaccine Adverse Event Reporting System (VAERS). New licensed vaccines are routinely monitored in near-real time by VSD to identify safety issues. VSD investigators have published more than 200 research studies on diverse vaccine safety topics. The VSD is conducting several COVID-19 studies to assess vaccine safety.

Funding Source: Centers for Disease Control and Prevention
PI: Edward Belongia, MD and Maria Sundaram, PhD


Recently Completed Projects:

Prospective Assessment of COVID-19 in a Community (PACC) 
This was a prospective cohort study of 1520 participants with weekly illness surveillance for up to 26 months conducted in collaboration with CDC and University of Wisconsin-Madison. Participant collected respiratory specimens with qualifying illness and serum specimens periodically to identify SARS-CoV-2 and influenza infections. Assessed incidence, seroprevalence, and vaccine effectiveness and immune response. Results have been published in several journals. 

Funding Source: Centers for Disease Control and Prevention 
PI: Huong Nguyen, PhD, MPH

Assessment of the Effectiveness of COVID-19 and Influenza Vaccines for Preventing Transmission in Households 
Transmission of respiratory viruses in households play a large role in the spread of epidemics. This was a case-ascertained household study that followed participants who have COVID-19 or influenza and their household contacts to describe how the SARS-CoV-2 and influenza virus spreads among household members and whether vaccination can help reduce the risk of transmission. Marshfield Clinic Research Institute (MCRI) is one of 7 enrollment sites in this respiratory virus transmission network led by investigators at Vanderbilt University Medical Center. Results have been published in several journals. 

Funding Source: Centers for Disease Control and Prevention 
PI:Huong Nguyen, PhD, MPH

Persistence of Measles, Mumps, and Rubella Antibodies following Receipt of a Third Dose of Measles-Mumps-Rubella (MMR) Vaccine 
In the United States, third doses of MMR vaccine have been administered in recent mumps outbreaks among highly vaccinated populations. Third doses are also routinely administered to military recruits, healthcare personnel, women of child-bearing age before becoming pregnant or after delivery, college students, and international travelers. However, data on the long term immune response to a third dose of MMR vaccine are limited. In 2009-10, young adults were vaccinated with a third dose of MMR vaccine and were followed through 11 years after receipt of the third dose to assess the long term immune response.  

Funding Source: Centers for Disease Control and Prevention 
PI:Huong Nguyen, PhD, MPH 

Understanding and Addressing the Disparity in Vaccination Coverage Among U.S. Adolescents Living in Rural Versus Urban Areas 
This was a multi-year, multi-component collaboration with the Minnesota Department of Health (MDH), Wisconsin Department of Health Services (WDHS), and Centers for Disease Control and Prevention (CDC) to better understand the determinants of rural-urban differences in vaccine uptake among adolescents in the upper Midwest. Surveys and qualitative interviews were used to inform interventions. Several reminder / recall interventions targeting adolescents in the Health System were developed, implemented, and evaluated to improve adolescent vaccination coverage and inform strategies to increase vaccination rates. Results have been published in several journals. 

Funding Source: Centers for Disease Control and Prevention  
PI: Huong Nguyen, PhD, MPH