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Having long tracked infectious diseases and tested vaccines, KPWHRI now leads research efforts on COVID-19.

Models of the coronavirus (left, background) and its spike protein (right, foreground). Credit: NIH

Scientists at Kaiser Permanente Washington Health Research Institute (KPWHRI) are on the forefront of efforts to understand, prevent, diagnose, and treat COVID-19. This includes vaccines, medications, forecasts, and impacts of the virus on various health conditions.

Vaccine trials
Vaccine trial registries
Vaccine safety monitoring
Studies now enrolling Kaiser Permanente Washington members
Research on COVID-19 risk factors and disparities
Other COVID-19 studies
Voluntary symptom reporting

Vaccine trials

KPWHRI builds on its background of longstanding participation as a Vaccine and Treatment Evaluation Unit and collaboration with the Centers for Disease Control and Prevention (CDC) and the National Institute of Allergy and Infectious Diseases (NIAID), among other partners, to help develop vaccines to prevent COVID-19. Our work includes the following:

NIH-Moderna vaccine
On March 16, 2020, KPWHRI gave the world’s first-ever injection of an investigational vaccine for COVID-19 to volunteers in a phase 1 clinical trial led by Senior Investigator Lisa A. Jackson, MD, MPH.

The vaccine — which was co-developed by the National Institutes of Health (NIH) and Moderna Inc. — was well tolerated and generated an immune response that exceeded the average responses from a group of people recovering from the disease, according to a New England Journal of Medicine report on the phase 1 trial findings. After the trial was expanded to include adults 56 years and older, a second paper was published in the New England Journal of Medicine, reporting that the vaccine was well-tolerated and generated a strong immune response in older adults. 

On July 27, 2020, a phase 3 trial was launched to test the effectiveness — and continue to test the safety — of the NIH-Moderna vaccine. KPWHRI is one of 100 locations in this ongoing trial. A review of the phase 3 data found that the vaccine is safe and effective at preventing symptomatic COVID-19 in adults, with an efficacy rate of 94.1%.

Additional evidence of the vaccine’s benefits were reported Dec. 3, 2020, in a letter in the New England Journal of Medicine co-authored by Dr. Jackson. Based on data from the phase 1 clinical trial, investigators found that the vaccine continued to provide a significant immune response 119 days after first vaccination and 90 days after second vaccination in 34 healthy adults.

On the strength of these and other findings, the U.S. Food and Drug Administration approved an emergency use authorization of the NIH-Moderna vaccine on Dec. 18, 2020. KPWHRI continues to monitor the people vaccinated in the phase 1 and phase 3 trials of this vaccine.

In April 2021, KPWHRI began testing an investigational vaccine developed by Moderna to protect against the coronavirus variant first detected in the Republic of South Africa. Led and funded by NIAID, the trial is testing the immune response generated by the new vaccine candidate as well as its safety. The trial will not determine whether the vaccine prevents infection by the new variant or stops its spread in the population.


Janssen and HDT Bio Corp. vaccines
On Nov. 18, 2020, KPWHRI began enrolling volunteers in another phase 3 clinical trial to evaluate a COVID-19 vaccine made by Janssen Pharmaceutical Companies of Johnson & Johnson.

The team is also slated to collaborate with HDT Bio Corp. on a phase 1 clinical trial of the firm’s experimental COVID-19 vaccine.

Mix-and-match COVID-19 vaccine-booster trial

KPWHRI is recruiting volunteers in the Seattle area for a national clinical trial funded by the NIH exploring the possible benefits of pairing doses from different COVID-19 vaccines.

In the study, KPWHRI and 8 other research centers in the Infectious Diseases Clinical Research Consortium will assess the use of different boosters that may or may not match the type of vaccine that participants received earlier. The researchers aim to determine the safety and effects of mix-and-match boosters on immunity to SARS-CoV-2, the coronavirus that causes COVID-19.

Persons who have not received any COVID-19 vaccine and are interested in participating in this booster study can email the study team at KPWA.vaccine@kp.org. Seattle-area residents who are interested in being contacted about current and future COVID-19 vaccine studies can join the KPWHRI vaccine registry at https://corona.kpwashingtonresearch.org. Additional information about the trial is available on the clinicaltrials.gov website, maintained by the National Library of Medicine at the National Institutes of Health.

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Vaccine trial registries

Interested in volunteering for a COVID-19 vaccine trial? KPWHRI has established a registry to collect information from people in the Seattle area who want to participate in current and future trials. Initially, only adults 18 and older were eligible for this registry. In February 2021, the registry expanded to allow Seattle-area parents to add the names of children under age 18. Potential volunteers can contact the registry at corona.kpwashingtonresearch.org.

The COVID-19 Prevention Trials Network also has a volunteer screening registry of people nationwide who are interested in participating in a broader range of vaccines and other preventive therapies at various research facilities in Seattle and around the country: coronaviruspreventionnetwork.org.

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Vaccine safety monitoring

KPWHRI researchers are working with the Centers for Disease Control and Prevention (CDC), the U.S. Food and Drug Administration (FDA), and colleagues in other KP regions and other health systems on projects that monitor the safety and effectiveness of the vaccines now being distributed to the general population. To learn more, see KP biostatisticians help monitor COVID-19 vaccine safety.

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Studies now enrolling Kaiser Permanente Washington members

Kaiser Permanente Washington members may be contacted for possible participation in the following COVID-19 studies:

Self-Swab Respiratory Virus Study
KPWHRI researchers are contacting select patients who recently received care in person or virtually from a Kaiser Permanente Washington provider or who recently spoke with the Consulting Nurse Service about a cold or flu-like illness. When people agree to join the study, they are sent a kit to self-collect a swab that will be tested for SARS-CoV-2, flu, and other respiratory viruses. This allows researchers to explore how many people get sick with COVID-19, what kinds of symptoms they have, how risk varies across populations, and what factors increase risk of severe illness.

Stool test kit
KPWHRI and University of Washington researchers are collaborating to develop and evaluate a test kit to detect virus shed into stool. This study will enroll some patients at Kaiser Permanente Washington.

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Research on COVID-19 risk factors and disparities

KPWHRI has launched a research project to evaluate risk factors for COVID-19 with Kaiser Permanente Colorado and Kaiser Permanente Northwest. The research collaboration follows a KPWHRI study, published in the American Journal of Hypertension, finding no association between the use of angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) medications and the risk of COVID-19 infection or hospitalization. The multi-site effort, which is being supported by the Garfield Memorial Fund, includes 3 inquiries:

  • Whether oral contraceptives and hormone replacement therapy affect risk of COVID-19 infection or severe disease
  • Whether diabetes and diabetes medications affect risk of COVID-19 infection or severe outcomes
  • An analysis of racial and ethnic disparities in COVID-19 infection rates and severity
     
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Other COVID-19 studies

KPWHRI is a major contributor to understanding of the spread of COVID-19 in Washington state, because researchers have access to comprehensive information about a large real-world population. KPWHRI has also provided a variety of resources and support to the Kaiser Permanente Washington care-delivery system to help prevent, screen for, and treat COVID-19, such as:

  • Predictive analytics to identify Kaiser Permanente Washington Medicare-age patients at highest risk for complications of COVID-19, so care providers can proactively reach out to these patients offering care and support
  • Consultation to Washington state’s COVID-19 Health System Response Management team in developing a database to track hospital and intensive care unit (ICU) use statewide
  • Helping Kaiser Permanente Washington’s newly formed Business Command Center to understand, improve, and evaluate the “Virtual First” care model that is quickly evolving from the system’s rapid COVID-19 response
  • Rapidly reviewing scientific evidence related to COVID-19 care
  • Exploring how the virus affects physical and mental health, as well as how it affects care for conditions such as depression and anxiety, cancer, chronic pain, diabetes, and heart disease
  • Working with Kaiser Permanente Washington Community Health and various community partnerships to identify and share resources with care providers in the region’s federally qualified health centers, including in-clinic workflows for COVID-19 and collaboratives to plan for emerging social needs resulting from the pandemic

In addition, the many Kaiser Permanente enrollees who participate in the Kaiser Permanente Research Bank are providing blood samples and medical information that will be useful in the organization's ongoing COVID-19 research nationally. The Research Bank has collected COVID-19 survey data on biobank participants that is available for research use.

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Voluntary symptom reporting

Along with the research activities described above, Kaiser Permanente and the Permanente Medical Group are conducting a voluntary symptom tracking program focused on targeted prevention to stop the spread of COVID-19. The program aims to help Kaiser Permanente’s COVID-19 response teams to assess a large sample of Kaiser Permanente members, monitor the spread of the virus, and try to proactively curb the pandemic. The program staff is reaching out via email and/or SMS text to a random sample of Kaiser Permanente Washington members, inviting them to participate over a 2-month period. Although this program is not considered a research activity, the data collected will be used to track and predict the spread of the virus, catch clusters of the virus early, identify new outbreaks, and better prepare our medical staff and facilities for possible spikes in cases.

Kaiser Permanente Washington members can find information about testing, diagnosis, and treatment for COVID-19 here.

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Volunteers needed

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COVID-19 booster trial seeks unvaccinated volunteers

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news

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COVID-19 vaccine trial registry open for volunteers

KPWHRI seeks Seattle-area residents for studies of COVID-19 vaccines.

Drugs, diabetes, disparities

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Studying COVID-19 risk and outcomes

Dr. Sascha Dublin tells how studies of KP electronic health record data can improve COVID-19 treatment and prevention.

1-year anniversary

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Looking back: Our COVID-19 vaccine trial at 1 year

Dr. Rita Mangione-Smith reflects on the year since KPWHRI launched the world's first clinical trial for a COVID-19 vaccine.

Vaccine Safety

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Biostatisticians track COVID-19 vaccine safety

Dr. Jennifer Nelson explains how KP scientists are helping the CDC and FDA keep an eye out for rare adverse events.

KPWHRI In the Media

Seattle-based clinical trial tweaks mRNA vaccines to fight COVID variants

Seattle NPR affiliate KUOW-FM, April 8, 2021