Allina launches COVID-19 vaccine trial in Minnesota

A second COVID-19 vaccine trial is launching in Minnesota as infections, hospitalizations and deaths rise in the pandemic.

Allina Health on Thursday enrolled its first 10 participants, who either received an experimental vaccine made by Janssen Pharmaceuticals Inc. or a nonmedicating placebo at the trial site in Minneapolis.

The goal is to enroll hundreds of local participants this winter to learn how the vaccine works and compares with others being rapidly developed against the highly infectious SARS-CoV-2 virus that causes COVID-19, said Dr. Frank Rhame, the Allina virologist running the Ensemble trial.

"It's actually a good idea to look at those vaccines trials collectively," he said, "because we need to find out which of these vaccines works the best, and it's not obvious at all. They all produce a very similar antigen — the antigen being what produces our immunity — but they do so in extremely different ways."

Minnesotans have shown substantial interest in experimental COVID-19 vaccines, even before the latest surge of the pandemic that has caused at least 2,555 deaths and 164,865 infections. That includes 25 deaths and a single-day record 3,956 infections reported Thursday by the Minnesota Department of Health.

When Bloomington-based Health­Partners launched enrollment in AstraZeneca's COVID-19 vaccine trial in early September, the resulting interest briefly crashed the recruiting website. Enrollment for that trial resumed last week after a pause to evaluate whether health problems in a trial participant in England were due to the vaccine.

A spokesman on Thursday said HealthPartners has now enrolled 127 people and is rescheduling hundreds of appointments with people who had expressed interest in the trial online before the study was paused.

The Janssen trial briefly paused as well last month, before Allina got started, and Rhame said that is an expected and positive development.

"That's what happens if you vaccinate a lot of people," he said. "There are going to be some weird things that are going to happen, so you stop the trials and look carefully. In both cases, it was decided after a lot of effort that the events that occurred were unrelated to the vaccine."

Both the Janssen and AstraZeneca vaccine candidates in phase 3 trials use genetically modified viruses to teach the immune system and coax a protective response against SARS-CoV-2. Another vaccine in a phase 3 trial by Moderna Inc. uses a different pathway of messenger RNA to produce an immune response.

AstraZeneca officials announced Thursday that they are seeking effectiveness data by year's end and are ramping up production for potential distribution in January.

Rhame said key questions in all of the trials include whether the vaccines prevent infection or just the onset of severe illness. The longevity of protection also is an open question, along with whether the vaccine prevents people from spreading the virus.

"It's a really more complicated question than, does the vaccine work or not?" he said.

In the absence of widely available vaccines, Minnesota health officials urged people to follow recommended mitigation steps to slow the spread of the virus and to get influenza shots and seek COVID-19 testing when needed.

The combination of mask-wearing, social distancing, avoiding crowded gatherings and staying home when sick is believed to slow transmission of the virus that is now regularly producing lab-confirmed infections in all 87 Minnesota counties.

"Right now, it feels like we are losing ground," state Health Commissioner Jan Malcolm said, noting that infection growth is almost doubling testing growth and that the positivity rate of testing has risen to 9.2% "We're seeing record numbers of new cases ... and it's because we are falling behind the rapid spread of this virus."

The number of Minnesota hospital beds with COVID-19 patients increased to 931, including a record 216 patients who needed intensive care because of breathing problems or complications from their infections, according to Thursday's updated state pandemic dashboard.

"Beyond these numbers are health care heroes and care teams that are working 24/7 weekdays and weekends," said Dr. Rahul Koranne of the Minnesota Hospital Association. "They deserve our help right now. ... We are worried about the increasing community spread for sure, but also now about the increasing level of hospitalizations."

More than 15,000 Minnesota health care workers — mostly in long-term care facilities — have tested positive for COVID-19, and 525 have been hospitalized.

Rhame said Allina health care workers have been encouraged to sign up for the vaccine trial by Janssen, a subsidiary of Johnson & Johnson. The trial also is targeting minorities and people in high-risk occupations for viral exposures.

People must first register online and schedule appointments at the trial site in a medical office building next to Phillips Eye Institute in south Minneapolis.

People will receive stipends for their participation, which includes an initial four-hour visit to consent and receive the injection. Participants will take part in eight visits over two years and provide regular online check-ins about their health.

Rhame said the process has been orchestrated to reduce the threat of viral transmission. Participants watch an introductory film together, for example, but in a hall where they are spaced out and the ventilation has been increased to improve airflow.

Allina is planning to enroll up to 20 participants per day, starting next week, after trial runs with initial participants this week.

Jeremy Olson • 612-673-7744