How to volunteer for a COVID-19 vaccine trial

What's the time investment like and how disruptive is the experience?
/ Source: TODAY

Wanted: Adults of all ages to test a vaccine to prevent COVID-19.

Volunteering has taken on a new meaning in the age of the coronavirus as governments race to develop a shot that will stop the pandemic.

A vaccine created by the biotech company Moderna and the National Institutes of Health is the first U.S. candidate to enter phase 3 trials as part of Operation Warp Speed — the government’s mission to have a safe and effective COVID-19 vaccine available by January 2021.

The study, which began in late July, is still recruiting volunteers — 30,000 in all. More phase 3 trials are to come and they're also looking for tens of thousands of volunteers to take part.

“I would encourage people to sign up if they’re in a position to do so. It’s not right for everybody — it’s a little bit of a time commitment, nothing major,” Ian Haydon, a 29-year-old Seattle resident and veteran of phase 1 of the Moderna vaccine trial, told TODAY.

“If you’re in a position where you qualify for the study, you live near a study site, you can get there reliably and safely, I think it’s an important way that anyone can help out during this time.”

Haydon’s mother is now taking part in the phase 3 trial, which he called exciting.

Ian Haydon will be monitored over 14 months as part of his phase 1 vaccine trial.Courtesy Ian Haydon

People interested in volunteering can start by filling out a screening questionnaire on the government’s COVID-19 Prevention Network website.

What to expect:

Here’s what to know about volunteering for a phase 3 trial, based on Moderna’s study:

  • Organizers are looking for adults of all ages who have an “appreciable risk of exposure” to the new coronavirus whether because of where they live or work, or other life circumstances.
  • The trial will accept both healthy people and those with pre-existing medical conditions who are in stable condition.
  • Women who could get pregnant can take part only if they’re not expecting a baby at the start of the trial and agree to use contraception or abstain from sex for about four months after.
  • Men who could make a partner pregnant also have to practice adequate contraception and can’t donate sperm for that period of time.
  • People accepted into the trial have a 50/50 chance of getting the inoculation: Volunteers are randomly assigned to either receive the vaccine candidate or a placebo. They then get two injections about 28 days apart. The goal is to find out how people who get the actual shot compare to the dummy shot group.
  • Volunteers will get a nasopharyngeal swab at an initial screening and their blood will be drawn. They’ll be followed for two years after the second shot and give additional blood samples. In all, most studies require coming into a research site for 10 or more visits, NIH noted.
  • There are 89 research sites across the country.
  • Volunteers get compensated. Haydon was paid $100 per trip to the clinic, but this amount may vary depending on the study.

A volunteer’s real-life experience:

Haydon was injected with the Moderna vaccine candidate in April and then in May as part of the phase 1 clinical trial, which was much smaller and didn’t involve any placebos. Researchers were still trying to figure out the correct dosage during that early study and Haydon experienced a severe reaction after the second shot, including high fever, nausea, headache, muscle fatigue and a brief fainting spell.

He later found out he received the highest dose of the vaccine tested in the phase 1 trial. That high dose wouldn’t be used in future studies, company officials have said.

Haydon noted he’s had “absolutely no issues” since that 24-hour episode. The only other side effect he’s had is muscle soreness at the injection site for a couple of hours after the shot, which is common for vaccines.

He offered this advice for phase 3 volunteers:

Ask lots of questions: “These vaccines are moving along very quickly… that doesn’t mean anyone should be rushed through this process,” Haydon said. “It was really important to me that the people involved in the trial did answer all my questions and they were very patient with me.”

He felt taken care of during the study and praised the clinic staff for being professional, efficient, kind and calming.

Be prepared for a little time investment: Haydon expected to make about a dozen trips to the clinic over the course of his trial and follow-up. Most visits take about 30 minutes and involve seeing a nurse, getting a quick blood draw and leaving. The two injection visits lasted much longer — three hours each, in his case. Most of that extra time was staying for observation to make sure he didn’t have any immediate adverse reactions.

Every day for the week after he received the shot, Haydon was also asked to record whether he experienced any side effects and if so, how severe they were.

Expect the experience to be pretty uneventful: “I wasn’t worried at any point during the trial, even on the days when I got the injections. The thing I was most worried about was getting stuck by the needle, which I don’t like,” Haydon recalled.

The shots, which he received in his left shoulder, were “very, very quick; very painless.” The routine blood draw was probably more unpleasant, he noted. Overall, the volunteering experience has been much less disruptive than he expected.

Don’t assume you’re immune to COVID-19: Tests show Haydon and other phase 1 volunteers have developed neutralizing antibodies and T-cell responses, but researchers don’t know if that means they’re immune. Haydon still wears a face mask and practices social distancing. “Nobody should make any drastic changes just because they got this experimental vaccine,” he said.

Remember the upside: Haydon was “absolutely” glad he volunteered and had no regrets. “The whole world is sort of frozen right now and if you can fight through the nerves and muster up some courage to go do what is a pretty simple clinical procedure, that really can help so many people,” he said.