•    The couple’s decision to join the clinical study turned from uninterested to interested as more news about the benefits of vaccination came out.
•    The clincher to them was when the vaccine brand was granted an emergency use authorization by the US Food and Drug Administration.
•    They finally decided to join because study participants will be closely monitored for the next two years.
•    The preparation process included a tutorial which gave detailed instructions on how to use the app for the regular and bi-weekly reporting; what to do when one develops symptoms that may be related to the COVID-19; how to get one’s temperature reading, pulse rate and oxygen level using the oximeter; and how to use the nasal swab and saliva testing kits.

What goes on in a clinical trial for a COVID-19 vaccine?

 (AFP)

More important, what goes on in the minds of people chosen to participate in the clinical trail of a vaccine against a virus that has changed our lives, pulled down economies, and brought anxiety and emotional turmoil to people around the world?

Two people who are part of a clinical trial for one of the vaccines share how they made their decision to join the study and the many processes they had to go through to prepare for the jab.

The two are seniors — Henry and Elizabeth — who have been married for 40 years. They first heard about the trial from a doctor-friend of one of their daughters. Months later, they were informed that they had been chosen to be part of a group of 500 participants in the clinical trial in Bacolod City. (The number was later reduced to 300.)

The trial is part of the “phase 3 study to assess the efficacy and safety of a vaccine against COVID-19 in adults 18 years and older.”

The study for the Philippines involved 3,000 individuals in Metro Manila, Iloilo and Bacolod.

Like most clinical trial subjects, there was disinterest at first, but when they were given more information about the vaccine, the couple became interested because it presented a chance to get vaccinated ahead.

“The clincher was when news came out that the vaccine brand was issued by the U.S. Food and Drug Administration an Emergency Use Authorization for its COVID-19 vaccine.

On March 2, a doctor screened Henry and Elizabeth and signed the consent forms clearing them for the program.  That evening, they received an email with a mobile app, a secure online platform which was going to be used in this study.

Their first “let’s get out of this” thought came after they read that they will undergo a nasal swab testing and blood tests which will draw a minimum of 42.5 ml prior to the day of vaccination.

But they were encouraged by many news items on the benefits of getting vaccinated. Henry said what encouraged them most was the item on health authorities and doctors saying that it is highly recommended to get any brand of vaccine, even one with the minimum acceptable efficacy rate of 50 percent, because some type of protection is better than none.  Furthermore, if one contracts the virus, the vaccine will prevent one’s condition from becoming serious or critical.

(MANILA BULLETIN)

“There were other reasons why we eventually decided to join the study.  A brother-in-law, who worked with a multinational pharmaceutical company for many years, told me that we are lucky that we will be vaccinated as part of a study because we will be closely monitored. And, if one requires medical treatment or hospitalization as a result of the vaccination, the pharmaceutical company will shoulder all the expenses,” they said.

Later in the process, they would be told that the close monitoring would require them to report twice a week through the app.

The couple, being very religious, brought the whole matter in prayer.  “I specifically asked the Lord that if this was not for us, He would place an obstacle to our participating in the study.  Somehow, I felt at peace during the waiting period.  I took it as a sign that this was for us,” Henry said.

On March 17, they received a text message asking if were available for vaccination the next morning.  The next day, Henry and Elizabeth went to the hospital and joined 10 other persons who were part of the trial.

He said there were actually 14 persons expected but two did not show up.

Then the coordinator arrived and started to distribute a kit with name tags and unique ID numbers, an ID card, and a pulse oximeter, digital thermometer, nasal swab kit, saliva sample kit, two handouts which will be given to the hospital in case we are confined any time post our vaccination. There was a box to keep all these items and a hand bag to hold the box.

Elizabeth said that they were taught how to use the gadgets for temperature reading, and pulse rate and oxygen level.

The next step was the orientation on the use of the online platform which Henry observed “took quite some time” because the participants were seniors.

“We went over the tutorial “Participants Training” which was in the app.  It gave detailed instructions on how and when to use the platform, especially for the regular, bi-weekly reporting, as well as when one develops symptoms that may be related to the COVID-19,” he said.

The orientation also included instructions on how to do nasal swabs and saliva collection using the kits in case one develops symptoms of COVID-19.  They were told that a courier will pick-up the samples.

Henry said they were told that after this, there will be close monitoring and guidance from the local principal investigator.

The ID card contained more information than just identifying the participant in the study. It also identified the brand of the COVID-19 vaccine given to them; the doctor-principal investigator from the hospital and his mobile phone number; and listed the emergency toll-free telephone numbers for any emergency 24/7.

That done, a medical staff took the blood pressure of each participant, who was then interviewed again by a doctor who assessed a participant’s information on that day and on the first visit.  Again, they were checked for their BP, temperature, heart rate and oxygen level readings.

After lunch, a female doctor arrived and she encouraged the participants to ask questions.

“We were able to ask the all-important question of what will happen to those who will be injected with the placebo.  She clarified that they will be notified about one month hence, and will then be inoculated with the real vaccine.  That was reassuring to know that the wait will be not that long.”

“Those who will receive the vaccine in the trial will be notified about two months later, and they will be asked to return for a second dose.

Finally, the time for the inoculation came.

“One could feel the suspense building-up, even a certain degree of anxiety.  Just to put all of us at ease, we started to throw funny remarks as one participant volunteered to be the first.  We cheered the brave soul because the vaccinator placed a seat in front of all of us, with the person facing the group,” Henry said.

As he took his seat, people started to cheer “picture, picture”!”

“Our turn came shortly after.  My wife and I didn’t feel when the needle was inserted, as the vaccinator assured us that he was using the finest needle size,” Henry said.

After the injection, the participants were asked to remain for 30 minutes to make sure that there were no immediate adverse reactions to the vaccine.  Again they took each participant’s blood pressure to check if there was no change from the one taken in the morning.

“That evening, my wife and I started to feel some body weakness, but very mild.  This continued the next day; but it did not deter me from carrying-out my planned tasks for the day.  I was able to drive my car, made visits to the bank, another office and our restaurant.  By the next day, the feeling of mild body weakness was gone.  We were hoping, of course, that this was already the sign that we did get the vaccine and not a placebo.”

“As part of the requirements of the study, we will have to accomplish the Symptom Check questionnaire every Monday and Thursday.  If one feels no symptom related to COVID-19, you just have to answer “no” and no further questions will be asked.

“And, at any time during the other days that one develops any symptom, you will have to fill-up the questionnaire, which is available anytime in the app which also has a calendar which sets our next visits to the center.  Visit no. 3 has been set 28 days after the inoculation,” Henry explained.

Now the waiting begins, but Henry and Elizabeth feel some confidence that they have either been already vaccinated, or are on the way to get vaccinated, if they were given a placebo.  Either way, the long wait for immunity against the virus is nearly over.


Source: Manila Bulletin (https://mb.com.ph/2021/04/19/how-is-a-clinical-trial-for-a-covid-vaccine-conducted-2-participants-tell-of-the-many-processes-before-the-jab/?utm_source=rss&utm_medium=rss&utm_campaign=how-is-a-clinical-trial-for-a-covid-vaccine-conducted-2-participants-tell-of-the-many-processes-before-the-jab)