Volunteers share Sanofi Pasteur/GSK COVID-19 vaccine trial experiences

Peninsula Research Associates/Jordan WertheimerBy LAUREN MELTZER, ABC News

(ROLLING HILLS ESTATES, Calif.) — As the global COVID-19 pandemic continues to escalate, health experts say it is critical for multiple vaccines to be produced and circulated worldwide in order to eradicate the illness.

Peninsula Research Associates, based in Rolling Hills Estates, California, began operating in September as one of 10 testing sites nationwide to partake in a vaccine trial developed in partnership between pharmaceutical companies Sanofi Pasteur and GlaxoSmithKline.

This study’s vaccine includes adjuvants, which are ingredients that help vaccines work better at boosting the immune system to develop antibodies against COVID-19.

Phase one included a total of 441 volunteers, 73 of whom were located at the California clinic. All trial participants received one vaccination on the first day and a booster shot on day 22 if they were a part of the group receiving two doses. The ratio was an eight-to-two randomization of active to placebo, dependent on participants age.

“There’s numerous different reasons why people want to participate in our trial,” said Jordan Wertheimer, vice president of clinical operations at Peninsula Research Associates. “There’s a lot of patients who had family members test positive for COVID-19, some who passed away. A lot of people also just want to help humanity.”

Early data shows there is a clear differentiation between the two groups of trial participants; two doses are far more effective than one dose, according to Wertheimer.

Right now, Peninsula Research Associates and the other testing sites are awaiting protocols to begin Phase 2B in February 2021. The amount of patients for this phase remains unclear.

In December, a data readout revealed Sanofi Pasteur/GSK had halted the next phase of the study in order to fix the antigen concentration of their vaccine so that a higher rate of antibodies would develop. If the vaccine meets all clinical requirements and is approved by authorities, it could possibly be expected in circulation toward the end of 2021, the companies said in a press release.

“With due time, we’re hopefully going to have multiple vaccines for the physicians, the health departments and the counties all to be able to use,” said Dr. Lawrence Sher, allergist and immunologist at Peninsula Research Associates. “It’s important that we have it all out there and not consider it a race, rather, consider it production of more and more excellent vaccines. We are doing something for the greater good, which is a good feeling.”

To date, the coronavirus has killed about 1.8 million people worldwide, including more than 332,000 in the United States, according to the Centers for Disease Control and Prevention.

“We’re very excited for the opportunity to work on this kind of study,” Wertheimer said. “We just want to do our part to help progress medicine forward. We’re really apt on participating in the next studies and just coming out with a vaccine to help eradicate this.”

Two volunteers involved in Peninsula Research Associates’ trial spoke with ABC News about what motivated them to join the vaccine study. Here are their stories.

The loss of a loved one

Pat Brewster, 84, lost her husband, Bob, due to the effects of COVID-19.

Prior to his coronavirus diagnosis, Bob was living in a hospice facility to receive care for Parkinson’s disease, Brewster said. On April 4, she noticed an abnormal tremor in both of her husband’s hands, which prompted her to call for a caregiver to examine him.

A low-grade fever, among other symptoms, left Bob’s doctor presuming he had a gastrointestinal virus, not COVID-19. But Brewster decided to have paramedics transport her husband to a hospital for further examination. The 88-year-old tested positive for COVID-19 on April 10 and died at the hospital three days later.

Brewster twice tested negative for COVID-19. When she received word by mailing list about a vaccine study happening locally near her Rancho Palos Verdes home in California, she jumped on the opportunity to raise awareness.

“This seemed about the only thing I could do to fight this illness,” she said. “This disease is real. A lot of people don’t think it is, or it won’t affect them. To see people not taking the precautions, I just feel like screaming, you know? It’s not just the people who die, it affects the families, too.”

Brewster joined the Sanofi Pasteur/GSK study in September, which she recalls involved a lot of forms and paperwork. During the first visit, Brewster received a urine test, blood test, nasal swab and one vaccine injection. She said she did not experience any side effects.

“I was given a chart and had to take my temperature every day for the next week or so,” she explained. “I think I went back in after two weeks and did another urine and blood test. I had a telephone conference in November, and now I don’t go back in until January.”

Due to her age, Brewster may be eligible to receive a vaccine that is currently in circulation, from Pfizer or Moderna. If the opportunity arises, the study she’s participating in will reveal whether she received the placebo or the vaccine in order to ensure she receives the best form of protection against COVID-19.

“This year has been a year of heartbreak and deprivation,” Brewster concluded. “We are still in a very dangerous stage of this pandemic. But as we head into the new year, we are armed now with hope, with more knowledge of the virus than we had originally and with the promise of highly effective vaccines. We all have a responsibility to protect ourselves and others, to do whatever we can to fight this vicious and stealthy virus.”

Giving back to the community

Debbie Hays, 59, is no stranger to helping her community for the greater good. But COVID-19 also hits too close to home. Her 79-year-old mother, who lives in an assisted living facility and has dementia, is currently battling the illness.

So when her friend reached out asking to spread the word for volunteers in the Sanofi Pasteur/GSK study, Hays jumped into action and put her own name in the hat.

“I’m one who always gives back to the community but more on the level of neighborhood cleanup or getting groceries for those who need them,” Hays said. “I never thought I’d be a part of a biomedical research study. But then I decided, ‘Hey, why not?’ It’s just nice to be able to give back to humanity in this way.”

“I’m in perfect health, so that’s another reason why I decided I could take one for the team,” she added.

According to the Torrance, California, resident, her experience in the trial thus far has been “very painless and easy.”

Intake involved a blood draw, a urine sample, temperatures taken, a health questionnaire and a vaccine, she said. Hays monitored her temperature and any changes in health on a chart at home for eight days. She then went back to the clinic to be evaluated and receive a second shot, as she was part of the trial group who received a booster vaccine.

“Some patients are on a one-shot program,” she said. “I happened to be on the two shot program. They’re trying to determine if the vaccine is strong enough to be taken care of in one or two doses.”

Hays then repeated the charting process for another eight days. She said she has not experienced any side effects to date.

“The team is really fantastic,” she said. “They explain everything so there are no surprises. They’re appreciative of us participating, and their follow-through is excellent.”

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