First trial of a coronavirus vaccine under way in Houston

Linda Lamberth dutifully wears a mask and practices social distancing, but at 66, she figures a little additional protection couldn’t hurt.

So Lamberth rolled up her sleeve Friday and became the first participant in a Baylor College of Medicine clinical trial testing the effectiveness of an experimental coronavirus vaccine, one of the world’s great hopes to halt the pandemic and restore a semblance of normalcy.

“There needs to be a vaccine, and if I can help that process, I thought that was something I should do,” said Lamberth, a Spring resident who works in a Texas Medical Center laboratory that conducts research on bacteria. “It’s nice to know that my taking the vaccine could make life safer for other generations, both younger and older, and that if evidence from the trial shows it works, it’ll make others want to get it.”

The Baylor trial brings to Houston the latest chapter in the battle against the coronavirus — pivotal, late-stage testing of a vaccine candidate developed in record time using new genetic technology. If it works, it could result in more wide-scale deployment by early next year.

The vaccine, arguably the most hyped of the many coronavirus vaccines in development, was made by the biotech firm Moderna. At the University of Texas Medical Branch at Galveston, researchers last week began testing another genetic vaccine, made by Pfizer and the German firm BioNTech. The vaccines, both part of President Donald Trump’s Operation Warp Speed project to accelerate an effort that usually takes years, are the two furthest along of more than 100 in development.

Through the two trials, 60,000 people will receive either the vaccine or a placebo at more than 200 sites this summer. Neither participant nor medical staff providing the inoculations will know which is being given.

The trials will assess whether fewer vaccinated people contract COVID-19, the disease caused by the novel coronavirus. They will also determine whether the vaccine prevents severe cases of COVID-19 and death; whether it blocks the infection entirely; and whether effectiveness requires one or more doses.

Both Houston-area trials are still enrolling participants and open to those interested in volunteering. Those who are eligible include people whose work or home circumstances put them at high risk of exposure and those who are older or have underlying conditions that raise their risk of complications from COVID-19.

The head of the Baylor trial said interest has been “robust,” a reflection of the promise the two vaccines have demonstrated and the widespread public interest in a vaccine as an answer to the virus’ relentless spread.

“We’re hopeful based on previous research in animals and small clinical trials,” said Dr. Hana El Sahly, a Baylor professor of molecular virology and microbiology and a primary investigator of the national Moderna trial. “But we need to conduct rigorous testing before drawing any conclusions about whether the vaccine works.”

Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, said last week that results showing a vaccine protects 60 percent of people who get it “would be a major, huge step at controlling this outbreak.” He said ideally the figure would be higher, “but we’ll take that amount.”

Both the Baylor and UTMB trials aim to enroll about 300 participants and wrap up in September. Researchers will monitor the participants for two years but begin analyzing the data before then. El Sahly called it difficult to know how long it will take to have meaningful data because it depends on the prevalence of the virus in communities, but said the earliest would be at least a few months.

UTMB already has inoculated more than 50 patients in the Pfizer/BioNTech trial. Baylor, whose strategy is to start slow and pick up speed, has a few more participants scheduled to be inoculated Monday, El Sahly said.

UTMB will also be a site for the Moderna trial, likely starting next week, officials said. That trial will be in League City. The Pfizer/BioNTech trial is on the island.

DM Clinical Research, a clinical arm of HCA Gulf Coast division, is giving either of both vaccines or a placebo at sites in Houston and Tomball. Those are open only to employees.

A Baylor/Texas Children’s team has its own coronavirus vaccine under development, but it not expected to go into clinical trials until early next year.

todd.ackerman@chron.com

More Information

Contact information to participate in Houston-area vaccine trials

Baylor College of Medicine:

713-798-4912

Covid__vax@bcm.edu.

UTMB-Galveston:

832-340-2313 for Moderna trial

409-772-5278 for Pfizer trial

sivsctp@utmb.edu


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