Without Quality Data, We Cannot Develop Effective Vaccines and Therapies

In our recent webinar, “Successful Outbreak Responses Depend on Reliable Data,” Dr. Michelle Berrey, infectious disease expert, and Claudia Christian, FHI Clinical Senior Vice President of Clinical Operations, discussed how to identify reliable, usable data to stay informed about an outbreak, plan trials and develop vaccines and therapeutics.
In this second blog post of this series from the webinar, we reinforce the need for quality data to ensure that vaccines and therapies in development are focused on the right targets and deliver the expected outcomes. In the midst of an outbreak, it is often necessary to treat patients and conduct research in places with weaker infrastructure that may not be well-versed in good clinical practice (GCP) and data collection procedures for clinical trials. How do we ensure that we have access to patients at sites that are prepared to collect the high-quality data needed for regulatory approval?
Meeting the Sites Where They Are
According to Christian, the first challenge is understanding the epidemiological data to know where the patients are located. The next step is finding and assessing the facilities and clinicians that are treating the patients in these areas. Christian explains:

“It's a two-way street of ensuring that what we're requiring and requesting of the sites is realistic and that they can give us patients within those parameters. Then, we need to give the sites the necessary training and support to make sure they're able to continuously capture the data.”

The clinical sites might have excellent clinicians skilled at clinical work and treating patients, but the principal investigator and study coordinator at a new clinical trial site might not have experience in clinical trials. To address this challenge, we have to meet the sites where their needs are. FHI Clinical relies on its established outbreak response, a battery of processes and procedures that it keeps current and ready to deploy, to train the site on data collection. In addition, FHI Clinical has procedures in place to provide remote support in order to limit travel to sites experiencing an epidemic. Remote data monitoring and query resolution is key.
It is also crucial to have open lines of communication with sponsors and partners about what is happening at each of the sites. For example, physicians and first responders may be providing care for patients according to the best clinical response for their situation, which may result in some patients being excluded because the current standard of care does not align with the trial protocol. Is it okay to modify the protocol to include standard of care? Can these patients be included potentially in a subanalysis? Are we able to adapt as we go? These situations need to be considered.
Immunity and Vaccine Development
When considering the hot topic of vaccine development, we need to understand disease-specific immunity to know if vaccines are working. Are we able to achieve sterilizing immunity, the gold standard for preventive vaccination, or is only some immunity achieved? Will we need to develop vaccines for different SARS-CoV-2 strains, as we do for the flu, or will we need to administer booster vaccines?
To have a reliable, validated, safe, widely available vaccine, we need to demonstrate durability of the vaccine and collect longer-term safety data, which takes time. In previous outbreaks, efficacy and safety data collection was expedited using broad testing with health care workers, who are generally healthy but at high risk because of their exposure. This provides some early data on which we can base decisions. In addition, the industry has been moving quickly during the current outbreak. According to Dr. Berrey:

“It has been promising to see the government partnering with individuals and companies who have been doing this for decades, which will help move more quickly than in the past. To get a vaccine this early in phase 1 was remarkably quick.”

Measuring Efficacy of Vaccines and Therapies
Levels of neutralizing antibodies, which bind to a virus in a manner that blocks infection, provide a method of assessing if a vaccine or treatment is working. Our webinar audience was particularly interested in our current knowledge of neutralizing antibodies for SARS-CoV-2.
Webinar Questions
What is the average titer of neutralizing antibodies in COVID-19 patients?

Claudia Christian: Titers vary significantly by patient population, age and critically ill versus moderately ill. The only data I've found was about approximately 173 hospitalized patients in China — of which 30 percent didn't generate any antibodies at all, and 50 percent generated extremely high antibodies. The government-funded ACTT program has enrolled more than 1,000 patients and has provided some initial global data about neutralizing antibodies. I think we will continuously add to the dataset and achieve better normals or better averages. But physicians are saying that it may also be wildly different all the time, and it may be that we can't make any decisions on treatment based on that.

What is your view on plasma therapy? Does it work on critically ill patients?

Dr. Michelle Berrey: During the Ebola outbreak, we asked patients who had recovered to donate convalescent sera so we could utilize the neutralizing antibodies in their sera to possibly help others. Of course, the effectiveness depends on how far along in the disease process patients are. Convalescent sera helps to reduce the viral load if that is what is causing most of the symptoms. If the patient has transitioned into a robust immune/cytokine storm, the convalescent sera may not be as helpful. Some of the new therapeutics start with data from recovered patients. It looks at their effective antibodies, both for vaccines and for potentially monoclonal antibodies as well. The scientific community is doing a great job at sharing information.

“Data are critical when in the midst of an outbreak,” as Dr. Berrey simply put it. But it must be reliable, accurate, quality data. With that, we can do the work to test and treat patients, predict and find hotspots, and create vaccines and therapeutics to get our country and the world fully-reopened.

To learn more about quality data, view the on-demand webinar.

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