A nationwide National Institutes of Health (NIH) study hopes to gather data on COVID-19 antibodies to shed light on how many Americans may have developed immunity to the virus. 

Researchers enrolled more than 11,000 people from across the country to gather data and blood samples from April 1 to September 15 for analysis. The study data will be used to inform future public health initiatives, to evaluate vaccines and to understand herd immunity. It will also help determine false positive and false negative rates of tests.

Dr. Matthew Memoli, director of the LID Clinical Studies Unit Laboratory of Infectious Diseases at the National Institute of Allergy and Infectious Diseases (NIAID), is the leader of the NIH National SARS-COV-2 Pandemic Serosurvey and Blood Sampling study. Several branches of the NIH are working together on the project, and it is a part of the government’s response to the pandemic. 

Phase one’s primary objective is to characterize the number of people with detectable antibodies from adults who had not been diagnosed with COVID-19 prior to enrollment. Phase two starts October 1 and will look at the change over time of detectable antibodies at a six-month and 12-month follow up. 

This will be used to understand how long antibodies last and what kind of protection from infection they provide.

 “It’s highly likely that there were cases of COVID-19 around the world well before we knew about them. What we were diagnosing at the time [and continue to diagnose] was most likely the tip of the iceberg,” Memoli said during a teleconference hosted by the National Center for Health Research on Sept. 25, 2020.

Memoli said the study data will answer questions such as:

  • How many Americans have actually been infected and exposed to COVID-19 that we have not diagnosed that are not captured in case numbers from CDC and various other case trackers?
  • How much immunity actually exists in the U.S.?
  • Could immunity be due to a full clinical infection, asymptomatic infection, mild exposure or immunity to other viruses that protects against COVID-19? 
  • What factors make it more or less likely that someone was exposed or infected?

Analyzed Data Will Give Clear Positivity Rates

Each test is analyzed with about 40 different parameters including state, living environment, sex, race, ethnicity, occupation and underlying illness. These parameters will allow researchers to look at immunity and the risk of infection in these groups. 

Researchers can then expand data gathered from study participants to an accurate representation of the entire country. 

“That data will allow different groups to go through it, compare it with other data, look at it in the context of case numbers in each state versus the immunity numbers … once the initial primary analysis is done. We should be able to give a clear positivity rate in the U.S., for each state and possibly for those 40 other parameters,” Memoli said. 

They are also doing sub studies, including looking at the immunity in the mucus membranes of the nose and respiratory tract. 

“This is where the action happens to protect you, and so getting a better idea of what the immunity looks like at that site I think will be key not only for understanding immunity in the community but also for understanding how the vaccines will work once they are up and running,” Memoli said. “Pandemics have happened in the past, and they will continue to happen in the future. We just need to try to be as ready as we can for them.”

Memoli said that they hope to have preliminary data from phase one analyzed by the end of October.