The HIV Prevention Trials Network (HPTN) is a worldwide collaborative clinical trials network. Based at the Nobel laureates-driven Fred Hutchinson Cancer Research Center and funded by NIH, HVTN joined the COVID-19 response by initiating their first clinical trial. The study, called HVTN 405/HPTN 1901, is underway at clinical trial sites across North and South America and will describe immune responses in study participants with a history of infection with SARS-CoV-2.
Dr Larry Corey MD, Protocol Chair and Principal Investigator, HVTN Leadership Operations Center, says the HVTN study includes an important milestone needed for SARS-CoV-2 vaccine development and will help create the infrastructure required to do sophisticated vaccine trials. Edited excerpts:
SARS-CoV-2 is a novel virus and there is hardly any data available on the nature of the human immune response to this infection. Nevertheless, a large number of clinical trials evaluating the potential of several vaccine candidates are underway. How will the lack of understanding of the underlying immune mechanisms impact the development of a successful vaccine?
One of the main aim of studies called HVTN 405/HPTN 1901, which are currently underway, is to develop antibody assays that can be reliably used to detect SARS-CoV-2 infection in vaccine and monoclonal antibody studies to prevent COVID-19. This information will be critical in illuminating the path to the development and testing of safe and effective vaccine and antibody interventions to prevent COVID-19.
In what ways do HVTN/HPTN trials support the development of an effective vaccine?
HVTN 405/HPTN 1901 will describe immune responses in study participants with a history of recovery from SARS-CoV-2 infection.
Studies conducted in Italy and France indicate that only a very small percentage of the population (recovered from the infection) have antibodies against the virus in spite of high infectivity and huge death tolls. What do these findings show?
Trials not coordinated by the network are not commented on.
Other than facilitating vaccine development, what are the other possibilities that HVTN/HPTN look at by studying the human immune response data to SARS-CoV-2?
[The study aims] to measure SARS-CoV-2-specific adaptive immune responses in order to identify immune markers of COVID-19 disease severity and the duration in different demographic groups such as the age, gender etc and in people with different medical histories, including pre-existing conditions, new acute or chronic medical conditions, and concomitant medications.
The studies also aim to characterise presentations of SARS-CoV-2 infection, including the clinical course of COVID-19, among individuals who have recovered from COVID-19.