The COVID-19 Prevention Network (CoVPN), funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), was formed in spring 2020 to create a coordinated, efficient and scientifically rigorous approach to developing the COVID-19 vaccines in order to help end the pandemic.
In partnership with the AIDS Clinical Trials Group (ACTG) and International Maternal Pediatric Adolescent AIDS Clinical Trials Network (IMPAACT), the HVTN is conducting an integrated clinical trials program for TB that includes immunological, microbiological and diagnostic technologies. This will enhance the TB vaccine field globally by evaluating the safety and immunogenicity of TB vaccines for all age groups. We seek to identify vaccines that (1) prevent TB infection, (2) prevent progression from TB infection to disease, and (3) reduce the risk of unfavorable treatment outcomes, particularly treatment failure and recurrent TB, and post-treatment morbidity and mortality when used adjunctively with TB treatment.
Our approach of integrated science gives us the ability to look at the whole picture of HIV prevention, enabling us to not only fine-tune our study vaccines, monoclonal antibodies (mAbs) and recruiting methods, but also to prepare for the day when an effective vaccine is found.
The questions we ask go far beyond, “Does this vaccine/mAb protect people from HIV/AIDS?”
The HVTN maintains a vigorous program to facilitate the development and assessment of novel candidate vaccines and passive immunization approaches. We are leading the field in designing, validating and implementing advanced immunological assays to accurately and reproducibly evaluate the broad range of immune responses elicited by candidate HIV vaccines. Our standardized datasets provide a means to compare vaccine regimens in great detail and identify the most promising candidates for further studies of efficacy.
Our Laboratory Center, which include multiple labs in the United States and South Africa, has developed over 20 assays to support international HVTN clinical trials, and continues to evolve our approaches as new methods become available — descriptions of Laboratory Center assays.
Our laboratories have developed, standardized, qualified and validated several methods of sampling, processing and testing samples from trial participants, allowing the HVTN to evaluate immune responses in different tissues and in blood. Understanding immune responses in different tissues and parts of the body can help researchers design vaccines that will target HIV at the point of entry.
The HVTN Statistical and Data Management Center (SDMC) develops statistical methods for clinical trial design and analysis. Their work includes creating a framework to understand immune responses and developing new models for defining vaccine effects. Their achievements to date include:
Accurate behavioral measures are important for many reasons, including:
The social sciences look at the interactions of humans with each other, in large and small groups. The HVTN uses theoretical models and evidence from social science to look at factors that may have an effect on the efficacy of our study vaccines, and to improve our strategies for engaging communities and recruiting study volunteers.
Our social science work benefits our mission in many ways, including: