Vaccine and Treatment Evaluation Unit

Infectious diseases and pandemics are not new and neither are the organizations poised to help figure out ways to prevent and treat them. In 1962, the National Institute of Allergy and Infectious Diseases (NIAID) established the Vaccine and Treatment Evaluation Units (VTEUs) to provide a ready resource for conducting clinical trials of vaccines and treatments.

VTEUs have played a key role in the NIAID effort to develop new and improved vaccines and therapies against infectious diseases for almost 50 years. They have conducted hundreds of clinical trials, many of which have led to vaccine and therapeutics licensure.

Introduction

An important strength of the VTEUs is their ability to enroll large numbers of volunteers into trials rapidly and vaccinate them in a safe, effective, and quick manner. This rapid-response capability is especially important for testing vaccines designed to counteract emerging public health concerns.

One of the primary goals of the VTEU is to develop new vaccines against infectious diseases including vaccines against pandemic agents most recently SARS-CoV-2. 

Combination vaccines minimize needle sticks and trips to the doctor by delivering more than one vaccine at a time. This was the case when a VTEU trial evaluated the impact of inactivated (killed) poliovirus vaccine versus oral poliovirus vaccines when given with a combined vaccine against Haemophilus influenza type b, pertussis, diphtheria, and tetanus.

VTEUs also test new ways to deliver vaccines for example by testing decades ago how to deliver the influenza vaccine by nasal spray. Issues such as lack of refrigeration can make immunizing people using traditional vaccines very difficult in developing countries. Edible vaccines, made from plants, may be an inexpensive and effective way to immunize people in developing countries and were tested within the VTEUs. Other efforts led by the Hope Clinic, though outside the VTEUs, looked at microneedle patch as a way to deliver influenza vaccines.  

In response to concern that smallpox virus could be used as a bioterrorist weapon against the United States, NIAID used the VTEU network to explore the best way to use existing supplies of Dryvax smallpox vaccine to protect military and civilian populations.

In the summer of 2009, the VTEUs were critical in testing candidate vaccines for the pandemic H1N1 influenza. In addition, multiple other VTEU studies looked at influenza vaccines with pandemic potential. 

In 2013, the ability of the VTEU network was expanded to conduct research in domestic and international research locations, including resource-poor settings. This expanded scope will allow researchers to study infectious diseases where they are endemic, enabling them to learn more about the origin and evolution of emerging and reemerging infectious diseases.

Leadership Group and VTEU Sites

More recently, in 2019, NIAID established the Infectious Diseases Clinical Research Consortium (IDCRC), a network of elite national & globally-affiliated research programs and scientific experts in infectious disease based out the top academic institutions in the country. The IDCRC serves as a hub with NIAID and the VTEUs to support the development and implementation of clinical research & foster a collaborative approach to the science. The consortium is currently headed by co-principal investigators David S. Stephens, MD, of Emory University, and Kathleen M. Neuzil, MD, MPH, of the University of Maryland School of Medicine. Hope Clinic is one of 10 VTEU sites.