NIAID conducts and supports basic research in areas such as infectious diseases, microbiology, and immunology to generate the knowledge essential for developing safe and effective vaccines. NIAID also supports clinical research on vaccines against bacterial, viral, and parasitic microbes in people of all ages and risk categories. Vaccine safety is an integral component of all NIAID vaccine research and development.
NIAID vaccine research areas include the following:
- Vaccines for diseases such as HIV, tuberculosis, malaria, and sexually transmitted diseases
- Vaccines to serve special populations such as infants, the elderly, and people with weakened immune systems
- Novel vaccine approaches such as oral, transcutaneous (for example, skin patches), and combination vaccines
- Research to improve existing vaccines
- Basic immunology studies that underpin all vaccine research and development
All vaccines licensed for use in the United States undergo a rigorous process to test for both safety and efficacy. Safety testing is an integral part of every vaccine development stage—from lab studies to clinical trials to post-licensure evaluation.
Once in use, vaccines continue to be monitored for safety and efficacy by the Food and Drug Administration and the Centers for Disease Control and Prevention. In addition, the federal government has numerous checks and balances in place to monitor the safety and efficacy of vaccines and to ensure that recommendations about immunization practices and procedures reflect the best available science. The National Vaccine Program Office within the U.S. Department of Health and Human Services has responsibility for coordinating and ensuring collaboration among the many federal agencies involved in these efforts.
Recently, several National Institutes of Health (NIH) Institutes, including NIAID, have come together to develop a program announcement (PA) to solicit research proposals that broadly address important scientific questions relating to vaccine safety.
Dale and Betty Bumpers Vaccine Research Center
In 2000, NIAID established the Dale and Betty Bumpers Vaccine Research Center (VRC). At the VRC, vaccines can be developed from initial concept to final product. Scientists at the center conduct basic research on microbes and the immune system’s response to them, design candidate vaccines, and, with their collaborators, test the most promising vaccines in preclinical and clinical trials.
VRC scientists work on vaccines against multiple microbes, with an emphasis on developing therapeutic and preventive vaccines against HIV. The first human trial of an Ebola vaccine began in the center’s clinic in 2003. In 2006, the world’s first human trial of a DNA vaccine against H5N1 avian influenza opened to volunteers.
In recent years, VRC researchers have increased their understanding of the immune system and how it fights off harmful microbes. Scientists working on vaccines also have advanced technology, including recombinant DNA technology and the ability to “read” and analyze the genomes of disease-causing organisms. This new knowledge and technology has helped usher in a renaissance in the already vital field of vaccinology.
HVTN and CHAVI
In 1999, NIAID created the HIV Vaccine Trials Network (HVTN), a collaboration of investigators in the United States and abroad that tests candidate HIV vaccines in clinical trials. HVTN includes sites in Africa, Asia, South America, and the Caribbean. The international sites enable studies that examine differences in genetic makeup, nutrition, access to health care, and HIV subtypes in various populations—all crucial factors in creating a vaccine that is effective worldwide.
In 2005, NIAID established the Center for HIV/AIDS Vaccine Immunology (CHAVI), a consortium of researchers based at institutions across the country who work together to tackle some of the biggest obstacles in developing an HIV vaccine. Among their efforts, CHAVI scientists are seeking a better understanding of the earliest events in the immune system’s response to HIV infection, identifying which immune reactions give the best indications that a candidate vaccine is eliciting a protective response, and testing new HIV vaccines in early phase clinical trials.
NIAID supports several immunology networks that aim to better understand—and ultimately enhance—how the immune system responds to infection and vaccination. For example, the Large-Scale Antibody and T Cell Epitope Discovery program brings together multidisciplinary teams to identify novel antibody and T cell epitopes (parts of proteins that antibodies or T cells will recognize) of microorganisms associated with emerging and re-emerging infectious diseases. This work contributes to the development of new vaccine candidates and new reagents for characterizing those immune responses that correlate with vaccine protection.
Additionally, the Atopic Dermatitis and Vaccinia Network supports research to reduce the incidence and severity of eczema vaccinatum (EV), a viral infection following smallpox immunization that occurs almost exclusively in people with atopic dermatitis. The network conducts clinical and animal studies of innate and adaptive immunity, skin barrier function, and gene expression identify the risk of EV from exposure to the smallpox vaccine.
Vaccine and Treatment Evaluation Units
In 1962, NIAID transformed the cumbersome, piecemeal approach to clinical vaccine studies by establishing a network of Vaccine and Treatment Evaluation Units (VTEUs) nationwide. The VTEUS, based at university medical research centers and community clinics across the country, make it possible to systematically test candidate vaccines that are a national priority.
The network can rapidly recruit volunteers for clinical studies, and it played a major role in the studies that led to the licensing of vaccines for Haemophilus influenzae Type B and for a new vaccine for pertussis. VTEU investigators have also tested vaccines for pneumonia, influenza, cholera, malaria, and tuberculosis. More recently, they have been called upon to conduct critical studies of vaccines against smallpox and avian influenza.
Vaccine Goals and Priorities
Despite many accomplishments in vaccine research over the years, much remains to be done. NIAID-supported investigators in the United States and other countries and in NIAID laboratories in Bethesda, Maryland, and Hamilton, Montana, are working to reduce the burden of illness by helping to develop vaccines against diseases old and new.
NIAID has three broad goals in vaccine research:
- Identify new vaccine candidates to prevent diseases for which no vaccines currently exist.
- Improve the safety and efficacy of existing vaccines.
- Design novel vaccine approaches, such as new delivery systems and adjuvants.
To achieve these goals, NIAID conducts and supports basic and applied research in fields such as immunology, microbiology, and disease pathology.
Hundreds of millions of people around the world suffer illness and death from HIV/AIDS and from the ancient scourges of malaria and tuberculosis. For this reason, NIAID has made developing new or improved vaccines for these illnesses a top priority. Other priorities include vaccine research on disease-causing agents that either arise naturally, such as dengue virus and the bacterium that causes tuberculosis, or that might be deliberately released in an act of bioterrorism, such as the smallpox virus. Finding ways to more quickly produce vaccines against strains of influenza that occur seasonally and those that experts fear may spark a pandemic is another priority area in which NIAID-supported researchers are making progress.
Vaccines against such emerging microbes must be safe, easy to administer, and fast-acting—even to the point of providing immunity shortly after exposure to the microbe. In addition to developing vaccines against classic infectious diseases, NIAID and other government agencies are working to develop new and improved vaccines against chronic diseases with infectious origins as well as autoimmune diseases and other immune-mediated conditions.