National Institute of Allergy and Infectious Diseases

The National Institute of Allergy and Infectious Diseases (NIAID) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.^[1]

NIAID has "intramural" (in-house) laboratories in Maryland and Montana, and funds research conducted by scientists at institutions in the United States and throughout the world. NIAID also works closely with partners in academia, industry, government, and non-governmental organizations in multifaceted and multidisciplinary efforts to address emerging health challenges such as the pandemic H1N1/09 virus.

History

NIAID traces its origins to a small laboratory established in 1887 at the Marine Hospital on Staten Island, New York^[2] (now the Bayley Seton Hospital). Officials of the Marine Hospital Service in New York decided to open a research laboratory to study the link between microscopic organisms and infectious diseases. Dr. Joseph J. Kinyoun, a medical officer with the Marine Hospital Service, was selected to create this laboratory, which he called a "laboratory of hygiene."^[3]

Kinyoun's lab was renamed the Hygienic Laboratory in 1891 and moved to Washington, D.C., where Congress authorized it to investigate "infectious and contagious diseases and matters pertaining to the public health."^[4] With the passage of the Ransdell Act in 1930, the Hygienic Laboratory became the National Institute of Health. In 1937, the Rocky Mountain Laboratory, then part of the United States Public Health Service, was transferred to Division of Infectious Diseases, part of the NIH.

In mid-1948, the National Institute of Health became the National Institutes of Health (NIH) with the creation of four new institutes.^[5] On October 8, 1948, the Rocky Mountain Laboratory and the Biologics Control Laboratory were joined with the NIH Division of Infectious Diseases and Division of Tropical Diseases to form the National Microbiological Institute. In 1955, Congress changed the name of the National Microbiological Institute to the National Institute of Allergy and Infectious Diseases to reflect the inclusion of allergy and immunology research. That change became effective on December 29, 1955.^[6]

Organizational structure

NIAID is composed of the Office of the Director (OD), four extramural divisions:

1. Division of Acquired Immunodeficiency Syndrome (DAIDS)
2. Division of Allergy, Immunology, and Transplantation (DAIT)
3. Division of Microbiology and Infectious Diseases (DMID)
4. Division of Extramural Activities (DEA)

and three intramural divisions:

1. Division of Clinical Research (DCR)
2. Division of Intramural Research (DIR)
3. Vaccine Research Center (VRC)^[7]

The Dale and Betty Bumpers Vaccine Research Center^[8] is composed of four laboratories and two programs:

• Immunology Laboratory
• Viral Pathogenesis Laboratory
• Virology Laboratory
• Vaccine Production Program Laboratory
• Clinical Trials Program
• Translational Research Program^[9]

Research priorities

NIAID’s research priorities are focused on:

1. “expanding the breadth and depth of knowledge in all areas of infectious, immunologic, and allergic diseases”
2. “developing flexible domestic and international research capacities to respond appropriately to emerging and re-emerging disease threats wherever they may occur.”^[1]:8

NIAID's mission areas are:

HIV-infected T Cell

Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome (HIV/AIDS)

The goals in this area are finding a cure for HIV-infected individuals; developing preventive strategies, including vaccines and treatment as prevention; developing therapeutic strategies for preventing and treating co-infections such as TB and hepatitis C in HIV-infected individuals; and addressing the long-term consequences of HIV treatment.

Biodefense and Emerging Infectious Diseases (BioD)

The goals of this mission area are to better understand how these deliberately emerging (i.e., intentionally caused) and naturally emerging infectious agents cause disease and how the immune system responds to them.

Infectious and Immunologic Diseases (IID)

The goal of this mission area is to understand how aberrant responses of the immune system play a critical role in the development of immune-related disorders such as asthma, allergies, autoimmune diseases, and transplant rejection. This research helps improve the understanding of how the immune system functions when it is healthy or unhealthy and provides the basis for development of new diagnostic tools and interventions for immune-related diseases.

Achievements

NIAID has established a reputation for being on the cutting edge of scientific progress both through its intramural labs and through the research it funds at academic institutions.^[10] For example, NIAID collaborations with various partners led to the development of FDA-approved vaccines for influenza (FluMist), hepatitis A (Havrix), and rotavirus (RotaShield). NIAID also was instrumental in the development and licensure of acellular pertussis vaccines, conjugate vaccines for Streptococcus pneumoniae and Haemophilus influenzae type b or Hib, and a preventive therapy for respiratory syncytial virus or RSV (Synagis). Additionally, NIAID partnerships with industry and academia have led to the advancement of diagnostic tests for several important infectious diseases, including malaria (ParaSight F), tuberculosis (GeneXpert MTB/RIF), and norovirus (Ridascreen Norovirus 3rd Generation EIA).

NIAID is a recognized pioneer in the study of HIV/AIDS and has helped improve standards of care of HIV-infected people in the United States and abroad. For example, its research on mother-to-child transmission (MTCT) of HIV has paved the way for new health interventions that have saved many lives. In 1994, a landmark study co-sponsored by NIAID demonstrated that the drug AZT, given to HIV-infected women who had little or no prior antiretroviral therapy (ART), reduced the risk of MTCT by two-thirds. This and other findings since then have helped reduce perinatal HIV infections in the United States by more than 90 percent, according to the Centers for Disease Control and Prevention.

In 1999, an NIAID-funded study in Uganda found that two oral doses of the inexpensive drug nevirapine—one given to HIV-infected mothers at the onset of labor and another to their infants soon after birth—reduced MTCT by half when compared with a similar course of AZT. Subsequent clinical trials, including some funded by NIAID, showed that AIDS drugs also can reduce the risk of MTCT through breast milk. These and other studies have led to World Health Organization recommendations that can help prevent MTCT while allowing women in resource-limited settings to breastfeed their infants safely.

More recently, NIAID-funded scientists found that testing at-risk infants for HIV and then giving ART immediately to those who test positive dramatically reduces rates of illness and death. HIV-infected infants were four times less likely to die if given ART immediately after they were diagnosed with HIV, when compared with the standard of care (beginning ART in infants when they showed signs of HIV illness or a weakened immune system).

This finding helped influence the World Health Organization (WHO) to change its guidelines for treating HIV-infected infants. The guidelines now strongly recommend starting ART in all children under age 2 immediately after they have been diagnosed with HIV, regardless of their health status.

Clinical training programs

NIAID offers three-year fellowships for medical trainees in allergy/immunology and infectious diseases. These Accreditation Council for Graduate Medical Education (ACGME)-accredited fellowships provide intensive clinical training and research mentorship in clinical and basic science laboratories.^[11] Both NIAID fellowship training programs include one full year of clinical responsibilities including two or three months of the first year caring for patients at the NIH Clinical Center, the nation’s largest hospital devoted to clinical research. The subsequent two years are dedicated to research.

Allergy and immunology

The Allergy and Immunology Clinical Fellowship Program is open to physicians who are on track to complete an approved internal medicine or pediatric medicine residency program.^[12] Fellows are eligible to sit for the Board of Allergy and Immunology certification examination after two years. Dr. Kelly Stone, M.D., Ph.D. is the Director of the fellowship training program.

Candidates are selected through the National Residency Matching Program. There are two to four positions available per year. Candidates should apply for the program in the summer a year prior to entry via the ERAS system.

Infectious diseases

The Infectious Diseases Fellowship Program is open to physicians who have completed three years of an internal medicine residency program in the United States or Canada.^[13] Fellows are eligible to sit for the ABIM Infectious Disease certification examination after two years. Dr. Tara N. Palmore is the Program Director for the Infectious Diseases fellowship program.

Candidates are selected through the National Residency Matching Program. There are four positions available per year. Candidates should apply for the program in the summer a year and a half prior to entry via the ERAS system.

Investigation of commercial partnerships

On 10 June 2011, the Office of Inspector General (OIG) published its results from an audit of a contract between the NIAID and the University of California at San Francisco, which read in part:^[14]

NIAID initially funded only $35.3 million of the $134.8 million Contract obligation with fiscal year 2001 appropriations. NIAID obligated a total of $99.5 million in violation of the bona fide needs rule: $19.5 million of fiscal year 2002 appropriated funds, $22.4 million of fiscal year 2003 appropriated funds, $23.4 million of fiscal year 2004 appropriated funds, $22.7 million of fiscal year 2005 appropriated funds, and $11.5 million of fiscal year 2006 appropriated funds. In addition, when it awarded a fiscal year 2007 Contract modification for nonseverable services, NIAID initially funded only $40.3 million of the $220.5 million contract obligation with fiscal year 2007 appropriations. Because the Contract was a nonseverable service contract, which represents a single undertaking and provides for a single outcome, NIAID was required to record the full amount of the Contract using fiscal year 2001 or fiscal year 2007 appropriated funds. By not doing so, NIAID potentially violated the Antideficiency Act. NIAID complied with the purpose requirements of appropriations statutes. …

In written comments on our draft report, NIH agreed that an Antideficiency Act violation had occurred but did not concur with our findings and recommendations regarding the characterization of the Contract as a nonseverable service contract. While the Contract may contain severable elements, we maintain that, on balance, the Contract is nonseverable. We determined that the Contract was overall nonseverable based on the language describing the tasks included in the statement of work.

On 21 September 2011, the OIG published its results from two separate audits of NIAID contracts with Avecia Biologics Limited and NexBio, Inc. The reports read in part:^[15][16]

Our review found that during fiscal years 2003 through 2009, NIH's National Institute of Allergy and Infectious Diseases (NIAID) did not comply with the time and amount requirements specified in appropriations statutes in administering contract N01-AI-3-0052 (the Contract) with Avecia Biologics Limited. …

NIAID funded only $40.0 million of the $71.3 million initial Contract obligation with fiscal year 2003 appropriations. NIAID obligated a total of $31.3 million in violation of the bona fide needs rule: $26.0 million of fiscal year 2004 appropriated funds and $5.3 million of fiscal year 2005 appropriated funds. Because the Contract was for nonseverable services, NIAID was required to record the full amount of the Contract using fiscal year 2003 appropriated funds. By not doing so, NIAID potentially violated the Antideficiency Act. (When services are severable they are continuing and recurring and chargeable to the fiscal year in which the services are provided.)

Our review found that during fiscal years 2006 through 2009, NIH's National Institute of Allergy and Infectious Diseases (NIAID) did not comply with the time requirements and may not have complied with the amount requirements specified in appropriations statutes in administering contract HHSN266-2006-00015C (the Contract) with NexBio, Inc. …

NIAID funded only $19.8 million of the $49.8 million Contract obligation with fiscal year 2006 appropriations. NIAID obligated a total of $20.0 million in violation of the bona fide needs rule: $10.0 million of fiscal year 2007 appropriated funds and $10.0 million of fiscal year 2009 appropriated funds. NIAID planned to obligate future-year appropriated funds as well. Because the Contract was a nonseverable service contract (a single undertaking that provides for a single outcome chargeable to the fiscal year in which the contract is awarded), NIAID was required to record the full amount of the Contract using fiscal year 2006 appropriated funds. By not doing so, NIAID potentially violated the Antideficiency Act. (When services are severable they are continuing and recurring and chargeable to the fiscal year in which the services are provided.) NIAID complied with the purpose requirements of appropriations statutes.

We recommended that NIAID (1) deobligate $10.0 million of fiscal year 2007 funds and $10.0 million of fiscal year 2009 funds, (2) record the remaining $30.0 million of the $49.8 million Contract obligation against fiscal year 2006 funds, and (3) report an Antideficiency Act violation if fiscal year 2006 funds are not available.

NIH concurred with the findings that the Contract is nonseverable and that it should have been funded at the time the Contract was awarded. NIH said that the Department of Health and Human Services would report the violation as required. NIH did not address our recommendations to correct the improper funding for the first 4 years of the Contract.

On 31 October 2011, the OIG published its results from an audit of a contract between NIAID and the EMMES Corporation, which read in part:^[17]

NIAID violated both the bona fide needs rule and the Antideficiency Act by obligating funds in advance of an appropriation. The initial contract action obligated fiscal year 2008 funds for a period of approximately 14 months (March 1, 2008, through April 30, 2009). Subsequent modifications obligated fiscal year 2008 and 2009 funds through May 31, 2011. Because the Contract was for severable services, NIAID should have obligated only those fiscal year 2008 funds needed for program year 1 and only those fiscal year 2009 funds needed for program year 2.

Additionally, NIAID violated the bona fide needs rule by obligating more funds than it needed for program year 1 and using those funds to pay for costs incurred after program year 1. Using the program year estimates provided in the Contract as evidence of the bona fide need, NIAID must resolve these violations by deobligating $16.9 million ($23.7 million less $6.8 million) of fiscal year 2008 funds that were obligated in excess of the agency's bona fide need for program year 1 and obligating the appropriate fiscal year funds for the program years in which the services were provided. If NIAID does not have adequate fiscal year funds available, it will violate the Antideficiency Act for these fiscal years as well.

Furthermore, although NIAID estimated that it would require $6.8 million for program year 1, at the time of our audit, it had expended only $4.9 million. NIAID may not use the remaining funds for costs incurred in subsequent program years. Rather, NIAID will need to deobligate an additional $1.9 million ($6.8 million less $4.9 million) of fiscal year 2008 appropriations if it is determined that they are no longer needed during their period of availability. NIAID funded the Contract in compliance with the purpose requirements of appropriations statutes. …

NIH did not address our recommendations to correct the improper funding for the first 2 program years of the Contract. Until NIH makes these adjustments, HHS cannot report the correct amount of its Antideficiency Act violation. Therefore, we continue to recommend that NIH record the correct Contract obligations and expenditures against the correct fiscal year funds.

Antibacterial resistance partnership

Vaccine News Daily reports that Duke University received a $2 million award to start a clinical research network focused on antibacterial resistance, partnering with NIAID to do a leadership group. The group and clinical trials will be headquartered at Duke University. NIAD will help lead the trials to test diagnostics, examine best practices in infection control programs to prevent the spread and development of resistant infections, perform clinical trials to optimize currently licensed antibacterial drugs to reduce resistance risk and conduct early-stage clinical evaluation of new antibacterial drugs.^[18]

References

External links

Wikimedia Commons has media related to National Institute of Allergy and Infectious Diseases.

• NIAID home page
• Anthony S. Fauci official biography