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Major Collaborative Research Agreements in Effect in Fiscal Year 2007

NIAID Technology Transfer Activities
Technology Transfer Highlights
CRADAs
MCRADAs
RCAs
Conditional Gift Acceptance Letters
CTAs

NIAID Technology Transfer Activities

Fiscal Year Pending US Pat. Appls. Issued US Patents Licenses In Effect Active CRADAs
1998 158 128 119 95
1999 162 148 145 74
2000 171 161 138 86
2001 167 174 147 93
2002 188 187 157 85
2003 207 189 153 71
2004 221 203 142 70
2005 234 207 159 76
2006 229 214 154 73
2007 244 227 148 60

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Technology Tranfer Highlights

In FY 2007, NIAID participated in and OTD negotiated or facilitated, the following partnership agreements:

CRADAs

Division Collaborator PI Title
DCR Omrix Lane The Development of Passive Immunotherapy Product(s) Against Influenza
DIR AlphaVax Cohen Pre-Clinical Evaluation of Alphavaccine vectors against rhesus lymphocryptovirus as a model for a prophylactic human vaccine against Epstein-Barr virus (EBV)
DIR Wellstat Diagnostics Lenardo Development of novel diagnostic assays for early detection and monitoring of infectious and immune disorders in humans using a proprietary electrochemiluminescense (“ECL”) technology
DIR Wellstat Diagnostics Lenardo Development of novel tolerogen therapeutics for human immune disease processes
DMID GlaxoSmithKline Deal Amendment #2 to CRADA –A double-blind, randomized, controlled Phase III study to assess the prophylactic efficacy of rgD/Alum/MPL vaccine in the prevention of genital herpes disease in young sexually active women (DMID#01-643)
VRC GenVec Graham Evaluation of Adenoviral Vectors Encoding Surface Glycoproteins from Respiratory Syncytial Virus
VRC ImmuRx Seder Induction of Broad-Based Immunity Following Vaccination with Protein, CD40 Agonists and Toll-like Receptor Ligands or Type 1 Interferon

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MCRADAs

Division Collaborator PI Title
DIR Antigenics Farber Immunogenicty studies with vaccinia, HIV/SIV, and SARS antigens in combination with Antigenics' proprietary QS21 adjuvant
DIR Centocor Strober The role of Interleukin-12 Family Cytokines in Trinitrobenzene sulphonic acid (TNBS)-Colitis, Oxazolone Colitis and Other Experimental Colitides
DIR Domantis Ltd Subbarao Effect of Monoclonal antibody to Interferon Gamma on H5N1 isolates of Influenza type-A
DIR Wyeth-Ayerst Wynn The elucidation of the role of interleukin-22 (IL-22) in modulating immune responses after pathogen challenges
VRC Crucell Holland, B.V. Koup Continuing Studies to Screen Potential Vaccine Recipients for the Presence and Levels of Neutralizing Antibodies Against Ad5, Ad11, Ad35, Ad49 and Ad5.HVR48 Adenoviral Vectors
VRC GSK Douek Treatment of Simian Immunodeficiency Virus (SIV)–infected rhesus macaques with CRX-526, a Toll-Like Receptor 4 (TLR4) Antagonist

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RCAs

Division Collaborator PI Title
DIR Bar Harbor BioTechnology Morse Alpha-Testing of ImmunoQuant Arrays Prototypes by Assessing Gene expression Profiles
DIR Duke University Connors Explore whether the HCP5 or HLA-C polymorphisms have an effect on viral load that is independent of the effects of HLA B57
DIR International Livestock Research Institute Ribeiro Comparative EST Sequencing of Infected Tick Salivary Gland Tissue
DIR National Center for Parasitology, Entomology and Malaria Control (CNM), Ministry of Health of the Kingdom of Cambodia Gwadz Association of Genetic Polymorphism and Malaria in Cambodians
DIR Novartis Inst. for Tropical Diseases Barry Drug development for chronic tuberculosis
DIR PanThera Biopharma, LLC Leppla Characterization of Specific Anthrax Lethal Factor Inhibitors
DIR Promedior Inc. Wynn Characterization of hSAP's role in fibrosis development and the immune response to schistosome infection
DIR Trellis Bioscience Pierce Study of memory B cells specific for malaria parasite, P. falciparum
DIR Tropical Medicine Institute Gwadz Malarial Parasite Diversity and Drug Resistance
DIR Walter Reed Army Institute of Research Long Optimization of in vitro assys for immunogenicity testing of malaria vaccine candidates
VRC BioDelivery Sciences International Inc. Graham Improved Immunogenicity of the RSV when Formulated in Cochleates
VRC Bioject Graham The use of Needle-free Injection System in DNA Influenza Vaccine Study (Protocol#305)
VRC Children's Hosp. of Philadelphia Graham Evaluation of Adeno-Associated Virus (AAV) Vector Technology as a Method for Vaccination against RSV
VRC Columbia University Sullivan Generation of Ebola antigen-specific monoclonal antibodies from B-cells of vaccinated macaques
VRC Inst. for Research in Biomedicine Sullivan Generation of human Mabs reactive to Ebola GP
VRC Merck Gomez Merck know-how on large scale vaccine production
VRC Merck Wyatt Amendment #1 - HIV Neutralizing Antibody Responses When Formulated in Lipophilic System
VRC Schrodinger Kwong In Silico Model of gp120-CCR5-N terminus
VRC University of Geneva Nabel Generation of human Mabs reactive to Ebola GP
VRC University of Medicine & Dentistry of New Jersey Wyatt The Effect of Mutations Introduced into HIV-1 Env on Neutralizing Activity of Ser

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Conditional Gift Acceptance Letters

Division Collaborator PI Title
DIR Canadian Institute for Advanced Research Grigg CIFAR Program in Integrated Microbial Diversity
DIR Fraunhofer USA CMB Miller Development of the Transmission Blocking Vaccine
DIR PATH Long Malaria in vitro growth inhibition assays
VRC Beth Israel Deaconess Medical Center Nabel Novel Recombinant Adenovirus, Plasmid DNA and Mycobacteria Vector Based Vaccines for HIV-1
VRC Duke University Medical Center/Gates Mascola Comprehensive Antibody Vaccine Immune Monitoring Consortium (CA-VIMC)
VRC FNIH/Gates Koup Comprehensive T Cell Vaccine Immune Monitoring Consortium (CTC-VIMC)
VRC IAVI/Gates Koup Comprehensive T Cell Vaccine Immune Monitoring Consortium (CTC-VIMC)
VRC UAB/Gates Kwong Wyatt Amendment #4 - Molecular Analysis and Modeling of HIV-1 Transmission, Containment and Escape

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CTAs

Division Collaborator PI Title
DAIDS Tibotec   The Optimized Treatment that Includes or Omits NRTIs (OPTIONS) Trial: A Randomized Strategy Study for Treatment-Experienced Subjects Using the cPSS to Select an Effective Regimen
DIR Human Genome Sciences Kottilil An open label non-randomized trial to assess safety and tolerability of albumin interferon alpha-2b 1200 mcg and 1800 mcg every two weeks with ribavirin among HIV’HCV coinfected individuals
DIR PATH Miller Phase 1 Study of the Safety, Reactogenicity and Immunigenicity of AMA1C/ISA720
DIR Takeda Pharmaceuticals North America Hadigan  
DIR Tercica Malech Treatment for Growth Failure in Patients with X-linked Severe Combined Immunodeficiency (XSCID): A Phase II Study Assessing Safety and Clinical Response to Treatment with IGF-1
DMID Emergent Product Development UK Rubin A phase 1 open-label dose-escalation single center study to evaluate the safety, tolerability and immunogenicity of a single-component and two-component protein GBS vaccine administrered to adults on three occasions each 28 days apart
DMID Hoffman-La Roche Ltd   A Phase III, Randomized, Placebo-Controlled, Blinded Investigation of Six Weeks Vs. Six Months of oral Valganciclovir Therapy in Infants with Symptomatic Congenital Cytomegalovirus infection (CASG 112)
DMID Joint Vaccine Acquisition Program (JVAP) of Chemical Biological Medical Systems   DMID Protocol 01-003: “Phase 1 Trial of the Safety and Immunogenicity of the rPA from Baccilus anthracis [Delta Sterne-1 (pPA102) CR4 Strain] Vaccine Anthrax
DMID Sanofi-Pasteur, Inc. Rubin Safety and Immunogenicity of DTaP Vaccine in Healthy Pregnant Women, Safety in their Neonates, and Effect of Maternal Immmunization on Infant Immune Responses to DTaP Vaccine
VRC/DAIDS IAVI   IAVI Protocol V002 “A Phase 2, Randomized, Placebo-Controlled, Double-Blind Trial to Evaluate the Safety and Immunogenicity of a Multiclade HIV-1 DNA Plasmid Vaccine Followed by Recombinant, Multiclade HIV-1 Adenoviral Vector Vaccine in Healthy Adult Volunteers at Risk for HIV Infection
VRC/DAIDS IAVI   (IAVI/PAVE 100) A Phase IIB Test-of-Concept, Randomized, Double-Blinded, Placebo-Controlled, International Clinical Trial to Evaluate the Efficacy, Safety and Immunogenicity of Multiclade HIV-1 DNA Plasmid Vaccine, VRC-HIVDNA016-00-VP, Followed by a multiclade Recombinant Adenoviral Vector Vaccine, VRC-HIVADV014-00-VP, in HIV-Uninfected Persons
VRC/DAIDS Merck & Co., Inc.   HVTN protocol #071 “A Phase I B clinical trial to define assays and methods to be used for evaluating potential correlates of immunity following administration of the Merck Adenovirus serotype 5 HIV-1 gag/pol/nef vaccine in healthy, HIV-1 uninfected adult participants

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