Document text
Principal Investigator: LISA A JACKSON
Organization: KAISER FOUNDATION RESEARCH INSTITUTE
Fiscal Year: 2021
Award: $2,014,564
Funding agency: National Institute of Allergy and Infectious Diseases
This Supplemental Funding application requests funding for the Kaiser Washington Vaccine and Treatment
Evaluation Unit (VTEU) to function as a clinical site for DMID study 21-0012, a Phase 1/2 study of delayed
heterologous SARS-CoV-2 vaccine dosing (boost) after receipt of EUA vaccines. This clinical trial will evaluate
the safety and immunogenicity of different heterologous delayed doses (boosts) in those who received an EUA
vaccine (either prior to participation in this trial, or as part of this trial).
Since the 1960s the VTEUs have conducted trials of vaccines and therapeutic candidates for infectious
diseases of public health importance (other than HIV) including, for example, influenza, malaria, smallpox,
anthrax, and pneumococcal infection. Kaiser Washington has been continuously funded as a VTEU site since
2007, and in 2019 was awarded a seven-year cooperative agreement as one of ten VTEU sites in the newly
formed NIAID Infectious Diseases Clinical Research Consortium (IDCRC).
In 2020, the NIH and the IDCRC responded to the COVID-19 pandemic by launching the first trial (20-0003) of
a candidate COVID-19 vaccine (mRNA-1273), an mRNA vaccine co-developed by the NIH Vaccine Research
Center and Moderna, Inc, in March 2020. The Kaiser Washington VTEU was originally the sole site for that trial
which was later expanded in terms of enrollment and sites, to also include the Emory University School of
Medicine VTEU and the NIH Vaccine Research Center sites. mRNA-1273 has been granted Emergency Use
Authorization, as has an mRNA vaccine from Pfizer and an adenovirus-vectored vaccine from Janssen.
Knowledge of the safety, tolerability, and immunogenicity of a boost vaccine using a heterologous platform with
the homologous or variant spike lineage administered after an EUA primary dosing is a critical piece of
information needed to inform public health decisions. The heterologous boost strategy will also provide an
opportunity to thoroughly evaluate innate, cellular, and humoral immune responses elicited from the multiple
prime boost combinations using very similar immunogens, utilizing mRNA, adenovirus- vectored, and protein-
based platforms. As new vaccines are manufactured to emerging variants, these foundational data will be key
to the evaluation of future variant and heterologous prime-boost strategies.
Terms: <2019-nCoV vaccine><AIDS Virus><Acquired Immune Deficiency Syndrome Virus><Acquired Immunodeficiency Syndrome Virus><Ad vector><Adenoviral Vector><Adenovirus Vector><Anthrax><Anthrax disease><Antigens><Award><COVID crisis><COVID epidemic><COVID pandemic><COVID-19 crisis><COVID-19 epidemic><COVID-19 global health crisis><COVID-19 global pandemic><COVID-19 health crisis><COVID-19 pandemic><COVID-19 public health crisis><COVID-19 vaccine><COVID19 crisis><COVID19 epidemic><COVID19 global health crisis><COVID19 global pandemic><COVID19 health crisis><COVID19 pandemic><COVID19 public health crisis><COVID19 vaccine><Clinical Research><Clinical Study><Clinical Trials><Communicable Diseases><Conduct Clinical Trials><Cooperative Agreements><Data><Diagnostic><Dose><Emerging Communicable Diseases><Emerging Infectious Diseases><Enrollment><Evaluation><FDA EUA><FDA Emergency Use Authorization><Food and Drug Administration EUA><Food and Drug Administration Emergency Use Authorization><Foundations><Funding><Future><Grant><Grippe><HIV><Human Immunodeficiency Viruses><Immune response><Immunological response><Infectious Disease Pathway><Infectious Diseases><Infectious Disorder><Influenza><Knowledge><LAV-HTLV-III><Lymphadenopathy-Associated Virus><Malaria><Messenger RNA><Moderna COVID-19 vaccine><Moderna coronavirus disease 2019 vaccine><NIAID><NIH><NIH RFA><NIH Vaccine Research Center><National Institute of Allergy and Infectious Disease><National Institutes of Health><Paludism><Persons><Phase><Plasmodium Infections><Pneumococcal Infections><Proteins><Protocol><Protocols documentation><Public Health><RNA vaccine><RNA-based vaccine><Request for Applications><SARS-CoV-2 epidemic><SARS-CoV-2 global health crisis><SARS-CoV-2 global pandemic><SARS-CoV-2 pandemic><SARS-CoV-2 vaccine><SARS-CoV2 epidemic><SARS-CoV2 pandemic><SARS-CoV2 vaccine><SARS-coronavirus-2 epidemic><SARS-coronavirus-2 pandemic><SARS-coronavirus-2 vaccine><Safety><Series><Severe Acute Respiratory Syndrome CoV 2 epidemic><Severe Acute Respiratory Syndrome CoV 2 pandemic><Severe Acute Respiratory Syndrome CoV 2 vaccine><Severe acute respiratory syndrome coronavirus 2 epidemic><Severe acute respiratory syndrome coronavirus 2 pandemic><Severe acute respiratory syndrome coronavirus 2 vaccine><Site><Smallpox><Streptococcus pneumoniae Infections><Therapeutic><U-Series Cooperative Agreements><United States National Institutes of Health><Universities><Vaccines><Variant><Variation><Variola><Virus-HIV><Washington><adeno vector><adenovector><base><clinical research site><clinical site><corona virus disease 2019 epidemic><corona virus disease 2019 pandemic><corona virus disease 2019 vaccine><coronavirus disease 2019 crisis><coronavirus disease 2019 epidemic><coronavirus disease 2019 global health crisis><coronavirus disease 2019 global pandemic><coronavirus disease 2019 health crisis><coronavirus disease 2019 pandemic><coronavirus disease 2019 public health crisis><coronavirus disease 2019 vaccine><coronavirus disease crisis><coronavirus disease epidemic><coronavirus disease pandemic><emergency use authorization><enroll><host response><immune system response><immunogen><immunogenicity><immunoresponse><mRNA><mRNA vaccine><mRNA-1273><mRNA-based vaccine><mRNA1273><medical college><medical schools><new vaccines><next generation vaccines><novel vaccines><plasmid vaccine><pneumococcal disease><pneumococcus infection><research study><school of medicine><severe acute respiratory syndrome coronavirus 2 global health crisis><severe acute respiratory syndrome coronavirus 2 global pandemic><small pox><therapeutic candidate><vaccination study><vaccination trial><vaccine against 2019-nCov><vaccine against SARS-CoV-2><vaccine against SARS-CoV2><vaccine against SARS-coronavirus-2><vaccine against Severe Acute Respiratory Syndrome CoV 2><vaccine against Severe acute respiratory syndrome coronavirus 2><vaccine candidate><vaccine for novel coronavirus><vaccine study><vaccine trial><variola major><vector vaccine>