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Principal Investigator: Lesia Dropulic
Organization: NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES
Fiscal Year: 2024
Award: $2,658,032
Funding agency: National Institute of Allergy and Infectious Diseases
Evaluation of the investigational vaccines in this project are part of the VRC mission related to biodefense and emerging pathogens. Targets include influenza, Ebola, Nipah, West Nile, malaria, and others.
Published results from clinical trials have included:
VRC 204: Ebola DNA vaccine study: Clin Vaccine Immunol. 2006. 13(11):1267-77
VRC 302: West Nile virus DNA vaccine study: J Infect Dis. 2007. 196(12):1732-40
VRC 301: SARS DNA vaccine study vaccine study. 2008 Nov 25;26(50):6338-43
VRC 303: Second generation West Nile virus DNA vaccine study: J Infect Dis. 2011, May 15;203(10)
VRC 205: Second generation Ebola rAd5 vaccine study: Vaccine. 2010 Oct 27
VRC 306: H5N1 gene based prime, inactivated boost vaccine study: Lancet Infect Dis. 2011 Dec;11(12):916-24
VRC 304 and VRC 305: H5 DNA vaccine study and H5 route study: Clin Vaccine Immunol. 2012 Nov; 19(11):1792-7
VRC 310: Follow on H5N1 prime, inactivated boost interval examination study: J Infect Dis. 2013 Aug 1; 208(3):413-7, J Infect Dis. 2013 Aug 1; 208(3):418-22
VRC 312: Dose-escalation with experimental challenge to evaluate intravenous administration of PfSPZ vaccine trial: Science. 2013 Sep 20;341(6152):1359-65
VRC 311: VLP vaccine for Chikungunya virus: Lancet. 2014 Aug 14
VRC 206: Ebola and Marburg vaccine study: J Infect Dis. 2015 Feb 15;211(4):549-57
VRC 207: cAd3-EBO Ebola vaccine study: N Engl J Med. 2014 Nov 26
RV 247: Ebola and Marburg vaccine study in Uganda: Lancet. 2015 Apr 18;385(9977):1545-54
VRC 308: Pandemic H1 DNA vaccine study: PLoS One. 2015 Apr 17;10(4):e0123969
VRC 307 and VRC 309: Seasonal influenza HA DNA followed by TIV boost vaccine study: Contemp Clin Trials. 2015 Aug 11
VRC 314: Experimental controlled human malaria infections to evaluate safety and durability following intravenous and intramuscular administration of PfSPZ vaccine in malaria-naive adults: Nat Med. 2016 Jun;22(6):614-23
VRC 315: Avian influenza H7 DNA and H7N9 MIV vaccine study: NPJ Vaccines. 2017 Jun 1;2:15
VRC 319 and VRC 320: Zika virus DNA vaccine studies: Lancet. 2018 Feb 10;391(10120):552-562
VRC 317: RSV vaccine study: Science. 2019 Aug 2;365(6452):505-509.
VRC 704: Phase 2 VLP vaccine for Chikungunya virus: JAMA. 2020 Jul 28;324(4):400.
VRC 313: Phase 1 Trivalent virus-like particle vaccine against Western, eastern, and Venezuelan equine encephalitis viruses.Lancet Infect Dis. 2022 Aug; 22(8):1210-1220.
VRC 316: Phase 1 A novel ferritin nanoparticle H2 influenza vaccine. Nat Med. 2022 Feb;28(2):383-391.
VRC 321: An influenza hemagglutinin stem nanoparticle vaccine induces cross-group 1 neutralizing antibodies in healthy adults. Sci Trans. Med. 2023 April.
Project work conducted in FY2024:
VRC 323: This is a phase 1 trial that evaluated the dose, safety, tolerability, and immunogenicity of an H10 stabilized stem ferritin vaccine in healthy adults. The study completed enrollment in January 2022. Manuscript accepted for publication (August 2024)
VRC 325: This is a phase 1 trial to evaluate the safety, tolerability, and immunogenicity of a first-in-human lumazine synthase particle-based, mosaic, quadrivalent influenza vaccine, FluMos-v1, compared with a license inactivated seasonal QIV in healthy adults 18 to 50 years of age (NCT04896086). Study completed enrollment in FY23. Data analysis is ongoing.
VRC 322: VRC322/DMID 21-0016 is phase 1, dose-escalation, open-label clinical trial that evaluates the safety, tolerability, and immunogenicity of a Nipah virus mRNA vaccine, mRNA-1215, in healthy adults 18 to 60 years of age. The VRC Vaccination Clinic is the site for this study with DMID as the sponsor. Four groups, each with 10 participants, will be dosed with the following regimens: group 1, 25 mcg intramuscularly (IM) on Day 0 and Day 28; group 2, 50 mcg IM on Day 0 and Day 28; and group 3, 100 mcg IM on Day 0 and Day 28. A fourth, higher dose group may be enrolled based on the safety and immunogenicity data from the described groups. This trial completed enrollment in August 2023 (NCT05398796). Data analysis is ongoing.
VRC 326: This phase 1 study evaluating the safety and immunogenicity of a mosaic hexavalent influenza vaccine (FluMos-v2) in healthy adults was that initiated in August 2023. Part B of the study included sampling of germinal centers in reactive lymph nodes after vaccination.
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