Biodefense and Emerging Infectious Disease Vaccine Studies

National Institute Of Allergy And Infectious Diseases

Investigators

Linked publications & trials

Abstract

Evaluation of the investigational vaccines in this project are part of the VRC mission related to biodefense and emerging pathogens. Targets include influenza, Ebola, malaria, and others. Further evaluation of vaccine approaches will continue as the VRC develops additional candidate vaccine regimens. 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. Trials conducted in FY22: 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. Part A of this trial opened to accrual in spring of FY21 and was fully enrolled by the summer of FY21. A total of 20 participants received the FluMos-v1 vaccine: five participants received a 20 microgram (mcg) one time dose of FluMos-v1 intramuscularly (IM) and 15 participants received a 60 mcg dose IM. In addition, 15 participants received the Flucelvax vaccine at 60 mcg IM. Follow-up visits were completed in spring FY22. Data analyses are ongoing. Based on an interim immunogenicity analysis, Part B of an amended protocol will evaluate a higher dose of FluMos-V1 with or without the adjuvant, Adjuplex (NCT04896086). 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 began enrolling in FY22 and has enrolled 13 participants to date (NCT05398796).