grant

Pushing HIV-1 Vaccine Protection to the Mucosal Barrier

Organization MAYO CLINIC ROCHESTERLocation ROCHESTER, UNITED STATESPosted 19 Jul 2024Deadline 31 May 2026
NIHUS FederalResearch GrantFY20242019 novel corona virus2019 novel coronavirus2019-nCoV2019-nCoV S protein2019-nCoV spike glycoprotein2019-nCoV spike protein2019-nCoV vaccineAIDS VirusAcquired Immune Deficiency Syndrome VirusAcquired Immunodeficiency Syndrome VirusAddressAdenoviridaeAdenoviridae InfectionsAdenovirus InfectionsAdenovirusesAdjuvantAnimalsAntibodiesAntibody ResponseAntigensAutomobile DrivingBenchmarkingBest Practice AnalysisBody WeightCOVID crisisCOVID epidemicCOVID pandemicCOVID-19 S proteinCOVID-19 crisisCOVID-19 epidemicCOVID-19 eraCOVID-19 global health crisisCOVID-19 global pandemicCOVID-19 health crisisCOVID-19 pandemicCOVID-19 periodCOVID-19 public health crisisCOVID-19 spikeCOVID-19 spike glycoproteinCOVID-19 spike proteinCOVID-19 vaccineCOVID-19 virusCOVID-19 yearsCOVID19 virusCartoonsCell BodyCellsCoV-2CoV2ColonColon or RectumColorectalDNADataDefectDeoxyribonucleic AcidDistantEventExposure toGender IdentityGenesHIVHIV vaccineHIV-1HIV-1 vaccineHIV-IHIV/AIDS VaccinesHIV1HIV1 vaccineHumanHuman Immunodeficiency Virus Type 1Human Immunodeficiency VirusesHuman immunodeficiency virus 1ImmuneImmune responseImmunesImmunizationImmunizeImmunological responseInfectionInfectious AgentInferiorIntramuscularIntravaginal AdministrationKineticsLAV-HTLV-IIILungLung Respiratory SystemLymphadenopathy-Associated VirusM mulattaM. mulattaMacacaMacaca mulattaMacaqueMediatingMessenger RNAModelingModern ManMucosaMucosal Immune ResponsesMucosal TissueMucous MembraneOralProductionProteinsRNA vaccineRNA-based vaccineRectumReproducibilityRhesus MacaqueRhesus MonkeyRiskRouteSARS corona virus 2SARS-CO-V2SARS-COVID-2SARS-CoV-2SARS-CoV-2 SSARS-CoV-2 S proteinSARS-CoV-2 epidemicSARS-CoV-2 global health crisisSARS-CoV-2 global pandemicSARS-CoV-2 pandemicSARS-CoV-2 spikeSARS-CoV-2 spike glycoproteinSARS-CoV-2 spike proteinSARS-CoV-2 vaccineSARS-CoV2SARS-associated corona virus 2SARS-associated coronavirus 2SARS-coronavirus-2SARS-coronavirus-2 epidemicSARS-coronavirus-2 pandemicSARS-coronavirus-2 vaccineSARS-related corona virus 2SARS-related coronavirus 2SARSCoV2SHIVSIVSalivaSevere Acute Respiratory Coronavirus 2Severe Acute Respiratory Distress Syndrome CoV 2Severe Acute Respiratory Distress Syndrome Corona Virus 2Severe Acute Respiratory Distress Syndrome Coronavirus 2Severe Acute Respiratory Syndrome CoV 2Severe Acute Respiratory Syndrome CoV 2 epidemicSevere Acute Respiratory Syndrome CoV 2 pandemicSevere Acute Respiratory Syndrome CoV 2 vaccineSevere Acute Respiratory Syndrome-associated coronavirus 2Severe Acute Respiratory Syndrome-related coronavirus 2Severe acute respiratory syndrome associated corona virus 2Severe acute respiratory syndrome coronavirus 2Severe acute respiratory syndrome coronavirus 2 S proteinSevere acute respiratory syndrome coronavirus 2 epidemicSevere acute respiratory syndrome coronavirus 2 pandemicSevere acute respiratory syndrome coronavirus 2 spike glycoproteinSevere acute respiratory syndrome coronavirus 2 spike proteinSevere acute respiratory syndrome coronavirus 2 vaccineSevere acute respiratory syndrome related corona virus 2Simian Immunodeficiency VirusesSiteSurfaceTestingTimeTransgenesTranslatingVaccinatedVaccinationVaccine AntigenVaccinesVaginaVaginal AdministrationViralViral BurdenViral LoadViral Load resultViral load measurementVirionVirusVirus ParticleVirus-HIVWomanWorkWuhan coronavirusbenchmarkbooster dosebooster shotbooster vaccinecolorectumcombatcoronavirus disease 2019 S proteincoronavirus disease 2019 crisiscoronavirus disease 2019 epidemiccoronavirus disease 2019 global health crisiscoronavirus disease 2019 global pandemiccoronavirus disease 2019 health crisiscoronavirus disease 2019 pandemiccoronavirus disease 2019 public health crisiscoronavirus disease 2019 spike glycoproteincoronavirus disease 2019 spike proteincoronavirus disease 2019 vaccinecoronavirus disease 2019 viruscoronavirus disease crisiscoronavirus disease epidemiccoronavirus disease pandemiccoronavirus disease-19 global pandemiccoronavirus disease-19 pandemiccoronavirus disease-19 vaccinecoronavirus disease-19 viruscross immunitycross protectiondeliver vaccinesdrivingfemale genital tractfemale reproductive tracthCoV19host responsehuman immunodeficiency virus vaccineimmune system responseimmunogenimmunoresponseimprovedinfectious organismmRNAmRNA vaccinemRNA-based vaccinemenmucosal sitemucosal vaccinenCoV vaccinenCoV-19 vaccinenCoV19 vaccinenCoV2pathogenpenispreservationpreventpreventingpulmonaryrecruitresponsesevere acute respiratory syndrome coronavirus 2 global health crisissevere acute respiratory syndrome coronavirus 2 global pandemicsex identitysexual identitysimian HIVsimian human immunodeficiency virusspike proteins on SARS-CoV-2transgenevaccine against 2019-nCovvaccine against COVID-19vaccine against SARS-CoV-2vaccine against SARS-coronavirus-2vaccine against Severe Acute Respiratory Syndrome CoV 2vaccine against Severe acute respiratory syndrome coronavirus 2vaccine boostvaccine candidates against SARS-CoV-2vaccine deliveryvaccine for novel coronavirusvaccines preventing COVIDvaccines to prevent COVIDvirus loadwomen's genital tractwomen's reproductive tract
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Full Description

Abstract
Most gene-based vaccines are replication-defective mRNA, DNA, or adenovirus (Ad) vaccines. In each case,
the vaccine delivers its one copy of an antigen gene and expresses "1X" of the antigens that are encoded by the
vaccine. We developed single cycle Ad (SC-Ad) vaccines that replicate vaccine antigen genes up to 10,000-fold
in every cell to amplify antigen production but do not produce infectious progeny viruses. When RD-Ad and SC-
Ad6 expressing HIV-1 antigens or SARS-CoV-2 spike are compared, SC-Ad produces 100 times more antigen
than RD-Ad and generates significantly higher antibodies than RD-Ad-Spike or mRNA vaccines. When spike-
immunized animals were challenged 10.5 months after single immunization, SC-Ad reduced SARS-CoV-2 lung
viral loads and damage and preserved body weights better than RD-Ad.
During the COVID-19 pandemic, we tested SC-Ads expressing SIV gag and clade C HIV-1 Env in rhesus
macaques by intramuscular (IM), intranasal (IN), and intravaginal (IVAG) routes of immunization in combination
with IM co-immunization with adjuvanted clade C SOSIP protein. When the macaques were challenged vaginally
with clade C SHIV.CH505.375H.dCT 1.5 years after last vaccine, PBS, IN, and IM vaccinated animals became
infected with similar kinetics with only one IN animal resisting infection. In contrast, 50% of the IVAG macaques
resisted vaginal challenge.
These data suggest there are great merits to creating a mucosal barrier against incoming SHIV at the site of viral
entry. Given this, this project will determine the reproducibility of this protection and examine how vaginal
immunization drives local-regional immune responses in the female reproductive tract (FRT) and if these
responses might be amplified by co-immunization in this site.
Proof of concept here for being able to “push” immune responses into the FRT in macaques will allow these
approaches to be translated for humans, to protect not just women, but all sexes and gender identities from
vaginal, rectal, or penile exposures to HIV-1.

Grant Number: 1R56AI184121-01A1
NIH Institute/Center: NIH
Principal Investigator: Michael Barry

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