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GEO-D03 DNA vaccine

Phase 1

HIV Infections | Monoclonal antibody | Infectious Disease |GeoVax Labs, Inc.|Last Updated: Oct 15, 2021

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment48
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01571960Evaluating the Safety and Immune Response of a Prime-Boost HIV Vaccine Regimen in Healthy, HIV-Uninfected, Vaccinia-Naive AdultsPHASE1 COMPLETED 48 — — Apr 1, 2012Jan 1, 2016Oct 15, 20214 United States
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Study Endpoints
Primary Endpoints
Frequency and severity of local injection site reactogenicity signs and symptoms
Measured within the initial 72-hour period following each vaccination visit (Days 0, 56, 112, 168, 224, and 303)

Signs and symptoms include pain, tenderness, erythema, induration, and maximum severity of pain and/or tenderness.

Frequency and severity of systemic reactogenicity signs and symptoms and maximum severity of systemic symptoms
Measured within the initial 72-hour period following each vaccination visit (Days 0, 56, 112, 168, 224, and 303)

Systemic reactogenicity signs and symptoms include fever, malaise/fatigue, myalgia, headache, nausea, vomiting, chills, and arthralgia.

Distribution of values of safety laboratory measures: complete blood count (CBC), alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, and creatinine
Group 1: Measured through Day 334; Group 2: Measured through Day 394; Group 3: Measured through Day 334
Frequency of adverse events (AEs) categorized by MedDRA System Organ Class and MedDRA Preferred Term; severity and assessed relationship to study products; detailed description of all AEs meeting DAIDS criteria for expedited reporting
Group 1: Measured through Day 425; Group 2: Measured through Day 667; Group 3: Measured through Day 607
Report of the number of participants with early discontinuation of vaccinations, by treatment group and reason for discontinuation
Group 1: Measured through Day 425; Group 2: Measured through Day 667; Group 3: Measured through Day 607
Secondary Endpoints
Frequency and magnitude of HIV-1 envelope (env)-specific binding antibody and isotypes
Group 2: Measured at Day 317; Group 3: Measured at Day 238
Frequency of neutralizing antibody responses to HIV-1
Group 2: Measured at Day 317; Group 3: Measured at Day 238
In individuals with neutralizing antibodies to HIV-1, neutralizing antibody titers (magnitude) and breadth of neutralizing activity
Group 2: Measured at Day 317; Group 3: Measured at Day 238
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Group 1: study vaccineEXPERIMENTALParticipants in this arm will receive a 0.3-mg dose injection of GEO-D03 DNA vaccine at Days 0 and 56, followed by injections of MVA62B vaccine at Days 112, 168, and 224.
Group 1: placebo vaccinePLACEBO_COMPARATORParticipants in this arm will receive injections of placebo for GEO-D03 DNA vaccine at Days 0 and 56, followed by injections of placebo for MVA62B vaccine at Days 112, 168, and 224.
Group 2: study vaccineEXPERIMENTALParticipants in this arm will receive a 3-mg dose injection of GEO-D03 DNA vaccine at Days 0 and 56, followed by injections of MVA62B vaccine at Days 112, 168, and 303.
Group 2: placebo vaccinePLACEBO_COMPARATORParticipants in this arm will receive injections of placebo for GEO-D03 DNA vaccine at Days 0 and 56, followed by injections of placebo for MVA62B vaccine at Days 112, 168, and 303.
Group 3: study vaccineEXPERIMENTALParticipants in this arm will receive a 3-mg dose injection of GEO-D03 DNA vaccine at Days 0 and 56, followed by injections of MVA62B vaccine at Days 112 and 224.
Group 3: placebo vaccinePLACEBO_COMPARATORParticipants in this arm will receive injections of placebo for GEO-D03 DNA vaccine at Days 0 and 56, followed by injections of placebo for MVA62B vaccine at Days 112 and 224.
Interventions
NameTypeDescription
GEO-D03 DNA vaccineBIOLOGICALEither a 0.3-mg (Group 1: study vaccine) or 3-mg dose (Groups 2 and 3: study vaccine) administered as a 1-mL IM injection into the deltoid
MVA/HIV62B (MVA62B) vaccineBIOLOGICAL1 x 10\^8-TCID50 dose of MVA62B vaccine, administered as a 1-mL IM injection into the deltoid
Placebo for GEO-D03 DNABIOLOGICALAdministered as a 1-mL IM injection into the deltoid
Placebo for MVA62B:BIOLOGICALAdministered as a 1-mL IM injection into the deltoid
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Eligibility Criteria
Age Range18 Years — 50 Years
SexALL
Healthy VolunteersYes
Study Sites4

Inclusion Criteria: * Access to a participating HIV Vaccine Trials Network (HVTN) clinical research site (CRS) and willingness to be followed for the planned duration of the study * Ability and willingness to provide informed consent * Assessment of understanding: participant demonstrates understan...

Countries:United States
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Competitive Landscape -Bacterial Infections 62 trials
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