Study Stopped
Protocol undergoing additional revisions.
Evaluating the Safety and Immunogenicity of a Prime-boost Vaccine Regimen of GEO-D02 DNA and MVA/HIV62B With and Without B63521^11 gp120 and IHV01 gp120 Env Proteins in Healthy, HIV-uninfected Adult Participants
A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of a Prime-boost Vaccine Regimen of GEO-D02 DNA and MVA/HIV62B With and Without B63521^11 gp120 and IHV01 gp120 Env Proteins in Healthy, HIV-uninfected Adult Participants *Imatinib Mesylate Per Oral as a Clinical Therapeutic for TB
2 other identifiers
interventional
N/A
0 countries
N/A
Brief Summary
The purpose of this study is to evaluate the safety and immunogenicity of a prime-boost vaccine regimen of GEO-D02 DNA and MVA/HIV62B with and without B63521\^11 gp120 and IHV01 gp120 Env proteins in healthy, HIV-uninfected adult participants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Mar 2022
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 31, 2019
CompletedFirst Posted
Study publicly available on registry
August 1, 2019
CompletedStudy Start
First participant enrolled
March 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2023
CompletedOctober 15, 2021
October 1, 2021
7 months
July 31, 2019
October 13, 2021
Conditions
Outcome Measures
Primary Outcomes (9)
Frequency of local reactogenicity signs and symptoms
Local symptoms include pain and/or tenderness at the injection site.
Measured through Month 10
Frequency of systemic reactogenicity signs and symptoms
Systemic symptoms include increased body temperature, malaise and/or fatigue, myalgia, headache, chills, arthralgia, and nausea.
Measured through Month 10
Frequency of adverse events
Summarized using Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class and preferred terms
Measured through Month 16
Frequency of serious adverse events
Summarized using MedDRA System Organ Class and preferred terms
Measured through Month 16
HIV-specific IgG binding magnitude to cross-clade panels of gp120 and V1V2, and gp41
As assessed by binding antibody multiplex assay (BAMA)
Measured through Month 10.5
HIV-specific IgG binding response rate to cross-clade panels of gp120 and V1V2, and gp41
As assessed by BAMA
Measured through Month 10.5
HIV-specific IgG binding breadth to cross-clade panels of gp120 and V1V2, and gp41
As assessed by BAMA
Measured through Month 10.5
Response rate of CD4+ T-cell responses to Env
As assessed by intracellular cytokine staining (ICS)
Measured through Month 10.5
Magnitude of CD4+ T-cell responses to Env
As assessed by ICS
Measured through Month 10.5
Secondary Outcomes (15)
HIV-specific IgG binding magnitude to V3, CD4i and gp41 IDR
Measured through Month 10.5
HIV-specific IgG binding response rate to V3, CD4i and gp41 IDR
Measured through Month 10.5
IgA responses to gp120, V1V2, and gp41
Measured through Month 10.5
IgG3 responses to gp120, V1V2, and gp41
Measured through Month 10.5
IgG avidity to defined epitope specificities
Measured through Month 10.5
- +10 more secondary outcomes
Study Arms (5)
Group 1 (T1): DNA + MVA + Placebo (IM)
EXPERIMENTALParticipants will receive 3 mg of GEO-D02 DNA by intramuscular (IM) injection at Months 0 and 2. Participants will also receive 1×10\^8 50% tissue culture infective dose (TCID50) of MVA/HIV62B plus placebo for B63521\^11 gp120 plus placebo for IHV01, each by IM injection at Months 4, 6, and 10.
Group 2 (T1): DNA + MVA + Placebo (SC)
EXPERIMENTALParticipants will receive 3 mg of GEO-D02 DNA by IM injection at Months 0 and 2. Participants will also receive 1×10\^8 TCID50 of MVA/HIV62B by IM injection plus placebo for B63521\^11 gp120 by subcutaneous (SC) injection plus placebo for IHV01 by SC injection at Months 4, 6, and 10.
Group 3 (T2): DNA + MVA + IHV01 + B63
EXPERIMENTALParticipants will receive 3 mg of GEO-D02 DNA by IM injection at Months 0 and 2. Participants will also receive 1×10\^8 TCID50 of MVA/HIV62B plus 150 mcg of B63521\^11 gp120 plus 150 mcg of IHV01, each by IM injection at Months 4, 6, and 10.
Group 4 (T3): DNA + MVA +IHV01 + Placebo
EXPERIMENTALParticipants will receive 3 mg of GEO-D02 DNA by IM injection at Months 0 and 2. Participants will also receive 1×10\^8 TCID50 of MVA/HIV62B plus placebo for B63521\^11 gp120 plus 150 mcg of IHV01, each by IM injection at Months 4, 6, and 10.
Group 5 (T4): DNA + MVA +IHV01 (SC)+ B63 (SC)
EXPERIMENTALParticipants will receive 3 mg of GEO-D02 DNA by IM injection at Months 0 and 3. Participants will also receive 1×10\^8 TCID50 of MVA/HIV62B by IM injection plus 150 mcg of B63521\^11 gp120 by SC injection plus 150 mcg of IHV01 by SC injection at Months 4, 6, and 10.
Interventions
Administered by IM injection into the vastus lateralis
Administered by IM injection into the vastus lateralis
Administered as a IM or SC injection into the vastus lateralis or overlying subcutaneous tissue as the MVA dose
Administered as a IM or SC injection into the vastus lateralis or overlying subcutaneous tissue as the MVA dose
Sodium Chloride for Injection, 0.9% USP Administered as a IM or SC injection into the vastus lateralis or overlying subcutaneous tissue as the MVA dose
Eligibility Criteria
You may qualify if:
- General and Demographic Criteria
- Age of 18 to 50 years
- Access to a participating 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: volunteer demonstrates understanding of this study; completes a questionnaire prior to first vaccination with verbal demonstration of understanding of all questionnaire items answered incorrectly
- Willing to be contacted after completion of scheduled clinic visits for a total of 2 years following initial study injection
- Agrees not to enroll in another study of an investigational research agent while in this study
- Good general health as shown by medical history, physical exam, and screening laboratory tests
- HIV-Related Criteria:
- Willingness to receive HIV test results
- Willingness to discuss HIV infection risks and amenable to HIV risk reduction counseling
- Assessed by the clinic staff as being at "low risk" for HIV infection and committed to maintaining behavior consistent with low risk of HIV exposure through the last required protocol clinic visit (see the study protocol).
- Hemogram/Complete blood count (CBC)
- Hemoglobin greater than or equal to 11.0 g/dL for volunteers who were assigned female sex at birth, greater than or equal to 13.0 g/dL for volunteers who were assigned male sex at birth. For transgender participants who have been on hormone therapy for more than 6 consecutive months, determine hemoglobin eligibility based on the gender with which they identify (ie, a transgender female who has been on hormone therapy for more than 6 consecutive months should be assessed for eligibility using the hemoglobin parameters for persons assigned female sex at birth).
- White blood cell count equal to 2,500 to 12,000 cells/mm\^3 with normal differential, or differential approved by Investigator of Record (IoR) as not clinically significant
- +25 more criteria
You may not qualify if:
- Blood products received within 120 days before first vaccination.
- Investigational research agents received within 30 days before first vaccination.
- Body mass index (BMI) greater than or equal to 40.
- Volunteer has 2 or more of the following cardiac risk factors:
- Participant report of history of elevated blood cholesterol defined as fasting low-density lipoprotein (LDL) greater than 160 mg/dL;
- First degree relative (eg, mother, father, brother, or sister) who had coronary artery disease before the age of 50 years;
- Current smoker; or
- BMI greater than or equal to 35.
- Intent to participate in another study of an investigational research agent or any other study that requires non-HVTN HIV antibody testing during the planned duration of the HVTN 132 study.
- Pregnant or breastfeeding.
- Active duty and reserve US military personnel.
- Vaccines and other Injections
- Smallpox vaccine received within the last 5 years.
- HIV vaccine(s) received in a prior HIV vaccine trial. For volunteers who have received control/placebo in an HIV vaccine trial, the HVTN 132 PSRT will determine eligibility on a case-by-case basis.
- Non-HIV experimental vaccine(s) received within the last 1 year in a prior vaccine trial. Exceptions may be made by the HVTN 132 PSRT for vaccines that have subsequently undergone licensure by the FDA or by the national regulatory authority where the volunteer is enrolling. For volunteers who have received control/placebo in an experimental vaccine trial, the HVTN 132 PSRT will determine eligibility on a case-by-case basis. For volunteers who have received an experimental vaccine(s) greater than 1 year ago, eligibility for enrollment will be determined by the HVTN 132 PSRT on a case-by-case basis.
- +33 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)lead
- HIV Vaccine Trials Network (HVTN), Fred Hutch / University of Washingtoncollaborator
- GeoVax Labs, Inccollaborator
- Duke Universitycollaborator
- University of Maryland, Baltimorecollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Michael Keefer
University of Rochester
- STUDY CHAIR
Mark Pilkinton
Vanderbilt University
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 31, 2019
First Posted
August 1, 2019
Study Start
March 1, 2022
Primary Completion
September 30, 2022
Study Completion
May 31, 2023
Last Updated
October 15, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will not share