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HIV-1 InfectionPhase 1NCT01378156

A Safety and Immunogenicity Study of a Plasmid DNA Prime and MVA Boost Vaccine in HIV-1 Infected Adults on ART

A Phase 1 study testing JS7 plasmid DNA and MVA62B vaccine in people with HIV-1 Infection, run by GeoVax, Inc. at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

GV-TH-01 is an open label Phase 1 study of 9 HIV-1 infected adults with suppressed viremia who started anti-retroviral therapy (ART) within 18 months of a negative HIV antibody test. This study has 3 phases. Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
HIV-1 Infection
What is being tested?
JS7 plasmid DNA and MVA62B vaccine
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
3 sitesUnited States
Study dates
Jun 2010to May 2014
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Age 18-50 yrs.
  • ART started within 18 mo. of last documented negative HIV Ab test, or within 13 mo. of last negative detuned HIV-1 Ab assay, or within 18 mo. of evolution of Western blot from indeterminate to positive in the presence of a positive Ab test
  • No changes to ART treatment within 4 wks. of study entry
  • Documentation of level of plasma HIV-1 RNA and CD4+ counts prior to ART
  • On stable suppressive ART [HIV-1 RNA < 50 copies/mL (PCR) or < 75 copies/mL (bDNA) for at least 6 mo. prior to starting vaccination]
  • No history of virologic failure
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  • CD4+ > 500 cells/µL
  • Nadir CD4+ > 350 cells/µL unless measured in the setting of acute infection
  • Laboratory values:
  • Hemoglobin ≥ 10g/dL (male) or 9g/dL (women)
  • ANC > 1000 cells/µL
  • ALT, AST ≤ 2.5 ULN
  • Total bilirubin < 1.5 x ULN (≤ 5 x ULN on atazanavir)
  • Fasting glucose ≤ 125 mg/dL
  • Serum creatine < 1.5 x ULN
  • Creatinine clearance ≥ 60 mL/min (Cockcroft-Gault)
  • Serum creatine phosphokinase (CPK) ≤ 1.5 x ULN
  • UA negative for hemoglobin and glucose and no greater than 1+ protein
  • Any abnormalities must be assessed by the investigator as not clinically significant
  • ECG without evidence of current or past MI, or ischemic heart disease
  • Willing to provide signed informed consent
  • Females: a negative serum or urine β-HCG pregnancy test at screening
  • Female subjects of reproductive potential who engage in sexual activity that could lead to pregnancy must agree to avoid pregnancy and agree to consistently use contraception for at least 21 days prior to first vaccination until the last protocol visit.
  • Male subjects participating in the study must agree to not attempt to impregnate a female, or participate in sperm donation programs
  • Males engaging in sexual activity that could lead to pregnancy must use a condom from the date of receipt of the first study vaccine until the last protocol visit
  • Agreement to use condoms for protection against HIV-1 transmission throughout the study
  • Participants must be willing to comply with all study requirements and expected to be available for the duration of the study
  • Participants must be willing to temporarily discontinue antiretroviral therapy for up to 12 wks. post-vaccinations

Who cannot join

  • Known infection with HIV-1 subtype other than Clade B
  • Chemotherapy for active malignancy in the past 12 mo.
  • Prior vaccinations with any HIV-1 vaccine
  • Prior vaccination against smallpox within the last 15 yrs.
  • History of or known cardiac disease
  • History of myositis
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  • Diagnosis of HIV-associated nephropathy
  • Evidence of active HBV or HCV infection
  • Framingham Global Risk Assessment Score consistent with high short-term (10 yr.) cardiac risk
  • Receipt of immunomodulatory agents, systemic corticosteroids (including nonprescription street steroids), gamma globulin, or investigational agents (other than H1N1 influenza vaccine) within 6 mo. of screening
  • Any immunization within 1 mo. of screening and within 2 wks. of any inoculation in this study
  • Creatine supplements within 14 days of baseline and unwillingness to discontinue use throughout the trial
  • Changes in ART regimen prior to entry due to virologic failure (not including toxicity)
  • Pregnancy or breastfeeding
  • Any clinically significant diseases (other than HIV-1 infection) or clinically significant findings during the screening medical history or physical examination that, in the investigator's opinion, would compromise participant safety
  • Active alcohol or substance abuses
  • Allergy to chicken egg derived products
  • Contraindication to intramuscular injection
  • Unwilling to forego vigorous exercise 3 days prior to each vaccination

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • AIDS Research Consortium of Atlanta

    Atlanta, Georgia, 30312

  • The University of Alabama at Birmingham Alabama Vaccine Research Clinic

    Birmingham, Alabama, 35294

  • AIDS Research Alliance

    Los Angeles, California, 90015

Other trials in United States

About this study

Official title: A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of pGA2/JS7 DNA and MVA/HIV62B in HIV-infected Adults With Suppressed Viremia Who Started ART Within 18 Months of a Negative HIV Antibody Test

GV-TH-01 is an open label Phase 1 study of 9 HIV-1 infected adults with suppressed viremia who started anti-retroviral therapy (ART) within 18 months of a negative HIV antibody test. This study has 3 phases. The first phase is the vaccination phase, where patients are vaccinated with pGA2/JS7 (JS7)DNA and MVA62B vaccines on a prime/boost regimen. The second phase of the study is a treatment interruption phase, whereby ART is interrupted for a 12 week period approximately 8 weeks following the last vaccination. The third phase occurs after the 12 week treatment interruption phase and is called the treatment reinstitution phase, because subjects reinstitute ART and are followed for an additional 24 weeks. The primary objective is to evaluate the safety of the vaccines during the three phases of the study. A secondary objective is to evaluate the immunogenicity of the vaccines during the vaccination phase of the study.

Read the detailed description

GV-TH-01 is an open label Phase 1 study of 9 HIV-1 infected adults with suppressed viremia who started anti-retroviral therapy (ART) within 18 months of a negative HIV antibody test. This study has 3 phases. The first phase is the vaccination phase, where patients are vaccinated with pGA2/JS7 (JS7)DNA and MVA62B vaccines on a prime/boost regimen at weeks 1 and 9 (JS7 DNA vaccine) and weeks 17 and 25 (MVA62B). Both vaccines express Gag, Pol, and Env. The second phase of the study is a treatment interruption phase, whereby ART is interrupted for a 12 week period approximately 8 weeks following the last vaccination. The third phase occurs after the 12 week treatment interruption phase and is called the treatment reinstitution phase, because subjects reinstitute ART and are followed for an additional 24 weeks. The primary objective is to evaluate the safety of the vaccines during the three phases of the study. A secondary objective is to evaluate the immunogenicity of the vaccines during the vaccination phase of the study.

Conditions
HIV-1 Infection
Being tested
JS7 plasmid DNA and MVA62B vaccine
Keywords
Therapy for HIV Infection, Suppressive ART with no failures, Treatment interruption

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JS7 plasmid DNA and MVA62B vaccineBiological

    Also called pGA2/JS7 and MVA/HIV62B vaccine

    JS7 plasmid DNA (3 mg at weeks 1 and 9) and MVA62B vaccine (10(8) TCID(50) at weeks 17 and 25)

Study groups in NCT01378156
Study groupRoleWhat they receive
JS7 plasmid DNA and MVA62B vaccinesExperimentalAll subjects receive JS7 plasmid DNA (at 1 and 9 weeks) and MVA62B vaccines (17 and 25 weeks), followed (in 2 months after last vaccination) by a 12-week treatment interruption phase. Subjects reinstitute therapy after the treatment interruption and are followed for 6 months.
Receives: Biological: JS7 plasmid DNA and MVA62B vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety in all phases of study.

    Frequency and severity of adverse events, laboratory abnormalities, and local and systemic reactogenicity signs and symptoms following vaccinations. Vaccination(virologic failure): HIV-1 RNA >200 copies/mL and CD4+ <350 cells/uL; genotypic resistance patterns of re-emergent virus. Treatment interruption:number(#)and percentage(%): 1)meet HIV-1 RNA and CD4+ criteria to re-institute anti-retroviral therapy before 12 wks; 2)genotypic resistance in re-emergent virus. Treatment reinstitution:# and %: 1)meet criteria for virologic failure; 2)genotypic resistance in patients with virologic failure.

    Measured: Throughout study - up to 77 weeks

Secondary outcomes (1)

  1. Immunogenicity

    Magnitude of interferon (ifn) gamma \&/or interleukin-2 (IL-2) producing CD4+ and CD8+ T cells at 1 week (wk) post 2nd MVA (modified vaccinia ankara) vaccination (vacc); titer \& avidity index of binding aby for Env at 2 wks post 2nd MVA vacc. Magnitude of ifn-gamma \&/or IL-2 producing CD4+ \& CD8+ cells, # and id of Gag-specific CD8+ responses \& titers of binding aby for Env at 2 wks post detection of re-emergent virus. Log change in HIV-1 RNA from before antiretroviral therapy to end of treatment interruption; time to HIV-1 rebound to >200 copies/mL.

    Measured: Throughout vaccination and treatment interruption phases

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2011 (estimated)
  2. Study startJun 2010
  3. Primary completionMay 2014
  4. Study completionMay 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01378156
Sponsor's protocol ID
GV-TH-01
Status last verified
Nov 2017
First submitted
30 Jul 2010
Last updated
14 Nov 2017
Results posted
No
Data monitoring committee
No

Publications

  • Thompson M, Heath SL, Sweeton B, Williams K, Cunningham P, Keele BF, Sen S, Palmer BE, Chomont N, Xu Y, Basu R, Hellerstein MS, Kwa S, Robinson HL. DNA/MVA Vaccination of HIV-1 Infected Participants with Viral Suppression on Antiretroviral Therapy, followed by Treatment Interruption: Elicitation of Immune Responses without Control of Re-Emergent Virus. PLoS One. 2016 Oct 6;11(10):e0163164. doi: 10.1371/journal.pone.0163164. eCollection 2016.

    PubMed 27711228

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing JS7 plasmid DNA and MVA62B vaccine in people with HIV-1 Infection, run by GeoVax, Inc. at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 28 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety in all phases of study. (time frame: Throughout study - up to 77 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01378156, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2017.

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Clinical Trial NCT01378156 | AzTrials