HIV InfectionsPhase 1NCT01909414

Evaluating the Safety and Immune Response of DNA/MVA Vaccines in HIV-1-Infected Young Adults Taking Anti-HIV Medications

A Phase 1 study testing GEO-D03 DNA Vaccine and MVA/HIV62B Vaccine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID).

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

The purpose of this study is to evaluate the safety of two HIV vaccines in HIV-1-infected young adults who are taking anti-HIV medications and have very low virus levels. This study will also look at how the immune system responds to the vaccines. Read more about this study

Who is it for?: Ages 18 to 24 years
Conditions the study is for: HIV Infections
What is being tested?: GEO-D03 DNA Vaccine and MVA/HIV62B Vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 0 participants
Where: No sites listed yet
Study dates: Start not givento Nov 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 24 years
All sexes
No healthy volunteers
Adult

Who may be able to join

HIV-1 infected. More details on this criterion can be found in the protocol.
Likely HIV-1 acquisition in North America or Europe (in the opinion of the site investigator)
Likely HIV-1 acquisition from sexual transmission (in the opinion of the site investigator)
On stable HAART, defined as at least three different antiretrovirals (ARVs) from two different classes, with plasma HIV-1 RNA levels fewer than 100 copies/mL for at least 12 months prior to screening. Furthermore, at least two plasma HIV-1 RNA levels fewer than 100 copies/mL (and none with plasma HIV-1 RNA levels 100 or more copies/mL), separated by at least 3 months must have been documented during the 6-month period prior to enrollment.
Ability and willingness of participant to provide signed written informed consent
CD4 count 400 cells/mm^3 or greater at screening

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The following lab values (at screening visit):
Creatine phosphokinase no higher than 5 times the upper limit of normal (ULN). More details on this criterion can be found in the protocol.
Troponin I no more than 1.0 times ULN
Hemoglobin greater than 10 g/dL
Absolute neutrophil count greater than 1,000 mm^3
Platelets greater than 100,000 mm^3
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) no greater than 1.5 times ULN
Total bilirubin no greater than 1.5 times ULN (less than 5 times ULN if taking atazanavir)
Creatinine less than 2.0 mg/dL
Female participants who engage in sexual activity that could lead to pregnancy must agree to avoid pregnancy and to consistently use two methods of contraception, including at least one form of barrier contraception, from the screening visit until 90 days after the final vaccination. Medically acceptable contraceptives include barrier methods (such as a condom or diaphragm) used with a spermicide, an intrauterine device (IUD), or approved hormonal contraceptives, such as birth control pills, Depo Provera, or Lupron Depot. Condoms are recommended because their appropriate use is the only contraception method effective for preventing HIV-1 transmission. Two methods of barrier contraception (condom and diaphragm) may be combined to meet this requirement. Sexually active female study participants without reproductive potential are eligible without requiring the use of contraception. Written or oral documentation communicated by clinician or clinician's staff from one of the following is required for participants: physician report/letter or discharge summary.
To prevent pregnancies, male participants 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 90 days after receipt of the last study vaccine.
To prevent HIV-1 transmission to a partner, all participants participating in sexual activity must agree to use effective barrier methods (condoms)
Willing to comply with all study requirements, including adherence to ARV treatment as prescribed by regular healthcare provider and the expectation to be available for the duration of the study

Who cannot join

Documentation of infection with HIV-1 other than Clade B (e.g., if genotype data are available from pre-treatment viral resistance analyses)
Documentation that the last CD4 T-cell count prior to the initiation of ARV was fewer than 300 cells/mm^3
Hepatitis B surface antigen positive
Hepatitis C virus RNA positive
History of or known active cardiac disease including:
evidence of past or evolving myocardial infarction

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angina pectoris
congestive heart failure with permanent sequelae
cardiomyopathy (hypertrophic or dilated)
myocarditis
pericarditis
clinically significant arrhythmia (including any arrhythmia requiring medication, treatment, or clinical follow-up)
stroke or transient ischemic attack
anginal chest pain or shortness of breath with mild activity (such as walking upstairs) due to cardiac disease (New York Heart Association [NYHA] class 2-4)
Screening ECG with clinically significant findings or features that would interfere with the assessment of myo/pericarditis, including any of the following:
Conduction disturbance (complete left or complete right bundle branch block or nonspecific intraventricular conduction disturbance with QRS greater than 120 ms, atrioventricular (AV) block of any degree, or QTc prolongation (greater than 450 ms)
Pathologic repolarization (ST segment or T wave) abnormality
Significant atrial or ventricular arrhythmia
Frequent atrial or ventricular ectopy (e.g., frequent premature atrial contractions, multifocal or two or more premature ventricular contractions in a row)
Clinically significant, HIV-related renal disease at screening or enrollment (creatinine at least 2.0 mg/dL; persistent high grade proteinuria greater than 2+). If either of these findings is present at screening, tests may be repeated once with option for enrollment if these findings resolve.
Past or present, HIV-related neurocognitive disease identified by a care provider
Known hypersensitivity to vaccine components
Receipt of chemotherapy for active malignancy in the past 12 months
Prior vaccinations with any HIV-1 vaccine
Prior immunization with any poxvirus, including vaccinia
Receipt of immunomodulatory agents, oral or injected systemic corticosteroids for more than 7 days at a time (including nonprescription street steroids), gamma globulin, or investigational agents within 6 months of screening. Use of intranasal or inhaled corticosteroids is allowed.
Receipt of any other live licensed vaccine within 4 weeks or inactivated licensed vaccine within 2 weeks prior to study enrollment
Pregnancy or breastfeeding
Current documented or suspected serious bacterial infection, metabolic illness, malignancy, or immediate life-threatening conditions
Any clinically significant diseases (other than HIV infection) or clinically significant findings during the screening medical history or physical examination that, in the site investigator's opinion, would compromise the outcome of this study
Active alcohol or substance abuse (abuse is defined as use of alcohol or other substance such that it is likely to interfere with the ability of the participant to adhere to medications or to return for study visits or is likely to lead to AEs)
Any foreseeable circumstances that, in the opinion of the site investigator, are likely to jeopardize participant adherence to HAART (i.e., insurance problems, housing instability, or unemployment)

About this study

Official title: A Phase 1 Study of the Safety and Immunogenicity of DNA/MVA Immunizations With Co-Expressed GM-CSF in HIV-1 Infected Young Adults With Suppressed Viremia on HAART

Read the detailed description

This study will evaluate the safety and immune response of the combination of two vaccines: a multigene DNA HIV-1 vaccine that also expresses GM-CSF (GEO-D03) and a MVA HIV-1 (MVA/HIV62B) vaccine. HIV-1-infected young adults who have suppressed viral levels, have likely acquired (Clade B) HIV-1 infection from sexual contact, and are on highly active antiretroviral therapy (HAART) will be randomly assigned to one of two study arms. Arm A participants will receive the GEO-D03 vaccine at entry and Week 8 and the MVA/HIV62B vaccine at Weeks 16 and 24. Arm B participants will receive placebo vaccines at entry and at Weeks 8, 16, and 24.

Study duration will be 120 weeks (24 weeks for vaccinations plus 96 weeks of follow-up). Study participants will remain on HAART throughout the study. Study visits will occur at screening, entry, and at Weeks 1, 8, 9, 16, 17, 24, 25, 36, 48, 72, 96, and 120. At each study visit, participants will undergo blood collection, a physical exam, and an adherence assessment. At screening, participants will also undergo an electrocardiogram (ECG) and urine collection. Some blood samples will be stored for future use.

Conditions: HIV Infections
Being tested: GEO-D03 DNA Vaccine, MVA/HIV62B Vaccine, Placebo for DNA GEO-D03, Placebo for MVA/HIV62B Vaccine
Medical subject headings: HIV Infections

What participants receive

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

GEO-D03 DNA VaccineBiological
DNA GEO-D03 vaccine will be administered as a 3 mg dose IM.
MVA/HIV62B VaccineBiological
MVA/HIV62B vaccine will be administered as a 1 x 10^8 TCID50 dose IM.
Placebo for DNA GEO-D03Biological
Placebo for DNA GEO-D03 (administered as 0.9 percent Sodium Chloride for Injection) will be administered IM.
Placebo for MVA/HIV62B VaccineBiological
Placebo for MVA/HIV62B 1 x 10^8 TCID50 (administered as 0.9 percent Sodium Chloride for Injection) will be administered IM.

Study groups in NCT01909414
Study group	Role	What they receive
Arm A: GEO-D03 DNA and MVA/HIV62B vaccines	Experimental	At study entry and Week 8, participants will receive the GEO-D03 DNA vaccine administered as 1 mL intramuscularly (IM) in either deltoid. At Weeks 16 and 24, they will receive the MVA/HIV62B vaccine administered as 1 mL IM in either deltoid. Receives: Biological: GEO-D03 DNA Vaccine; Biological: MVA/HIV62B Vaccine
Arm B: Placebo for GEO-D03 and MVA/HIV62B	Placebo comparator	At study entry and Week 8, participants will receive the placebo for GEO-D03 DNA vaccine administered as 1 mL IM in either deltoid. At Weeks 16 and 24, they will receive the placebo for MVA/HIV62B vaccine administered as 1 mL IM in either deltoid. Receives: Biological: Placebo for DNA GEO-D03; Biological: Placebo for MVA/HIV62B Vaccine

What is being measured

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

Grade 3 or higher adverse events (AEs)
Measured: Measured through Week 120
Progression of HIV disease status: immunological decline
Immunological decline defined as a fall in CD4 T-cell count to fewer than 350 cells/mm^3 OR a decline to a level less than 50 percent of baseline, if baseline CD4 T-cell count is more than 700 cells/mm^3 at study entry
Measured: Measured through Week 120
Progression of HIV disease status: RNA 1,000 copies/mL or greater measured on two occasions at least 1 week apart
Measured: Measured through Week 120
Progression of HIV disease status: development of an AIDS-defining opportunistic infection or malignancy
Measured: Measured through Week 120
A greater than or equal to two-fold increase in the frequency of responding HIV-1 Gag-specific CD8 T cells between entry visit and Week 17 visit
Measured: Measured through Week 17

Secondary outcomes (2)

Grade 3 or higher AEs at least possibly related to study treatment
Measured: Measured through Week 120
A greater than or equal to two-fold increase in the frequency of responding HIV-1 Gag-specific CD8 T cells per individual between entry visit and Week 25 visit
Measured: Measured through Week 25

Timeline

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

?Nov 2014

First posted26 Jul 2013 (estimated)
Primary completionNov 2014 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for HIV InfectionsStudies of the same condition, open and under way.
More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Care provider
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01909414
Sponsor's protocol ID: P1082
Other IDs: 10776
Status last verified: Aug 2013
First submitted: 24 Jul 2013
Last updated: 11 Nov 2021
Results posted: No

Publications

Rosenberg ES, Graham BS, Chan ES, Bosch RJ, Stocker V, Maenza J, Markowitz M, Little S, Sax PE, Collier AC, Nabel G, Saindon S, Flynn T, Kuritzkes D, Barouch DH; AIDS Clinical Trials Group A5187 Team. Safety and immunogenicity of therapeutic DNA vaccination in individuals treated with antiretroviral therapy during acute/early HIV-1 infection. PLoS One. 2010 May 10;5(5):e10555. doi: 10.1371/journal.pone.0010555.
PubMed 20479938
Persaud D, Luzuriaga K, Ziemniak C, Muresan P, Greenough T, Fenton T, Blackford A, Ferguson K, Neu N, Cunningham CK. Effect of therapeutic HIV recombinant poxvirus vaccines on the size of the resting CD4+ T-cell latent HIV reservoir. AIDS. 2011 Nov 28;25(18):2227-34. doi: 10.1097/QAD.0b013e32834cdaba.
PubMed 21918423
Goepfert PA, Elizaga ML, Sato A, Qin L, Cardinali M, Hay CM, Hural J, DeRosa SC, DeFawe OD, Tomaras GD, Montefiori DC, Xu Y, Lai L, Kalams SA, Baden LR, Frey SE, Blattner WA, Wyatt LS, Moss B, Robinson HL; National Institute of Allergy and Infectious Diseases HIV Vaccine Trials Network. Phase 1 safety and immunogenicity testing of DNA and recombinant modified vaccinia Ankara vaccines expressing HIV-1 virus-like particles. J Infect Dis. 2011 Mar 1;203(5):610-9. doi: 10.1093/infdis/jiq105. Epub 2011 Jan 31.
PubMed 21282192

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 11 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1 Study of the Safety and Immunogenicity of DNA/MVA Immunizations With Co-Expressed GM-CSF in HIV-1 Infected Young Adults With Suppressed Viremia on HAART
ClinicalTrials.gov ID: NCT01909414
Acronym / sponsor ID: P1082
Conditions: HIV Infections
Phase: Phase 1
Study type: Interventional
Recruitment status: Withdrawn
Enrolment: 0 participants (actual)
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
Primary completion: Nov 2014 (estimated)
First posted: 26 Jul 2013 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, care provider)
Number of arms: 2

Arm	Type	Receives
Arm A: GEO-D03 DNA and MVA/HIV62B vaccines	Experimental	Biological: GEO-D03 DNA Vaccine, Biological: MVA/HIV62B VaccineAt study entry and Week 8, participants will receive the GEO-D03 DNA vaccine administered as 1 mL intramuscularly (IM) in either deltoid. At Weeks 16 and 24, they will receive the MVA/HIV62B vaccine administered as 1 mL IM in either deltoid.
Arm B: Placebo for GEO-D03 and MVA/HIV62B	Placebo comparator	Biological: Placebo for DNA GEO-D03, Biological: Placebo for MVA/HIV62B VaccineAt study entry and Week 8, participants will receive the placebo for GEO-D03 DNA vaccine administered as 1 mL IM in either deltoid. At Weeks 16 and 24, they will receive the placebo for MVA/HIV62B vaccine administered as 1 mL IM in either deltoid.

Who may qualify

Ages: 18 to 24 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (19 listed)

HIV-1 infected. More details on this criterion can be found in the protocol.
Likely HIV-1 acquisition in North America or Europe (in the opinion of the site investigator)
Likely HIV-1 acquisition from sexual transmission (in the opinion of the site investigator)
On stable HAART, defined as at least three different antiretrovirals (ARVs) from two different classes, with plasma HIV-1 RNA levels fewer than 100 copies/mL for at least 12 months prior to screening. Furthermore, at least two plasma HIV-1 RNA levels fewer than 100 copies/mL (and none with plasma HIV-1 RNA levels 100 or more copies/mL), separated by at least 3 months must have been documented during the 6-month period prior to enrollment.
Ability and willingness of participant to provide signed written informed consent

Key exclusion criteria (32 listed)

Documentation of infection with HIV-1 other than Clade B (e.g., if genotype data are available from pre-treatment viral resistance analyses)
Documentation that the last CD4 T-cell count prior to the initiation of ARV was fewer than 300 cells/mm^3
Hepatitis B surface antigen positive
Hepatitis C virus RNA positive
History of or known active cardiac disease including:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GEO-D03 DNA VaccineDNA GEO-D03 vaccine will be administered as a 3 mg dose IM.	Biological	Arm A: GEO-D03 DNA and MVA/HIV62B vaccines
MVA/HIV62B VaccineMVA/HIV62B vaccine will be administered as a 1 x 10^8 TCID50 dose IM.	Biological	Arm A: GEO-D03 DNA and MVA/HIV62B vaccines
Placebo for DNA GEO-D03Placebo for DNA GEO-D03 (administered as 0.9 percent Sodium Chloride for Injection) will be administered IM.	Biological	Arm B: Placebo for GEO-D03 and MVA/HIV62B
Placebo for MVA/HIV62B VaccinePlacebo for MVA/HIV62B 1 x 10^8 TCID50 (administered as 0.9 percent Sodium Chloride for Injection) will be administered IM.	Biological	Arm B: Placebo for GEO-D03 and MVA/HIV62B

Primary outcome

Grade 3 or higher adverse events (AEs)
Time frame: Measured through Week 120
Progression of HIV disease status: immunological decline
Time frame: Measured through Week 120
Immunological decline defined as a fall in CD4 T-cell count to fewer than 350 cells/mm^3 OR a decline to a level less than 50 percent of baseline, if baseline CD4 T-cell count is more than 700 cells/mm^3 at study entry
Progression of HIV disease status: RNA 1,000 copies/mL or greater measured on two occasions at least 1 week apart
Time frame: Measured through Week 120
Progression of HIV disease status: development of an AIDS-defining opportunistic infection or malignancy
Time frame: Measured through Week 120
A greater than or equal to two-fold increase in the frequency of responding HIV-1 Gag-specific CD8 T cells between entry visit and Week 17 visit
Time frame: Measured through Week 17

2 secondary outcomes

Grade 3 or higher AEs at least possibly related to study treatment
Time frame: Measured through Week 120
A greater than or equal to two-fold increase in the frequency of responding HIV-1 Gag-specific CD8 T cells per individual between entry visit and Week 25 visit
Time frame: Measured through Week 25

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2021.
Background: PubMed 20479938Rosenberg ES, Graham BS, Chan ES, Bosch RJ, Stocker V, Maenza J, Markowitz M, Little S, Sax PE, Collier AC, Nabel G, Saindon S, Flynn T, Kuritzkes D, Barouch DH; AIDS Clinical Trials Group A5187 Team. Safety and immunogenicity of therapeutic DNA vaccination in individuals treated with antiretroviral therapy during acute/early HIV-1 infection. PLoS One. 2010 May 10;5(5):e10555. doi: 10.1371/journal.pone.0010555.
Background: PubMed 21918423Persaud D, Luzuriaga K, Ziemniak C, Muresan P, Greenough T, Fenton T, Blackford A, Ferguson K, Neu N, Cunningham CK. Effect of therapeutic HIV recombinant poxvirus vaccines on the size of the resting CD4+ T-cell latent HIV reservoir. AIDS. 2011 Nov 28;25(18):2227-34. doi: 10.1097/QAD.0b013e32834cdaba.
Background: PubMed 21282192Goepfert PA, Elizaga ML, Sato A, Qin L, Cardinali M, Hay CM, Hural J, DeRosa SC, DeFawe OD, Tomaras GD, Montefiori DC, Xu Y, Lai L, Kalams SA, Baden LR, Frey SE, Blattner WA, Wyatt LS, Moss B, Robinson HL; National Institute of Allergy and Infectious Diseases HIV Vaccine Trials Network. Phase 1 safety and immunogenicity testing of DNA and recombinant modified vaccinia Ankara vaccines expressing HIV-1 virus-like particles. J Infect Dis. 2011 Mar 1;203(5):610-9. doi: 10.1093/infdis/jiq105. Epub 2011 Jan 31.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Thomas Greenough, MD study chair

University of MA Medical School (UMMS)-II Biotech

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GEO-D03 DNA Vaccine and MVA/HIV62B Vaccine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID).

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 19 inclusion and 32 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: withdrawn, as of the sponsor's last update on 11 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.

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?

Grade 3 or higher adverse events (AEs) (time frame: Measured through Week 120). The study lists 5 primary outcomes in all. 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 NCT01909414, which also lists 3 linked publications.

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 11 Nov 2021.