HIV InfectionsPhase 1/2NCT00614640
Safety and Tolerability of a Therapeutic DNA Dendritic Cell Vaccine in HIV-Infected Children, Adolescents, and Young Adults
A Phase 1/2 study testing DermaVir patch in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID).
Trial summary
The therapeutic DNA vaccine, DermaVir, represents an immunization strategy that targets lymph node dendritic cells. Because of the high percentage of naive CD4 cells in children and adolescents, the potential for effective new HIV-specific CD4 cell responses may be more achievable in children than in adults. Read more about this study
- Who is it for?
- Ages 6 to 23 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- DermaVir patch
- Type of treatment
- Vaccines
- 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 2013
- Phase
- Phase 1/2
- 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 6 to 23 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- HIV infected
- Receiving HAART consisting of drugs from at least 2 different classes for at least 12 months prior to study entry
- CD4 count of 350 cells/mm3 or greater
- Viral load less than 400 copies/ml for at least 12 months prior to screening
- If female, agree to avoid pregnancy and use two methods of contraception. More information on this criterion can be found in the protocol.
- If male, agree to avoid attempting to impregnate a female and not participate in sperm donation programs. Male participants must agree to use a condom during sexual activity from the date of receipt of the first study vaccination until 6 months after receipt of the last study vaccination.
Who cannot join
- Failing antiretroviral regimen
- Skin diseases, including active atopic dermatitis, active or history of psoriasis, active urticaria, known hypersensitivity to adhesive tape, history of keloid, and active or history of vitiligo
- Tattoos or changes in pigment at selected skin vaccination sites
- Hair or tattoo removal in close proximity to vaccine site on skin
- Acute or chronic illness. More information on this criterion can be found in the protocol.
- Chronic autoimmune disease, clinically significant bleeding disorder, or insulin dependent diabetes mellitus
Show all 15Show fewer
- Clinical toxicity (Grade 2 or greater) at screening
- Prior treatment with any HIV vaccine
- Treatment with any HIV immune modulating agents or chemotherapy for malignancy within 12 months of study entry
- Vaccinations within 28 days of study entry
- Participation in an investigational new drug protocol within 60 days prior to screening
- Systemic steroid therapy within 28 days of study entry
- Abnormal laboratory values. More information on this criterion can be found in the protocol.
- Excessive exposure to the sun
- Breastfeeding or pregnant
About this study
Official title: A Phase I/II Study of the Safety, Tolerability, and Immunogenicity of a Topical Therapeutic DNA Dendritic Cell Vaccine (DermaVir Patch) in Children, Adolescents, and Young Adults With HIV-1 Infection on Highly Active Antiretroviral Therapy (HAART)
The therapeutic DNA vaccine, DermaVir, represents an immunization strategy that targets lymph node dendritic cells. Because of the high percentage of naive CD4 cells in children and adolescents, the potential for effective new HIV-specific CD4 cell responses may be more achievable in children than in adults. The primary purpose of this study is to evaluate the safety and tolerability of DermaVir in children and young adults.
Read the detailed description
The introduction of highly active antiretroviral therapy (HAART) for children and adolescents has resulted in improved control of viral replication for prolonged periods of time and a significant reduction in morbidity. However, when compared to the responses seen in adults, children have overall inferior virologic responses. The therapeutic vaccine, DermaVir, represents an immunization strategy that targets lymph node dendritic cells. Because of the high percentage of naive CD4 cells in children and adolescents, the potential for effective new HIV-specific CD4 cell responses may be more achievable in children than in adults. The primary purpose of this study is to evaluate the safety and tolerability of DermaVir in children and young adults.
This study will last up to 61 weeks (up to 13 weeks of treatment with an additional 48 weeks for follow-up). Participants will be randomly stratified according to age and dosage. Group 1 will consist of 8 adolescents and young adults (between ages 13 and 23) and 8 children (between ages 6 and 12). Group 1 participants will have one 0.8 ml DermaVir patch and one control patch applied on Days 0, 42, and 84. Group 2 will consist of 4 adolescents and young adults and 4 children. Group 2 participants will have four 0.8 ml DermaVir patches applied on Days 0, 42, and 84. Group 3 will consist of 4 adolescents and young adults and 4 children. Group 3 participants will have four 0.8 ml DermaVir patches applied on Days 0, 7, 42, 49, 84, and 91.
There will be 14 study visits for each participant. They will occur at screening and Days 0, 7, 21, 42, 49, 63, 84, 91, 105, 126, 168, 259, and 427. Screening will occur up to 30 days before the first vaccination (Day 0). Medical history and physical exam will occur at all visits. Blood and urine collection and an adherence assessment will occur at most visits. A urine pregnancy test will occur for females at most visits.
- Conditions
- HIV Infections
- Being tested
- DermaVir patch, Placebo patch
- Keywords
- HAART, Therapeutic 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.
DermaVir patchBiological
Also called LC002
DNA Vaccine
Placebo patchBiological
Also called LC002 placebo
10% dextrose (D-glucose) solution
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | One 0.8 ml vaccine-containing patch and 1 placebo patch placed on upper back or upper thigh for 24 hours on Days 0, 42, and 84 Receives: Biological: DermaVir patch; Biological: Placebo patch |
| 2 | Experimental | Four 0.8 ml vaccine-containing patches placed on upper back or upper thigh for 24 hours on Days 0, 42, and 84 Receives: Biological: DermaVir patch |
| 3 | Experimental | Four 0.8 ml vaccine-containing patches placed on upper back or upper thigh for 24 hours on Days 0, 7, 42, 49, 84, and 91 Receives: Biological: DermaVir patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Suspected adverse drug reaction (SADR) attributable to vaccine, excluding reaction to patch adhesive
Measured: Throughout study
Toxicity attributable to the adhesive on patch and not to the vaccine product
Measured: Throughout study
Decrease in CD4 count by 1/3 of baseline in 2 separate measurements at least 1 month apart
Measured: Throughout study
Viral load greater than 1000 copies/ml on 2 separate measurements at least 2 weeks apart
Measured: Throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2008 (estimated)
- Primary completionNov 2013 (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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- International Maternal Pediatric Adolescent AIDS Clinical Trials Group
- Responsible party
- Sponsor
- Investigators
- Hans M.L. Spiegel, MD, Study chair, George Washington University School of MedicineWillaim Borkowsky, MD, Study chair, NYU Langone HealthRam Yogev, MD, Study chair, CMRC Children's Memorial HospitalElizabeth McFarland, MD, Study chair, University of Colorado Health Sciences Ctr.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00614640
- Sponsor's protocol ID
- P1049
- Other IDs
- 10165, IMPAACT P1049
- Status last verified
- Oct 2021
- First submitted
- 11 Feb 2008
- Last updated
- 1 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Calarota SA, Weiner DB, Lori F, Lisziewicz J. Induction of HIV-specific memory T-cell responses by topical DermaVir vaccine. Vaccine. 2007 Apr 20;25(16):3070-4. doi: 10.1016/j.vaccine.2007.01.024. Epub 2007 Jan 22.
PubMed 17292518Lisziewicz J, Calarota SA, Lori F. The potential of topical DNA vaccines adjuvanted by cytokines. Expert Opin Biol Ther. 2007 Oct;7(10):1563-74. doi: 10.1517/14712598.7.10.1563.
PubMed 17916048Lori F, Weiner DB, Calarota SA, Kelly LM, Lisziewicz J. Cytokine-adjuvanted HIV-DNA vaccination strategies. Springer Semin Immunopathol. 2006 Nov;28(3):231-8. doi: 10.1007/s00281-006-0047-y. Epub 2006 Oct 20.
PubMed 17053912
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of the Safety, Tolerability, and Immunogenicity of a Topical Therapeutic DNA Dendritic Cell Vaccine (DermaVir Patch) in Children, Adolescents, and Young Adults With HIV-1 Infection on Highly Active Antiretroviral Therapy (HAART)
- ClinicalTrials.gov ID
- NCT00614640
- Acronym / sponsor ID
- P1049
- Conditions
- HIV Infections
- Keywords
- HAART, Therapeutic vaccine
- Phase
- Phase 1/2
- 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
- Collaborators
- International Maternal Pediatric Adolescent AIDS Clinical Trials Group
- Primary completion
- Nov 2013 (estimated)
- First posted
- 13 Feb 2008 (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.
The therapeutic DNA vaccine, DermaVir, represents an immunization strategy that targets lymph node dendritic cells. Because of the high percentage of naive CD4 cells in children and adolescents, the potential for effective new HIV-specific CD4 cell responses may be more achievable in children than in adults. The primary purpose of this study is to evaluate the safety and tolerability of DermaVir in children and young adults.
Detailed description
The introduction of highly active antiretroviral therapy (HAART) for children and adolescents has resulted in improved control of viral replication for prolonged periods of time and a significant reduction in morbidity. However, when compared to the responses seen in adults, children have overall inferior virologic responses. The therapeutic vaccine, DermaVir, represents an immunization strategy that targets lymph node dendritic cells. Because of the high percentage of naive CD4 cells in children and adolescents, the potential for effective new HIV-specific CD4 cell responses may be more achievable in children than in adults. The primary purpose of this study is to evaluate the safety and tolerability of DermaVir in children and young adults.
This study will last up to 61 weeks (up to 13 weeks of treatment with an additional 48 weeks for follow-up). Participants will be randomly stratified according to age and dosage. Group 1 will consist of 8 adolescents and young adults (between ages 13 and 23) and 8 children (between ages 6 and 12). Group 1 participants will have one 0.8 ml DermaVir patch and one control patch applied on Days 0, 42, and 84. Group 2 will consist of 4 adolescents and young adults and 4 children. Group 2 participants will have four 0.8 ml DermaVir patches applied on Days 0, 42, and 84. Group 3 will consist of 4 adolescents and young adults and 4 children. Group 3 participants will have four 0.8 ml DermaVir patches applied on Days 0, 7, 42, 49, 84, and 91.
There will be 14 study visits for each participant. They will occur at screening and Days 0, 7, 21, 42, 49, 63, 84, 91, 105, 126, 168, 259, and 427. Screening will occur up to 30 days before the first vaccination (Day 0). Medical history and physical exam will occur at all visits. Blood and urine collection and an adherence assessment will occur at most visits. A urine pregnancy test will occur for females at most visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: DermaVir patch, Biological: Placebo patchOne 0.8 ml vaccine-containing patch and 1 placebo patch placed on upper back or upper thigh for 24 hours on Days 0, 42, and 84 |
| 2 | Experimental | Biological: DermaVir patchFour 0.8 ml vaccine-containing patches placed on upper back or upper thigh for 24 hours on Days 0, 42, and 84 |
| 3 | Experimental | Biological: DermaVir patchFour 0.8 ml vaccine-containing patches placed on upper back or upper thigh for 24 hours on Days 0, 7, 42, 49, 84, and 91 |
Who may qualify
- Ages
- 6 to 23 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- HIV infected
- Receiving HAART consisting of drugs from at least 2 different classes for at least 12 months prior to study entry
- CD4 count of 350 cells/mm3 or greater
- Viral load less than 400 copies/ml for at least 12 months prior to screening
- If female, agree to avoid pregnancy and use two methods of contraception. More information on this criterion can be found in the protocol.
Key exclusion criteria (15 listed)
- Failing antiretroviral regimen
- Skin diseases, including active atopic dermatitis, active or history of psoriasis, active urticaria, known hypersensitivity to adhesive tape, history of keloid, and active or history of vitiligo
- Tattoos or changes in pigment at selected skin vaccination sites
- Hair or tattoo removal in close proximity to vaccine site on skin
- Acute or chronic illness. More information on this criterion can be found in the protocol.
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 |
|---|---|---|
| DermaVir patchAlso: LC002DNA Vaccine | Biological | 1, 2, 3 |
| Placebo patchAlso: LC002 placebo10% dextrose (D-glucose) solution | Biological | 1 |
Primary outcome
Suspected adverse drug reaction (SADR) attributable to vaccine, excluding reaction to patch adhesive
Time frame: Throughout study
Toxicity attributable to the adhesive on patch and not to the vaccine product
Time frame: Throughout study
Decrease in CD4 count by 1/3 of baseline in 2 separate measurements at least 1 month apart
Time frame: Throughout study
Viral load greater than 1000 copies/ml on 2 separate measurements at least 2 weeks apart
Time frame: Throughout study
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 1 Nov 2021.
- Background: PubMed 17292518Calarota SA, Weiner DB, Lori F, Lisziewicz J. Induction of HIV-specific memory T-cell responses by topical DermaVir vaccine. Vaccine. 2007 Apr 20;25(16):3070-4. doi: 10.1016/j.vaccine.2007.01.024. Epub 2007 Jan 22.
- Background: PubMed 17916048Lisziewicz J, Calarota SA, Lori F. The potential of topical DNA vaccines adjuvanted by cytokines. Expert Opin Biol Ther. 2007 Oct;7(10):1563-74. doi: 10.1517/14712598.7.10.1563.
- Background: PubMed 17053912Lori F, Weiner DB, Calarota SA, Kelly LM, Lisziewicz J. Cytokine-adjuvanted HIV-DNA vaccination strategies. Springer Semin Immunopathol. 2006 Nov;28(3):231-8. doi: 10.1007/s00281-006-0047-y. Epub 2006 Oct 20.
Related trials for HIV Infections
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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.
Hans M.L. Spiegel, MD study chair
George Washington University School of Medicine
Willaim Borkowsky, MD study chair
NYU Langone Health
Ram Yogev, MD study chair
CMRC Children's Memorial Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing DermaVir patch 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 6 inclusion and 15 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 1 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Suspected adverse drug reaction (SADR) attributable to vaccine, excluding reaction to patch adhesive (time frame: Throughout study). The study lists 4 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 NCT00614640, 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 1 Nov 2021.