Safety and Tolerability of a Therapeutic DNA Dendritic Cell Vaccine in HIV-Infected Children, Adolescents, and Young Adults

NCT00614640 | Withdrawn Phase 1 DMC

• 3 other identifiers: P104910165IMPAACT P1049
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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. The primary purpose of this study is to evaluate the safety and tolerability of DermaVir in children and young adults.

Conditions

HIV Infections

Keywords

HAART; Therapeutic vaccine

Outcome Measures

Primary Outcomes (4)

• Suspected adverse drug reaction (SADR) attributable to vaccine, excluding reaction to patch adhesive

  Throughout study

• Toxicity attributable to the adhesive on patch and not to the vaccine product

  Throughout study

• Decrease in CD4 count by 1/3 of baseline in 2 separate measurements at least 1 month apart

  Throughout study

• Viral load greater than 1000 copies/ml on 2 separate measurements at least 2 weeks apart

  Throughout study

Study Arms (3)

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

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

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

Biological: DermaVir patch

Interventions

DermaVir patch BIOLOGICAL

DNA Vaccine

Also known as: LC002

1; 2; 3

Placebo patch BIOLOGICAL

10% dextrose (D-glucose) solution

Also known as: LC002 placebo

1

Eligibility Criteria

• Age: 6 Years - 23 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• International Maternal Pediatric Adolescent AIDS Clinical Trials Group: collaborator

Related Publications (3)

• 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.

  PMID: 17292518 BACKGROUND

• Lisziewicz 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.

  PMID: 17916048 BACKGROUND

• Lori 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.

  PMID: 17053912 BACKGROUND

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Hans M.L. Spiegel, MD

  George Washington University School of Medicine

  STUDY CHAIR

• Willaim Borkowsky, MD

  NYU Langone Health

  STUDY CHAIR

• Ram Yogev, MD

  CMRC Children's Memorial Hospital

  STUDY CHAIR

• Elizabeth McFarland, MD

  University of Colorado Health Sciences Ctr.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2008
• First Posted: February 13, 2008
• Primary Completion: November 1, 2013
• Last Updated: November 1, 2021

Record last verified: 2021-10