A Phase I Trial of APL 400-003 Vaccine: Safety and Immune Response Evaluations of Multiple Injections at Escalating Doses in Asymptomatic HIV-Infected Patients

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002350
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: July 1997
  Purpose

To evaluate safety and immune response in HIV-infected patients treated with multiple injections of APL 400-003 vaccine.

PER 2/27/96 AMENDMENT: To evaluate the safety of the vaccine when administered via the Biojector 2000 Needle-Free Injection Management System.

Facilitated DNA inoculation, a new type of DNA vaccine, involves direct injection of non-infectious HIV genes into a patient's muscle, along with agents that promote uptake of the genes into host cells. Host cells that have taken up these genes then produce viral proteins in a form that elicits immune responses in the form of antibodies, killer T-cells, and helper T-cells. The safety of this new vaccine approach needs to be assessed.

PER 2/27/96 AMENDMENT: The Biojector 2000 provides an option for delivering the vaccine without a needle and employs a single-use syringe to avoid cross-contamination.


Condition Intervention Phase
HIV Infections
Biological: APL 400-003
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Trial of APL 400-003 Vaccine: Safety and Immune Response Evaluations of Multiple Injections at Escalating Doses in Asymptomatic HIV-Infected Patients

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment: 16
Detailed Description:

Facilitated DNA inoculation, a new type of DNA vaccine, involves direct injection of non-infectious HIV genes into a patient's muscle, along with agents that promote uptake of the genes into host cells. Host cells that have taken up these genes then produce viral proteins in a form that elicits immune responses in the form of antibodies, killer T-cells, and helper T-cells. The safety of this new vaccine approach needs to be assessed.

PER 2/27/96 AMENDMENT: The Biojector 2000 provides an option for delivering the vaccine without a needle and employs a single-use syringe to avoid cross-contamination.

Patients are given intramuscular injections of APL 400-003 at one of three doses (30, 100, or 300 mcg) on day 0 and again at weeks 10 and 20, and followed for 16 weeks after the final dose. An 8-week period prior to initial dosing is required for immortalizing the patient's PBMCs.

PER 2/27/96 AMENDMENT: Five patients will be evaluated at the 300 mcg dose with the Biojector 2000.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Low doses of nonprescription NSAIDS, acetaminophen, ibuprofen, aspirin, replacement hormone therapy, and vitamin supplements.

Patients must have:

  • Asymptomatic HIV infection with no acute related infection.
  • CD4 count >= 500 cells/mm3.
  • Normal hematologic, renal, hepatic, metabolic, and endocrine function.

NOTE:

  • No more than one patient over 50 years of age is permitted at each dose level.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Residual toxicity from prior drug treatment.
  • Hypersensitivity to bupivacaine or amide-type local anesthetic.
  • Active viral hepatitis, autoimmune disorders, or other debilitating chronic diseases.

Concurrent Medication:

Excluded:

  • Medications that affect immune function.
  • Antiretrovirals.

Patients with the following prior conditions are excluded:

  • Malignancies other than curatively treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
  • History of anaphylaxis to vaccines.

Prior Medication:

Excluded:

  • Prior immunization with any experimental HIV vaccines.
  • Other experimental therapy within 30 days prior to study entry.
  • Prior cancer chemotherapy.
  • Antiretrovirals within 3 months prior to study entry.

Prior Treatment:

Excluded:

  • Prior radiotherapy. IV drug use or any other high-risk behavior.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002350

Locations
United States, Pennsylvania
Univ of Pennsylvania Med Ctr
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Apollon
  More Information

Publications:
MacGregor RR, Gluckman S, Lacy K, Kaniefski B, Boyer J, Wang B, Bagarazzi M, William WV, Francher D, Ginsberg R, Higgins T, Weiner D. First human trial of a facilitated DNA plasmid vaccine for HIV-1: safety and host response. Int Conf AIDS. 1996 Jul 7-12;11(2):23 (abstract no WeB293)
MacGregor R, Gluckman S, Lacy K, Wang B, Ugen K, Chattergoon M, Bagarazzi J, Williams W, Ginsberg R, Higgins T, Boyer J, Weiner D. A DNA plasmid vaccine for HIV-1: experience in the first human trial indicates humoral and cell-immune responses. Conf Retroviruses Opportunistic Infect. 1997 Jan 22-26;4th:142 (abstract no 421)

ClinicalTrials.gov Identifier: NCT00002350     History of Changes
Other Study ID Numbers: 089, APL 400-003RX101
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Vaccines, Synthetic
AIDS Vaccines
DNA, Viral

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on October 21, 2014