Safety/Immunogenicity of Immunizations of ALVAC-DC-SC vs ALVAC-SC

NCT00026624 | Completed Phase 1

• 4 other identifiers: A5130AACTG A513010080ACTG A5130
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to determine how safe it is to give patients a shot that has a mixture of a vaccine and dendritic cells (DCs), a special kind of immune cell, and how safe it is to give a shot of the vaccine alone. Current HIV vaccines have not been strong enough to give good immune responses. Research has shown that the immune response to a vaccine delivered by DCs is greater than the response without DC delivery. A5130 is a study that seeks to give good delivery of the vaccine to important immune cells of the body.

Conditions

HIV Infections

Keywords

Virus Replication; Injections, Subcutaneous; HIV-1; AIDS Vaccines; Dendritic Cells; Adoptive Transfer; Keyhole-Limpet Hemocyanin; HIV Therapeutic Vaccine

Interventions

ALVAC(2)120(B,MN)GNP (vCP1452) BIOLOGICAL

Keyhole-Limpet Hemocyanin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients may be eligible for this study if they:
• Are HIV-infected.
• Took 3 or more anti-HIV drugs for 3 or more months before study entry.
• Have a viral load of 400 copies/ml or less for a period of 3 months before study start and within 30 days before study start.
• Have a CD4 count of 400 cells/mm3 or more for a period of 3 months before study start and within 30 days before study start.
• Have a CD4 count of 400 cells/mm3 or more at study screening.
• Have a viral load of 50 copies/ml or less at study screening.
• Are at least 18 years old.
• Agree not to become pregnant or to impregnate during the study and for 12 weeks after the study, if able to have children.

You may not qualify if:

• Patients may not be eligible for this study if they:
• Have a short-term but intense infection or serious illness within 14 days before study start and have not completed therapy or are not clinically stable on therapy.
• Have viral load values greater than 400 copies/ml within 3 months before study start.
• Have CD4 counts less than 400 cells/mm3 within 3 months before study start.
• Have close contact with canaries through work (e.g., breeding farms, bird shops). Does not apply to pet canaries.
• Are allergic to eggs or neomycin. Have a history of serious allergic reactions including allergy-induced asthma.
• Are sensitive or allergic to study drugs.
• Use drugs or alcohol in a way that would interfere with the patients' ability to follow the study requirements.
• Have become HIV-positive within 1 year before study start.
• Are pregnant or breast-feeding.
• Have had lymph node irradiation.
• Have had any HIV vaccine.
• Have used hydroxyurea within 45 days of study start.
• Have received drugs that affect the immune system, such as corticosteriods, within 30 days before study start.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (2)

Massachusetts General Hospital ACTG CRS

Boston, Massachusetts, 02114, United States

Location

Beth Israel Med. Ctr., ACTU

New York, New York, 10003, United States

Location

Related Publications (1)

• Gandhi RT, O'Neill D, Bosch RJ, Chan ES, Bucy RP, Shopis J, Baglyos L, Adams E, Fox L, Purdue L, Marshak A, Flynn T, Masih R, Schock B, Mildvan D, Schlesinger SJ, Marovich MA, Bhardwaj N, Jacobson JM; AIDS Clinical Trials Group A5130 team. A randomized therapeutic vaccine trial of canarypox-HIV-pulsed dendritic cells vs. canarypox-HIV alone in HIV-1-infected patients on antiretroviral therapy. Vaccine. 2009 Oct 9;27(43):6088-94. doi: 10.1016/j.vaccine.2009.05.016. Epub 2009 May 29.

  PMID: 19450647 DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

keyhole-limpet hemocyanin

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

• Jeffrey Jacobson

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2001
• First Posted: November 13, 2001
• Study Completion: October 1, 2006
• Last Updated: November 1, 2021

Record last verified: 2021-10

Locations

US (2)