Safety and Effectiveness of Administering an HIV Vaccine in the Groin Versus the Arm

NCT00076817 | Completed Phase 1

• 2 other identifiers: 5R01AI050467-03UCLA MIG-003
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the safety of and immune system response to the ALVAC-HIV (vCP205) vaccine when it is injected either into the groin area or into the arm. The goal is to determine if injecting the vaccine into the groin area produces a better immune response in the lining of the rectum.

Conditions

HIV Infections; HIV Seronegativity

Keywords

HIV Preventive Vaccine; ALVAC Vaccine; Immunization Site; Deltoid; Groin; Targeted Inguinal Lymph Node; TILN

Outcome Measures

Primary Outcomes (1)

• Safety of administering vCP205 vaccinations to healthy adult individuals

  Throughout study

Secondary Outcomes (3)

• Immunogenicity of SC vaccination with four doses of vCP205 administered in the groin area versus four doses administered IM in the deltoid region, as measured by CTL activity directed to canarypox and HIV-1 env, gag and pol gene products

  Throughout study

• Immunogenicity of SC vaccination with four doses of vCP205 administered in the groin area versus four doses administered IM in the deltoid region, as measured by anti-HIV-1 directed CD4+ T cell proliferative response to soluble p24 antigen

  Throughout study

• Immunogenicity of SC vaccination with four doses of vCP205 administered in the groin area versus four doses administered IM in the deltoid region, as measured by CD8+ T cell specificity for HIV-1 epitopes

  Throughout study

Study Arms (2)

1

EXPERIMENTAL

Participants will receive vaccine injections in the groin area or the upper arm

Biological: ALVAC-HIV (vCP205)

2

PLACEBO COMPARATOR

Participants will receive vaccine placebo injections in the groin area or the upper arm

Biological: ALVAC-HIV (vCP205)

Interventions

ALVAC-HIV (vCP205) BIOLOGICAL

Canarypox virus vector vaccine

1

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• HIV uninfected
• Low risk for acquiring HIV-1 (no sexually transmitted disease within 1 year of study entry, no history of injection drug use, no sex with an HIV infected individual or active injection drug user within 6 months of study entry, no unsafe sexual activity with unknown partners) or mutually monogamous relationship with a known HIV seronegative partner (per report) for 6 months prior to study entry
• Willing to abstain from receptive anal intercourse during the 14 months of the study
• Available for follow-up during the 14 months of the study
• Acceptable methods of contraception

You may not qualify if:

• Pregnant or lactating woman
• Allergy to eggs or neomycin
• Gastrointestinal complaints such as inflammatory bowel disease or chronic diarrhea
• Immunosuppression of any type, including those related to lupus, rheumatoid arthritis, leukemia, lymphoma, generalized malignancy, agammaglobulinemia, and therapy with alkylating agents, antimetabolites, or radiation
• Use of immunosuppressive medications within 6 months prior to study entry
• Thyroid disease
• Unstable asthma
• Exposure to or active tuberculosis
• Seizure disorders
• Bleeding disorders
• Splenectomy
• Hypertension (blood pressure less than 150/100 if on medication)
• Medical or psychiatric condition or occupational responsibilities which preclude participant's compliance with the study; specifically excluded are people with a history of suicide attempts, recent suicidal ideation, or who have past or present psychosis.
• Received HIV vaccines or placebo in a prior HIV vaccine trial
• Blood products within 120 days prior to study entry

Sponsors & Collaborators

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

Study Sites (1)

UCLA Center for HIV and Digestive Diseases

Los Angeles, California, 90095-7019, United States

Location

Related Publications (1)

• Yang OO, Ibarrondo FJ, Price C, Hultin LE, Elliott J, Hultin PM, Shih R, Hausner MA, Ng HL, Hoffman J, Jamieson BD, Anton PA. Differential blood and mucosal immune responses against an HIV-1 vaccine administered via inguinal or deltoid injection. PLoS One. 2014 Feb 18;9(2):e88621. doi: 10.1371/journal.pone.0088621. eCollection 2014.

  PMID: 24558403 DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

AIDSVAX

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

• Peter Anton, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2004
• First Posted: February 6, 2004
• Study Start: June 1, 2006
• Primary Completion: September 1, 2007
• Study Completion: September 1, 2008
• Last Updated: October 29, 2012

Record last verified: 2012-10

Locations

US (1)