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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00076817
First received: February 3, 2004
Last updated: October 26, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
HIV Infections
HIV Seronegativity
Biological: ALVAC-HIV (vCP205)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Prevention
Official Title: A Phase I Double Blind Placebo Controlled Trial to Evaluate the Safety and Immunogenicity of the Aventis Pasteur ALVAC-HIV (vCP205) Administered to the Groin Area Versus the Deltoid Area

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • Safety of administering vCP205 vaccinations to healthy adult individuals [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: June 2006
Study Completion Date: September 2008
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Participants will receive vaccine injections in the groin area or the upper arm
Biological: ALVAC-HIV (vCP205)
Canarypox virus vector vaccine
Placebo Comparator: 2
Participants will receive vaccine placebo injections in the groin area or the upper arm
Biological: ALVAC-HIV (vCP205)
Canarypox virus vector vaccine placbo

Detailed Description:

HIV is most commonly transmitted via a mucosal surface. The mucosal lining is a potential site of both humoral and cellular protection through the activity of B lymphocytes, activated memory T lymphocytes, secretory IgA, and antigen presenting cells. In addition to systemic immunity, a preventive HIV vaccine should induce immune responses at the mucosal surfaces that are portals of HIV entry into the body.

Targeted lymph node immunization involves vaccine injection into the subcutaneous tissue near a lymph node. This strategy has proven effective in the simian immunodeficiency virus (SIV)/rhesus macaque model. The iliac and inguinal lymph nodes in the groin are the primary draining lymph nodes of the genitourinary and rectal tracts. This study will evaluate and compare the safety and immunogenicity of ALVAC-HIV (vCP205) when administered subcutaneously in the groin and intramuscularly in the deltoid region. ALVAC-HIV (vCP205) is a canarypox virus vector vaccine expressing portions of the gp120, Gag, and Pol genes.

Participants in this study will be randomly assigned to receive vaccine or placebo injections in the groin area or the upper arm. All participants will have three baseline visits for blood tests and sigmoidoscopies to measure baseline immune functions. After these visits, participants will receive weekly injections for 4 weeks. Groin injections will be given subcutaneously (under the skin) and upper arm injections will be given intramuscularly (into the muscle). Participants will have follow-up visits 5 and 11 months after the last immunization. Participants will have blood draws and sigmoidoscopies and will receive HIV risk reduction counseling throughout the study. Total length of participation will be approximately 14 months. Participants may continue to contact the study for HIV testing and study-related concerns for 1 year after study participation.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • Pregnant or lactating woman
  • Allergy to eggs or neomycin
  • Live attenuated vaccines within 60 days of study. Medically indicated subunit or killed vaccines (e.g., influenza, pneumococcal) are not exclusionary, but should be given at least 1 month prior to study immunizations.
  • 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
  • Immunoglobulin within 60 days prior to study entry
  • Anaphylaxis or other serious adverse reactions to vaccines
  • Serious allergic reaction to any substance requiring hospitalization or emergent medical care (e.g., Stevens-Johnson syndrome, bronchospasm, or hypotension)
  • Nonprescribed injection drug use
  • Investigational research agents within 30 days prior to study entry
  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: NCT00076817

Locations
United States, California
UCLA Center for HIV and Digestive Diseases
Los Angeles, California, United States, 90095-7019
Sponsors and Collaborators
Investigators
Principal Investigator: Peter Anton, MD University of California, Los Angeles
  More Information

Additional Information:
No publications provided by National Institute of Allergy and Infectious Diseases (NIAID)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00076817     History of Changes
Other Study ID Numbers: 5R01AI050467-03, UCLA MIG-003, 5 R01 AI050467-03
Study First Received: February 3, 2004
Last Updated: October 26, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
HIV Preventive Vaccine
ALVAC Vaccine
Immunization Site
Deltoid
Groin
Targeted Inguinal Lymph Node
TILN

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

ClinicalTrials.gov processed this record on October 19, 2014