search
Back to results

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

Primary Purpose

HIV Infections, HIV Seronegativity

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ALVAC-HIV (vCP205)
ALVAC-HIV (vCP205)
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring HIV Preventive Vaccine, ALVAC Vaccine, Immunization Site, Deltoid, Groin, Targeted Inguinal Lymph Node, TILN

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • UCLA Center for HIV and Digestive Diseases

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

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

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

Outcomes

Primary Outcome Measures

Safety of administering vCP205 vaccinations to healthy adult individuals

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
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
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

Full Information

First Posted
February 3, 2004
Last Updated
October 26, 2012
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
search

1. Study Identification

Unique Protocol Identification Number
NCT00076817
Brief Title
Safety and Effectiveness of Administering an HIV Vaccine in the Groin Versus the Arm
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, HIV Seronegativity
Keywords
HIV Preventive Vaccine, ALVAC Vaccine, Immunization Site, Deltoid, Groin, Targeted Inguinal Lymph Node, TILN

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Participants will receive vaccine injections in the groin area or the upper arm
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Participants will receive vaccine placebo injections in the groin area or the upper arm
Intervention Type
Biological
Intervention Name(s)
ALVAC-HIV (vCP205)
Intervention Description
Canarypox virus vector vaccine
Intervention Type
Biological
Intervention Name(s)
ALVAC-HIV (vCP205)
Intervention Description
Canarypox virus vector vaccine placbo
Primary Outcome Measure Information:
Title
Safety of administering vCP205 vaccinations to healthy adult individuals
Time Frame
Throughout study
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Anton, MD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA Center for HIV and Digestive Diseases
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-7019
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24558403
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs