A Phase I Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV vCP300 and HIV-1 SF-2 rgp120 in HIV-1 Uninfected Adult Volunteers
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ClinicalTrials.gov Identifier: NCT00001072 |
Recruitment Status
:
Completed
First Posted
: August 31, 2001
Last Update Posted
: May 18, 2012
|
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To evaluate, in HIV-negative volunteers, the safety and immunogenicity of ALVAC-HIV MN120TMGNP (vCP300) followed by or combined with boosting using rgp120/HIV-1SF2. To compare ALVAC-HIV vCP300 with ALVAC-RG rabies glycoprotein (vCP65) as a control. To evaluate an accelerated immunization schedule at 0, 1, 3, and 6 months versus 0, 1, 6, and 9 months.
The combination of a live recombinant primer followed by a subunit boost has the potential to induce not only cytotoxic T lymphocytes but also neutralizing antibody.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Biological: ALVAC-HIV MN120TMGNP (vCP300) Biological: ALVAC-RG Rabies Glycoprotein (vCP65) Biological: rgp120/HIV-1 SF-2 | Phase 1 |
The combination of a live recombinant primer followed by a subunit boost has the potential to induce not only cytotoxic T lymphocytes but also neutralizing antibody.
Volunteers are randomized to one of seven groups to receive immunizations with either ALVAC-HIV vCP300 or ALVAC-RG vCP65 (control), plus simultaneous or sequential boosting with rgp120/HIV-1SF2 or placebo. Immunizations are given at 0, 1, 6, and 9 months or 0, 1, 3, and 6 months. Volunteers are followed for at least 24 months.
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 140 participants |
Masking: | Double |
Primary Purpose: | Prevention |
Official Title: | A Phase I Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV vCP300 and HIV-1 SF-2 rgp120 in HIV-1 Uninfected Adult Volunteers |
Actual Study Completion Date : | January 1999 |


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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria
Volunteers must have:
- Normal history and physical exam.
- ELISA and Western blot negative for HIV.
- CD4 count >= 400 cells/mm3.
- Normal urine dipstick with esterase and nitrite.
- Lower risk sexual behavior.
Exclusion Criteria
Co-existing Condition:
Subjects with the following symptoms or conditions are excluded:
- Positive hepatitis B surface antigen.
- Medical or psychiatric condition (such as recent suicidal ideation or present psychosis) that precludes compliance.
- Active syphilis. NOTE: Subjects with serology documented to be a false positive or due to a remote (> 6 months) treated infection are eligible.
- Active tuberculosis. NOTE: Subjects with a positive PPD and a normal chest x-ray showing no evidence of TB and not requiring isoniazid therapy are eligible.
- Allergy to egg products or neomycin.
Subjects with the following prior conditions are excluded:
- History of immunodeficiency, chronic illness, autoimmune disease, or use of immunosuppressive medications.
- History of anaphylaxis or other serious adverse reactions to vaccines.
- Prior immunization against rabies.
- History of serious allergic reaction to any substance, requiring hospitalization or emergent medical care (e.g., Stevens-Johnson syndrome, bronchospasm, or hypotension).
- Prior psychiatric condition (such as history of suicide attempts or past psychosis) that precludes compliance.
- History of cancer unless there has been surgical excision that is considered to have achieved cure.
Prior Medication:
Excluded:
- Live attenuated vaccines within 60 days prior to study entry. NOTE: Medically indicated killed or subunit vaccines (e.g., influenza, pneumococcal) do not exclude if administered at least 2 weeks from HIV immunizations.
- Experimental agents within 30 days prior to study entry.
- Prior HIV vaccines.
- Prior rabies immunization.
Prior Treatment:
Excluded:
- Blood products or immunoglobulin within 6 months prior to study entry. Identifiable high-risk behavior for HIV infection, such as
- injection drug use within past 12 months.
- higher or intermediate risk sexual behavior.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001072
United States, Alabama | |
UAB AVEG | |
Birmingham, Alabama, United States, 35294 | |
United States, Maryland | |
JHU AVEG | |
Baltimore, Maryland, United States | |
United States, Missouri | |
St. Louis Univ. School of Medicine AVEG | |
St Louis, Missouri, United States, 63104 | |
United States, New York | |
Univ. of Rochester AVEG | |
Rochester, New York, United States, 14642 | |
United States, Tennessee | |
Vanderbilt Univ. Hosp. AVEG | |
Nashville, Tennessee, United States, 37232 | |
United States, Washington | |
UW - Seattle AVEG | |
Seattle, Washington, United States, 98144 |
Study Chair: | Keefer M | ||
Study Chair: | Evans T |
Publications:
Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00001072 History of Changes |
Other Study ID Numbers: |
AVEG 026 10576 ( Registry Identifier: DAIDS ES Registry Number ) |
First Posted: | August 31, 2001 Key Record Dates |
Last Update Posted: | May 18, 2012 |
Last Verified: | May 2012 |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Vaccines, Synthetic HIV Envelope Protein gp120 AIDS Vaccines |
HIV Seronegativity Avipoxvirus HIV Preventive Vaccine |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Krestin |
Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Antibiotics, Antineoplastic Antineoplastic Agents Antiviral Agents Anti-Infective Agents Interferon Inducers Radiation-Protective Agents Protective Agents |