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HIV InfectionsPhase 1NCT00027261

Safety and Immune Response Study of High-Dose Canarypox ALVAC-HIV Vaccine in Healthy, HIV Uninfected Adults

A Phase 1 study testing ALVAC(2)120(B,MN)GNP (vCP1452) in people with HIV Infections and HIV Seronegativity, run by National Institute of Allergy and Infectious Diseases (NIAID) at 13 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to see if the experimental vaccine, ALVAC-HIV (vCP1452) is safe and to study how the immune system responds to the vaccine. This trial is designed to determine whether a higher vaccine dose (6 times the usual dose) will elicit a higher immune response. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
HIV Infections, HIV Seronegativity
What is being tested?
ALVAC(2)120(B,MN)GNP (vCP1452)
How many people
110 participants
Where
13 sitesUnited States
Study dates
Start not givento Dec 2005
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Participants may be eligible for this study if they:
  • Are between the ages of 18 and 60.
  • Are in good general health.
  • Have a CD4 count of 400 or more cells/mm3.
  • Do not have hepatitis C or active hepatitis B.
  • Have had a negative HIV blood test within 8 weeks prior to enrollment.
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  • Use approved methods of contraception.
  • Have access to a participating site and are available for follow-up for 18 months.
  • Complete a questionnaire evaluating the participant's understanding of the study prior to enrollment.
  • Give written informed consent.

Who cannot join

  • Participants may not be eligible for this study if they:
  • Are pregnant or breast-feeding.
  • Have received a live vaccine within 30 days prior to enrollment.
  • Have received a killed vaccine or allergy treatment with injections within 14 days prior to study vaccine.
  • Have used experimental research agents within 30 days prior to enrollment.
  • Have received HIV-1 vaccines or placebo in a previous HIV vaccine trial.
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  • Have received blood products 120 days before HIV screening.
  • Have received immunoglobulin 60 days before HIV screening.
  • Have a history of serious harmful reactions to vaccines.
  • Have a history of disease of the immune system.
  • Have a history of cancer, unless it has been surgically removed and in the estimate of the investigator is not likely to happen again during the study period.
  • Are using or have used (within past 6 months) drugs that interfere with the immune system.
  • Have a history of type I or type II diabetes.
  • Have thyroid disease.
  • Have unstable asthma.
  • Are currently taking preventive anti-TB therapy.
  • Have a seizure disorder.
  • Have a bleeding disorder that was diagnosed by a physician.
  • Have had their spleen removed.
  • Have angioedema with serious episodes.
  • Have active syphilis.
  • Have hypertension.
  • Have mental problems that would interfere with the protocol.
  • Have any other problems that, in the judgment of the investigator, would interfere with the study.
  • Have a body mass index less than 20.
  • Are allergic or sensitive to egg products.
  • Have active tuberculosis.

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

United States13 sites

  • Infectious Diseases Physicians, Inc.

    Annandale, Virginia

  • Project Brave HIV Vaccine CRS

    Baltimore, Maryland

  • Alabama Vaccine CRS

    Birmingham, Alabama, 35294

  • Brigham and Women's Hosp. CRS

    Boston, Massachusetts, 02115

  • Fenway Community Health Clinical Research Site (FCHCRS)

    Boston, Massachusetts, 02115

  • Vanderbilt Vaccine CRS

    Nashville, Tennessee, 37232

  • NY Blood Ctr./Union Square CRS

    New York, New York, 10021

  • Miriam Hospital's HVTU

    Providence, Rhode Island, 02906

  • Univ. of Rochester HVTN CRS

    Rochester, New York, 14642

  • San Francisco Vaccine and Prevention CRS

    San Francisco, California, 94102

  • UCSF, Gen. Clinical Research Ctr., Mt. Zion Hosp.

    San Francisco, California

  • FHCRC/UW Vaccine CRS

    Seattle, Washington, 98109

  • Saint Louis Univ Health Sciences Ctr

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: A Phase I Trial to Evaluate the Safety, Tolerability and Immunogenicity of High-Dose Live Recombinant Canarypox ALVAC-HIV Vaccine (vCP1452) in Healthy, HIV-1 Uninfected Adult Participants

The purpose of this study is to see if the experimental vaccine, ALVAC-HIV (vCP1452) is safe and to study how the immune system responds to the vaccine. This trial is designed to determine whether a higher vaccine dose (6 times the usual dose) will elicit a higher immune response.

As of May 2001, over 200 people received the ALVAC-HIV (vCP1452) vaccine at the lower dose. The higher dose of the vaccine to be used in this study has not been given to humans previously. High doses of a similar vaccine have been given to a few people without serious side effects. In a recent study done in mice, higher doses of ALVAC-HIV produced stronger immune responses. It is possible that the doses of ALVAC-HIV given to humans are below the amount needed for the maximum immune response. Because the exact relationship between an increased immune response and its effectiveness in preventing HIV infection is uncertain, the HVTN will use the highest dose that can be manufactured.

Read the detailed description

To date, adverse reactions to immunization with the various ALVAC-HIV candidate vaccines, including ALVAC-HIV (vCP1452), have been similar to those observed in healthy adults who have received other licensed vaccines of similar types. In a previous trial, even high doses of recombinant ALVAC vaccine were well tolerated in a group of participants that were significantly immunocompromised. In a recent study done in mice concerning dose escalation using the ALVAC-HIV vectors, the data demonstrated more robust immune responses with higher doses of ALVAC-HIV (vCP1452) in mice. It is certainly possible that the doses of ALVAC-HIV given to humans are well below the amount needed for a maximal cytotoxic T lymphocyte (CTL) response. As the predictive value of a CTL response is at present unknown with respect to its efficacy in preventing or ameliorating HIV acquisition or infection, the HVTN will utilize the highest dose that can be currently manufactured.

All study products are to be administered intramuscularly. Participants will receive 1 of 3 injections. Group A will receive a high dose of vaccine, group B will receive a low dose of vaccine, and group C will receive a placebo. Participants are inoculated at 4 time points. Assessment of product safety includes clinical observation, monitoring of hematological, chemical, and immunologic parameters, and a social harms questionnaire. Safety will be evaluated by monitoring of participants for local and systemic adverse reactions during the course of the trial. Participants will be monitored longitudinally for HIV-specific serologic and cellular immune responses.

Being tested
ALVAC(2)120(B,MN)GNP (vCP1452)
Keywords
Vaccines, Synthetic, HIV-1, AIDS Vaccines, CD8-Positive T-Lymphocytes, HIV Seronegativity, Avipoxvirus, Dose-Response Relationship, Immunologic, HIV Preventive Vaccine
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ALVAC(2)120(B,MN)GNP (vCP1452)Biological

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Nov 2001 (estimated)
  2. Study completionDec 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Masking
Double blind
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00027261
Sponsor's protocol ID
HVTN 039
Other IDs
10200
Status last verified
Oct 2021
First submitted
29 Nov 2001
Last updated
14 Oct 2021
Results posted
No

Publications

  • Goepfert PA, Horton H, McElrath MJ, Gurunathan S, Ferrari G, Tomaras GD, Montefiori DC, Allen M, Chiu YL, Spearman P, Fuchs JD, Koblin BA, Blattner WA, Frey S, Keefer MC, Baden LR, Corey L; NIAID HIV Vaccine Trials Network. High-dose recombinant Canarypox vaccine expressing HIV-1 protein, in seronegative human subjects. J Infect Dis. 2005 Oct 1;192(7):1249-59. doi: 10.1086/432915. Epub 2005 Aug 31.

    PubMed 16136469

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ALVAC(2)120(B,MN)GNP (vCP1452) in people with HIV Infections and HIV Seronegativity, run by National Institute of Allergy and Infectious Diseases (NIAID) at 13 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00027261, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2021.

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