HIV InfectionsPhase 1NCT00000884
A Randomized Phase I Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV vCP205 Delivered by Alternate Mucosal Routes in HIV-1 Uninfected Adult Volunteers
A Phase 1 study testing MN rgp120/HIV-1 and GNE8 rgp120/HIV-1, ALVAC-HIV MN120TMG (vCP205) and ALVAC-RG Rabies Glycoprotein (vCP65) in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 6 sites in United States.
Trial summary
To compare the safety of ALVAC-HIV vCP205 to that of ALVAC-RG vCP65 rabies glycoprotein, delivered by a variety of mucosal routes. To evaluate the antibody, humoral, and cellular immune responses resulting from ALVAC-HIV vCP205. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- MN rgp120/HIV-1 and GNE8 rgp120/HIV-1, ALVAC-HIV MN120TMG (vCP205) and ALVAC-RG Rabies Glycoprotein (vCP65)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 6 sitesUnited States
- Study dates
- Start not givento Oct 2000
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Volunteers must have:
- Negative ELISA for HIV within 8 weeks of immunization.
- No envelope bands in Western blot for HIV-1 within 8 weeks of immunization.
- Normal history and physical examination.
Who cannot join
- Co-existing Condition:
- Volunteers with the following conditions are excluded:
- Medical or psychiatric condition or occupational responsibilities that preclude compliance with the protocol, including recent suicidal attempt or ideation or present psychosis.
- Active syphilis (if the serology is documented to be a false positive or due to a remote [more than 6 months] treated infection, the volunteer is eligible).
- Active tuberculosis (volunteers with a positive PPD and a normal chest x-ray showing no evidence of TB and not requiring INH therapy are eligible).
- Allergy to egg products or neomycin (used to prepare ALVAC vaccines).
Show all 30Show fewer
- Occupational or household exposure to birds (no known pathogenicity of avipox for birds).
- Episode of severe diarrhea within 1 week prior to immunization.
- Abnormal pelvic exam with evidence of sexually transmitted disease or other genital tract infection or trauma, including vaginitis, cervicitis, ecchymosis, vulvar or cervicovaginal lesions or abrasions, or chronic cervical and/or abnormal PAP smear changes.
- Recent history of rectal bleeding or repeatedly positive hemocult test (within 1 month).
- Positive for Hepatitis B surface antigen.
- Volunteers with the following prior conditions are excluded:
- History of immunodeficiency, chronic illness (in particular, chronic inflammatory disease or gastroenteritis), malignancy, or autoimmune disease.
- History of cancer unless there has been surgical excision followed by a sufficient observation period to give a reasonable assurance of cure.
- History of anaphylaxis or history of other serious adverse reactions to vaccines.
- History of serious allergic reaction to any substance, requiring hospitalization or emergent medical care (e.g., Stevens-Johnson syndrome, bronchospasm, or hypotension).
- Prior Medication:
- Excluded:
- Live attenuated vaccines within 60 days of study. NOTE: Medically indicated subunit or killed vaccines (e.g., influenza, pneumococcal) are not exclusionary, but should be given at least 2 weeks away from HIV immunizations.
- Experimental agents within 30 days prior to study.
- HIV-1 vaccines or placebo received in a previous HIV vaccine trial.
- Previous immunization against rabies.
- Prior Treatment:
- Excluded:
- Prior hysterectomy.
- Blood products or immunoglobulin in the past 6 months.
- Risk Behavior:
- Excluded:
- Volunteers with identifiable higher-risk behavior, or whose partners have an identifiable higher-risk behavior for HIV infection as determined by screening questions designed to identify risk factors for HIV infection (i.e., AVEG Risk Groups C or D); specific exclusions include:
- history of injection drug use within the last 12 months prior to enrollment or higher-risk sexual behavior as defined by the AVEG.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
JHU AVEG
Baltimore, Maryland
UAB AVEG
Birmingham, Alabama, 35294
Vanderbilt Univ. Hosp. AVEG
Nashville, Tennessee, 37232
Univ. of Rochester AVEG
Rochester, New York, 14642
UW - Seattle AVEG
Seattle, Washington, 98144
St. Louis Univ. School of Medicine AVEG
St Louis, Missouri, 63104
About this study
To compare the safety of ALVAC-HIV vCP205 to that of ALVAC-RG vCP65 rabies glycoprotein, delivered by a variety of mucosal routes. To evaluate the antibody, humoral, and cellular immune responses resulting from ALVAC-HIV vCP205. [AS PER AMENDMENT 8/3/98: To obtain safety data on AIDSVAX B/B boosting administered by the intramuscular and intranasal routes in the context of previous immunization via alternate mucosal routes or intramuscularly with a canarypox vector expressing HIV-1 antigens (vCP205). To obtain immunogenicity data on AIDSVAX B/B boosting.] One of the earliest observations in the HIV epidemic was the demonstration of HIV infection at mucosal surfaces of cells in the genital tract. These data suggest that priming of immune defenses of viral infected cells may be an important component in the strategy of developing an effective HIV vaccine. Direct immunization of relevant mucosal surfaces with a vectored vaccine may stimulate mucosal immunity. The ALVAC-HIV vCP205 immunogen is constructed from a live recombinant canarypox vector that has a good safety profile in volunteers and should allow mucosal induction of immunity.
Read the detailed description
One of the earliest observations in the HIV epidemic was the demonstration of HIV infection at mucosal surfaces of cells in the genital tract. These data suggest that priming of immune defenses of viral infected cells may be an important component in the strategy of developing an effective HIV vaccine. Direct immunization of relevant mucosal surfaces with a vectored vaccine may stimulate mucosal immunity. The ALVAC-HIV vCP205 immunogen is constructed from a live recombinant canarypox vector that has a good safety profile in volunteers and should allow mucosal induction of immunity.
This randomized, double-blind trial evaluates the safety of and immune response to vaccination with ALVAC-HIV vCP205 given at 0, 1, 3, and 6 months. Patients are randomly assigned to 1 of 7 drug administration routes as follows:
Group A: Intramuscular Group B: Oral Group C: Intranasal Group D: Intrarectal Group E: Intravaginal Group F: Intranasal/intramuscular Group G: Intrarectal/intramuscular Twelve patients are randomized to each group, 8 of whom receive experimental therapy with ALVAC-HIV vCP205 and 4 of whom receive control therapy with ALVAC-RG vCP2058 (rabies vaccine). Women are preferentially enrolled, with a goal of 60% women (minimum of 4 women per treatment arm); only women are randomized to Group E. Blinding is maintained with respect to drug assignment rather than route of administration, after randomization. NOTE: The protocol will be amended to add 2 boost vaccinations with subunit products at approximately Months 9 and 12 when a suitable boost product is identified. [AS PER AMENDMENT 8/3/98: The protocol has been modified to include 2 booster vaccinations to be administered at 9 and 12 months. Patients in Group A receive booster vaccination with ALVAC-HIV VCP205 or ALVAC-RG intranasally. Patients in Groups B through G are boosted with AIDSVAX B/B vaccine (a bivalent vaccine consisting of MN rgp120/HIV-1 antigen and GNE8 rgp120/HIV-1 antigen in alum adjuvant) or with Imovax diploid cell rabies vaccine; vaccinations for these patients are given intramuscularly.] [AS PER AMENDMENT 11/19/98: The second booster vaccination for group A will be administered at study Month 15.]
- Conditions
- HIV Infections
- Being tested
- MN rgp120/HIV-1 and GNE8 rgp120/HIV-1, ALVAC-HIV MN120TMG (vCP205), ALVAC-RG Rabies Glycoprotein (vCP65)
- Keywords
- Vaccines, Synthetic, Injections, Intramuscular, HIV-1, Immunity, Cellular, AIDS Vaccines, HIV Seronegativity, Mucous Membrane, Antibodies, Viral, Avipoxvirus, Genetic Vectors, HIV Envelope Protein gp120, Immunity, Mucosal, Rabies Vaccines, 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.
MN rgp120/HIV-1 and GNE8 rgp120/HIV-1Biological
Dosage will vary based on route of administration
ALVAC-HIV MN120TMG (vCP205)Biological
Dosage will vary based on route of administration
ALVAC-RG Rabies Glycoprotein (vCP65)Biological
Dosage will vary based on route of administration
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants will undergo treatment intramuscularly Receives: Biological: ALVAC-HIV MN120TMG (vCP205); Biological: ALVAC-RG Rabies Glycoprotein (vCP65) |
| 2 | Experimental | Participants will undergo treatment orally Receives: Biological: MN rgp120/HIV-1 and GNE8 rgp120/HIV-1; Biological: ALVAC-HIV MN120TMG (vCP205); Biological: ALVAC-RG Rabies Glycoprotein (vCP65) |
| 3 | Experimental | Participants will undergo treatment intranasally Receives: Biological: MN rgp120/HIV-1 and GNE8 rgp120/HIV-1; Biological: ALVAC-HIV MN120TMG (vCP205); Biological: ALVAC-RG Rabies Glycoprotein (vCP65) |
| 4 | Experimental | Participants will undergo treatment intrarectally Receives: Biological: MN rgp120/HIV-1 and GNE8 rgp120/HIV-1; Biological: ALVAC-HIV MN120TMG (vCP205); Biological: ALVAC-RG Rabies Glycoprotein (vCP65) |
| 5 | Experimental | Participants will undergo treatment intravaginally Receives: Biological: MN rgp120/HIV-1 and GNE8 rgp120/HIV-1; Biological: ALVAC-HIV MN120TMG (vCP205); Biological: ALVAC-RG Rabies Glycoprotein (vCP65) |
| 6 | Experimental | Participants will undergo treatment intranasally and intramuscularly Receives: Biological: MN rgp120/HIV-1 and GNE8 rgp120/HIV-1; Biological: ALVAC-HIV MN120TMG (vCP205); Biological: ALVAC-RG Rabies Glycoprotein (vCP65) |
| 7 | Experimental | Participants will undergo treatment intrarectally and intramuscularly Receives: Biological: MN rgp120/HIV-1 and GNE8 rgp120/HIV-1; Biological: ALVAC-HIV MN120TMG (vCP205); Biological: ALVAC-RG Rabies Glycoprotein (vCP65) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the safety of ALVAC-HIV vCP205 to that of ALVAC-RG vCP65 rabies glycoprotein, delivered by a variety of mucosal routes
Measured: Throughout study
To evaluate the antibody, humoral, and cellular immune responses resulting from ALVAC-HIV vCP205
Measured: Throughout study
To obtain safety data on AIDSVAX B/B boosting administered by the intramuscular and intranasal routes in the context of previous immunization via alternate mucosal routes or intramuscularly with a canarypox vector expressing HIV-1 antigens (vCP205)
Measured: Throughout study
To obtain immunogenicity data on AIDSVAX B/B boosting
Measured: Throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
- Study completionOct 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- P Wright, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000884
- Sponsor's protocol ID
- AVEG 027
- Other IDs
- 10577
- Status last verified
- Oct 2021
- First submitted
- 2 Nov 1999
- Last updated
- 29 Oct 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase I Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV vCP205 Delivered by Alternate Mucosal Routes in HIV-1 Uninfected Adult Volunteers
- ClinicalTrials.gov ID
- NCT00000884
- Acronym / sponsor ID
- AVEG 027
- Conditions
- HIV Infections
- Keywords
- Vaccines, Synthetic, Injections, Intramuscular, HIV-1, Immunity, Cellular, AIDS Vaccines, HIV Seronegativity, Mucous Membrane, Antibodies, Viral
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study completion
- Oct 2000 (actual)
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the safety of ALVAC-HIV vCP205 to that of ALVAC-RG vCP65 rabies glycoprotein, delivered by a variety of mucosal routes. To evaluate the antibody, humoral, and cellular immune responses resulting from ALVAC-HIV vCP205. [AS PER AMENDMENT 8/3/98: To obtain safety data on AIDSVAX B/B boosting administered by the intramuscular and intranasal routes in the context of previous immunization via alternate mucosal routes or intramuscularly with a canarypox vector expressing HIV-1 antigens (vCP205). To obtain immunogenicity data on AIDSVAX B/B boosting.] One of the earliest observations in the HIV epidemic was the demonstration of HIV infection at mucosal surfaces of cells in the genital tract. These data suggest that priming of immune defenses of viral infected cells may be an important component in the strategy of developing an effective HIV vaccine. Direct immunization of relevant mucosal surfaces with a vectored vaccine may stimulate mucosal immunity. The ALVAC-HIV vCP205 immunogen is constructed from a live recombinant canarypox vector that has a good safety profile in volunteers and should allow mucosal induction of immunity.
Detailed description
One of the earliest observations in the HIV epidemic was the demonstration of HIV infection at mucosal surfaces of cells in the genital tract. These data suggest that priming of immune defenses of viral infected cells may be an important component in the strategy of developing an effective HIV vaccine. Direct immunization of relevant mucosal surfaces with a vectored vaccine may stimulate mucosal immunity. The ALVAC-HIV vCP205 immunogen is constructed from a live recombinant canarypox vector that has a good safety profile in volunteers and should allow mucosal induction of immunity.
This randomized, double-blind trial evaluates the safety of and immune response to vaccination with ALVAC-HIV vCP205 given at 0, 1, 3, and 6 months. Patients are randomly assigned to 1 of 7 drug administration routes as follows:
Group A: Intramuscular Group B: Oral Group C: Intranasal Group D: Intrarectal Group E: Intravaginal Group F: Intranasal/intramuscular Group G: Intrarectal/intramuscular Twelve patients are randomized to each group, 8 of whom receive experimental therapy with ALVAC-HIV vCP205 and 4 of whom receive control therapy with ALVAC-RG vCP2058 (rabies vaccine). Women are preferentially enrolled, with a goal of 60% women (minimum of 4 women per treatment arm); only women are randomized to Group E. Blinding is maintained with respect to drug assignment rather than route of administration, after randomization. NOTE: The protocol will be amended to add 2 boost vaccinations with subunit products at approximately Months 9 and 12 when a suitable boost product is identified. [AS PER AMENDMENT 8/3/98: The protocol has been modified to include 2 booster vaccinations to be administered at 9 and 12 months. Patients in Group A receive booster vaccination with ALVAC-HIV VCP205 or ALVAC-RG intranasally. Patients in Groups B through G are boosted with AIDSVAX B/B vaccine (a bivalent vaccine consisting of MN rgp120/HIV-1 antigen and GNE8 rgp120/HIV-1 antigen in alum adjuvant) or with Imovax diploid cell rabies vaccine; vaccinations for these patients are given intramuscularly.] [AS PER AMENDMENT 11/19/98: The second booster vaccination for group A will be administered at study Month 15.]
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: ALVAC-HIV MN120TMG (vCP205), Biological: ALVAC-RG Rabies Glycoprotein (vCP65)Participants will undergo treatment intramuscularly |
| 2 | Experimental | Biological: MN rgp120/HIV-1 and GNE8 rgp120/HIV-1, Biological: ALVAC-HIV MN120TMG (vCP205), Biological: ALVAC-RG Rabies Glycoprotein (vCP65)Participants will undergo treatment orally |
| 3 | Experimental | Biological: MN rgp120/HIV-1 and GNE8 rgp120/HIV-1, Biological: ALVAC-HIV MN120TMG (vCP205), Biological: ALVAC-RG Rabies Glycoprotein (vCP65)Participants will undergo treatment intranasally |
| 4 | Experimental | Biological: MN rgp120/HIV-1 and GNE8 rgp120/HIV-1, Biological: ALVAC-HIV MN120TMG (vCP205), Biological: ALVAC-RG Rabies Glycoprotein (vCP65)Participants will undergo treatment intrarectally |
| 5 | Experimental | Biological: MN rgp120/HIV-1 and GNE8 rgp120/HIV-1, Biological: ALVAC-HIV MN120TMG (vCP205), Biological: ALVAC-RG Rabies Glycoprotein (vCP65)Participants will undergo treatment intravaginally |
| 6 | Experimental | Biological: MN rgp120/HIV-1 and GNE8 rgp120/HIV-1, Biological: ALVAC-HIV MN120TMG (vCP205), Biological: ALVAC-RG Rabies Glycoprotein (vCP65)Participants will undergo treatment intranasally and intramuscularly |
| 7 | Experimental | Biological: MN rgp120/HIV-1 and GNE8 rgp120/HIV-1, Biological: ALVAC-HIV MN120TMG (vCP205), Biological: ALVAC-RG Rabies Glycoprotein (vCP65)Participants will undergo treatment intrarectally and intramuscularly |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Negative ELISA for HIV within 8 weeks of immunization.
- No envelope bands in Western blot for HIV-1 within 8 weeks of immunization.
- Normal history and physical examination.
Key exclusion criteria (30 listed)
- Medical or psychiatric condition or occupational responsibilities that preclude compliance with the protocol, including recent suicidal attempt or ideation or present psychosis.
- Active syphilis (if the serology is documented to be a false positive or due to a remote [more than 6 months] treated infection, the volunteer is eligible).
- Active tuberculosis (volunteers with a positive PPD and a normal chest x-ray showing no evidence of TB and not requiring INH therapy are eligible).
- Allergy to egg products or neomycin (used to prepare ALVAC vaccines).
- Occupational or household exposure to birds (no known pathogenicity of avipox for birds).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MN rgp120/HIV-1 and GNE8 rgp120/HIV-1Dosage will vary based on route of administration | Biological | 2, 3, 4, 5, 6, 7 |
| ALVAC-HIV MN120TMG (vCP205)Dosage will vary based on route of administration | Biological | 1, 2, 3, 4, 5, 6, 7 |
| ALVAC-RG Rabies Glycoprotein (vCP65)Dosage will vary based on route of administration | Biological | 1, 2, 3, 4, 5, 6, 7 |
Primary outcome
To compare the safety of ALVAC-HIV vCP205 to that of ALVAC-RG vCP65 rabies glycoprotein, delivered by a variety of mucosal routes
Time frame: Throughout study
To evaluate the antibody, humoral, and cellular immune responses resulting from ALVAC-HIV vCP205
Time frame: Throughout study
To obtain safety data on AIDSVAX B/B boosting administered by the intramuscular and intranasal routes in the context of previous immunization via alternate mucosal routes or intramuscularly with a canarypox vector expressing HIV-1 antigens (vCP205)
Time frame: Throughout study
To obtain immunogenicity data on AIDSVAX B/B boosting
Time frame: Throughout study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
P Wright study chair
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MN rgp120/HIV-1 and GNE8 rgp120/HIV-1, ALVAC-HIV MN120TMG (vCP205) and ALVAC-RG Rabies Glycoprotein (vCP65) in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 6 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 4 inclusion and 30 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 29 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 6 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.
What does the primary outcome measure?
To compare the safety of ALVAC-HIV vCP205 to that of ALVAC-RG vCP65 rabies glycoprotein, delivered by a variety of mucosal routes (time frame: Throughout study). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Oct 2021.