HIV InfectionsPhase 2NCT00007332
Safety and Immune Response Study of the Vaccine ALVAC vCP1452 Alone or in Combination With AIDSVAX B/B
A Phase 2 study testing ALVAC(2)120(B,MN)GNP (vCP1452) and MN rgp120/HIV-1 and GNE8 rgp120/HIV-1 in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 17 sites in United States.
Trial summary
The purpose of this study is to see if the vaccines tested are safe when given alone and when given together, and how the immune system responds to the vaccines. Vaccines are given to people to try to prevent an infection or disease. 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
- What is being tested?
- ALVAC(2)120(B,MN)GNP (vCP1452) and MN rgp120/HIV-1 and GNE8 rgp120/HIV-1
- How many people
- 330 participants
- Where
- 17 sitesUnited States
- Study dates
- Start not givento Apr 2003
- Phase
- Phase 2
- 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
- Volunteers may be eligible for this study if they:
- Are HIV-negative.
- Are 18 to 60 years old.
- Have a CD4 cell count of 400 cells/mm3 or more.
- Agree to use adequate birth control for 1 month before study entry and during the study (female participants).
- Have a normal history and physical examination.
- Are available for 12 months of follow-up for the planned duration of the study.
- Have a negative pregnancy test within 3 days prior to injections.
Who cannot join
- Volunteers will not be eligible for this study if they:
- Are pregnant or breast-feeding.
- Have chronic hepatitis B.
- Are taking medications that affect the immune system.
- Have an immune system problem, any long-term illness, or any autoimmune disease.
- Have cancer, except if it has been removed with surgery and cure is likely.
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- Have a physical condition, mental condition, or job or work that may interfere with the study.
- Have been suicidal, or have ever needed medicines for a serious mental condition.
- Have received certain vaccines within 60 days of study entry.
- Have used experimental drugs within 30 days prior to study entry.
- Have received any blood products, such as immunoglobulin, in the last 6 months.
- Have active syphilis.
- Have active tuberculosis.
- Have history of severe allergy or any serious reactions to vaccines.
- Have had HIV-1 vaccines in a clinical study.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Infectious Diseases Physicians, Inc.
Annandale, Virginia, 22003
Project Brave HIV Vaccine CRS
Baltimore, Maryland, 21201
Johns Hopkins Bloomberg School of Public Health, Ctr. for Immunization Research, Project SAVE-DC
Baltimore, Maryland, 21205
Johns Hopkins Bloomberg School of Public Health,Ctr for Immunization Research,Project SAVE-Baltimore
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, 02215
Vanderbilt Vaccine CRS
Nashville, Tennessee, 37232
HIV Prevention & Treatment CRS
New York, New York, 10032
NY Blood Ctr./Union Square CRS
New York, New York
Miriam Hospital's HVTU
Providence, Rhode Island, 02906
Univ. of Rochester HVTN CRS
Rochester, New York, 14642
San Francisco Dept. of Public Health, San Francisco Gen. Hosp.
San Francisco, California, 94102
San Francisco Vaccine and Prevention CRS
San Francisco, California
FHCRC/UW Vaccine CRS
Seattle, Washington, 98104
Saint Louis Univ. School of Medicine, HVTU
St Louis, Missouri, 63110
NY Blood Ctr./Bronx CRS
The Bronx, New York, 10456
About this study
Official title: A Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of a Combined Regimen Using ALVAC vCP1452 and AIDSVAX B/B
The purpose of this study is to see if the vaccines tested are safe when given alone and when given together, and how the immune system responds to the vaccines.
Vaccines are given to people to try to prevent an infection or disease. Early testing in a few people has shown that the HIV vaccines ALVAC vCP1452 and AIDSVAX B/B seem to be safe to use.
Read the detailed description
There is no cure for HIV infection or AIDS, and drug therapy is too expensive for most affected populations. For this reason, the development of safe, effective vaccines to prevent HIV infections worldwide is needed. ALVAC vCP1452 and MN rgp120/HIV-1 have been shown to be well tolerated in Phase I and II studies. ALVAC vCP1452 given alone or in combination with subunit antigens [AS PER AMENDMENT 10/12/00: antigen] is a candidate vaccine to be evaluated for the ability to produce and express vaccine antigen in greater quantity for a longer time and with improved immunogenicity.
Volunteers are randomized to 1 of 7 [AS PER AMENDMENT 10/12/00: 1 of 4] groups and stratified by risk status. Prior to immunization, evaluations and blood draws are done to monitor hematological, chemical, and immunologic parameters. Volunteers receive 2 injections of the following vaccines at Months 0, 1, 3, and 6:
Group A: ALVAC vCP1452 and alum placebo [AS PER AMENDMENT 10/12/00: AIDSVAX placebo (aluminum hydroxide adjuvant)] at Months 0, 1, 3, and 6.
Group B: ALVAC vCP1452 and alum placebo [AS PER AMENDMENT 10/12/00: AIDSVAX placebo] at Months 0 and 1 and ALVAC vCP1452 and AIDSVAX B/B at Months 3 and 6.
Group C: ALVAC placebo and alum placebo. [AS PER AMENDMENT 10/12/00: ALVAC vCP1452 and AIDSVAX B/B at Months 0, 1, and 6 and ALVAC vCP1452 and AIDSVAX placebo at Month 3.] Group D: ALVAC vCP1452 and alum placebo at Months 0 and 1 and ALVAC vCP1452 and MN rgp120 at Months 3 and 6. [AS PER AMENDMENT 10/12/00: ALVAC placebo and AIDSVAX placebo at Months 0, 1, 3, and 6.] Group E: ALVAC vCP1452 and AIDSVAX B/B at Months 0, 1, and 6; ALVAC vCP1452 and alum placebo at Month 3. [AS PER AMENDMENT 10/12/00: Group E has been discontinued.] Group F: ALVAC vCP1452 and AIDSVAX B/B. [AS PER AMENDMENT 10/12/00: Group F has been discontinued.] Group G: ALVAC vCP1452 and alum placebo at Months 0 and 1; ALVAC vCP1452 and AIDSVAX B/E at Months 3 and 6. [AS PER AMENDMENT 10/12/00: Group G has been discontinued.] Following each pair of injections, volunteers are observed in the clinic for 30 minutes. Volunteers keep a record of body temperature and any other symptoms and report results to their AIDS Vaccine Evaluation Unit. Evaluations are performed by telephone or clinic visit on Days 1 and 2 after each vaccination. [AS PER AMENDMENT 10/12/00: Volunteers record all relevant signs and symptoms occurring 48 hours after each vaccination and provide that information at each clinic visit.] HIV testing is conducted every 3 to 6 months and volunteers are asked to complete social harms questionnaires once at Day 168 and once at the end of the study. Volunteers are followed on the study for a minimum of 18 months after the first immunization. Safety is evaluated by closely monitoring for local and systemic adverse reactions during the course of the trial.
- Conditions
- HIV Infections
- Being tested
- ALVAC(2)120(B,MN)GNP (vCP1452), MN rgp120/HIV-1 and GNE8 rgp120/HIV-1
- Keywords
- Drug Therapy, Combination, HIV Envelope Protein gp120, AIDS Vaccines, CD8-Positive T-Lymphocytes, HIV Seronegativity, AIDSVAX, 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
MN rgp120/HIV-1 and GNE8 rgp120/HIV-1Biological
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 completionApr 2003
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 2
- Primary purpose
- Prevention
- Masking
- Double blind
- Enrolment
- 330 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Barney Graham, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00007332
- Sponsor's protocol ID
- HVTN 203
- Other IDs
- AVEG 203, 10596
- Status last verified
- Oct 2021
- First submitted
- 16 Dec 2000
- Last updated
- 15 Oct 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of a Combined Regimen Using ALVAC vCP1452 and AIDSVAX B/B
- ClinicalTrials.gov ID
- NCT00007332
- Acronym / sponsor ID
- HVTN 203
- Conditions
- HIV Infections
- Keywords
- Drug Therapy, Combination, HIV Envelope Protein gp120, AIDS Vaccines, CD8-Positive T-Lymphocytes, HIV Seronegativity, AIDSVAX, HIV Preventive Vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study completion
- Apr 2003 (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.
The purpose of this study is to see if the vaccines tested are safe when given alone and when given together, and how the immune system responds to the vaccines.
Vaccines are given to people to try to prevent an infection or disease. Early testing in a few people has shown that the HIV vaccines ALVAC vCP1452 and AIDSVAX B/B seem to be safe to use.
Detailed description
There is no cure for HIV infection or AIDS, and drug therapy is too expensive for most affected populations. For this reason, the development of safe, effective vaccines to prevent HIV infections worldwide is needed. ALVAC vCP1452 and MN rgp120/HIV-1 have been shown to be well tolerated in Phase I and II studies. ALVAC vCP1452 given alone or in combination with subunit antigens [AS PER AMENDMENT 10/12/00: antigen] is a candidate vaccine to be evaluated for the ability to produce and express vaccine antigen in greater quantity for a longer time and with improved immunogenicity.
Volunteers are randomized to 1 of 7 [AS PER AMENDMENT 10/12/00: 1 of 4] groups and stratified by risk status. Prior to immunization, evaluations and blood draws are done to monitor hematological, chemical, and immunologic parameters. Volunteers receive 2 injections of the following vaccines at Months 0, 1, 3, and 6:
Group A: ALVAC vCP1452 and alum placebo [AS PER AMENDMENT 10/12/00: AIDSVAX placebo (aluminum hydroxide adjuvant)] at Months 0, 1, 3, and 6.
Group B: ALVAC vCP1452 and alum placebo [AS PER AMENDMENT 10/12/00: AIDSVAX placebo] at Months 0 and 1 and ALVAC vCP1452 and AIDSVAX B/B at Months 3 and 6.
Group C: ALVAC placebo and alum placebo. [AS PER AMENDMENT 10/12/00: ALVAC vCP1452 and AIDSVAX B/B at Months 0, 1, and 6 and ALVAC vCP1452 and AIDSVAX placebo at Month 3.] Group D: ALVAC vCP1452 and alum placebo at Months 0 and 1 and ALVAC vCP1452 and MN rgp120 at Months 3 and 6. [AS PER AMENDMENT 10/12/00: ALVAC placebo and AIDSVAX placebo at Months 0, 1, 3, and 6.] Group E: ALVAC vCP1452 and AIDSVAX B/B at Months 0, 1, and 6; ALVAC vCP1452 and alum placebo at Month 3. [AS PER AMENDMENT 10/12/00: Group E has been discontinued.] Group F: ALVAC vCP1452 and AIDSVAX B/B. [AS PER AMENDMENT 10/12/00: Group F has been discontinued.] Group G: ALVAC vCP1452 and alum placebo at Months 0 and 1; ALVAC vCP1452 and AIDSVAX B/E at Months 3 and 6. [AS PER AMENDMENT 10/12/00: Group G has been discontinued.] Following each pair of injections, volunteers are observed in the clinic for 30 minutes. Volunteers keep a record of body temperature and any other symptoms and report results to their AIDS Vaccine Evaluation Unit. Evaluations are performed by telephone or clinic visit on Days 1 and 2 after each vaccination. [AS PER AMENDMENT 10/12/00: Volunteers record all relevant signs and symptoms occurring 48 hours after each vaccination and provide that information at each clinic visit.] HIV testing is conducted every 3 to 6 months and volunteers are asked to complete social harms questionnaires once at Day 168 and once at the end of the study. Volunteers are followed on the study for a minimum of 18 months after the first immunization. Safety is evaluated by closely monitoring for local and systemic adverse reactions during the course of the trial.
Study design
- Primary purpose
- Prevention
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Are HIV-negative.
- Are 18 to 60 years old.
- Have a CD4 cell count of 400 cells/mm3 or more.
- Agree to use adequate birth control for 1 month before study entry and during the study (female participants).
- Have a normal history and physical examination.
Key exclusion criteria (15 listed)
- Are pregnant or breast-feeding.
- Have chronic hepatitis B.
- Are taking medications that affect the immune system.
- Have an immune system problem, any long-term illness, or any autoimmune disease.
- Have cancer, except if it has been removed with surgery and cure is likely.
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 |
|---|---|---|
| ALVAC(2)120(B,MN)GNP (vCP1452) | Biological | – |
| MN rgp120/HIV-1 and GNE8 rgp120/HIV-1 | Biological | – |
Primary outcome
Not reported in the source record.
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 15 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.
Barney Graham study chair
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ALVAC(2)120(B,MN)GNP (vCP1452) and MN rgp120/HIV-1 and GNE8 rgp120/HIV-1 in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 17 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 8 inclusion and 15 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 15 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 17 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
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 15 Oct 2021.