HIV InfectionsPhase 2NCT00011037
ALVAC-HIV vCP1452 Alone and Combined With MN rgp120
A Phase 2 study testing ALVAC(2)120(B,MN)GNP (vCP1452) and MN rgp120/HIV-1 in people with HIV Infections and HIV Seronegativity, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 sites in 4 countries.
Trial summary
The purpose of this study is to test how the body's immune system responds to the vaccine ALVAC-HIV vCP1452 and to determine if the vaccine is safe when given alone and with MN rgp120. HIV infection and AIDS have no cure, in spite of recent advances in anti-HIV drugs. 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) and MN rgp120/HIV-1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Start not givento Jul 2004
- 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 from Brazil (Rio de Janeiro), Haiti, Peru, or Trinidad and Tobago.
- Are 18 to 60 years old.
- Are HIV-negative.
- Have not developed a sexually transmitted disease in the last 6 months.
- Have had no more than 2 sexual partners in the last 6 months.
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- Have not injected drugs or used crack cocaine in the last 6 months.
- Have not exchanged sex for money or drugs in the last 6 months.
- Have used an adequate birth control method for 1 month prior to study injections and intend to continue for the injection period (7 months).
- Are available for 18 months of follow-up.
- Have a normal history and physical examination.
- (The criteria for inclusion have been changed from the original.)
Who cannot join
- Volunteers will not be eligible for this study if they:
- Have had immune diseases, chronic illness, or cancer (unless cured by surgical removal), or have used medications affecting the immune system.
- Have a medical or mental condition, or job that interferes with the study requirements.
- Have a sexual partner who is HIV-infected, unless practicing abstinence or have always used condoms for the last 6 months.
- Have a sexual partner at high risk of HIV infection.
- Have received live vaccines or experimental agents within 30 days prior to planned vaccination.
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- Have received blood products or immunoglobulin in the past 6 months.
- Have active tuberculosis.
- Have had a severe allergic reaction, including 1 requiring hospitalization or medical care, or a serious reaction to vaccines.
- Have received HIV-1 vaccines or placebo in a previous HIV vaccine trial.
- Are pregnant or breast-feeding.
- Are allergic to egg products, thimerosal, or neomycin.
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
Trinidad and Tobago1 site
CCPRI Med. Ctr. - Med. Research Foundation of Trinidad & Tobago
Port of Spain
About this study
Official title: A Multisite Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of ALVAC-HIV vCP1452 Alone and Combined With MN rgp120
The purpose of this study is to test how the body's immune system responds to the vaccine ALVAC-HIV vCP1452 and to determine if the vaccine is safe when given alone and with MN rgp120.
HIV infection and AIDS have no cure, in spite of recent advances in anti-HIV drugs. Many worldwide populations cannot afford the antiviral treatments for infected people. HIV vaccines offer hope for disease prevention. In this trial, 2 experimental HIV vaccines called ALVAC vCP1452 and MN rgp120 will be given to volunteers in Haiti, Brazil, Peru, and Trinidad and Tobago. The study will determine how volunteers' immune systems respond to the vaccines. (This protocol has been changed by adding new international sites.)
Read the detailed description
There is no cure for HIV infection or AIDS in spite of recent advances in antiviral therapy. Furthermore, drug therapy is too expensive for most affected populations. For this reason, there is a commitment to the development of safe, effective vaccines to prevent HIV infection and AIDS worldwide. This study evaluates the immunogenicity and safety of candidate HIV-1 vaccines, based on the canarypox vector termed ALVAC, alone and combined with an MN rgp120 product, at 3 [AS PER AMENDMENT 7/19/01: 5] international sites.
[AS PER AMENDMENT 7/19/01: Volunteers in Rio de Janeiro, Haiti, and Trinidad and Tobago comprise Part I; volunteers in Sao Paulo and Peru comprise Part II.] Volunteers from Haiti, Brazil, [AS PER AMENDMENT 7/19/01: Peru] and Trinidad and Tobago are enrolled into 1 of 3 arms and followed for 18 months. Arm 1 volunteers receive ALVAC-HIV vCP1452 at 0, 1, 3, and 6 months. Arm 2 volunteers receive ALVAC-HIV vCP1452 on the same schedule as Arm 1 and receive HIV-1 MN rgp120 subunit simultaneously with the 3-month and 6-month vaccine doses. Arm 3 volunteers receive a placebo. Blood and urine samples are collected for immunologic assays, virologic determinations, pregnancy testing, and safety assessments. Risk behavior and social harms are assessed every 6 months during follow-up [AS PER AMENDMENT 7/19/01: Social harms are assessed every 3 months during follow-up and risk behavior every 6 months]. At all clinic visits volunteers receive counseling on avoidance of HIV infection and pregnancy. Participants are tested for HIV-1 every 3 [AS PER AMENDMENT 7/19/01: the following text has been deleted: to 6] months. Counseling and follow-up for any needed medical care are provided.
- Conditions
- HIV Infections, HIV Seronegativity
- Being tested
- ALVAC(2)120(B,MN)GNP (vCP1452), MN rgp120/HIV-1, ALVAC(2)120(B,MN)GNP (vCP1452) placebo, MN rgp120/HIV-1 placebo
- Keywords
- HIV Antibodies, HIV Antigens, HIV Envelope Protein gp120, AIDS Vaccines, CD4-Positive T-Lymphocytes, CD8-Positive T-Lymphocytes, Neutralization Tests, Haiti, Brazil, Cytotoxicity, Immunologic, Epitopes, Viral Proteins, Trinidad and Tobago, Peru, HIV Preventive Vaccine, HIV Seronegativity
- 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
1 x 10^ 7 TCID50 administered intramuscularly
MN rgp120/HIV-1Biological
0.6 mg administered intramuscularly
ALVAC(2)120(B,MN)GNP (vCP1452) placeboBiological
ALVAC placebo administered intramuscularly
MN rgp120/HIV-1 placeboBiological
Alum placebo administered intramuscularly
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants will receive ALVAC-HIV vCP1452 at 0, 1, 3, and 6 months and MN rgp120 and Months 3 and 6 Receives: Biological: ALVAC(2)120(B,MN)GNP (vCP1452); Biological: MN rgp120/HIV-1 |
| 2 | Experimental | Participants will receive ALVAC-HIV vCP1452 at 0, 1, 3, and 6 months and MN rgp120 placebo and Months 3 and 6 Receives: Biological: ALVAC(2)120(B,MN)GNP (vCP1452); Biological: MN rgp120/HIV-1 placebo |
| 3 | Placebo comparator | Participants will receive ALVAC-HIV vCP1452 placebo at 0, 1, 3, and 6 months and MN rgp120 placebo and Months 3 and 6 Receives: Biological: ALVAC(2)120(B,MN)GNP (vCP1452) placebo; Biological: MN rgp120/HIV-1 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity and safety of two vaccine regimens
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 completionJul 2004
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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Peter Wright, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00011037
- Sponsor's protocol ID
- HVTN 026/HIVNET 026
- Other IDs
- 10529, HIVNET 026
- Status last verified
- Oct 2021
- First submitted
- 8 Feb 2001
- Last updated
- 14 Oct 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multisite Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of ALVAC-HIV vCP1452 Alone and Combined With MN rgp120
- ClinicalTrials.gov ID
- NCT00011037
- Acronym / sponsor ID
- HVTN 026/HIVNET 026
- Conditions
- HIV Infections, HIV Seronegativity
- Keywords
- HIV Antibodies, HIV Antigens, HIV Envelope Protein gp120, AIDS Vaccines, CD4-Positive T-Lymphocytes, CD8-Positive T-Lymphocytes, Neutralization Tests, Haiti
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study completion
- Jul 2004 (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 test how the body's immune system responds to the vaccine ALVAC-HIV vCP1452 and to determine if the vaccine is safe when given alone and with MN rgp120.
HIV infection and AIDS have no cure, in spite of recent advances in anti-HIV drugs. Many worldwide populations cannot afford the antiviral treatments for infected people. HIV vaccines offer hope for disease prevention. In this trial, 2 experimental HIV vaccines called ALVAC vCP1452 and MN rgp120 will be given to volunteers in Haiti, Brazil, Peru, and Trinidad and Tobago. The study will determine how volunteers' immune systems respond to the vaccines. (This protocol has been changed by adding new international sites.)
Detailed description
There is no cure for HIV infection or AIDS in spite of recent advances in antiviral therapy. Furthermore, drug therapy is too expensive for most affected populations. For this reason, there is a commitment to the development of safe, effective vaccines to prevent HIV infection and AIDS worldwide. This study evaluates the immunogenicity and safety of candidate HIV-1 vaccines, based on the canarypox vector termed ALVAC, alone and combined with an MN rgp120 product, at 3 [AS PER AMENDMENT 7/19/01: 5] international sites.
[AS PER AMENDMENT 7/19/01: Volunteers in Rio de Janeiro, Haiti, and Trinidad and Tobago comprise Part I; volunteers in Sao Paulo and Peru comprise Part II.] Volunteers from Haiti, Brazil, [AS PER AMENDMENT 7/19/01: Peru] and Trinidad and Tobago are enrolled into 1 of 3 arms and followed for 18 months. Arm 1 volunteers receive ALVAC-HIV vCP1452 at 0, 1, 3, and 6 months. Arm 2 volunteers receive ALVAC-HIV vCP1452 on the same schedule as Arm 1 and receive HIV-1 MN rgp120 subunit simultaneously with the 3-month and 6-month vaccine doses. Arm 3 volunteers receive a placebo. Blood and urine samples are collected for immunologic assays, virologic determinations, pregnancy testing, and safety assessments. Risk behavior and social harms are assessed every 6 months during follow-up [AS PER AMENDMENT 7/19/01: Social harms are assessed every 3 months during follow-up and risk behavior every 6 months]. At all clinic visits volunteers receive counseling on avoidance of HIV infection and pregnancy. Participants are tested for HIV-1 every 3 [AS PER AMENDMENT 7/19/01: the following text has been deleted: to 6] months. Counseling and follow-up for any needed medical care are provided.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: ALVAC(2)120(B,MN)GNP (vCP1452), Biological: MN rgp120/HIV-1Participants will receive ALVAC-HIV vCP1452 at 0, 1, 3, and 6 months and MN rgp120 and Months 3 and 6 |
| 2 | Experimental | Biological: ALVAC(2)120(B,MN)GNP (vCP1452), Biological: MN rgp120/HIV-1 placeboParticipants will receive ALVAC-HIV vCP1452 at 0, 1, 3, and 6 months and MN rgp120 placebo and Months 3 and 6 |
| 3 | Placebo comparator | Biological: ALVAC(2)120(B,MN)GNP (vCP1452) placebo, Biological: MN rgp120/HIV-1 placeboParticipants will receive ALVAC-HIV vCP1452 placebo at 0, 1, 3, and 6 months and MN rgp120 placebo and Months 3 and 6 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Are from Brazil (Rio de Janeiro), Haiti, Peru, or Trinidad and Tobago.
- Are 18 to 60 years old.
- Are HIV-negative.
- Have not developed a sexually transmitted disease in the last 6 months.
- Have had no more than 2 sexual partners in the last 6 months.
Key exclusion criteria (12 listed)
- Have had immune diseases, chronic illness, or cancer (unless cured by surgical removal), or have used medications affecting the immune system.
- Have a medical or mental condition, or job that interferes with the study requirements.
- Have a sexual partner who is HIV-infected, unless practicing abstinence or have always used condoms for the last 6 months.
- Have a sexual partner at high risk of HIV infection.
- Have received live vaccines or experimental agents within 30 days prior to planned vaccination.
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)1 x 10^ 7 TCID50 administered intramuscularly | Biological | 1, 2 |
| MN rgp120/HIV-10.6 mg administered intramuscularly | Biological | 1 |
| ALVAC(2)120(B,MN)GNP (vCP1452) placeboALVAC placebo administered intramuscularly | Biological | 3 |
| MN rgp120/HIV-1 placeboAlum placebo administered intramuscularly | Biological | 2, 3 |
Primary outcome
Immunogenicity and safety of two vaccine regimens
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 14 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.
Peter Wright study chair
4 sites in 4 countries: 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 in people with HIV Infections and HIV Seronegativity, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 sites in 4 countries.
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 12 inclusion and 12 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 4 sites in Brazil, Haiti, Peru, Trinidad and Tobago. 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. Some participants in this study may receive a placebo. 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.
What does the primary outcome measure?
Immunogenicity and safety of two vaccine regimens (time frame: Throughout study). 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 14 Oct 2021.