HIV InfectionsPhase 1NCT00001042
A Phase I, Randomized, Double-Blind, Placebo-Controlled, Clinical Trial to Compare the Safety and Immunogenicity of Recombinant Envelope Protein rgp120/HIV-1SF2 (BIOCINE) Combined With Seven Adjuvants in Healthy HIV-1 Uninfected Individuals
A Phase 1 study testing Aluminum hydroxide, Lipid A, Monophosphoryl and Lipid A, Liposome-encapsulated monophosphoryl in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 3 sites in United States.
Trial summary
To determine in healthy HIV-negative volunteers the safety and immunogenicity of rgp120/HIV-1SF2 (BIOCINE) formulated with each of seven adjuvants. PER AMENDMENT 3/6/96: Purpose of the extension study - To determine the ability of immunization with rgp 120/SF-2 to induce an HIV-1 envelope-specific delayed-type… 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?
- Aluminum hydroxide, Lipid A, Monophosphoryl and Lipid A, Liposome-encapsulated monophosphoryl
- How many people
- 112 participants
- Where
- 3 sitesUnited States
- Study dates
- Start not givento Mar 1996
- 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
- Subjects must have:
- HIV negativity by ELISA.
- Normal history and physical exam.
- CD4 count >= 400 cells/mm3.
- Lower risk sexual behavior.
- Normal urine dipstick with esterase and nitrite.
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- PER AMENDMENT 3/6/96:
- Extension study -
- Consenting Protocol 015 volunteers who have received four immunizations.
Who cannot join
- Co-existing Condition:
- Subjects with the following symptoms or conditions are excluded:
- Hepatitis B surface antigen.
- Active syphilis. NOTE:Subjects for whom serology is 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 normal chest x-ray showing no evidence of TB and not requiring isoniazid therapy are eligible.
- Medical or psychiatric condition or occupational responsibilities that would preclude compliance.
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- Subjects with the following prior conditions are excluded:
- History of immunodeficiency, chronic illness, or autoimmune disease.
- History of anaphylaxis or other serious adverse reactions to vaccines.
- PER AMENDMENT 3/6/96: Extension study -
- History of eczema or allergic-type reactions to vaccine in Protocol 015.
- Prior Medication:
- Excluded:
- Live attenuated vaccines within 60 days prior to study entry. (NOTE: Medically indicated subunit or killed vaccines, such as influenza or pneumococcal, are allowed but should be given at least 2 weeks prior to HIV immunizations.)
- Experimental agents within 30 days prior to study entry.
- Prior HIV vaccines.
- PER AMENDMENT 3/6/96: Extension study -
- Use of systemic steroids in the past month.
- Prior Treatment:
- Excluded:
- Blood products or immunoglobulin within 6 months prior to study entry. Higher risk behavior for HIV infection (as determined by screening questionnaire), including history of injection drug use within the last 12 months and higher or intermediate risk sexual behavior.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
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 determine in healthy HIV-negative volunteers the safety and immunogenicity of rgp120/HIV-1SF2 (BIOCINE) formulated with each of seven adjuvants.
PER AMENDMENT 3/6/96: Purpose of the extension study - To determine the ability of immunization with rgp 120/SF-2 to induce an HIV-1 envelope-specific delayed-type hypersensitivity (DTH) response in volunteers who receive rsgp 120/MN skin testing.
One approach to improve the immunogenicity of an HIV-1 subunit protein vaccine is to combine the immunogen with an adjuvant. Adjuvants may augment vaccine immunogenicity by several mechanisms, and as a result induce a more favorable antibody response with high titers, which appear earlier in the course of immunization and persist over time.
Read the detailed description
One approach to improve the immunogenicity of an HIV-1 subunit protein vaccine is to combine the immunogen with an adjuvant. Adjuvants may augment vaccine immunogenicity by several mechanisms, and as a result induce a more favorable antibody response with high titers, which appear earlier in the course of immunization and persist over time.
Volunteers are randomized to receive 50 mcg rgp120/HIV-1SF2 in combination with one of seven different adjuvants: aluminum hydroxide (alum), monophosphoryl lipid A, liposome-encapsulated monophosphoryl lipid A, MF59, MTP-PE/MF59, Syntex adjuvant formulation (SAF/2), and SAF/2 plus threonyl muramyl dipeptide (threonyl MDP). An additional placebo control arm of volunteers receive alum only. Doses are administered at 0, 2, and 6 months. Volunteers are followed for 1 year after the last immunization. Per 8/5/94 amendment, eligible volunteers except those who received monophosphoryl lipid A for the first three immunizations may receive a fourth dose at month 15.
PER AMENDMENT 3/6/96: Extension Study- Protocol 015 has been modified to add a special DTH study. At the end of the study, on day 784, intradermal injections of MN rsgp 120 will be administered to consenting volunteers who have received 4 immunizations as part of protocol 015. Follow up will be extended to 56 days after administration of the intradermal injections.
- Conditions
- HIV Infections
- Being tested
- Aluminum hydroxide, Lipid A, Monophosphoryl, Lipid A, Liposome-encapsulated monophosphoryl, Syntex adjuvant formulation, MF59
- Keywords
- Vaccines, Synthetic, Drug Therapy, Combination, Adjuvants, Immunologic, HIV Envelope Protein gp120, Acetylmuramyl-Alanyl-Isoglutamine, monophosphoryl lipid A, AIDS Vaccines, HIV Seronegativity, 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.
Aluminum hydroxideBiological
Lipid A, MonophosphorylBiological
Lipid A, Liposome-encapsulated monophosphorylBiological
Syntex adjuvant formulationBiological
MF59Biological
Threonyl Muramyl DipeptideBiological
rgp120/HIV-1 SF-2Biological
MTP-PE/MF59Biological
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 completionMar 1996
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Masking
- Double blind
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- McElrath J, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001042
- Sponsor's protocol ID
- AVEG 015
- Other IDs
- 10563
- Status last verified
- Oct 2021
- First submitted
- 2 Nov 1999
- Last updated
- 4 Nov 2021
- Results posted
- No
Publications
Zolla-Pazner S, Alving C, Belshe R, Berman P, Burda S, Chigurupati P, Clements ML, Duliege AM, Excler JL, Hioe C, Kahn J, McElrath MJ, Sharpe S, Sinangil F, Steimer K, Walker MC, Wassef N, Xu S. Neutralization of a clade B primary isolate by sera from human immunodeficiency virus-uninfected recipients of candidate AIDS vaccines. J Infect Dis. 1997 Apr;175(4):764-74. doi: 10.1086/513969.
PubMed 9086128
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Double-Blind, Placebo-Controlled, Clinical Trial to Compare the Safety and Immunogenicity of Recombinant Envelope Protein rgp120/HIV-1SF2 (BIOCINE) Combined With Seven Adjuvants in Healthy HIV-1 Uninfected Individuals
- ClinicalTrials.gov ID
- NCT00001042
- Acronym / sponsor ID
- AVEG 015
- Conditions
- HIV Infections
- Keywords
- Vaccines, Synthetic, Drug Therapy, Combination, Adjuvants, Immunologic, HIV Envelope Protein gp120, Acetylmuramyl-Alanyl-Isoglutamine, monophosphoryl lipid A, AIDS Vaccines, HIV Seronegativity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study completion
- Mar 1996 (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 determine in healthy HIV-negative volunteers the safety and immunogenicity of rgp120/HIV-1SF2 (BIOCINE) formulated with each of seven adjuvants.
PER AMENDMENT 3/6/96: Purpose of the extension study - To determine the ability of immunization with rgp 120/SF-2 to induce an HIV-1 envelope-specific delayed-type hypersensitivity (DTH) response in volunteers who receive rsgp 120/MN skin testing.
One approach to improve the immunogenicity of an HIV-1 subunit protein vaccine is to combine the immunogen with an adjuvant. Adjuvants may augment vaccine immunogenicity by several mechanisms, and as a result induce a more favorable antibody response with high titers, which appear earlier in the course of immunization and persist over time.
Detailed description
One approach to improve the immunogenicity of an HIV-1 subunit protein vaccine is to combine the immunogen with an adjuvant. Adjuvants may augment vaccine immunogenicity by several mechanisms, and as a result induce a more favorable antibody response with high titers, which appear earlier in the course of immunization and persist over time.
Volunteers are randomized to receive 50 mcg rgp120/HIV-1SF2 in combination with one of seven different adjuvants: aluminum hydroxide (alum), monophosphoryl lipid A, liposome-encapsulated monophosphoryl lipid A, MF59, MTP-PE/MF59, Syntex adjuvant formulation (SAF/2), and SAF/2 plus threonyl muramyl dipeptide (threonyl MDP). An additional placebo control arm of volunteers receive alum only. Doses are administered at 0, 2, and 6 months. Volunteers are followed for 1 year after the last immunization. Per 8/5/94 amendment, eligible volunteers except those who received monophosphoryl lipid A for the first three immunizations may receive a fourth dose at month 15.
PER AMENDMENT 3/6/96: Extension Study- Protocol 015 has been modified to add a special DTH study. At the end of the study, on day 784, intradermal injections of MN rsgp 120 will be administered to consenting volunteers who have received 4 immunizations as part of protocol 015. Follow up will be extended to 56 days after administration of the intradermal injections.
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 (9 listed)
- HIV negativity by ELISA.
- Normal history and physical exam.
- CD4 count >= 400 cells/mm3.
- Lower risk sexual behavior.
- Normal urine dipstick with esterase and nitrite.
Key exclusion criteria (21 listed)
- Hepatitis B surface antigen.
- Active syphilis. NOTE:Subjects for whom serology is 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 normal chest x-ray showing no evidence of TB and not requiring isoniazid therapy are eligible.
- Medical or psychiatric condition or occupational responsibilities that would preclude compliance.
- History of immunodeficiency, chronic illness, or autoimmune disease.
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 |
|---|---|---|
| Aluminum hydroxide | Biological | – |
| Lipid A, Monophosphoryl | Biological | – |
| Lipid A, Liposome-encapsulated monophosphoryl | Biological | – |
| Syntex adjuvant formulation | Biological | – |
| MF59 | Biological | – |
| Threonyl Muramyl Dipeptide | Biological | – |
| rgp120/HIV-1 SF-2 | Biological | – |
| MTP-PE/MF59 | 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 4 Nov 2021.
- Background: PubMed 9086128Zolla-Pazner S, Alving C, Belshe R, Berman P, Burda S, Chigurupati P, Clements ML, Duliege AM, Excler JL, Hioe C, Kahn J, McElrath MJ, Sharpe S, Sinangil F, Steimer K, Walker MC, Wassef N, Xu S. Neutralization of a clade B primary isolate by sera from human immunodeficiency virus-uninfected recipients of candidate AIDS vaccines. J Infect Dis. 1997 Apr;175(4):764-74. doi: 10.1086/513969.
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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.
McElrath J study chair
3 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 Aluminum hydroxide, Lipid A, Monophosphoryl and Lipid A, Liposome-encapsulated monophosphoryl in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 3 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 9 inclusion and 21 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 4 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 NCT00001042, 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 4 Nov 2021.