HIV InfectionsPhase 1NCT00000956
A Phase I Multicenter Trial to Evaluate the Safety and Immunogenicity of HIV-1 Recombinant Envelope Glycoprotein gp160
A Phase 1 study testing gp160 Vaccine (MicroGeneSys) in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in United States.
Trial summary
To evaluate the safety and immune response to 640 and 1280 mcg HIV-1 recombinant envelope glycoprotein gp160. To evaluate the duration of antibody response and its relationship to dose and frequency of inoculation. 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?
- gp160 Vaccine (MicroGeneSys)
- Type of treatment
- Vaccines
- How many people
- 25 participants
- Where
- 2 sitesUnited States
- Study dates
- Start not givento Mar 1993
- 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
- Patients must have:
- Normal history and physical exam.
- Negative for HIV infection by ELISA and Western blot (i.e., no reactivity at gp160, gp120, gp41, or p24).
- T4 count >= 800 cells/mm3.
- Normal chest x-ray and urinalysis.
- Negative hepatitis B surface antigen.
- Negative HIV p24 antigen test.
- Normal skin reactivity by Merieux test.
Who cannot join
- Co-existing Condition:
- Subjects with the following symptoms or conditions are excluded:
- Positive PPD.
- Syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease).
- Subjects with the following prior conditions are excluded:
- History of immunodeficiency, chronic illness, or use of immunosuppressive medications.
Show all 14Show fewer
- Syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease) in the past 6 months.
- Prior Treatment:
- Excluded:
- Prior blood transfusions or cryoprecipitates within the past 6 months.
- Identifiable high-risk behavior for HIV infection (as determined by prescreening questions designed to identify risk factors for HIV infection), including:
- Any history of IV drug use.
- Syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease) in the past 6 months.
- More than two sexual partners, or sexual contact with a high-risk partner, in the past 6 months.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
JHU AVEG
Pittsburgh, Pennsylvania
St. Louis Univ. School of Medicine AVEG
St Louis, Missouri, 63104
About this study
To evaluate the safety and immune response to 640 and 1280 mcg HIV-1 recombinant envelope glycoprotein gp160. To evaluate the duration of antibody response and its relationship to dose and frequency of inoculation.
Evaluation of previous patients who received doses of 40 or 80 mcg gp160 vaccine indicates that, although serum anti-gp160 antibody responses were detected, the level and duration of those responses were limited. A preliminary observation suggests that weak functional antibody responses may develop following the 18 month booster of 40 or 80 mcg; therefore, a dose of gp160 vaccine having potentially greater immunogenicity is of particular interest.
Read the detailed description
Evaluation of previous patients who received doses of 40 or 80 mcg gp160 vaccine indicates that, although serum anti-gp160 antibody responses were detected, the level and duration of those responses were limited. A preliminary observation suggests that weak functional antibody responses may develop following the 18 month booster of 40 or 80 mcg; therefore, a dose of gp160 vaccine having potentially greater immunogenicity is of particular interest.
In the initial phase of the study, 20 healthy volunteers receive 640 mcg gp160 vaccine and 5 healthy volunteers receive alum placebo. At least 30 days later, 20 additional volunteers receive 1280 mcg gp160 vaccine and 5 volunteers receive placebo. Injections are given on days 0, 30, 180, and 365.
- Conditions
- HIV Infections
- Being tested
- gp160 Vaccine (MicroGeneSys)
- Keywords
- Vaccines, Synthetic, Vaccinia Virus, HIV-1, HIV Envelope Protein gp160, AIDS Vaccines, HIV Seronegativity, HIV Preventive Vaccine
- Medical subject headings
- HIV Infections, Vaccinia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gp160 Vaccine (MicroGeneSys)Biological
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 1993
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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
- 25 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Protein Sciences Corporation
- Responsible party
- Sponsor
- Investigators
- Belshe R, Study chairClements ML, Study chairCouch R, Study chairDolin R, Study chairLevine M, Study chairWright P, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000956
- Sponsor's protocol ID
- AVEG 003B
- Other IDs
- 10542
- Status last verified
- Oct 2021
- First submitted
- 2 Nov 1999
- Last updated
- 4 Nov 2021
- Results posted
- No
Publications
Keefer MC, Wolff M, Gorse GJ, Graham BS, Corey L, Clements-Mann ML, Verani-Ketter N, Erb S, Smith CM, Belshe RB, Wagner LJ, McElrath MJ, Schwartz DH, Fast P. Safety profile of phase I and II preventive HIV type 1 envelope vaccination: experience of the NIAID AIDS Vaccine Evaluation Group. AIDS Res Hum Retroviruses. 1997 Sep 20;13(14):1163-77. doi: 10.1089/aid.1997.13.1163.
PubMed 9310283VanCott TC, Bethke FR, Burke DS, Redfield RR, Birx DL. Lack of induction of antibodies specific for conserved, discontinuous epitopes of HIV-1 envelope glycoprotein by candidate AIDS vaccines. J Immunol. 1995 Oct 15;155(8):4100-10.
PubMed 7561123Stanhope PE, Liu AY, Pavlat W, Pitha PM, Clements ML, Siliciano RF. An HIV-1 envelope protein vaccine elicits a functionally complex human CD4+ T cell response that includes cytolytic T lymphocytes. J Immunol. 1993 May 15;150(10):4672-86.
PubMed 8097759Keefer MC, Graham BS, Belshe RB, Schwartz D, Corey L, Bolognesi DP, Stablein DM, Montefiori DC, McElrath MJ, Clements ML, et al. Studies of high doses of a human immunodeficiency virus type 1 recombinant glycoprotein 160 candidate vaccine in HIV type 1-seronegative humans. The AIDS Vaccine Clinical Trials Network. AIDS Res Hum Retroviruses. 1994 Dec;10(12):1713-23. doi: 10.1089/aid.1994.10.1713.
PubMed 7888231De Santis C, Robbioni P, Longhi R, Lopalco L, Siccardi AG, Beretta A, Roberts NJ Jr. Cross-reactive response to human immunodeficiency virus type 1 (HIV-1) gp120 and HLA class I heavy chains induced by receipt of HIV-1-derived envelope vaccines. J Infect Dis. 1993 Dec;168(6):1396-403. doi: 10.1093/infdis/168.6.1396.
PubMed 8245524Schwartz DH, Cosentino LM, Shirai A, Conover J, Daniel S, Klinman DM. Lack of correlation between the number of circulating B cells and the concentration of serum antibodies reactive with the HIV-1 envelope glycoprotein. J Acquir Immune Defic Syndr (1988). 1994 May;7(5):447-53.
PubMed 8158537
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 Multicenter Trial to Evaluate the Safety and Immunogenicity of HIV-1 Recombinant Envelope Glycoprotein gp160
- ClinicalTrials.gov ID
- NCT00000956
- Acronym / sponsor ID
- AVEG 003B
- Conditions
- HIV Infections
- Keywords
- Vaccines, Synthetic, Vaccinia Virus, HIV-1, HIV Envelope Protein gp160, AIDS Vaccines, HIV Seronegativity, HIV Preventive Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Protein Sciences Corporation
- Study completion
- Mar 1993 (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 evaluate the safety and immune response to 640 and 1280 mcg HIV-1 recombinant envelope glycoprotein gp160. To evaluate the duration of antibody response and its relationship to dose and frequency of inoculation.
Evaluation of previous patients who received doses of 40 or 80 mcg gp160 vaccine indicates that, although serum anti-gp160 antibody responses were detected, the level and duration of those responses were limited. A preliminary observation suggests that weak functional antibody responses may develop following the 18 month booster of 40 or 80 mcg; therefore, a dose of gp160 vaccine having potentially greater immunogenicity is of particular interest.
Detailed description
Evaluation of previous patients who received doses of 40 or 80 mcg gp160 vaccine indicates that, although serum anti-gp160 antibody responses were detected, the level and duration of those responses were limited. A preliminary observation suggests that weak functional antibody responses may develop following the 18 month booster of 40 or 80 mcg; therefore, a dose of gp160 vaccine having potentially greater immunogenicity is of particular interest.
In the initial phase of the study, 20 healthy volunteers receive 640 mcg gp160 vaccine and 5 healthy volunteers receive alum placebo. At least 30 days later, 20 additional volunteers receive 1280 mcg gp160 vaccine and 5 volunteers receive placebo. Injections are given on days 0, 30, 180, and 365.
Study design
- Primary purpose
- Prevention
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Normal history and physical exam.
- Negative for HIV infection by ELISA and Western blot (i.e., no reactivity at gp160, gp120, gp41, or p24).
- T4 count >= 800 cells/mm3.
- Normal chest x-ray and urinalysis.
- Negative hepatitis B surface antigen.
Key exclusion criteria (14 listed)
- Positive PPD.
- Syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease).
- History of immunodeficiency, chronic illness, or use of immunosuppressive medications.
- Syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease) in the past 6 months.
- Prior blood transfusions or cryoprecipitates within the past 6 months.
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 |
|---|---|---|
| gp160 Vaccine (MicroGeneSys) | 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 9310283Keefer MC, Wolff M, Gorse GJ, Graham BS, Corey L, Clements-Mann ML, Verani-Ketter N, Erb S, Smith CM, Belshe RB, Wagner LJ, McElrath MJ, Schwartz DH, Fast P. Safety profile of phase I and II preventive HIV type 1 envelope vaccination: experience of the NIAID AIDS Vaccine Evaluation Group. AIDS Res Hum Retroviruses. 1997 Sep 20;13(14):1163-77. doi: 10.1089/aid.1997.13.1163.
- Background: PubMed 7561123VanCott TC, Bethke FR, Burke DS, Redfield RR, Birx DL. Lack of induction of antibodies specific for conserved, discontinuous epitopes of HIV-1 envelope glycoprotein by candidate AIDS vaccines. J Immunol. 1995 Oct 15;155(8):4100-10.
- Background: PubMed 8097759Stanhope PE, Liu AY, Pavlat W, Pitha PM, Clements ML, Siliciano RF. An HIV-1 envelope protein vaccine elicits a functionally complex human CD4+ T cell response that includes cytolytic T lymphocytes. J Immunol. 1993 May 15;150(10):4672-86.
- Background: PubMed 7888231Keefer MC, Graham BS, Belshe RB, Schwartz D, Corey L, Bolognesi DP, Stablein DM, Montefiori DC, McElrath MJ, Clements ML, et al. Studies of high doses of a human immunodeficiency virus type 1 recombinant glycoprotein 160 candidate vaccine in HIV type 1-seronegative humans. The AIDS Vaccine Clinical Trials Network. AIDS Res Hum Retroviruses. 1994 Dec;10(12):1713-23. doi: 10.1089/aid.1994.10.1713.
- Background: PubMed 8245524De Santis C, Robbioni P, Longhi R, Lopalco L, Siccardi AG, Beretta A, Roberts NJ Jr. Cross-reactive response to human immunodeficiency virus type 1 (HIV-1) gp120 and HLA class I heavy chains induced by receipt of HIV-1-derived envelope vaccines. J Infect Dis. 1993 Dec;168(6):1396-403. doi: 10.1093/infdis/168.6.1396.
- Background: PubMed 8158537Schwartz DH, Cosentino LM, Shirai A, Conover J, Daniel S, Klinman DM. Lack of correlation between the number of circulating B cells and the concentration of serum antibodies reactive with the HIV-1 envelope glycoprotein. J Acquir Immune Defic Syndr (1988). 1994 May;7(5):447-53.
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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.
Belshe R study chair
Clements ML study chair
Couch R study chair
2 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 gp160 Vaccine (MicroGeneSys) in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 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 14 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 2 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 NCT00000956, which also lists 6 linked publications.
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.