HIV InfectionsPhase 1NCT00000957
A Phase I Multicenter Clinical Trial to Evaluate the Safety and Immunogenicity of Vaccinia Derived HIV-1 Recombinant Envelope Glycoprotein (gp160) of Human Immunodeficiency Virus: Evaluation of Accelerated Schedules
A Phase 1 study testing gp160 Vaccine (Immuno-AG) in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 3 sites in United States.
Trial summary
To evaluate the safety and immune response to vaccinia-derived HIV-1 recombinant envelope glycoprotein (gp160) using an accelerated dosage schedule; to evaluate duration of antibody response and its relationship to the dose and frequency of inoculation. 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?
- gp160 Vaccine (Immuno-AG)
- Type of treatment
- Vaccines
- How many people
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- Start not givento Aug 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients must be:
- Normal, healthy, HIV-negative adults who fully comprehend the purpose and details of the study.
- Available for 1 year of follow-up.
Who cannot join
- Co-existing Condition:
- Patients with the following conditions or symptoms are excluded:
- They or their sexual partners have identifiable high-risk behavior for HIV infection.
- Positive syphilis serology (e.g., VDRL).
- Positive for circulating hepatitis B antigen.
- Patients with the following prior conditions are excluded:
Show all 20Show fewer
- History of positive PPD (tuberculin test).
- History of immunodeficiency or chronic illness.
- Evidence of depression or under treatment for psychiatric problems during the past year.
- Prior Medication:
- Excluded:
- Immunosuppressive medications.
- Prior Treatment:
- Excluded:
- Blood transfusions or cryoprecipitates within the past 6 months.
- Risk Behavior: Excluded:
- High-risk behavior for HIV infection.
- History of intravenous drug use.
- More than one sexual partner in the last 6 months.
- Syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease) in the past 6 months.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Vanderbilt Univ. Hosp. AVEG
Nashville, Tennessee, 37232
JHU AVEG
Pittsburgh, Pennsylvania, 19104
St. Louis Univ. School of Medicine AVEG
St Louis, Missouri, 63104
About this study
To evaluate the safety and immune response to vaccinia-derived HIV-1 recombinant envelope glycoprotein (gp160) using an accelerated dosage schedule; to evaluate duration of antibody response and its relationship to the dose and frequency of inoculation.
Although recent advances have been made in antiviral therapy against AIDS, there is currently no cure for AIDS. It is likely that ultimate control of the disease depends on the development of safe and effective vaccines against HIV.
Read the detailed description
Although recent advances have been made in antiviral therapy against AIDS, there is currently no cure for AIDS. It is likely that ultimate control of the disease depends on the development of safe and effective vaccines against HIV.
Thirty healthy adult volunteers without identifiable high-risk behavior for HIV-1 are randomly assigned to receive vaccination with gp160 (50 mcg) according to one of the following schedules: Group 1 receives vaccine on days 0, 28, 56, and 140 and placebo on days 84 and 112; Group 2 receives vaccine on days 0, 28, 56, 84, and 112 and placebo on day 140. Subjects are followed for 1 year after the last injection. Per 05/13/94 amendment, 10 subjects at the St. Louis University site receive an additional boost 18-24 months after the last injection.
- Conditions
- HIV Infections
- Being tested
- gp160 Vaccine (Immuno-AG)
- Keywords
- Vaccines, Synthetic, Vaccinia Virus, Viral Vaccines, HIV-1, Drug Evaluation, HIV Envelope Protein gp160, Drug Administration Schedule, 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 (Immuno-AG)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 completionAug 1993
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- 30 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Immuno-US
- Responsible party
- Sponsor
- Investigators
- Belshe R, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000957
- Sponsor's protocol ID
- AVEG 004B
- Other IDs
- 10545
- 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 9310283Gorse GJ, Schwartz DH, Graham BS, Matthews TJ, Stablein DM, Frey SE, Belshe RB, Clements ML, Wright PF, Eibl M, et al. HIV-1 recombinant gp160 vaccine given in accelerated dose schedules. NIAID AIDS Vaccine Clinical Trials Network. Clin Exp Immunol. 1994 Nov;98(2):178-84. doi: 10.1111/j.1365-2249.1994.tb06122.x.
PubMed 7955519Gorse GJ, Patel GB, Newman FK, Mandava M, Belshe RB. Recombinant gp160 vaccination schedule and MHC HLA type as factors influencing cellular responses to HIV-1 envelope glycoprotein. NIAID AIDS Vaccine Clinical Trials Network. Vaccine. 1995 Sep;13(13):1170-9. doi: 10.1016/0264-410x(95)00020-2.
PubMed 8578800
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 Clinical Trial to Evaluate the Safety and Immunogenicity of Vaccinia Derived HIV-1 Recombinant Envelope Glycoprotein (gp160) of Human Immunodeficiency Virus: Evaluation of Accelerated Schedules
- ClinicalTrials.gov ID
- NCT00000957
- Acronym / sponsor ID
- AVEG 004B
- Conditions
- HIV Infections
- Keywords
- Vaccines, Synthetic, Vaccinia Virus, Viral Vaccines, HIV-1, Drug Evaluation, HIV Envelope Protein gp160, Drug Administration Schedule, AIDS Vaccines
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Immuno-US
- Study completion
- Aug 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 vaccinia-derived HIV-1 recombinant envelope glycoprotein (gp160) using an accelerated dosage schedule; to evaluate duration of antibody response and its relationship to the dose and frequency of inoculation.
Although recent advances have been made in antiviral therapy against AIDS, there is currently no cure for AIDS. It is likely that ultimate control of the disease depends on the development of safe and effective vaccines against HIV.
Detailed description
Although recent advances have been made in antiviral therapy against AIDS, there is currently no cure for AIDS. It is likely that ultimate control of the disease depends on the development of safe and effective vaccines against HIV.
Thirty healthy adult volunteers without identifiable high-risk behavior for HIV-1 are randomly assigned to receive vaccination with gp160 (50 mcg) according to one of the following schedules: Group 1 receives vaccine on days 0, 28, 56, and 140 and placebo on days 84 and 112; Group 2 receives vaccine on days 0, 28, 56, 84, and 112 and placebo on day 140. Subjects are followed for 1 year after the last injection. Per 05/13/94 amendment, 10 subjects at the St. Louis University site receive an additional boost 18-24 months after the last injection.
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 (3 listed)
- Normal, healthy, HIV-negative adults who fully comprehend the purpose and details of the study.
- Available for 1 year of follow-up.
Key exclusion criteria (20 listed)
- They or their sexual partners have identifiable high-risk behavior for HIV infection.
- Positive syphilis serology (e.g., VDRL).
- Positive for circulating hepatitis B antigen.
- History of positive PPD (tuberculin test).
- History of immunodeficiency or chronic illness.
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 (Immuno-AG) | 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 7955519Gorse GJ, Schwartz DH, Graham BS, Matthews TJ, Stablein DM, Frey SE, Belshe RB, Clements ML, Wright PF, Eibl M, et al. HIV-1 recombinant gp160 vaccine given in accelerated dose schedules. NIAID AIDS Vaccine Clinical Trials Network. Clin Exp Immunol. 1994 Nov;98(2):178-84. doi: 10.1111/j.1365-2249.1994.tb06122.x.
- Background: PubMed 8578800Gorse GJ, Patel GB, Newman FK, Mandava M, Belshe RB. Recombinant gp160 vaccination schedule and MHC HLA type as factors influencing cellular responses to HIV-1 envelope glycoprotein. NIAID AIDS Vaccine Clinical Trials Network. Vaccine. 1995 Sep;13(13):1170-9. doi: 10.1016/0264-410x(95)00020-2.
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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
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 gp160 Vaccine (Immuno-AG) 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 3 inclusion and 20 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 NCT00000957, which also lists 3 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.