HIV InfectionsNCT00000835
A Multicenter, Randomized, Placebo-Controlled, Double-Blind Trial to Evaluate the Safety and Immunogenicity of an HIV-1 Pseudovirion Vaccine
An observational study of HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID).
Trial summary
The purpose of this trial is to determine the safety and immunogenicity of an HIV-1 pseudovirion vaccine given at one antigen dose alone and in combination with each of two different adjuvants using two immunization schedules. 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
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Observational
- 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 have:
- Negative ELISA for HIV-1 antibody within 8 weeks of initial immunization.
- CD4 count >= 400 cells/mm3.
- Negative Hepatitis B surface antigen.
- Normal history and physical examination.
Who cannot join
- Co-existing Condition:
- Patients with the following conditions and symptoms are excluded:
- Medical or psychiatric condition or occupational responsibilities preclude compliance with the protocol.
- Present psychosis.
- Active syphilis (eligible if serology documented to be a false positive or due to remote, i.e., > 6 months treated infection).
- Active tuberculosis (eligible if positive purified protein derivative test and normal chest x-ray showing no evidence of TB and not requiring isoniazid therapy).
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- Hepatitis B antigenemia.
- Concurrent Medication:
- Excluded:
- Immunosuppressive medications.
- Patients with the following prior conditions are excluded:
- History of immunodeficiency, chronic illness, malignancy, or autoimmune disease.
- History of cancer unless there has been surgical excision followed by sufficient observation period to give a reasonable assurance of cure.
- History of suicide attempts, recent suicidal ideation or who have past psychosis.
- History of anaphylaxis or other serious adverse reactions to vaccines.
- History of serious allergic reaction to any substance, requiring hospitalization or emergent medical care (e.g. Stevens-Johnson syndrome, bronchospasm, or hypotension).
- Prior Medication:
- Excluded:
- Prior receipt of HIV-1 vaccines or placebo recipient in a previous HIV vaccine trial.
- Use of experimental agents within 30 days prior to study.
- Live attenuated vaccines within 60 days of study.
- Medically indicated subunit or killed vaccines (e.g., influenza, pneumococcal) within 2 weeks prior to study.
- Prior Treatment:
- Excluded:
- Receipt of blood products or immunoglobulin in the past 6 months.
- Risk Behavior:
- Excluded:
- Volunteers having identifiable higher risk behavior for HIV infection as determined by screening questions designed to identify risk factors for HIV infection, specifically:
- History of injection drug use within the last 12 months prior to enrollment.
- Higher or intermediate risk sexual behavior as defined by the AVEG ( i.e., meeting the criteria for AVEG Risk Group C or D).
- Volunteers risk behavior for HIV infection will be determined upon information obtained from a questionnaire and from the AIDS Vaccine Evaluation Group (AVEG) risk behavior guidelines.
- NOTE:
- Only those volunteers meeting the criteria for AVEG Risk Groups A and B will be enrolled in this study.
About this study
The purpose of this trial is to determine the safety and immunogenicity of an HIV-1 pseudovirion vaccine given at one antigen dose alone and in combination with each of two different adjuvants using two immunization schedules.
The pseudovirions are virus-like particles generated by in vitro production of HIV-1 viral proteins which are capable of assembly into particles. The presence of gag gene products in addition to envelope glycoprotein should assist in humoral and cellular immunologic responses to internal HIV-1 viral proteins. The pseudovirion vaccine has been tested in preclinical trials in mice, guinea pigs, rabbits, and nonhuman primates with good safety and immunogenicity profile.
Read the detailed description
The pseudovirions are virus-like particles generated by in vitro production of HIV-1 viral proteins which are capable of assembly into particles. The presence of gag gene products in addition to envelope glycoprotein should assist in humoral and cellular immunologic responses to internal HIV-1 viral proteins. The pseudovirion vaccine has been tested in preclinical trials in mice, guinea pigs, rabbits, and nonhuman primates with good safety and immunogenicity profile.
A total of 78 volunteers will be recruited and randomly assigned to receive pseudovirion vaccine and/or the placebo/adjuvant. All volunteers will receive injections intramuscularly at 0, 1, 3, 6, and 12 months.
Group I (30 volunteers): pseudovirion vaccine w/adjuvant or w/o adjuvant. Group II (30 volunteers): pseudovirion vaccine w/adjuvant or w/o adjuvant. Group III (18 volunteers): adjuvant (QS21 or alum) or saline placebo. NOTE: Group I will receive appropriate adjuvant or saline placebo at Month 3 without pseudovirion vaccine.
- Conditions
- HIV Infections
- Medical subject headings
- HIV Infections
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)
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
- Observational
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Gorse G, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000835
- Sponsor's protocol ID
- AVEG 025
- Other IDs
- 11541
- Status last verified
- Oct 2021
- First submitted
- 2 Nov 1999
- Last updated
- 29 Oct 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Placebo-Controlled, Double-Blind Trial to Evaluate the Safety and Immunogenicity of an HIV-1 Pseudovirion Vaccine
- ClinicalTrials.gov ID
- NCT00000835
- Acronym / sponsor ID
- AVEG 025
- Conditions
- HIV Infections
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- 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 trial is to determine the safety and immunogenicity of an HIV-1 pseudovirion vaccine given at one antigen dose alone and in combination with each of two different adjuvants using two immunization schedules.
The pseudovirions are virus-like particles generated by in vitro production of HIV-1 viral proteins which are capable of assembly into particles. The presence of gag gene products in addition to envelope glycoprotein should assist in humoral and cellular immunologic responses to internal HIV-1 viral proteins. The pseudovirion vaccine has been tested in preclinical trials in mice, guinea pigs, rabbits, and nonhuman primates with good safety and immunogenicity profile.
Detailed description
The pseudovirions are virus-like particles generated by in vitro production of HIV-1 viral proteins which are capable of assembly into particles. The presence of gag gene products in addition to envelope glycoprotein should assist in humoral and cellular immunologic responses to internal HIV-1 viral proteins. The pseudovirion vaccine has been tested in preclinical trials in mice, guinea pigs, rabbits, and nonhuman primates with good safety and immunogenicity profile.
A total of 78 volunteers will be recruited and randomly assigned to receive pseudovirion vaccine and/or the placebo/adjuvant. All volunteers will receive injections intramuscularly at 0, 1, 3, 6, and 12 months.
Group I (30 volunteers): pseudovirion vaccine w/adjuvant or w/o adjuvant. Group II (30 volunteers): pseudovirion vaccine w/adjuvant or w/o adjuvant. Group III (18 volunteers): adjuvant (QS21 or alum) or saline placebo. NOTE: Group I will receive appropriate adjuvant or saline placebo at Month 3 without pseudovirion vaccine.
Study design
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Negative ELISA for HIV-1 antibody within 8 weeks of initial immunization.
- CD4 count >= 400 cells/mm3.
- Negative Hepatitis B surface antigen.
- Normal history and physical examination.
Key exclusion criteria (33 listed)
- Medical or psychiatric condition or occupational responsibilities preclude compliance with the protocol.
- Present psychosis.
- Active syphilis (eligible if serology documented to be a false positive or due to remote, i.e., > 6 months treated infection).
- Active tuberculosis (eligible if positive purified protein derivative test and normal chest x-ray showing no evidence of TB and not requiring isoniazid therapy).
- Hepatitis B antigenemia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 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.
Gorse G study chair
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID).
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 5 inclusion and 33 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: withdrawn, as of the sponsor's last update on 29 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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 29 Oct 2021.