HIV InfectionsPhase 1NCT00002261
A Comparative Phase I Clinical Study of HIVAC-1e and Smallpox (Vaccinia) Vaccines in Previously (Vaccinia) Vaccinated and Unvaccinated Volunteers
A Phase 1 study testing Smallpox Vaccine, HIVAC-1e and gp160 Vaccine (MicroGeneSys) in people with HIV Infections, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
To determine the physiological and immunological responses in healthy HIV seronegative adult volunteers vaccinated with a) the HIVAC-1e (vaccinia-HIV) vaccine expressing the envelope glycoproteins of HIV and b) the Wyeth smallpox vaccine. The parameters to be studied will include: 1. 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?
- Smallpox Vaccine, HIVAC-1e and gp160 Vaccine (MicroGeneSys)
- Type of treatment
- Vaccines
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- 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
- Concurrent Medication:
- Allowed:
- All drugs, medications, and therapy which, by virtue of direct pharmacologic action or possible drug interaction, could influence the intended effects of the study vaccine or mask its side effects may be concomitantly administered only by prescription by the Principal Investigator and must be documented on the case report form (CRF).
- Any drug, even aspirin, which is administered after vaccination and during the follow up periods must be documented on the patient's CRF.
Who cannot join
- Co-existing Condition:
- Patients with the following conditions or symptoms are excluded:
- Failure to meet any criteria listed under Inclusion Criteria.
- Development of active eczema or other skin condition which would increase the risk of secondary vaccinia lesions.
- Appearance of serologic or clinical evidence of HIV infection prior to vaccination.
- Current evidence of clinically active viral infections such as Mononucleosis, Epstein-Barr Virus, or cytomegalovirus which may affect immunocompetence.
Show all 27Show fewer
- Active and overt parasitic, mycobacterial, or pyogenic infections that affect tests designated in Inclusion Criteria.
- Concurrent Medication:
- Excluded:
- All drugs, medications and therapy not prescribed by the Principal Investigator, and not documented on the case report form (CRF).
- Any drug, even aspirin, which is administered after vaccination and during the follow up periods which is not documented on the patient's CRF.
- Patients with the following are excluded:
- Failure to meet any criteria listed under Inclusion Criteria.
- Appearance of serologic or clinical evidence of HIV infection prior to vaccination.
- Current evidence of clinically active viral infections.
- Active and overt parasitic, mycobacterial, or pyogenic infections that affect tests designated in Inclusion Criteria.
- Risk Behavior:
- Patients who do not agree to behave sexually in a manner that will minimize the risk of HIV infection for the duration of the study are excluded.
- Patients must:
- Be HIV seronegative.
- Have excellent general health.
- Be unable to bear children.
- Have no immediate household contacts, sex partners, intimate contacts.
- Be free of clinical skin diseases.
- Have signed an informed consent.
- Control subjects receiving Smallpox vaccine will also be selected under the same inclusion criteria. They may be recruited from low risk behavior populations; from laboratory and hospital employees providing service to the study who would normally require Smallpox vaccination; and may be heterosexual, homosexual, or bisexual.
- Patients must agree to behave sexually in a manner that will minimize the risk of HIV infection for the duration of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Bristol - Myers Squibb Co
Wallingford, Connecticut, 064927600
About this study
To determine the physiological and immunological responses in healthy HIV seronegative adult volunteers vaccinated with a) the HIVAC-1e (vaccinia-HIV) vaccine expressing the envelope glycoproteins of HIV and b) the Wyeth smallpox vaccine. The parameters to be studied will include:
- The course of physiological responses to vaccination, including (a) lesion development, progression, and resolution; (b) physiological changes such as temperature, malaise, itching at the site, etc. and (c) any observable AE.
- The appearance, identity, quantity, and duration of humoral antibodies against HIV and vaccinia virus.
- The appearance, identity, quantity, and duration of cell-mediated immunity against HIV and vaccinia virus.
- The adequacy of a procedure using a special dressing to contain viral shedding from the vaccination site.
- The safety, humoral and cellular immune responses of a booster injection of the recombinant subunit gp160 vaccine (MicroGeneSys) in HIVAC-1e recipients.
- Conditions
- HIV Infections
- Being tested
- Smallpox Vaccine, HIVAC-1e, gp160 Vaccine (MicroGeneSys)
- Keywords
- Vaccines, Synthetic, Vaccinia Virus, Viral Vaccines, Smallpox Vaccine, HIV-1, AIDS Vaccines, HIV Seronegativity
- 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.
Smallpox VaccineBiological
HIVAC-1eBiological
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)
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 Bristol-Myers SquibbThe 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
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002261
- Sponsor's protocol ID
- 063A
- Other IDs
- AI452-003001
- Status last verified
- Sep 2007
- First submitted
- 2 Nov 1999
- Last updated
- 26 Sep 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Phase I Clinical Study of HIVAC-1e and Smallpox (Vaccinia) Vaccines in Previously (Vaccinia) Vaccinated and Unvaccinated Volunteers
- ClinicalTrials.gov ID
- NCT00002261
- Acronym / sponsor ID
- 063A
- Conditions
- HIV Infections
- Keywords
- Vaccines, Synthetic, Vaccinia Virus, Viral Vaccines, Smallpox Vaccine, HIV-1, AIDS Vaccines, HIV Seronegativity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- 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 the physiological and immunological responses in healthy HIV seronegative adult volunteers vaccinated with a) the HIVAC-1e (vaccinia-HIV) vaccine expressing the envelope glycoproteins of HIV and b) the Wyeth smallpox vaccine. The parameters to be studied will include:
- The course of physiological responses to vaccination, including (a) lesion development, progression, and resolution; (b) physiological changes such as temperature, malaise, itching at the site, etc. and (c) any observable AE.
- The appearance, identity, quantity, and duration of humoral antibodies against HIV and vaccinia virus.
- The appearance, identity, quantity, and duration of cell-mediated immunity against HIV and vaccinia virus.
- The adequacy of a procedure using a special dressing to contain viral shedding from the vaccination site.
- The safety, humoral and cellular immune responses of a booster injection of the recombinant subunit gp160 vaccine (MicroGeneSys) in HIVAC-1e recipients.
Study design
- Primary purpose
- Prevention
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- All drugs, medications, and therapy which, by virtue of direct pharmacologic action or possible drug interaction, could influence the intended effects of the study vaccine or mask its side effects may be concomitantly administered only by prescription by the Principal Investigator and must be documented on the case report form (CRF).
- Any drug, even aspirin, which is administered after vaccination and during the follow up periods must be documented on the patient's CRF.
Key exclusion criteria (27 listed)
- Failure to meet any criteria listed under Inclusion Criteria.
- Development of active eczema or other skin condition which would increase the risk of secondary vaccinia lesions.
- Appearance of serologic or clinical evidence of HIV infection prior to vaccination.
- Current evidence of clinically active viral infections such as Mononucleosis, Epstein-Barr Virus, or cytomegalovirus which may affect immunocompetence.
- Active and overt parasitic, mycobacterial, or pyogenic infections that affect tests designated in Inclusion Criteria.
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 |
|---|---|---|
| Smallpox Vaccine | Biological | – |
| HIVAC-1e | Biological | – |
| 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 26 Sep 2007.
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Smallpox Vaccine, HIVAC-1e and gp160 Vaccine (MicroGeneSys) in people with HIV Infections, run by Bristol-Myers Squibb at 1 site 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 4 inclusion and 27 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 26 Sep 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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 26 Sep 2007.