HIV InfectionsPhase 1NCT00062530
Safety of an Oral HIV Vaccine in HIV Uninfected Volunteers
A Phase 1 study testing SCBaL/M9 in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
This study will test the safety of and immune response to an oral HIV vaccine in healthy volunteers. The vaccine in this study uses a weakened bacterium called Salmonella typhi to deliver an HIV gene into the body through the mouth. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- SCBaL/M9
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- HIV uninfected
- Low risk sexual behavior
- Negative for Hepatitis B surface antigen
- Negative for Hepatitis C viral sequences and antibody
- Availability for follow-up for planned duration of the study (12 months)
- Acceptable methods of contraception
Who cannot join
- Receipt of HIV vaccines or placebo in a previous HIV vaccine trial
- History of immunodeficiency, chronic illness, autoimmune disease, or use of immunosuppressive medications
- History of cancer unless there has been surgical excision followed by a sufficient observation period to give a reasonable assurance of cure
- Medical or psychiatric condition or occupational responsibilities which preclude compliance with the protocol
- History of suicide attempts, recent suicidal ideation, or psychosis
- High risk behavior for HIV infection as determined by screening questionnaire
Show all 15Show fewer
- History of injection drug use within 12 months of study entry
- Live attenuated vaccines within 60 days of study entry. Medically indicated killed or subunit vaccines (e.g., influenza, pneumococcal) are not exclusionary, but should be given at least 2 weeks away from HIV immunizations.
- Use of experimental agents within 30 days of study entry
- Receipt of blood products or immunoglobulin within 6 months of study entry
- Active syphilis
- Active tuberculosis
- History of anaphylaxis or 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)
- Pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Institute of Human Virology
Baltimore, Maryland, 21201
About this study
Official title: Development of an Oral Prime-Boost AIDS Vaccine to Elicit Broadly Neutralizing Antibodies Against HIV-1
This study will test the safety of and immune response to an oral HIV vaccine in healthy volunteers. The vaccine in this study uses a weakened bacterium called Salmonella typhi to deliver an HIV gene into the body through the mouth. The body then produces an HIV protein from the gene; this protein stimulates an anti-HIV immune response. The vaccine contains only one of the many substances that HIV needs to make more copies of itself, so the vaccine itself cannot cause HIV or AIDS.
Read the detailed description
The transmission of HIV-1 by both sexual and parenteral routes makes it likely that a successful preventive vaccine against this virus will need to induce protective immunity in both mucosal and systemic compartments. The long-term objective of this program is to develop an HIV-1 vaccine that elicits protective immunity in both the mucosal and systemic compartments.
The study will evaluate the safety and immunogenicity of an oral recombinant Salmonella typhi HIV-1 gp120 vaccine (SCBaL/M9) in healthy human volunteers. This will be the first study in volunteers to use an intracellular bacterium to deliver a recombinant vector vaccine mucosally. The study will also develop an Env immunogen that elicits a broader spectrum of neutralizing antibodies than gp120 and that can be delivered by Salmonella typhi or as a soluble protein immunogen.
This is a Phase I dose-escalation study of two vaccine components that will be combined in a larger prime-boost protocol should the desired safety endpoints be obtained. Both components use a conformationally constrained gp120 that expresses epitopes recognized by broadly neutralizing antibodies. The priming immunogen will be the conformationally constrained gp120 gene delivered orally by live attenuated Salmonella typhi. The boosting immunogen will be a soluble subunit protein comprised solely of the conformationally constrained gp120.
All participants in this study will receive the vaccine. Participants will be randomized to different vaccine doses. Participants will have eight study visits over 20 weeks. Study visits will include brief medical interview, physical exam, blood and urine tests, and counseling on avoiding HIV infection and pregnancy. Participants will be tested for HIV infection 3 times during the study.
- Conditions
- HIV Infections
- Being tested
- SCBaL/M9
- Keywords
- AIDS, HIV seronegativity, HIV preventive vaccine
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCBaL/M9Biological
Oral recombinant Salmonella typhi HIV-1 gp120 vaccine
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | All participants will receive oral vaccine at study entry, although dosage will vary Receives: Biological: SCBaL/M9 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety, as judged by the lack of an immune response to CD4 epitopes or other significant adverse events as defined by the HVTN toxicity tables
Measured: Throughout study
Secondary outcomes (1)
Neutralizing antibody response against HIV-1
Measured: Throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2003 (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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- George K. Lewis, PhD, Principal investigator, Univesity of Maryland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00062530
- Sponsor's protocol ID
- P01AI047490
- Other IDs
- P01AI047490
- Status last verified
- Sep 2008
- First submitted
- 9 Jun 2003
- Last updated
- 26 Sep 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of an Oral Prime-Boost AIDS Vaccine to Elicit Broadly Neutralizing Antibodies Against HIV-1
- ClinicalTrials.gov ID
- NCT00062530
- Acronym / sponsor ID
- P01AI047490
- Conditions
- HIV Infections
- Keywords
- AIDS, HIV seronegativity, HIV preventive vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- First posted
- 12 Jun 2003 (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.
This study will test the safety of and immune response to an oral HIV vaccine in healthy volunteers. The vaccine in this study uses a weakened bacterium called Salmonella typhi to deliver an HIV gene into the body through the mouth. The body then produces an HIV protein from the gene; this protein stimulates an anti-HIV immune response. The vaccine contains only one of the many substances that HIV needs to make more copies of itself, so the vaccine itself cannot cause HIV or AIDS.
Detailed description
The transmission of HIV-1 by both sexual and parenteral routes makes it likely that a successful preventive vaccine against this virus will need to induce protective immunity in both mucosal and systemic compartments. The long-term objective of this program is to develop an HIV-1 vaccine that elicits protective immunity in both the mucosal and systemic compartments.
The study will evaluate the safety and immunogenicity of an oral recombinant Salmonella typhi HIV-1 gp120 vaccine (SCBaL/M9) in healthy human volunteers. This will be the first study in volunteers to use an intracellular bacterium to deliver a recombinant vector vaccine mucosally. The study will also develop an Env immunogen that elicits a broader spectrum of neutralizing antibodies than gp120 and that can be delivered by Salmonella typhi or as a soluble protein immunogen.
This is a Phase I dose-escalation study of two vaccine components that will be combined in a larger prime-boost protocol should the desired safety endpoints be obtained. Both components use a conformationally constrained gp120 that expresses epitopes recognized by broadly neutralizing antibodies. The priming immunogen will be the conformationally constrained gp120 gene delivered orally by live attenuated Salmonella typhi. The boosting immunogen will be a soluble subunit protein comprised solely of the conformationally constrained gp120.
All participants in this study will receive the vaccine. Participants will be randomized to different vaccine doses. Participants will have eight study visits over 20 weeks. Study visits will include brief medical interview, physical exam, blood and urine tests, and counseling on avoiding HIV infection and pregnancy. Participants will be tested for HIV infection 3 times during the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: SCBaL/M9All participants will receive oral vaccine at study entry, although dosage will vary |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- HIV uninfected
- Low risk sexual behavior
- Negative for Hepatitis B surface antigen
- Negative for Hepatitis C viral sequences and antibody
- Availability for follow-up for planned duration of the study (12 months)
Key exclusion criteria (15 listed)
- Receipt of HIV vaccines or placebo in a previous HIV vaccine trial
- History of immunodeficiency, chronic illness, autoimmune disease, or use of immunosuppressive medications
- History of cancer unless there has been surgical excision followed by a sufficient observation period to give a reasonable assurance of cure
- Medical or psychiatric condition or occupational responsibilities which preclude compliance with the protocol
- History of suicide attempts, recent suicidal ideation, or psychosis
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 |
|---|---|---|
| SCBaL/M9Oral recombinant Salmonella typhi HIV-1 gp120 vaccine | Biological | 1 |
Primary outcome
Safety, as judged by the lack of an immune response to CD4 epitopes or other significant adverse events as defined by the HVTN toxicity tables
Time frame: Throughout study
1 secondary outcome
Neutralizing antibody response against HIV-1
Time frame: Throughout study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2008.
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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.
George K. Lewis, PhD principal investigator
Univesity of Maryland
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 SCBaL/M9 in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) 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 6 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 26 Sep 2008. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact George K. Lewis, PhD (410- 706-4688, lewisg@umbi.umd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety, as judged by the lack of an immune response to CD4 epitopes or other significant adverse events as defined by the HVTN toxicity tables (time frame: Throughout study). It is what the study was designed to measure, not a finding.
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 2008; AzTrials last refreshed its copy on 8 Nov 2026.