HIV InfectionsPhase 1NCT00056745
Determining an Effective Site (Groin Versus Arm) for Giving HIV Vaccines
A Phase 1 study testing TBC-3B in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
The purpose of this study is to determine the safety and immune system response to the TBC-3B HIV vaccine when it is injected either into the groin area or into the arm. The goal is to determine which injection site is better at producing a particular type of immune response. Read more about this study
- Who is it for?
- Ages 18 to 33 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- TBC-3B
- How many people
- 12 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 33 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- HIV uninfected
- Low risk for HIV-1 (no sexually transmitted disease within 1 year of study entry, no history of injection drug use, no sex with an HIV infected individual or active injection drug user within 6 months of study entry, no unsafe sexual activity with unknown partners) or mutually monogamous relationship with a known HIV seronegative partner (per subject report) for 6 months prior to study entry
- Born after 1970
- Willingness to abstain from sexual activity for up to 30 days after each vaccination
- Willingness to abstain from receptive anal intercourse during the 20 months of the study
- Available for follow-up during the 20 month duration of the study
- Acceptable methods of contraception
Who cannot join
- Immunosuppression of any type, including those related to lupus, rheumatoid arthritis, leukemia, lymphoma, generalized malignancy, agammaglobulinemia, and therapy with alkylating agents, antimetabolites, radiation, or large doses of corticosteroids
- Gastrointestinal complaints such as inflammatory bowel disease or chronic diarrhea
- Medical or psychiatric condition or occupational responsibilities which preclude volunteer's compliance with the protocol; specifically excluded are people with a history of suicide attempts, recent suicidal ideation, or who have past or present psychosis
- Prior smallpox or vaccinia-based vaccination
- Live attenuated vaccines within 60 days of study. Medically indicated subunit or killed vaccines (e.g., influenza, pneumococcal) are not exclusionary, but should be given at least 1 month prior to TBC-3B immunizations.
- Anaphylaxis or other serious adverse reactions to vaccines
Show all 15Show fewer
- Serious allergic reaction to any substance requiring hospitalization or emergent medical care (e.g., Stevens-Johnson syndrome, bronchospasm, or hypotension)
- Sexually transmitted disease in the year prior to study entry
- Genital HSV (herpes) or other ulcerative genital lesions
- Active HBV (hepatitis B) or HCV (hepatitis C) infection
- Nonprescribed injection drug use
- Pregnant or lactating women
- Acute, chronic, or exfoliative skin conditions (e.g., atopic dermatitis, burns, impetigo, varicella zoster, eczema)
- Use of experimental agents within 30 days prior to study
- Household contacts with or ongoing occupational exposure to any of the following: pregnant women; children < 12 months of age; people with acute, chronic, or exfoliative skin conditions (e.g., atopic dermatitis, burns, impetigo, varicella zoster, eczema); people with an immunodeficiency or using immunosuppressive medications
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California at Los Angelos Center for HIV and Digestive Diseases
Los Angeles, California, 90095-7019
About this study
Official title: The Role of Immunization Site in Eliciting Mucosal Immunity
The purpose of this study is to determine the safety and immune system response to the TBC-3B HIV vaccine when it is injected either into the groin area or into the arm. The goal is to determine which injection site is better at producing a particular type of immune response. This study is not evaluating the effectiveness of the vaccine, so volunteers must maintain low risk behavior for HIV transmission throughout the study.
Read the detailed description
The goal of this vaccination study is to evaluate the safety and immunogenicity of the Therion Biologic Corporation (Cambridge, MA) TBC-3B vaccine. TBC-3B consists of live, recombinant vaccinia virus expressing the env and gag/pol genes of HIV-1 strain IIIB. TBC-3B will be administered by subcutaneous injection in the groin and in the deltoid region, with the aim of determining which site is better at inducing mucosal immune responses. Because the groin area drains to the inguinal lymph nodes, vaccines given there may stimulate local immunologic activity in the draining rectal mucosa as well as systemic immunologic activity in the blood.
Volunteers will be followed for 20 months. The first 2 months of the study will be an evaluation of volunteers' normal immune function. Volunteers will then be randomly selected to receive the TBC-3B experimental HIV vaccine in either the groin area or in the deltoid region. Neither volunteers nor study personnel will know which group the volunteer will be in until the day of the first immunization. All volunteers will receive TBC-3B.
During the 20 months of the study, volunteers will be asked to donate blood up to 14 times, undergo seven flexible sigmoidoscopies with biopsies, and receive three pairs of vaccine injections. For up to 36 days after each experimental vaccination, volunteers will be asked to abstain from activity that might spread the virus in the vaccine and put others at risk. Volunteers will receive specific instructions on how to avoid these risks. Volunteers will also be asked not to engage in receptive anal intercourse during the study.
- Conditions
- HIV Infections
- Being tested
- TBC-3B
- Keywords
- HIV seronegativity, HIV preventive vaccine
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TBC-3BBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of administering TBC-3B vaccinations to vaccinia naive individuals
Secondary outcomes (4)
Immunogenicity of subcutaneous vaccination with 3 doses of TBC-3B administered in the groin area, as measured by increased levels of CTL activity directed to vaccinia and HIV-1 env, gag and pol gene products
immunogenicity of subcutaneous vaccination with 3 doses of TBC-3B administered in the groin area, as measured by anti-HIV-1 directed CD4+ T cell proliferative response to soluble p24 antigen
immunogenicity of subcutaneous vaccination with 3 doses of TBC-3B administered in the groin area, as measured by CD8+ T cell specificity for HIV-1 epitopes
immunogenicity of subcutaneous vaccination with 3 doses of TBC-3B administered in the groin area, as measured by serum and mucosal immunoglobulins against HIV-1 epitopes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 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
- 12 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Peter Anton, MD, Principal investigator, University of California at Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00056745
- Sponsor's protocol ID
- R01AI050467
- Other IDs
- UCLA MIG-001, R01AI050467
- Status last verified
- Jul 2007
- First submitted
- 21 Mar 2003
- Last updated
- 18 Sep 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Immunization Site in Eliciting Mucosal Immunity
- ClinicalTrials.gov ID
- NCT00056745
- Acronym / sponsor ID
- R01AI050467
- Conditions
- HIV Infections
- Keywords
- HIV seronegativity, HIV preventive vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- First posted
- 24 Mar 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.
The purpose of this study is to determine the safety and immune system response to the TBC-3B HIV vaccine when it is injected either into the groin area or into the arm. The goal is to determine which injection site is better at producing a particular type of immune response. This study is not evaluating the effectiveness of the vaccine, so volunteers must maintain low risk behavior for HIV transmission throughout the study.
Detailed description
The goal of this vaccination study is to evaluate the safety and immunogenicity of the Therion Biologic Corporation (Cambridge, MA) TBC-3B vaccine. TBC-3B consists of live, recombinant vaccinia virus expressing the env and gag/pol genes of HIV-1 strain IIIB. TBC-3B will be administered by subcutaneous injection in the groin and in the deltoid region, with the aim of determining which site is better at inducing mucosal immune responses. Because the groin area drains to the inguinal lymph nodes, vaccines given there may stimulate local immunologic activity in the draining rectal mucosa as well as systemic immunologic activity in the blood.
Volunteers will be followed for 20 months. The first 2 months of the study will be an evaluation of volunteers' normal immune function. Volunteers will then be randomly selected to receive the TBC-3B experimental HIV vaccine in either the groin area or in the deltoid region. Neither volunteers nor study personnel will know which group the volunteer will be in until the day of the first immunization. All volunteers will receive TBC-3B.
During the 20 months of the study, volunteers will be asked to donate blood up to 14 times, undergo seven flexible sigmoidoscopies with biopsies, and receive three pairs of vaccine injections. For up to 36 days after each experimental vaccination, volunteers will be asked to abstain from activity that might spread the virus in the vaccine and put others at risk. Volunteers will receive specific instructions on how to avoid these risks. Volunteers will also be asked not to engage in receptive anal intercourse during the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 33 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- HIV uninfected
- Low risk for HIV-1 (no sexually transmitted disease within 1 year of study entry, no history of injection drug use, no sex with an HIV infected individual or active injection drug user within 6 months of study entry, no unsafe sexual activity with unknown partners) or mutually monogamous relationship with a known HIV seronegative partner (per subject report) for 6 months prior to study entry
- Born after 1970
- Willingness to abstain from sexual activity for up to 30 days after each vaccination
- Willingness to abstain from receptive anal intercourse during the 20 months of the study
Key exclusion criteria (15 listed)
- Immunosuppression of any type, including those related to lupus, rheumatoid arthritis, leukemia, lymphoma, generalized malignancy, agammaglobulinemia, and therapy with alkylating agents, antimetabolites, radiation, or large doses of corticosteroids
- Gastrointestinal complaints such as inflammatory bowel disease or chronic diarrhea
- Medical or psychiatric condition or occupational responsibilities which preclude volunteer's compliance with the protocol; specifically excluded are people with a history of suicide attempts, recent suicidal ideation, or who have past or present psychosis
- Prior smallpox or vaccinia-based vaccination
- Live attenuated vaccines within 60 days of study. Medically indicated subunit or killed vaccines (e.g., influenza, pneumococcal) are not exclusionary, but should be given at least 1 month prior to TBC-3B immunizations.
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 |
|---|---|---|
| TBC-3B | Biological | – |
Primary outcome
Safety of administering TBC-3B vaccinations to vaccinia naive individuals
4 secondary outcomes
Immunogenicity of subcutaneous vaccination with 3 doses of TBC-3B administered in the groin area, as measured by increased levels of CTL activity directed to vaccinia and HIV-1 env, gag and pol gene products
immunogenicity of subcutaneous vaccination with 3 doses of TBC-3B administered in the groin area, as measured by anti-HIV-1 directed CD4+ T cell proliferative response to soluble p24 antigen
immunogenicity of subcutaneous vaccination with 3 doses of TBC-3B administered in the groin area, as measured by CD8+ T cell specificity for HIV-1 epitopes
immunogenicity of subcutaneous vaccination with 3 doses of TBC-3B administered in the groin area, as measured by serum and mucosal immunoglobulins against HIV-1 epitopes
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 18 Sep 2007.
Related trials for HIV Infections
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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.
Peter Anton, MD principal investigator
University of California at Los Angeles
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 TBC-3B 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 7 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: finished, as of the sponsor's last update on 18 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.
What does the primary outcome measure?
Safety of administering TBC-3B vaccinations to vaccinia naive individuals. 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 18 Sep 2007.