HIV InfectionsPhase 1NCT01546818
Safety and Immune Response Assessment Study of Killed-whole HIV-1 Vaccine (SAV001-H) in Chronic HIV-1 Infected Patients
A Phase 1 study testing SAV001-H in people with HIV Infections, run by Sumagen at 1 site in United States.
Trial summary
The purpose of this study is to examine the safety, tolerability, and immune response to killed-whole HIV-1 (SAV001-H) vaccine as a primary vaccination regimen in HIV infected individuals. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- SAV001-H
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Sep 2013
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- HIV-1 infected
- Chronic HIV infection as defined by documentation of HIV infection for over ne year.
- Prior antiretroviral therapy defined as a minimum of 6 months of treatment with HAART. (HAART is defined as a combination of at least 2 antiretroviral agents.)
- CD4+ cell count more than 350 cells per mm3 for a period of 6 months prior to study entry at least at 3 different time points (one of which must be obtained at screening) obtained at any laboratory that possesses a CLIA certification or its equivalent.
- HIV-1 RNA levels less than 50 copies per mL for a period of 6 months prior to study entry at least at 3 different time points (one of which must be obtained at screening) by any laboratory that possesses a CLIA certification or its equivalent.
- Laboratory values obtained within 28 days prior to study entry
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- Men and women between 18 and 50 years of age
- Female study volunteers of reproductive potential (defined as girls who have reached menarche or women who have not been post-menopausal for at least 24 consecutive months, i.e. who have had menses within the preceding 24 months, or have not undergone surgical sterilization (e.g. hysterectomy, bilateral oophorectomy, or salpingotomy) must have a negative serum or urine pregnancy test performed within 3 days before initiating study-specified medication.
- If participating in sexual activity that could lead to pregnancy, the female study volunteer must use a form of contraception listed below while receiving protocol-specified medication and for 6 months after stopping the medication. At least one of the following methods MUST be used appropriately (with or without hormone-based method):
- Condoms (male or female) with or without a spermicidal agent
- Diaphragm or cervical cap with spermicide
- IUD
- Informed of, and willing and able to comply with, the investigational nature of the study, and have signed an informed consent form in accordance with institutional and regulatory guidelines
Who cannot join
- History of serious adverse reactions to vaccines including anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, and/or abdominal pain, except for subjects who have a history of an adverse reaction to pertussis vaccine as a child may enroll.
- History of CD4+ counts less than 350 cells per mm3, opportunistic infections, or AIDS-defining illnesses.
- History of autoimmune disease, immunodeficiency (other than HIV infection), asthma, diabetes (including Type II diabetes or insulin resistance) requiring insulin or oral hypoglycemics, thyroid disease, bleeding disorder, active malignancy, viral hepatitis, or asplenia.
- HBVsAg, HCV Ab, or RPR positive.
- Suspected allergy or adverse reaction to any components of the study agent.
- Changes in antiretroviral regimen within 6 months prior to entry due to virologic failure (not including toxicities).
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- Pregnancy or breast-feeding.
- Receipt of live attenuated vaccines or investigational research agents within 30 days prior to study entry.
- Receipt of blood products within 120 days prior to study entry.
- Receipt of immunoglobulin within 60 days prior to study entry.
- Receipt of medically indicated subunit or killed vaccines (e.g., influenza, pneumococcal, or allergy treatment with antigen injections) within 14 days prior to study entry.
- Receipt of prior experimental HIV vaccines.
- Any investigational antiretroviral agents that are not obtained through expanded access.
- Receipt of immunosuppressive medications within the past 6 months (e.g., oral/parenteral/inhaled corticosteroids, and/or cytotoxic medications). NOTE: The following will be allowed: corticosteroid nasal spray for allergic rhinitis; topical corticosteroids for acute, uncomplicated dermatitis; over the counter medications for acute, uncomplicated dermatitis for a period not longer than 14 days.
- Current anti-TB prophylaxis or therapy.
- Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements.
- Serious illness (requiring systemic treatment and/or hospitalization) until subject either completes therapy or is clinically stable on therapy, in the opinion of the investigator, for at least 14 days prior to study entry.
Trial locations and contacts
1 site in 1 country.
United States1 site
Anthony Mills, MD Internal Medicine
Los Angeles, California, 90069
About this study
Official title: A Phase I, Randomized, Observer-blinded, Placebo-controlled Clinical Study to Assess the Safety, Tolerability, and Immune Response of Killed-Whole HIV-1 Vaccine (SAV001-H) Administered Intramuscularly to Chronic HIV-1 Infected Patients Currently Under Treatment With Highly Active Antiretroviral Therapy (HAART)
The purpose of this study is to examine the safety, tolerability, and immune response to killed-whole HIV-1 (SAV001-H) vaccine as a primary vaccination regimen in HIV infected individuals.
- Conditions
- HIV Infections
- Being tested
- SAV001-H
- Keywords
- HIV, Vaccine, HIV-1 infections
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAV001-HBiological
A whole-killed HIV
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of at least one Grade 3 or higher adverse event, including signs/symptoms, lab toxicities, and/or clinical events possibly or definitely related to study treatment
Measured: 12 months
Secondary outcomes (1)
To evaluate the immune response of killed-whole HIV-1 (SAV001-H) administered intramuscularly in individuals with chronic HIV-1 infection on HAART
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionMar 2013
- Study completionSep 2013
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.
- 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
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sumagen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anthony M Mills, M.D., Principal investigator, Anthony Mills MD IncStefan Schneider, M.D., Principal investigator, Living Hope Clinical Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01546818
- Sponsor's protocol ID
- SAV-CT01
- Status last verified
- Sep 2013
- First submitted
- 9 Jun 2009
- Last updated
- 9 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Observer-blinded, Placebo-controlled Clinical Study to Assess the Safety, Tolerability, and Immune Response of Killed-Whole HIV-1 Vaccine (SAV001-H) Administered Intramuscularly to Chronic HIV-1 Infected Patients Currently Under Treatment With Highly Active Antiretroviral Therapy (HAART)
- ClinicalTrials.gov ID
- NCT01546818
- Acronym / sponsor ID
- SAV-CT01
- Conditions
- HIV Infections
- Keywords
- HIV, Vaccine, HIV-1 infections
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- SumagenIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 7 Mar 2012 (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 examine the safety, tolerability, and immune response to killed-whole HIV-1 (SAV001-H) vaccine as a primary vaccination regimen in HIV infected individuals.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- HIV-1 infected
- Chronic HIV infection as defined by documentation of HIV infection for over ne year.
- Prior antiretroviral therapy defined as a minimum of 6 months of treatment with HAART. (HAART is defined as a combination of at least 2 antiretroviral agents.)
- CD4+ cell count more than 350 cells per mm3 for a period of 6 months prior to study entry at least at 3 different time points (one of which must be obtained at screening) obtained at any laboratory that possesses a CLIA certification or its equivalent.
- HIV-1 RNA levels less than 50 copies per mL for a period of 6 months prior to study entry at least at 3 different time points (one of which must be obtained at screening) by any laboratory that possesses a CLIA certification or its equivalent.
Key exclusion criteria (17 listed)
- History of serious adverse reactions to vaccines including anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, and/or abdominal pain, except for subjects who have a history of an adverse reaction to pertussis vaccine as a child may enroll.
- History of CD4+ counts less than 350 cells per mm3, opportunistic infections, or AIDS-defining illnesses.
- History of autoimmune disease, immunodeficiency (other than HIV infection), asthma, diabetes (including Type II diabetes or insulin resistance) requiring insulin or oral hypoglycemics, thyroid disease, bleeding disorder, active malignancy, viral hepatitis, or asplenia.
- HBVsAg, HCV Ab, or RPR positive.
- Suspected allergy or adverse reaction to any components of the study agent.
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 |
|---|---|---|
| SAV001-HA whole-killed HIV | Biological | – |
Primary outcome
Occurrence of at least one Grade 3 or higher adverse event, including signs/symptoms, lab toxicities, and/or clinical events possibly or definitely related to study treatment
Time frame: 12 months
1 secondary outcome
To evaluate the immune response of killed-whole HIV-1 (SAV001-H) administered intramuscularly in individuals with chronic HIV-1 infection on HAART
Time frame: 12 months
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 9 Sep 2013.
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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.
Anthony M Mills, M.D. principal investigator
Anthony Mills MD Inc
Stefan Schneider, M.D. principal investigator
Living Hope Clinical Foundation
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 SAV001-H in people with HIV Infections, run by Sumagen 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 13 inclusion and 17 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 9 Sep 2013. 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?
Occurrence of at least one Grade 3 or higher adverse event, including signs/symptoms, lab toxicities, and/or clinical events possibly or definitely related to study treatment (time frame: 12 months). 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 9 Sep 2013.