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Safety and Immune Response Assessment Study of Killed-whole HIV-1 Vaccine (SAV001-H) in Chronic HIV-1 Infected Patients

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ClinicalTrials.gov Identifier: NCT01546818
Recruitment Status : Completed
First Posted : March 7, 2012
Last Update Posted : September 9, 2013
Information provided by (Responsible Party):

Brief 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.

Condition or disease Intervention/treatment Phase
HIV Infections Biological: SAV001-H Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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)
Study Start Date : March 2012
Actual Primary Completion Date : March 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS Vaccines

Intervention Details:
  • Biological: SAV001-H
    A whole-killed HIV

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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).
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01546818

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United States, California
Anthony Mills, MD Internal Medicine
Los Angeles, California, United States, 90069
Sponsors and Collaborators
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Principal Investigator: Anthony M Mills, M.D. Anthony Mills MD Inc
Principal Investigator: Stefan Schneider, M.D. Living Hope Clinical Foundation
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Responsible Party: Sumagen
ClinicalTrials.gov Identifier: NCT01546818    
Other Study ID Numbers: SAV-CT01
First Posted: March 7, 2012    Key Record Dates
Last Update Posted: September 9, 2013
Last Verified: September 2013
Keywords provided by Sumagen:
HIV-1 infections
Additional relevant MeSH terms:
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HIV Infections
Blood-Borne Infections
Communicable Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases