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미국 정부가 주관하고 있는 임상 진행 사이트에 Sumagen이
드디어 등록된 것에 대해 주주님들에게 축하의 메시지를 보냅니다.
HIVVACCINE님을 비롯해 자료를 올려주신 주주님께 감사드려며
간략한 커멘트 올려드립니다.
아래 첨부한 내용은 주로 임상 대상자의 조건에 대한 자세한 사항인만큼
번역은 하지 않도록 하겠습니다.
제가 오늘 급한 미팅이 있음에도 불구하고 미팅을 연기하면서까지
이 글을 올리는 이유는 바로 이것이 제가 기다리던 3가지 소식 중에 2번째이기 때문입니다.
첫 번째가 UN 반기문 총장과의 미팅을 통한 에이즈 백신 아프리카 임상에 대한 논의와
관련된 뉴스였고,
두 번째 뉴스가 임상 1상의 시작과 관련된 자세한 내용이었습니다.
첨부한 사진에 있는 내용을 보시면 현재 임상 대상자를 모집 중에 있으나
과거 기사에 의거하면 임상 대상자가 30명에서 40명으로 증가됨에 따라
추가 임상 대상자를 모집하는 것으로 추정 합니다.
사견으로는 이미 모집된 임상 대상자에 대한 임상은 이미 진행되고 있을 것으로 생각합니다.
다만, 아래에 명시된 예상 임상자수는 24명입니다.
물론 예상으로 명시한 만큼 최종 임상자수는 좀 더 지켜봐야 할 것으로 보입니다,
따라서 오늘부터 카운트 다운이 시작되었습니다.
이번 카운트 다운은 D - xx일이 아닌 D + xx일이 되어야 할 것입니다.
임상 시작과 동시에 언제 SAV001H백신의 안전성과 효과가 나타날 것인가
우리모두 기도하는 마음으로 차분히 기다리도록 합시다.
원숭이 실험에서는 1달을 사이에 두고 2번의 접종으로
충분한 항체가 형성되었기에 더 기대가 큽니다.
특히 이번에 임상자 모집과 임상을 주도하는 의사는 Anthony Mills박사님이신데
이쪽 분야에서 22년간의 경력을 가진 베테랑으로 HIV 의학 협회 및
American Academy of HIV Medicine 및 미국 의학 협회에서
상당히 인정 받는 분이라고 알고 있습니다.
현재 UCLA Medial Center와 Olympia Medical Center 그리고
St. Mary’s Medical Center와 연계되어 있습니다.
아마도 임상이 이 중 한 병원에서 진행되고 있을 것으로 예측합니다.
현재 Mills박사가 West Hollywood 캘리포니아에 있는 만큼
이번 임상 대상자 중 유명한 헐리우드 인사가 들어왔으면 좋겠네요.
감사합니다.
Safety and Immune Response Assessment Study of Killed-whole HIV-1 Vaccine (SAV001-H) in Chronic HIV-1 Infected Patients
This study is currently recruiting participants.
Verified March 2012 by Sumagen
First Received on June 9, 2009. Last Updated on March 1, 2012 History of Changes
Sponsor: Sumagen
Information provided by (Responsible Party): Sumagen ( Sumagen )
ClinicalTrials.gov Identifier: NCT01546818
Purpose
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.
흥미롭네요. 임상 1상임에도 불구하고 이번 임상의 목적이 HIV 감염환자에 대한
SAV001H 백신에 대한 안전성, 내성 및 면역 반응이라고 합니다.
헉!!! 면역반응까지 보겠다는 것은 상당히 고무적입니다.
Condition
Intervention
Phase
HIV Infections Biological: SAV001-H Phase I
Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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)
Resource links provided by NLM:
Genetics Home Reference related topics: complement factor I deficiency
MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources
Further study details as provided by Sumagen:
Primary Outcome Measures:
• 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 ] [ Designated as safety issue: Yes ]
안전성에 대한 최종 소요기간을 1년을 추정하고 있네요.
Secondary Outcome Measures:
• 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 ] [ Designated as safety issue: No ]
면역반응에 대한 최종 소요기간을 1년을 보고 있네요.
Estimated Enrollment: 24
예상 임상 대상자 수를 여기서는 24명으로 국한하고 있네요.
예상인 만큼 좀 더 지켜봐야 할 것으로 보입니다.
Study Start Date: March 2012
임상 시작: 2012년 3월
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
임상 완료: 2013년 3월. 여기서는 최종 완료되는 시점을 1년으로 보고 있지만
이보다 빠른 시일 안에 중간발표가 있을 것으로 기대하고 있습니다
Intervention Details:
Biological: SAV001-H
A whole-killed HIV
Eligibility
Ages Eligible for Study: 18 Years to 50 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria
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
o 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01546818
Contacts
Contact: Anthony M Mills, MD 310-550-1010 310-550-1010
Contact: Stefan Schneider, MD 562-624-4943 562-624-4943
Locations
United States, California
Anthony Mills, MD Internal Medicine Recruiting
Los Angeles, California, United States, 90069
Contact: Anthony M Mills, MD 310-550-1010 310-550-1010
Principal Investigator: Anthony M Mills, MD
Sponsors and Collaborators
Sumagen
Investigators
Principal Investigator: Anthony M Mills, M.D. Anthony Mills, MD, Inc.
Principal Investigator: Stefan Schneider, M.D. Living Hope Clinical Foundation
More Information
No publications provided
Responsible Party: Sumagen ( Sumagen )
ClinicalTrials.gov Identifier: NCT01546818 History of Changes
Other Study ID Numbers: SAV-CT01
Study First Received: June 9, 2009
Last Updated: March 1, 2012
Health Authority: United States: Food and Drug Administration
Keywords provided by Sumagen:
HIV
Vaccine
HIV-1 infections
Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
ClinicalTrials.gov processed this record on March 07, 2012