Phase I Safety Study of a Recombinant MVA HIV Multiantigen Vaccine in HIV-infected Subjects
This study has been completed.
Information provided by:
First received: February 19, 2008
Last updated: May 19, 2010
Last verified: May 2010
Monocentric study to assess the safety and immunogenicity of the recombinant MVA-HIV multiantigen vaccine MVA-mBN120B in HIV-infected subjects. 15 subjects will receive immunizations at day 0, after 4 and 12 weeks at a dose of 2E8 TCID50 MVA-mBN120B. The vaccine will be administered subcutaneously.
||Endpoint Classification: Safety Study
Primary Purpose: Diagnostic
||Phase I Vaccination Study Testing the Safety and Reactogenicity of a Recombinant MVA HIV Multiantigen Vaccine (MVA-mBN120B) in HIV-infected Subjects With CD4 Count > 350/µL
| Estimated Enrollment:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||February 2009 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years to 55 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Pregnant or breast-feeding women.
- Uncontrolled serious infection i.e. not responding to antimicrobial therapy.
- History of any serious medical condition, which in the opinion of the investigator would compromise the safety of the subject.
- History of suspected or active autoimmune disease. Persons with vitiligo or thyroid disease taking thyroid replacement therapy are not excluded.
- History of chronic alcohol abuse (40g / day for at least 6 months) and/or intravenous drug abuse (within the past 6 months).
- History of malignancy, other than squamous cell or basal cell skin cancer, unless there has been surgical excision that is considered to have achieved cure. Subjects with history of skin cancer at the vaccination site are excluded.
- Manifestation of clinically significant and severe haematological, pulmonary, central nervous, cardiovascular or gastrointestinal disorder.
- Clinically significant mental disorder not adequately controlled by medical treatment.
- Any condition which might interfere with study objectives or would limit the subject's ability to complete the study or to be compliant in the opinion of the investigator.
- History of coronary heart disease, myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, uncontrolled high blood pressure, or any other heart condition under the care of a doctor.
- History of an immediate family member (father, mother, brother, or sister) who died due to ischemic heart disease before age 50 years.
- Ten percent or greater risk of developing a myocardial infarction or coronary death within the next 10 years using the National Cholesterol Education Program's risk assessment tool. (http://hin.nhlbi.nih.gov/atpiii/calculator.asp?usertype=prof) NOTE: This criterion applies only to volunteers 20 years of age and older.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Known allergy to egg or aminoglycoside (gentamicin).
- History of anaphylaxis or severe allergic reaction.
- Having received any vaccinations or planned vaccinations with a live vaccine within 30 days prior or after study vaccination.
- Having received any vaccinations or planned vaccinations with a killed vaccine within14 days prior or after study vaccination.
- Chronic administration (defined as more than 14 days) of systemic immuno-suppressant drugs during a period starting from six months prior to administration of the vaccine and ending at study conclusion. (Corticosteroid nasal sprays are permissible. Persons who have used topical and inhaled steroids can be enrolled after their therapy is completed).
- Post organ transplant subjects whether or not receiving chronic immunosuppressive therapy.
- Any continuous therapy that may influence CD4 counts other than antiretroviral therapy.
- Administration or planned administration of immunoglobulins and/or any blood products during a period starting from 3 months prior to administration of the vaccine and ending at study conclusion.
- Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days or 7 half-lives (whichever is longer) preceding the first dose of the study vaccine, or planned administration of such a drug during the study period.
- Previous participation in another HIV vaccination study.
- Previous participation in any MVA vaccination study during the last 5 years.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00623259
|St. Louis, Missouri, United States, 63110 |
ClinicalTrials.gov processed this record on May 22, 2016
||Monika Fluer, Bavarian Nordic
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 19, 2008
||May 19, 2010
||United States: Food and Drug Administration