Status:
COMPLETED
Safety and Immunogenicity Of A Recombinant H5N1 Vaccine In Adults
Lead Sponsor:
Fraunhofer, Center for Molecular Biotechnology
Conditions:
Healthy
Eligibility:
All Genders
18-49 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to assess the safety, immunogenicity,and tolerability of a H5N1 Vaccine in healthy adults.
Eligibility Criteria
Inclusion
- Subjects accepted for this study must meet the following inclusion criteria:
- Male or female aged 18 to 49 years inclusive
- Able to give written informed consent to participate
- Healthy as determined by medical history, physical examination, vital signs, and clinical safety laboratory examinations at baseline
- Females should fulfill one of the following criteria:
- At least 1 year post-menopausal
- Surgically sterile
- Will use oral, implantable, transdermal, or injectable contraceptives for 30 days prior to first vaccination and until 28 days after each vaccination
- Willing to abstain from sexual intercourse or use another reliable form of contraception approved by the investigator (e.g., intrauterine device \[IUD\], female condom, diaphragm with spermicide, cervical cap, use of condom by the sexual partner, or a sterile sexual partner) for study duration and until 28 days after vaccination
- Women of childbearing potential must have a negative urine pregnancy test within 24 hours preceding receipt of each dose
- Comprehension of the study requirements, expressed availability for the required study period, and ability to attend scheduled visits and to be contacted by telephone throughout the follow-up period
Exclusion
- Any of the following are cause for exclusion from the study:
- Prior receipt of any influenza vaccine containing H5
- Presence of significant uncontrolled medical or psychiatric illness (acute or chronic); includes institution of new medical or surgical treatment or a significant dose alteration for uncontrolled symptoms or drug toxicity within 3 months of screening and reconfirmed on Day 1 prior to vaccination
- Positive serology for human immunodeficiency virus (HIV 1 or HIV 2), hepatitis B surface antigen (HBsAg). or hepatitis C (HCV)
- Cancer or treatment for cancer within 3 years excluding basal cell carcinoma or squamous cell carcinoma which are allowed
- Presence of any medical condition that may be associated with impaired immune responsiveness, including diabetes mellitus
- Presently receiving (or has a history of receiving) during the preceding 3 month period any medications or other treatments that may adversely affect the immune system, such as allergy injections, immune globulin, interferon, immunomodulators, cytotoxic drugs; other drugs known to be frequently associated with significant major organ toxicity; or systemic (oral or injectable) corticosteroids (inhaled and topical corticosteroids allowed)
- Receipt or planned administration of a nonstudy vaccine within 30 days prior to vaccination and during the study (Immunization on an emergency basis with Tetanus Toxoids Adsorbed for adult use vaccine-tetanus and diphtheria \[Td\] or tetanus, diphtheria, and pertussis \[Tdap\] up to 8 days before or at least 8 days after a dose of study vaccine will be allowed, and administration of study vaccine injection can be delayed if a nonstudy vaccine has been administered and will be given as soon as acceptable \[as described above\] provided the vaccine is not administered within 2 weeks prior to study enrollment.)
- History of significant allergic reactions (anaphylactic-type reactions, respiratory difficulties, or angioedema) to injected vaccines or to any of the study vaccine components
- History of drug or chemical abuse in the year before the study; positive urine drug screen at screening.
- Receipt of any investigational product or nonregistered drug within the 30 days prior to vaccination or currently enrolled in any investigational drug study or intends to enroll in such a study within the ensuing study period
- Receipt of blood or blood products 8 weeks prior to vaccination or planned administration during the study period
- Donation of blood or blood products within 8 weeks prior to vaccination or at any time during the study
- Acute disease within 72 hours prior to vaccination defined as the presence of a moderate or severe illness (as determined by the investigator through medical history and physical examination) with or without fever, or a fever \>38ºC orally (Study vaccine can be administered to persons with a minor illness, such as diarrhea, or mild upper respiratory tract infection with or without low-grade fever, and vaccination can be delayed until the subject has recovered.)
- Any condition that, in the opinion of the investigator, might interfere with the primary study objectives or the subject's safety
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01250795
Start Date
November 1 2010
End Date
July 1 2011
Last Update
May 12 2016
Active Locations (2)
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1
Heartland Research Associates, LLC
Wichita, Kansas, United States, 67207
2
The Center for Pharmaceutical Research
Kansas City, Missouri, United States, 64114