- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01250795
Safety and Immunogenicity Of A Recombinant H5N1 Vaccine In Adults
May 10, 2016 updated by: Fraunhofer, Center for Molecular Biotechnology
A Phase 1a/b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study to Investigate the Safety, Reactogenicity, and Immunogenicity of FhCMB HAI-05, a Recombinant Hemagglutinin (rHA) Vaccine Derived From Influenza A/Indonesia/05/2005 (H5N1), in Healthy Adults 18 to 49 Years
The purpose of this study is to assess the safety, immunogenicity,and tolerability of a H5N1 Vaccine in healthy adults.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Kansas
-
Wichita, Kansas, United States, 67207
- Heartland Research Associates, LLC
-
-
Missouri
-
Kansas City, Missouri, United States, 64114
- The Center for Pharmaceutical Research
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 49 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
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 Criteria:
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Saline
placebo
|
|
Experimental: 15 ug HAI-05 plus Alhydrogel
vaccine
|
injection, vaccine, twice every 3 weeks
|
Experimental: 45 ug HAI-05 plus Alhydrogel
vaccine
|
injection, vaccine, twice every 3 weeks
|
Experimental: 90 ug HAI-05 plus Alhydrogel
vaccine
|
injection, vaccine, twice every 3 weeks
|
Experimental: 90 ug HAI-05 in saline
vaccine
|
injection, vaccine, twice every 3 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
safety
Time Frame: 200 days
|
200 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
immunogenicity
Time Frame: day 43
|
day 43
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2010
Primary Completion (Actual)
July 1, 2011
Study Completion (Actual)
July 1, 2011
Study Registration Dates
First Submitted
November 29, 2010
First Submitted That Met QC Criteria
November 30, 2010
First Posted (Estimate)
December 1, 2010
Study Record Updates
Last Update Posted (Estimate)
May 12, 2016
Last Update Submitted That Met QC Criteria
May 10, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FhCMB HAI-05-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Chalmers University of TechnologyGöteborg UniversityCompletedHealthy | Nutrition, HealthySweden
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
-
King's College LondonUniversity of ReadingCompletedHealthy | Healthy AgingUnited Kingdom
Clinical Trials on Saline
-
Vanderbilt University Medical CenterActive, not recruitingPostural Tachycardia SyndromeUnited States
-
Johns Hopkins UniversityCystic Fibrosis FoundationCompletedCystic Fibrosis
-
University Hospital Inselspital, BerneCompletedCardiovascular Diseases | Valvular Heart DiseaseSwitzerland
-
Imam Abdulrahman Bin Faisal UniversityUnknownOtorhinolaryngologic Diseases | RhinosinusitisSaudi Arabia
-
Aalborg UniversityThe Danish Rheumatism AssociationCompleted
-
Dr. Michael FlavinWithdrawn
-
Szpital im. Św. Jadwigi ŚląskiejRecruiting
-
Makassed General HospitalCompletedLength of Hospital StayLebanon
-
Qassim UniversityCompletedApical Periodontitis | Post Operative Pain | Dental Pulp NecrosesSaudi Arabia
-
University of Washington, the Collaborative Health...Cystic Fibrosis FoundationCompleted