HealthyPhase 1NCT01250795
Safety and Immunogenicity Of A Recombinant H5N1 Vaccine In Adults
A Phase 1 study testing HAI-05 Influenza Vaccine and Saline in people with Healthy, run by Fraunhofer, Center for Molecular Biotechnology at 2 sites in United States.
Trial summary
The purpose of this study is to assess the safety, immunogenicity,and tolerability of a H5N1 Vaccine in healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- HAI-05 Influenza Vaccine and Saline
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2010to Jul 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The Center for Pharmaceutical Research
Kansas City, Missouri, 64114
Heartland Research Associates, LLC
Wichita, Kansas, 67207
About this study
Official title: 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.
- Conditions
- Healthy
- Being tested
- HAI-05 Influenza Vaccine, Saline
- Keywords
- Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HAI-05 Influenza VaccineBiological
injection, vaccine, twice every 3 weeks
SalineOther
| Study group | Role | What they receive |
|---|---|---|
| 15 ug HAI-05 plus Alhydrogel | Experimental | vaccine Receives: Biological: HAI-05 Influenza Vaccine |
| 45 ug HAI-05 plus Alhydrogel | Experimental | vaccine Receives: Biological: HAI-05 Influenza Vaccine |
| 90 ug HAI-05 plus Alhydrogel | Experimental | vaccine Receives: Biological: HAI-05 Influenza Vaccine |
| 90 ug HAI-05 in saline | Experimental | vaccine Receives: Biological: HAI-05 Influenza Vaccine |
| Saline | Placebo comparator | placebo Receives: Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety
Measured: 200 days
Secondary outcomes (1)
immunogenicity
Measured: day 43
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2010 (estimated)
- Study startNov 2010
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fraunhofer, Center for Molecular Biotechnology
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01250795
- Sponsor's protocol ID
- FhCMB HAI-05-001
- Status last verified
- May 2016
- First submitted
- 29 Nov 2010
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01250795
- Acronym / sponsor ID
- FhCMB HAI-05-001
- Conditions
- Healthy
- Keywords
- Prevention
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Fraunhofer, Center for Molecular BiotechnologyIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 1 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the safety, immunogenicity,and tolerability of a H5N1 Vaccine in healthy adults.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 15 ug HAI-05 plus Alhydrogel | Experimental | Biological: HAI-05 Influenza Vaccinevaccine |
| 45 ug HAI-05 plus Alhydrogel | Experimental | Biological: HAI-05 Influenza Vaccinevaccine |
| 90 ug HAI-05 plus Alhydrogel | Experimental | Biological: HAI-05 Influenza Vaccinevaccine |
| 90 ug HAI-05 in saline | Experimental | Biological: HAI-05 Influenza Vaccinevaccine |
| Saline | Placebo comparator | Other: Salineplacebo |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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:
- Women of childbearing potential must have a negative urine pregnancy test within 24 hours preceding receipt of each dose
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HAI-05 Influenza Vaccineinjection, vaccine, twice every 3 weeks | Biological | 15 ug HAI-05 plus Alhydrogel, 45 ug HAI-05 plus Alhydrogel, 90 ug HAI-05 in saline, 90 ug HAI-05 plus Alhydrogel |
| Saline | Other | Saline |
Primary outcome
safety
Time frame: 200 days
1 secondary outcome
immunogenicity
Time frame: day 43
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HAI-05 Influenza Vaccine and Saline in people with Healthy, run by Fraunhofer, Center for Molecular Biotechnology at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
safety (time frame: 200 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2016.