H1N1 FluPhase 1NCT01177202
Study of the Safety and Immunogenicity of H1N1 Vaccine
A Phase 1 study testing HAC1 Vaccine in people with H1N1 Flu, run by Fraunhofer, Center for Molecular Biotechnology at 1 site in United States.
Trial summary
The Purpose Of This Study Is To Assess The Safety, Immunogenicity, And Tolerability Of A H1N1 Vaccine In Healthy Adults Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- H1N1 Flu
- What is being tested?
- HAC1 Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Oct 2012
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female aged 18 - 50 years inclusive
- Able to give written informed consent to participate
- Score of at least 80% correct on a 10 question multiple-choice quiz (2 attempts)
- Healthy, as determined by medical history, physical examination, weight, vital signs, and clinical safety laboratory examinations at baseline
- Females must fulfill one of the following criteria: At least one year post-menopausal; Surgically sterile or have a surgically sterile partner; Willing to abstain from sexual intercourse; Willing to use a reliable form of contraception approved by the investigator (e.g., oral, implantable, transdermal or injectable contraceptives, intrauterine device (IUD), female condom, diaphragm with spermicide, cervical cap, or male condoms) for 30 days prior to first vaccination through 3 months after second 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
- Prior receipt of 2010-2011 seasonal influenza vaccine containing A/California/04/09-like virus
- Screening H1N1 titer of > 1:40
- Presence of significant uncontrolled medical or psychiatric illness (acute or chronic) including institution of new medical or surgical treatment or a significant dose alteration for uncontrolled symptoms or drug toxicity within 3 months of screening
- Presence of any medical condition that may be associated with impaired immune responsiveness, including diabetes mellitus
- Cancer, or treatment for cancer, within the previous 3 years, excluding basal cell carcinoma or squamous cell carcinoma
- Presently receiving or history of receiving, during the preceding 3-month period, any medications or other treatments that may adversely affect the immune system: This includes allergy injections, immune globulin, interferon, immunomodulators, cytotoxic drugs or other drugs known to be frequently associated with significant major organ toxicity, or systemic corticosteroids (oral or injectable); Inhaled and topical corticosteroids will be allowed
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- 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
- Receipt or planned administration of a nonstudy vaccine within 30 days prior to vaccination; Immunization on an emergency basis with Tetanus Toxoids Adsorbed for adult use (Td or Tdap) vaccine up to 8 days before or at least 8 days after a dose of study vaccine will be allowed
- History of anaphylactic type reaction to injected vaccines
- 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
- History of drug or chemical abuse in the year before the study
- Positive serology for HIV-1 or HIV-2, or HBsAg or HCV antibodies
- Unwilling to allow storage of specimens for future use
- Acute disease within 72 hours prior to vaccination: Acute disease is 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 (>38ºC />100.4ºF), or an oral temperature of >38ºC orally; Study vaccine can be administered to persons with a minor illness.
- Any condition that, in the opinion of the investigator, might interfere with interpretation of data supporting the primary study objectives
Trial locations and contacts
1 site in 1 country.
United States1 site
Walter Reed Army Institute of Research (WRAIR)
Silver Spring, Maryland, 20910
About this study
Official title: A Phase I Dose-Escalation Study to Investigate the Safety and Immunogenicity of the Fusion Protein Recombinant Influenza A (HAC1) Vaccine Derived From Influenza A/California/04/09 (H1N1) in Healthy Adults
The Purpose Of This Study Is To Assess The Safety, Immunogenicity, And Tolerability Of A H1N1 Vaccine In Healthy Adults
Read the detailed description
This is a single center, placebo-controlled, single blinded dose escalation study to preliminarily assess the safety, reactogenicity, and immunogenicity of different HAC1 vaccine formulations. This study will assess a novel HAC1 vaccine, which is plant derived. This vaccine will be compared to Placebo of normal (0.9%) saline, and reference vaccine consisting of an approved monovalent vaccine containing an A/California (H1N1)-like strain.
Subjects will receive 2 intramuscular injections of the experimental vaccine, placebo, or reference vaccine on Study Days 0 and 21
- Conditions
- H1N1 Flu
- Being tested
- HAC1 Vaccine
- Keywords
- HAC1, H1N1
- Medical subject headings
- Orthomyxoviridae Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HAC1 VaccineBiological
Subjects will come to the Clinical Trials Center up to 7 days prior to each vaccine dose to have blood drawn for research assays. The first dose of vaccine will be given on Day 0 and the second dose will be given 21 days later (± 3 days). Dose escalation will be staggered by at least 7 days as shown in Figure 1. Subjects from Groups G and H will be vaccinated with each of the other 6 groups. Two subjects from group A will be immunized on study day -1. The immunizations will be performed one hour apart with close monitoring. The remaining eight subjects from Group A will be immunized on study day 0. All subsequent immunizations for each group will occur on the same day. The principal investigator and the medical monitor will review all adverse events and make a determination on whether it is safe to proceed to the next higher dosage group. The control and reference vaccine groups can be vaccinated starting anytime after screening.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | HAC1 Dose = 15ug; Alum Dose = 0 Receives: Biological: HAC1 Vaccine |
| Group B | Experimental | HAC1 Dose = 15ug; Alum Dose = 0.75mg Receives: Biological: HAC1 Vaccine |
| Group C | Experimental | HAC1 Dose = 45ug; Alum Dose = 0 Receives: Biological: HAC1 Vaccine |
| Group D | Experimental | HAC1 Dose = 45ug; Alum Dose = 0.75mg Receives: Biological: HAC1 Vaccine |
| Group E | Experimental | HAC1 Dose = 90ug; Alum Dose = 0 Receives: Biological: HAC1 Vaccine |
| Group F | Experimental | HAC1 Dose = 90ug; Alum Dose = 0.75mg Receives: Biological: HAC1 Vaccine |
| Group G | Placebo comparator | Saline Receives: Biological: HAC1 Vaccine |
| Group H | Active comparator | H1N1 Receives: Biological: HAC1 Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety, reactogenicity, and tolerability of the HAC1 vaccine formulations.
The primary objective of this study is to assess the safety, reactogenicity, and tolerability of the HAC1 vaccine formulations delivered intramuscularly at doses of 15 μg, 45 μg or 90 µg (unadjuvanted or adjuvanted) in healthy adults 18 - 50 years of age.
Measured: Six Months
Secondary outcomes (1)
To assess and compare the immunogenicity to 2 injections of the 6 HAC1 vaccine formulations.
The secondary objective is to assess and compare the immunogenicity to 2 injections of the 6 HAC1 vaccine formulations using existing research assays and by measuring hemagglutination inhibition (HAI) titers.
Measured: Six Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2010 (estimated)
- Study startSep 2010
- Primary completionMay 2011
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for H1N1 FluStudies 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
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fraunhofer, Center for Molecular Biotechnology
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Walter Reed Army Institute of Research (WRAIR), Defense Advanced Research Projects Agency
- Responsible party
- Sponsor
- Investigators
- James F Cummings, MD, LTC(P), MC, USA, Principal investigator, Walter Reed Army Institute of Research (WRAIR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01177202
- Sponsor's protocol ID
- WRAIR 1758
- Status last verified
- Jul 2016
- First submitted
- 5 Aug 2010
- Last updated
- 26 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Cummings JF, Guerrero ML, Moon JE, Waterman P, Nielsen RK, Jefferson S, Gross FL, Hancock K, Katz JM, Yusibov V; Fraunhofer USA Center for Molecular Biotechnology Study Group. Safety and immunogenicity of a plant-produced recombinant monomer hemagglutinin-based influenza vaccine derived from influenza A (H1N1)pdm09 virus: a Phase 1 dose-escalation study in healthy adults. Vaccine. 2014 Apr 17;32(19):2251-9. doi: 10.1016/j.vaccine.2013.10.017. Epub 2013 Oct 12.
PubMed 24126211
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Dose-Escalation Study to Investigate the Safety and Immunogenicity of the Fusion Protein Recombinant Influenza A (HAC1) Vaccine Derived From Influenza A/California/04/09 (H1N1) in Healthy Adults
- ClinicalTrials.gov ID
- NCT01177202
- Acronym / sponsor ID
- WRAIR 1758
- Conditions
- H1N1 Flu
- Keywords
- HAC1, H1N1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Fraunhofer, Center for Molecular BiotechnologyIndustry (pharma, biotech, devices)
- Collaborators
- Walter Reed Army Institute of Research (WRAIR), Defense Advanced Research Projects Agency
- Study start
- Sep 2010
- Primary completion
- May 2011 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 6 Aug 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 H1N1 Vaccine In Healthy Adults
Detailed description
This is a single center, placebo-controlled, single blinded dose escalation study to preliminarily assess the safety, reactogenicity, and immunogenicity of different HAC1 vaccine formulations. This study will assess a novel HAC1 vaccine, which is plant derived. This vaccine will be compared to Placebo of normal (0.9%) saline, and reference vaccine consisting of an approved monovalent vaccine containing an A/California (H1N1)-like strain.
Subjects will receive 2 intramuscular injections of the experimental vaccine, placebo, or reference vaccine on Study Days 0 and 21
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Biological: HAC1 VaccineHAC1 Dose = 15ug; Alum Dose = 0 |
| Group B | Experimental | Biological: HAC1 VaccineHAC1 Dose = 15ug; Alum Dose = 0.75mg |
| Group C | Experimental | Biological: HAC1 VaccineHAC1 Dose = 45ug; Alum Dose = 0 |
| Group D | Experimental | Biological: HAC1 VaccineHAC1 Dose = 45ug; Alum Dose = 0.75mg |
| Group E | Experimental | Biological: HAC1 VaccineHAC1 Dose = 90ug; Alum Dose = 0 |
| Group F | Experimental | Biological: HAC1 VaccineHAC1 Dose = 90ug; Alum Dose = 0.75mg |
| Group G | Placebo comparator | Biological: HAC1 VaccineSaline |
| Group H | Active comparator | Biological: HAC1 VaccineH1N1 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male or female aged 18 - 50 years inclusive
- Able to give written informed consent to participate
- Score of at least 80% correct on a 10 question multiple-choice quiz (2 attempts)
- Healthy, as determined by medical history, physical examination, weight, vital signs, and clinical safety laboratory examinations at baseline
- Females must fulfill one of the following criteria: At least one year post-menopausal; Surgically sterile or have a surgically sterile partner; Willing to abstain from sexual intercourse; Willing to use a reliable form of contraception approved by the investigator (e.g., oral, implantable, transdermal or injectable contraceptives, intrauterine device (IUD), female condom, diaphragm with spermicide, cervical cap, or male condoms) for 30 days prior to first vaccination through 3 months after second vaccination
Key exclusion criteria (16 listed)
- Prior receipt of 2010-2011 seasonal influenza vaccine containing A/California/04/09-like virus
- Screening H1N1 titer of > 1:40
- Presence of significant uncontrolled medical or psychiatric illness (acute or chronic) including institution of new medical or surgical treatment or a significant dose alteration for uncontrolled symptoms or drug toxicity within 3 months of screening
- Presence of any medical condition that may be associated with impaired immune responsiveness, including diabetes mellitus
- Cancer, or treatment for cancer, within the previous 3 years, excluding basal cell carcinoma or squamous cell carcinoma
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 |
|---|---|---|
| HAC1 VaccineSubjects will come to the Clinical Trials Center up to 7 days prior to each vaccine dose to have blood drawn for research assays. The first dose of vaccine will be given on Day 0 and the second dose will be given 21 days later (± 3 days). Dose escalation will be staggered by at least 7 days as shown in Figure 1. Subjects from Groups G and H will be vaccinated with each of the other 6 groups. Two subjects from group A will be immunized on study day -1. The immunizations will be performed one hour apart with close monitoring. The remaining eight subjects from Group A will be immunized on study day 0. All subsequent immunizations for each group will occur on the same day. The principal investigator and the medical monitor will review all adverse events and make a determination on whether it is safe to proceed to the next higher dosage group. The control and reference vaccine groups can be vaccinated starting anytime after screening. | Biological | Group A, Group B, Group C, Group D, Group E, Group F, Group G, Group H |
Primary outcome
To assess the safety, reactogenicity, and tolerability of the HAC1 vaccine formulations.
Time frame: Six Months
The primary objective of this study is to assess the safety, reactogenicity, and tolerability of the HAC1 vaccine formulations delivered intramuscularly at doses of 15 μg, 45 μg or 90 µg (unadjuvanted or adjuvanted) in healthy adults 18 - 50 years of age.
1 secondary outcome
To assess and compare the immunogenicity to 2 injections of the 6 HAC1 vaccine formulations.
Time frame: Six Months
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 26 Jul 2016.
- Derived from this study: PubMed 24126211Cummings JF, Guerrero ML, Moon JE, Waterman P, Nielsen RK, Jefferson S, Gross FL, Hancock K, Katz JM, Yusibov V; Fraunhofer USA Center for Molecular Biotechnology Study Group. Safety and immunogenicity of a plant-produced recombinant monomer hemagglutinin-based influenza vaccine derived from influenza A (H1N1)pdm09 virus: a Phase 1 dose-escalation study in healthy adults. Vaccine. 2014 Apr 17;32(19):2251-9. doi: 10.1016/j.vaccine.2013.10.017. Epub 2013 Oct 12.
- 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.
James F Cummings, MD, LTC(P), MC, USA principal investigator
Walter Reed Army Institute of Research (WRAIR)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HAC1 Vaccine in people with H1N1 Flu, run by Fraunhofer, Center for Molecular Biotechnology at 1 site 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 7 inclusion and 16 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 26 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
To assess the safety, reactogenicity, and tolerability of the HAC1 vaccine formulations. (time frame: Six Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01177202, which also lists 1 linked publication.
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 26 Jul 2016.