InfluenzaPhase 1/2NCT01147068
Safety and Immunogenicity of PanBlok Influenza Vaccine in Healthy Adults
A Phase 1/2 study testing 0.5mL Intramuscular Injection in people with Influenza, run by Protein Sciences Corporation at 4 sites in United States.
Trial summary
The purpose of this study is to investigate the safety and immunogenicity of a recombinant hemagglutinin (rHA) influenza vaccine derived from A/Indonesia/05/2005 (H5N1) administered at 4 dose levels in adjuvanted (GLA-SE) rHA formulations and 2 dose levels in unadjuvanted rHA formulations. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- 0.5mL Intramuscular Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 392 participants
- Where
- 4 sitesUnited States
- Study dates
- Jun 2010to Oct 2011
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Male or female aged 18-49 years.
- Give written informed consent to participate.
- Healthy, as determined by medical history, physical examination, vital signs, and clinical safety laboratory evaluation
- Females should fulfill one of the following criteria:
- At least one year post-menopausal;
- Surgically sterile;
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- Will use oral, implantable, transdermal or injectable contraceptives for 30 days prior to first vaccination and until 28 days after the booster vaccination; or
- Willing to 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 30 days prior to first vaccination and until 28 days after the booster vaccination.
- Women of childbearing potential must have a negative urine pregnancy test within 24 hours preceding receipt of first and booster vaccinations
- Comprehension of the study requirements, expressed availability for the required study period, and ability to attend scheduled visits.
Who cannot join
- Persons under 18 years old or 50 years or older
- Persons with chronic illnesses such as cancer, diabetes, liver or kidney disease
- Persons taking medications or treatments that may adversely affect the immune system
- Persons with known allergy to eggs or other vaccine or adjuvant components
- Person currently pregnant, nursing mothers or planning a pregnancy within one month of vaccination
- Persons who have had a prior serious reaction to any influenza vaccine
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- Persons with a known history of Guillain-Barré Syndrome
- Persons with a history of anaphylactic-type reaction to injected vaccines
- Persons with a history of drug or chemical abuse in the year preceding the study
- Persons who previously received an H5N1 influenza vaccine or who plan to receive an H5N1 influenza vaccine while participating in the study
- Persons who received a seasonal influenza vaccine six months prior to enrollment (may delay enrollment)
- Persons who received any other vaccine within one week prior to enrollment (may delay enrollment)
- Persons who have had a respiratory illness or illness with fever within three days of study enrollment (may delay enrollment)
- Persons currently participating in another research study involving any study medications (investigational drugs or vaccines).
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Benchmark Research
Fort Worth, Texas, 76135
Meridian Clinical Research
Omaha, Nebraska, 68134
Vince and Associates Clinical Research
Overland Park, Kansas, 66210
University of Rochester
Rochester, New York, 14642
About this study
Official title: A Two-Part Placebo-Controlled Evaluation of the Safety and Immunogenicity of an A/Indonesia/5/05 Recombinant Hemagglutinin Influenza H5N1 Vaccine With and Without Glucopyranosyl Lipid A (GLA-SE) in Healthy Adults 18-49
The purpose of this study is to investigate the safety and immunogenicity of a recombinant hemagglutinin (rHA) influenza vaccine derived from A/Indonesia/05/2005 (H5N1) administered at 4 dose levels in adjuvanted (GLA-SE) rHA formulations and 2 dose levels in unadjuvanted rHA formulations.
Read the detailed description
All currently licensed influenza vaccines in the United States are produced in embryonated hen's eggs. There are several well-recognized disadvantages to the use of eggs as the substrate for influenza vaccine. Eggs require specialized manufacturing facilities and could be difficult to scale up rapidly in response to an emerging need such as a pandemic. It is usually necessary to adapt candidate vaccine viruses for high-yield growth in eggs, a process that can be time consuming, is not always successful, and can select receptor variants that may have suboptimal immunogenicity. In addition, agricultural diseases that affect chicken flocks, and that might be an important issue in a pandemic due to an avian influenza virus strain, could easily disrupt the supply of eggs for vaccine manufacturing. Therefore, development of alternative substrates for influenza vaccine production has been identified as a high-priority objective.
One potential alternative method for production of influenza vaccine is expression of the influenza virus hemagglutinin (HA) using recombinant DNA techniques. This alternative avoids dependence on eggs and is very efficient because of the high levels of protein expression under the control of the baculovirus polyhedrin promoter.
- Conditions
- Influenza
- Being tested
- 0.5mL Intramuscular Injection
- Keywords
- Influenza
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.5mL Intramuscular InjectionBiological
Also called rHA, recombinant hemagglutinin, PanBlok
0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle
| Study group | Role | What they receive |
|---|---|---|
| PanBlok 135µg No Adjuvant | Experimental | 135µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart Receives: Biological: 0.5mL Intramuscular Injection |
| PanBlok 45µg No Adjuvant | Experimental | 45µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart Receives: Biological: 0.5mL Intramuscular Injection |
| PanBlok 45µg and GLA 1.0µg, SE 2% | Experimental | 45µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart Receives: Biological: 0.5mL Intramuscular Injection |
| PanBlok 15µg and GLA 1.0µg, SE 2% | Experimental | 15µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart Receives: Biological: 0.5mL Intramuscular Injection |
| PanBlok 7.5µg and GLA 1.0µg, SE 2% | Experimental | 7.5µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart Receives: Biological: 0.5mL Intramuscular Injection |
| PanBlok 3.8µg and GLA 1.0µg, SE 2% | Experimental | 3.8µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart Receives: Biological: 0.5mL Intramuscular Injection |
| Placebo | Placebo comparator | 0.9% Sodium Chloride; Two 0.5 mL IM injections 21 days apart Receives: Biological: 0.5mL Intramuscular Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Immunogenicity Measured by Seroconversion Rates of PanBlok With and Without Adjuvant Compared to Placebo in Healthy Adults 18-49 Years of Age.
Immunogenicity was assessed by measuring the percentage of subjects in each group exhibiting seroconversion on Day 42. The treatment groups that received adjuvanted rHA were evaluated against non-adjuvanted rHA and placebo groups for whether they demonstrated seroconversion rates and 95% confidence intervals that met regulatory criterion for licensure.
Measured: 42 Days
Secondary outcomes (2)
Evaluation and Comparison of Immunogenicity From Geometric Mean Titers of PanBlok With and Without Adjuvant and Placebo in Healthy Adults 18-64 Years of Age.
Immunogenicity was assessed by measuring the proportion of subjects that exhibited a geometric mean titer change from Day 0 to Day 42. The geometric mean titers from the PanBlok groups (with and without adjuvant)and placebo group were then compared.
Measured: Day 0, and Day 42
Serologic Response Rates at Day 21 Using PanBlok With and Without Adjuvant and Placebo in Healthy Adults 18-64 Years of Age
Immunogenicity was assessed by measuring the seroconversion rates of subjects from Day 0 to Day 21 to determine and evaluate the immune response following a single dose of study vaccine. The results were compared using PanBlok with and without adjuvant and placebo in healthy adults
Measured: 21 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfluenzaStudies 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 392 participants (actual)
Sponsor and investigators
- Lead sponsor
- Protein Sciences Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Manon M.J. Cox, Protein Sciences Corporation
- Investigators
- John Treanor, MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01147068
- Sponsor's protocol ID
- PSC22 GLA-SE
- Status last verified
- Oct 2012
- First submitted
- 16 Jun 2010
- Last updated
- 26 Nov 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Treanor JJ, Essink B, Hull S, Reed S, Izikson R, Patriarca P, Goldenthal KL, Kohberger R, Dunkle LM. Evaluation of safety and immunogenicity of recombinant influenza hemagglutinin (H5/Indonesia/05/2005) formulated with and without a stable oil-in-water emulsion containing glucopyranosyl-lipid A (SE+GLA) adjuvant. Vaccine. 2013 Nov 19;31(48):5760-5. doi: 10.1016/j.vaccine.2013.08.064. Epub 2013 Sep 27.
PubMed 24075920
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-Part Placebo-Controlled Evaluation of the Safety and Immunogenicity of an A/Indonesia/5/05 Recombinant Hemagglutinin Influenza H5N1 Vaccine With and Without Glucopyranosyl Lipid A (GLA-SE) in Healthy Adults 18-49
- ClinicalTrials.gov ID
- NCT01147068
- Acronym / sponsor ID
- PSC22 GLA-SE
- Conditions
- Influenza
- Keywords
- Influenza
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 392 participants (actual)
- Lead sponsor
- Protein Sciences CorporationIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 22 Jun 2010 (estimated)
- Results
- Posted 26 Nov 2012
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 investigate the safety and immunogenicity of a recombinant hemagglutinin (rHA) influenza vaccine derived from A/Indonesia/05/2005 (H5N1) administered at 4 dose levels in adjuvanted (GLA-SE) rHA formulations and 2 dose levels in unadjuvanted rHA formulations.
Detailed description
All currently licensed influenza vaccines in the United States are produced in embryonated hen's eggs. There are several well-recognized disadvantages to the use of eggs as the substrate for influenza vaccine. Eggs require specialized manufacturing facilities and could be difficult to scale up rapidly in response to an emerging need such as a pandemic. It is usually necessary to adapt candidate vaccine viruses for high-yield growth in eggs, a process that can be time consuming, is not always successful, and can select receptor variants that may have suboptimal immunogenicity. In addition, agricultural diseases that affect chicken flocks, and that might be an important issue in a pandemic due to an avian influenza virus strain, could easily disrupt the supply of eggs for vaccine manufacturing. Therefore, development of alternative substrates for influenza vaccine production has been identified as a high-priority objective.
One potential alternative method for production of influenza vaccine is expression of the influenza virus hemagglutinin (HA) using recombinant DNA techniques. This alternative avoids dependence on eggs and is very efficient because of the high levels of protein expression under the control of the baculovirus polyhedrin promoter.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| PanBlok 135µg No Adjuvant | Experimental | Biological: 0.5mL Intramuscular Injection135µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart |
| PanBlok 45µg No Adjuvant | Experimental | Biological: 0.5mL Intramuscular Injection45µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart |
| PanBlok 45µg and GLA 1.0µg, SE 2% | Experimental | Biological: 0.5mL Intramuscular Injection45µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart |
| PanBlok 15µg and GLA 1.0µg, SE 2% | Experimental | Biological: 0.5mL Intramuscular Injection15µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart |
| PanBlok 7.5µg and GLA 1.0µg, SE 2% | Experimental | Biological: 0.5mL Intramuscular Injection7.5µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart |
| PanBlok 3.8µg and GLA 1.0µg, SE 2% | Experimental | Biological: 0.5mL Intramuscular Injection3.8µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart |
| Placebo | Placebo comparator | Biological: 0.5mL Intramuscular Injection0.9% Sodium Chloride; Two 0.5 mL IM injections 21 days apart |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Male or female aged 18-49 years.
- Give written informed consent to participate.
- Healthy, as determined by medical history, physical examination, vital signs, and clinical safety laboratory evaluation
- 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 first and booster vaccinations
Key exclusion criteria (14 listed)
- Persons under 18 years old or 50 years or older
- Persons with chronic illnesses such as cancer, diabetes, liver or kidney disease
- Persons taking medications or treatments that may adversely affect the immune system
- Persons with known allergy to eggs or other vaccine or adjuvant components
- Person currently pregnant, nursing mothers or planning a pregnancy within one month of vaccination
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 |
|---|---|---|
| 0.5mL Intramuscular InjectionAlso: rHA, recombinant hemagglutinin, PanBlok0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle | Biological | PanBlok 135µg No Adjuvant, PanBlok 15µg and GLA 1.0µg, SE 2%, PanBlok 3.8µg and GLA 1.0µg, SE 2%, PanBlok 45µg No Adjuvant, PanBlok 45µg and GLA 1.0µg, SE 2%, PanBlok 7.5µg and GLA 1.0µg, SE 2%, Placebo |
Primary outcome
Evaluation of Immunogenicity Measured by Seroconversion Rates of PanBlok With and Without Adjuvant Compared to Placebo in Healthy Adults 18-49 Years of Age.
Time frame: 42 Days
Immunogenicity was assessed by measuring the percentage of subjects in each group exhibiting seroconversion on Day 42. The treatment groups that received adjuvanted rHA were evaluated against non-adjuvanted rHA and placebo groups for whether they demonstrated seroconversion rates and 95% confidence intervals that met regulatory criterion for licensure.
2 secondary outcomes
Evaluation and Comparison of Immunogenicity From Geometric Mean Titers of PanBlok With and Without Adjuvant and Placebo in Healthy Adults 18-64 Years of Age.
Time frame: Day 0, and Day 42
Serologic Response Rates at Day 21 Using PanBlok With and Without Adjuvant and Placebo in Healthy Adults 18-64 Years of Age
Time frame: 21 Days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24075920Treanor JJ, Essink B, Hull S, Reed S, Izikson R, Patriarca P, Goldenthal KL, Kohberger R, Dunkle LM. Evaluation of safety and immunogenicity of recombinant influenza hemagglutinin (H5/Indonesia/05/2005) formulated with and without a stable oil-in-water emulsion containing glucopyranosyl-lipid A (SE+GLA) adjuvant. Vaccine. 2013 Nov 19;31(48):5760-5. doi: 10.1016/j.vaccine.2013.08.064. Epub 2013 Sep 27.
- Related InfoLink provided by the sponsor.
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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.
John Treanor, MD principal investigator
University of Rochester
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 0.5mL Intramuscular Injection in people with Influenza, run by Protein Sciences Corporation at 4 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 10 inclusion and 14 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 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Nov 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Evaluation of Immunogenicity Measured by Seroconversion Rates of PanBlok With and Without Adjuvant Compared to Placebo in Healthy Adults 18-49 Years of Age. (time frame: 42 Days). 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 NCT01147068, 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 Nov 2012.