InfluenzaPhase 1/2PSC25NCT01612000
Safety and Immunogenicity of PanBlok Influenza Vaccine in Healthy Adults
A Phase 1/2 study testing PanBlok and rHA adjuvant in people with Influenza, run by Protein Sciences Corporation at 5 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 3 dose levels in adjuvanted (SE) rHA formulations and 1 dose levels in an un-adjuvanted rHA formulation. 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?
- PanBlok and rHA adjuvant
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 341 participants
- Where
- 5 sitesUnited States
- Study dates
- May 2012to Dec 2013
- 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
- Young adults aged 18-49 years
- Able to give written informed consent to participate.
- Vital signs within normal limits.
- The subject must be in good health as determined by targeted physical examination, when necessary, based on medical history. Stable medical condition is defined as: no recent change in prescription medication, dose, or frequency of medication in the last 3 months and health outcomes of the specific disease are considered to be within acceptable limits in the last 6 months. Any change that is due to change of health care provider, insurance company, etc., or is done for financial reasons, as long as in the same class of medication, will not be considered a violation of the inclusion criterion. Any change to prescription medication due to improvement of a disease outcome will not be considered a violation of the inclusion criterion.
- Comprehensive Metabolic Panel and other tests for the following must fall within normal limits or not exceed a Grade 1 abnormality at screening. Any Grade 1 abnormality must be clinically acceptable to the investigator in the context of other parameters such the subject's medical history. However, this will not apply to an above the upper limit of the normal range for ALT. Subjects with values above the upper limit of the normal range for ALT at the screening visit will not be enrolled.
- Complete Blood Count with Cell Differential and urinalysis must fall within normal limits at screening except when clinically acceptable to the investigator in the context of other parameters such the subject's medical history.
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- Women of child-bearing potential (WOCBP) must have a negative urine pregnancy test within 24 hours preceding receipt of first and second vaccine doses.
- WOCBP must use medically acceptable contraception.
- Comprehension of the study requirements, expressed availability for the required study period, and ability to attend scheduled visits.
Who cannot join
- Previously received an H5N1 influenza vaccine or who plan to receive an H5N1 influenza vaccine while participating in the study
- An acute or chronic medical condition that, in the opinion of the investigator, would render vaccination unsafe or would interfere with the evaluation of responses
- Medications or treatments that may adversely affect the immune system
- An active neoplastic disease or a history of any hematological malignancy. For this criterion, "active" is defined as having received treatment within the past 5 years.
- A long-term use of supraphysiologic doses of oral or parenteral steroids, or high-dose inhaled steroids within the preceding 6 months.
- A history of documented autoimmune disease.
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- Pregnant, nursing mothers or women planning a pregnancy between enrollment and 42 days after randomization
- Prior serious reaction to any influenza vaccine
- History of Guillain-Barré Syndrome
- History of anaphylactic-type reaction to injected vaccines
- History of illicit drug use or alcohol abuse in the year preceding the study
- Received a seasonal influenza vaccine six months prior to enrollment
- Received any licensed inactivated or recombinant vaccine within 2 weeks prior to enrollment or any licensed live vaccine within 1 month prior to enrollment.
- Acute illness or fever within three days prior to study enrollment
- Participating in a study that involves an experimental agent or have received an experimental agent within 1 month prior to enrollment in this study, or who expect to receive another experimental agent during participation, or intend to donate blood during the 42-day primary study period.
- Received or expect to receive immunoglobulin or another blood product within the 3 months prior to enrollment in this study.
- An elevated liver function enzyme of ALT at baseline, regardless of the appraisal of clinical significance.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Benchmark Reseach
Austin, Texas, 78705
Baylor College of Medicine
Houston, Texas, 77030
Meridian Clinical Research
Omaha, Nebraska, 68134
University of Rochester Center for Vaccine Studies
Rochester, New York, 14627
Jean Brown Research
Salt Lake City, Utah, 84124
About this study
Official title: Phase 2 Observer-Blind, Randomized Trial to Evaluate the Immunogenicity and Safety of PanBlok at Three Dose Levels Adjuvanted With a Stable Oil-in-Water Emulsion Compared With PanBlok Without Adjuvant in Healthy Adults Aged 18 to 49 Years
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 3 dose levels in adjuvanted (SE) rHA formulations and 1 dose levels in an un-adjuvanted rHA formulation.
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
- PanBlok, rHA adjuvant
- 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.
PanBlokBiological
Also called rHA, recombinant hemagglutinin
Intramuscular injection
rHA adjuvantBiological
Also called SE
Intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| PanBlok 15µg in 2% SE | Experimental | 15µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle Receives: Biological: PanBlok; Biological: rHA adjuvant |
| PanBlok 3.8µg in 2% SE | Experimental | 3.8µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle Receives: Biological: PanBlok; Biological: rHA adjuvant |
| PanBlok 7.5µg No Adjuvant | Experimental | 7.5µg recombinant hemagglutinin, no adjuvant. 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle Receives: Biological: PanBlok |
| PanBlok 7.5µg in 2% SE | Experimental | 7.5µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle Receives: Biological: PanBlok; Biological: rHA adjuvant |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Difference in Seroconversion/Immunogenicity Between rHA Formulated in an oil-in- Water Adjuvant (SE) Compared to a rHA Antigen Alone.
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 a non-adjuvanted rHA treatment group for whether they demonstrated seroconversion rates and 95% confidence intervals.
Measured: 42 Days
The Difference in Geometric Mean Titer Between rHA Formulated in an oil-in- Water Adjuvant (SE) Compared to a rHA Antigen Alone.
Measured: 42 Days
Secondary outcomes (2)
Reactogenicity Immediately After Each Injection, Extending to Day 7.
Solicited events of local and systemic reactogenicity Days 0-7. These events are expected to occur and not considered or recorded as Adverse Events.
Measured: 7 Days
Long-term Safety
Incidence of Serious Adverse Events (SAEs), New Onset of Chronic Illnesses (NOCIs) and Adverse Events of Special Interest (AESIs) over 12 months following vaccination. Study subjects were followed every three months (for one year following Day 42) by telephone and visit for reports of SAEs, NOCIs, and AESIs.
Measured: 13 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2012 (estimated)
- Study startMay 2012
- Primary completionAug 2013
- Study completionDec 2013
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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 341 participants (actual)
Sponsor and investigators
- Lead sponsor
- Protein Sciences Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John J Treanor, MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01612000
- Sponsor's protocol ID
- PSC25
- Acronym
- PSC25
- Status last verified
- Oct 2015
- First submitted
- 7 May 2012
- Last updated
- 25 Nov 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Treanor JJ, Chu L, Essink B, Muse D, El Sahly HM, Izikson R, Goldenthal KL, Patriarca P, Dunkle LM. Stable emulsion (SE) alone is an effective adjuvant for a recombinant, baculovirus-expressed H5 influenza vaccine in healthy adults: A Phase 2 trial. Vaccine. 2017 Feb 7;35(6):923-928. doi: 10.1016/j.vaccine.2016.12.053. Epub 2017 Jan 11.
PubMed 28089141
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Observer-Blind, Randomized Trial to Evaluate the Immunogenicity and Safety of PanBlok at Three Dose Levels Adjuvanted With a Stable Oil-in-Water Emulsion Compared With PanBlok Without Adjuvant in Healthy Adults Aged 18 to 49 Years
- ClinicalTrials.gov ID
- NCT01612000
- Acronym / sponsor ID
- PSC25 / PSC25
- Conditions
- Influenza
- Keywords
- Influenza
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 341 participants (actual)
- Lead sponsor
- Protein Sciences CorporationIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 5 Jun 2012 (estimated)
- Results
- Posted 25 Nov 2015
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 3 dose levels in adjuvanted (SE) rHA formulations and 1 dose levels in an un-adjuvanted rHA formulation.
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
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PanBlok 15µg in 2% SE | Experimental | Biological: PanBlok, Biological: rHA adjuvant15µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle |
| PanBlok 3.8µg in 2% SE | Experimental | Biological: PanBlok, Biological: rHA adjuvant3.8µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle |
| PanBlok 7.5µg No Adjuvant | Experimental | Biological: PanBlok7.5µg recombinant hemagglutinin, no adjuvant. 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle |
| PanBlok 7.5µg in 2% SE | Experimental | Biological: PanBlok, Biological: rHA adjuvant7.5µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Young adults aged 18-49 years
- Able to give written informed consent to participate.
- Vital signs within normal limits.
- The subject must be in good health as determined by targeted physical examination, when necessary, based on medical history. Stable medical condition is defined as: no recent change in prescription medication, dose, or frequency of medication in the last 3 months and health outcomes of the specific disease are considered to be within acceptable limits in the last 6 months. Any change that is due to change of health care provider, insurance company, etc., or is done for financial reasons, as long as in the same class of medication, will not be considered a violation of the inclusion criterion. Any change to prescription medication due to improvement of a disease outcome will not be considered a violation of the inclusion criterion.
- Comprehensive Metabolic Panel and other tests for the following must fall within normal limits or not exceed a Grade 1 abnormality at screening. Any Grade 1 abnormality must be clinically acceptable to the investigator in the context of other parameters such the subject's medical history. However, this will not apply to an above the upper limit of the normal range for ALT. Subjects with values above the upper limit of the normal range for ALT at the screening visit will not be enrolled.
Key exclusion criteria (17 listed)
- Previously received an H5N1 influenza vaccine or who plan to receive an H5N1 influenza vaccine while participating in the study
- An acute or chronic medical condition that, in the opinion of the investigator, would render vaccination unsafe or would interfere with the evaluation of responses
- Medications or treatments that may adversely affect the immune system
- An active neoplastic disease or a history of any hematological malignancy. For this criterion, "active" is defined as having received treatment within the past 5 years.
- A long-term use of supraphysiologic doses of oral or parenteral steroids, or high-dose inhaled steroids within the preceding 6 months.
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 |
|---|---|---|
| PanBlokAlso: rHA, recombinant hemagglutininIntramuscular injection | Biological | PanBlok 15µg in 2% SE, PanBlok 3.8µg in 2% SE, PanBlok 7.5µg No Adjuvant, PanBlok 7.5µg in 2% SE |
| rHA adjuvantAlso: SEIntramuscular injection | Biological | PanBlok 15µg in 2% SE, PanBlok 3.8µg in 2% SE, PanBlok 7.5µg in 2% SE |
Primary outcome
The Difference in Seroconversion/Immunogenicity Between rHA Formulated in an oil-in- Water Adjuvant (SE) Compared to a rHA Antigen Alone.
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 a non-adjuvanted rHA treatment group for whether they demonstrated seroconversion rates and 95% confidence intervals.
The Difference in Geometric Mean Titer Between rHA Formulated in an oil-in- Water Adjuvant (SE) Compared to a rHA Antigen Alone.
Time frame: 42 Days
2 secondary outcomes
Reactogenicity Immediately After Each Injection, Extending to Day 7.
Time frame: 7 Days
Long-term Safety
Time frame: 13 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28089141Treanor JJ, Chu L, Essink B, Muse D, El Sahly HM, Izikson R, Goldenthal KL, Patriarca P, Dunkle LM. Stable emulsion (SE) alone is an effective adjuvant for a recombinant, baculovirus-expressed H5 influenza vaccine in healthy adults: A Phase 2 trial. Vaccine. 2017 Feb 7;35(6):923-928. doi: 10.1016/j.vaccine.2016.12.053. Epub 2017 Jan 11.
- sponsorLink 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 J Treanor, MD principal investigator
University of Rochester
5 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 PanBlok and rHA adjuvant in people with Influenza, run by Protein Sciences Corporation at 5 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 9 inclusion and 17 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 25 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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. 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 25 Nov 2015). 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?
The Difference in Seroconversion/Immunogenicity Between rHA Formulated in an oil-in- Water Adjuvant (SE) Compared to a rHA Antigen Alone. (time frame: 42 Days). The study lists 2 primary outcomes in all. 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 NCT01612000, 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 25 Nov 2015.