A Phase 1/2 interventional study of Panblok and rHA adjuvant in Influenza, sponsored by Protein Sciences Corporation. Completed at 9 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-10-26.
Sponsored by Protein Sciences Corporation · Phase 1/2, Interventional, and Prevention
The purpose of this study is to investigate the safety and immunogenicity of a recombinant hemagglutinin (rHA) influenza vaccine derived from A/Anhui/1/2013 (H7N9) administered at 3 dose levels in adjuvanted (SE) rHA formulations and 1 dose levels in an unadjuvanted rHA formulation.
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.
2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.
This study's enrollment of 407 is above the median of 238 across 1,853 interventional studies indexed under Influenza, Human.
Browse Influenza, Human studies →Protein Sciences Corporation is the lead sponsor of 12 studies on the registry; none are open to participants now.
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Women are considered not of child-bearing potential if they are:
Exclusion Criteria:
30µg 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
Biological: Panblok · Biological: rHA adjuvant
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
Biological: Panblok · Biological: rHA adjuvant
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
Biological: Panblok · Biological: rHA adjuvant
30µg recombinant hemagglutinin (no adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
Biological: Panblok
Intramuscular injection
Also known as: recombinant hemagglutinin, rHA
Intramuscular injection
Also known as: SE
Demonstrate That the Immunogenicity of Adjuvanted Panblok H7 rHA is Sufficient to Support Emergency Use Authorization in the Event of a Declared Pandemic.
The primary endpoint will be "seroprotection rate" to the selected dose of adjuvanted H7 rHA, defined by a post-vaccination HAI titer ≥40 on Day 42. The definition of success will be a lower bound of the two-sided 95% CI ≥ 70% for adults \<65 and ≥60% for adults ≥65 years of age.
Time frame: 42 Days
Reactogenicity Immediately After Each Injection, Extending to Day 7
Solicited events of local and systemic reactogenicity Days 0-7
Time frame: 7 Days
Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination
Time frame: 13 months
Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine
Unsolicited adverse events (UAEs) Days 0-42.
Time frame: 42 Days
| Milestone | Panblok 30µg in 2% SE | Panblok 15µg in 2% SE | Panblok 7.5µg in 2% SE | Panblok 30µg (No Adjuvant) |
|---|---|---|---|---|
| Started | 102 | 102 | 102 | 101 |
| Completed | 99 | 94 | 97 | 96 |
| Not completed | 3 | 8 | 5 | 5 |
The primary endpoint will be "seroprotection rate" to the selected dose of adjuvanted H7 rHA, defined by a post-vaccination HAI titer ≥40 on Day 42. The definition of success will be a lower bound of the two-sided 95% CI ≥ 70% for adults \<65 and ≥60% for adults ≥65 years of age.
| Participants | Panblok 7.5µg in 2% SE | Panblok 15µg in 2% SE | Panblok 30µg in 2% SE | Panblok 30µg (No Adjuvant) |
|---|---|---|---|---|
| Demonstrate That the Immunogenicity of Adjuvanted Panblok H7 rHA is Sufficient to Support Emergency Use Authorization in the Event of a Declared Pandemic. | 11 | 9 | 15 | 1 |
Solicited events of local and systemic reactogenicity Days 0-7
| Participants | Panblok 7.5µg in 2% SE | Panblok 15µg in 2% SE | Panblok 30µg in 2% SE | Panblok 30µg (No Adjuvant) |
|---|---|---|---|---|
| 7 Days After First Vaccination | 37 | 33 | 33 | 27 |
| 7 Days After Second Vaccination | 30 | 30 | 26 | 18 |
| Participants | Panblok 7.5µg in 2% SE | Panblok 15µg in 2% SE | Panblok 30µg in 2% SE | Panblok 30µg (No Adjuvant) |
|---|---|---|---|---|
| Angina unstable | 0 | 0 | 1 | 0 |
| Myocardial infarction | 0 | 0 | 0 | 1 |
| Sinus bradycardia | 0 | 0 | 1 | 0 |
| Chest pain | 0 | 0 | 1 | 0 |
| Appendicitis | 1 | 0 | 0 | 0 |
| Cellulitis | 0 | 1 | 0 | 0 |
| Rib fracture | 1 | 0 | 0 | 0 |
| Upper limb fracture | 0 | 0 | 0 | 1 |
| Arthralgia | 1 | 0 | 0 | 0 |
| Fracture malunion | 0 | 1 | 0 | 0 |
| Musculoskeletal pain | 1 | 0 | 0 | 0 |
| Osteoarthritis | 2 | 0 | 0 | 0 |
| Osteolysis | 0 | 1 | 0 | 0 |
| Cervicobrachial syndrome | 1 | 0 | 0 | 0 |
| Syncope | 0 | 0 | 1 | 0 |
| VIIth nerve paralysis | 1 | 0 | 0 | 0 |
| Suicide attempt | 0 | 1 | 0 | 0 |
| Peripheral arterial occlusive disease | 0 | 0 | 1 | 0 |
Unsolicited adverse events (UAEs) Days 0-42.
| Participants | Panblok 7.5µg in 2% SE | Panblok 15µg in 2% SE | Panblok 30µg in 2% SE | Panblok 30µg (No Adjuvant) |
|---|---|---|---|---|
| Cardiac disorders | 0 | 0 | 1 | 0 |
| Ear and labyrinth disorders | 1 | 0 | 0 | 0 |
| Endocrine disorders | 0 | 2 | 0 | 0 |
| Eye disorders | 0 | 0 | 1 | 0 |
| Gastrointestinal disorders | 5 | 2 | 2 | 4 |
| General disorders | 4 | 2 | 1 | 2 |
| Immune system disorders | 1 | 0 | 0 | 0 |
| Infections and infestations | 6 | 6 | 4 | 0 |
| Injury, poisoning and procedural complications | 3 | 3 | 2 | 0 |
| Investigations | 0 | 2 | 0 | 0 |
| Metabolism and nutrition disorders | 1 | 1 | 0 | 0 |
| Musculoskeletal and connective tissue disorders | 4 | 2 | 5 | 1 |
| Neoplasms benign, malignant and unspecified | 1 | 2 | 0 | 0 |
| Nervous system disorders | 3 | 2 | 5 | 1 |
| Psychiatric disorders | 0 | 0 | 0 | 1 |
| Reproductive system and breast disorders | 0 | 1 | 0 | 0 |
| Respiratory, thoracic and mediastinal disorders | 6 | 2 | 1 | 1 |
| Skin and subcutaneous tissue disorders | 1 | 0 | 2 | 1 |
| Vascular disorders | 0 | 1 | 0 | 1 |
Collected over Day 0 to Week 55. Non-serious events are listed at a 4% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Panblok 7.5µg in 2% SE | 0/100 (0%) | 4/100 (4%) | 0/100 (0%) |
| Panblok 15µg in 2% SE | 0/101 (0%) | 4/101 (4%) | 0/101 (0%) |
| Panblok 30µg in 2% SE | 0/102 (0%) | 3/102 (2.9%) | 0/102 (0%) |
| Panblok 30µg (No Adjuvant) | 1/97 (1%) | 2/97 (2.1%) | 0/97 (0%) |
| Event | Panblok 7.5µg in 2% SE | Panblok 15µg in 2% SE | Panblok 30µg in 2% SE | Panblok 30µg (No Adjuvant) |
|---|---|---|---|---|
| OsteoarthritisMusculoskeletal and connective tissue disorders | 2/100 | 0/101 | 0/102 | 0/97 |
| Myocardial infarctionCardiac disorders | 0/100 | 0/101 | 0/102 | 1/97 |
| Upper limb fractureInjury, poisoning and procedural complications | 0/100 | 0/101 | 0/102 | 1/97 |
| AppendicitisInfections and infestations | 1/100 | 0/101 | 0/102 | 0/97 |
| Rib fractureInjury, poisoning and procedural complications | 1/100 | 0/101 | 0/102 | 0/97 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 1/100 | 0/101 | 0/102 | 0/97 |
| Musculoskeletal painMusculoskeletal and connective tissue disorders | 1/100 | 0/101 | 0/102 | 0/97 |
| Cervicobrachial syndromeNervous system disorders | 1/100 | 0/101 | 0/102 | 0/97 |
| VIIth nerve paralysisNervous system disorders | 1/100 | 0/101 | 0/102 | 0/97 |
| CellulitisInfections and infestations | 0/100 | 1/101 | 0/102 | 0/97 |
Modified Per Protocol Population
| Age, Customized(Participants) | Panblok 7.5µg in 2% SE | Panblok 15µg in 2% SE | Panblok 30µg in 2% SE | Panblok 30µg (No Adjuvant) | Total |
|---|---|---|---|---|---|
| Age, Categorical — <65 Years | 45 | 45 | 49 | 42 | 181 |
| Age, Categorical — >=65 Years | 50 | 49 | 50 | 52 | 201 |
| Sex: Female, Male(Participants) | Panblok 7.5µg in 2% SE | Panblok 15µg in 2% SE | Panblok 30µg in 2% SE | Panblok 30µg (No Adjuvant) | Total |
|---|---|---|---|---|---|
| Female | 62 | 54 | 56 | 61 | 233 |
| Male | 33 | 40 | 43 | 33 | 149 |
This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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Protein Sciences Corporation