Safety and Immunogenicity of PanBlok Influenza Vaccine in Healthy Adults (PSC25)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Protein Sciences Corporation
ClinicalTrials.gov Identifier:
NCT01612000
First received: May 7, 2012
Last updated: October 26, 2015
Last verified: October 2015
Results First Received: December 19, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Influenza
Interventions: Biological: PanBlok
Biological: rHA adjuvant

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
PanBlok 15µg in 2% SE

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

PanBlok: Intramuscular injection

rHA adjuvant: Intramuscular injection

PanBlok 3.8µg in 2% SE

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

PanBlok: Intramuscular injection

rHA adjuvant: Intramuscular injection

PanBlok 7.5µg No Adjuvant

7.5µg recombinant hemagglutinin, no adjuvant. 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle

PanBlok: Intramuscular injection

PanBlok 7.5µg in 2% SE

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

PanBlok: Intramuscular injection

rHA adjuvant: Intramuscular injection


Participant Flow:   Overall Study
    PanBlok 15µg in 2% SE     PanBlok 3.8µg in 2% SE     PanBlok 7.5µg No Adjuvant     PanBlok 7.5µg in 2% SE  
STARTED     84     86     85     86  
COMPLETED     75     81     78     76  
NOT COMPLETED     9     5     7     10  
Lost to Follow-up                 6                 4                 4                 8  
Physician Decision                 0                 0                 1                 0  
Withdrawal by Subject                 3                 1                 2                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Healthy adults 18-49 years of age with no prior vaccination with H5 pandemic influenza

Reporting Groups
  Description
PanBlok 15µg in 2% SE

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

PanBlok: Intramuscular injection

rHA adjuvant: Intramuscular injection

PanBlok 3.8µg in 2% SE

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

PanBlok: Intramuscular injection

rHA adjuvant: Intramuscular injection

PanBlok 7.5µg No Adjuvant

7.5µg recombinant hemagglutinin, no adjuvant. 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle

PanBlok: Intramuscular injection

PanBlok 7.5µg in 2% SE

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

PanBlok: Intramuscular injection

rHA adjuvant: Intramuscular injection

Total Total of all reporting groups

Baseline Measures
    PanBlok 15µg in 2% SE     PanBlok 3.8µg in 2% SE     PanBlok 7.5µg No Adjuvant     PanBlok 7.5µg in 2% SE     Total  
Number of Participants  
[units: participants]
  84     86     85     86     341  
Age  
[units: years]
Mean (Full Range)
  32  
  (19 to 48)  
  31  
  (18 to 49)  
  32  
  (18 to 49)  
  30  
  (18 to 49)  
  31  
  (18 to 49)  
Gender  
[units: participants]
         
Female     52     58     49     48     207  
Male     32     28     36     38     134  
Race (NIH/OMB)  
[units: participants]
         
American Indian or Alaska Native     0     1     2     1     4  
Asian     2     3     1     2     8  
Native Hawaiian or Other Pacific Islander     2     2     3     0     7  
Black or African American     28     22     21     25     96  
White     52     58     56     58     224  
More than one race     0     0     1     0     1  
Unknown or Not Reported     0     0     1     0     1  
Ethnicity (NIH/OMB)  
[units: participants]
         
Hispanic or Latino     8     10     12     12     42  
Not Hispanic or Latino     76     76     73     74     299  
Unknown or Not Reported     0     0     0     0     0  
Region of Enrollment  
[units: participants]
         
United States     84     86     85     86     341  



  Outcome Measures
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1.  Primary:   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 ]

2.  Primary:   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 ]

3.  Secondary:   Reactogenicity Immediately After Each Injection, Extending to Day 7.   [ Time Frame: 7 Days ]

4.  Secondary:   Long-term Safety   [ Time Frame: 13 Months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Lisa M. Dunkle, M.D., Chief Medical Officer
Organization: Protein Sciences Corproation
phone: 203-599-6064 ext 153
e-mail: ldunkle@proteinsciences.com



Responsible Party: Protein Sciences Corporation
ClinicalTrials.gov Identifier: NCT01612000     History of Changes
Other Study ID Numbers: PSC25
Study First Received: May 7, 2012
Results First Received: December 19, 2014
Last Updated: October 26, 2015
Health Authority: United States: Food and Drug Administration