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Safety and Efficacy of SA4Ag Vaccine in Adults Having Elective Open Posterior Spinal Fusion Procedures With Multilevel Instrumentation (STRIVE)

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ClinicalTrials.gov Identifier: NCT02388165
Recruitment Status : Terminated (Study terminated by sponsor)
First Posted : March 13, 2015
Results First Posted : September 2, 2020
Last Update Posted : January 5, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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Brief Summary:
The purposes of the clinical trial are to determine whether the SA4Ag vaccine can prevent postoperative Staphylococcus aureus infections in patients who are undergoing elective spinal fusion surgery, and to evaluate the safety of SA4Ag in patients who are undergoing elective spinal surgery.

Condition or disease Intervention/treatment Phase
Staphylococcal Vaccine Biological: Staphylococcus aureus 4-Antigen (SA4Ag) Vaccine Other: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF STAPHYLOCOCCUS AUREUS 4 ANTIGEN VACCINE (SA4AG) IN ADULTS UNDERGOING ELECTIVE OPEN POSTERIOR SPINAL FUSION PROCEDURES WITH MULTILEVEL INSTRUMENTATION
Actual Study Start Date : July 2, 2015
Actual Primary Completion Date : June 26, 2019
Actual Study Completion Date : June 27, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaccines

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: SA4Ag
Staphylococcus aureus 4-antigen Vaccine
 Biological: Staphylococcus aureus 4-Antigen (SA4Ag) Vaccine
SA4Ag vaccine reconstituted in 0.5mL water for injection. Administered via IM injection, once 10 to 60 days prior to surgery
Other Name: Vaccine
Placebo Comparator: Placebo
Diluent (sterile water) for Placebo
 Other: Placebo
Vaccine excipients reconstituted in 0.5mL water for injections. Administered via IM injection given 10 to 60 days prior to surgery


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Postoperative Staphylococcus (S.) Aureus Bloodstream Infection (BSI) And/or Surgical-site Infection (SSI-Including Deep Incisional or Organ/Space) Occurred Within 90 Days After Spinal Surgery [ Time Frame: Day of surgery (Day 1) up to Day 90 ]
    BSI: clinical infection involved a recognized pathogen (S. aureus) cultured from 1 or more blood cultures or a commensal organism cultured from 2 or more blood cultures whether primary or secondary to infection at another site. SSI: infection at a surgical incision. Types of SSI in this outcome measure: Deep incisional SSI: infection involved deep soft tissues of incision (example [e.g.] fascial and muscle layers), Organ/space SSI: infection involved any part of body excluding skin incision, fascia or muscle layers, that was opened or manipulated during operative procedure. Overall number of participants with postoperative BSI and/or SSI (including deep incisional or organ/space), caused by S. aureus, occurred within 90 days of post elective open posterior spinal fusion surgery with multilevel instrumentation, as confirmed by event adjudication committee (EAC) have been reported. A participant may have met criteria for both BSI and SSI (deep incisional or organ/space).

  2. Percentage of Participants With Local Reactions Within 10 Days After Vaccination [ Time Frame: Within 10 days after Vaccination ]
    Local reactions were recorded using an electronic diary (e-diary). Local reactions included redness, swelling and pain at the injection site. Redness and swelling were categorized as mild (2.5 to 5.0 centimeters [cm]), moderate (5.5 to 10.0 cm) and, severe (greater than or equal to [>=] 10.5 cm). Pain at the injection site was defined as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity). Participants may be represented in more than 1 row. Here, "Any" for redness, swelling, pain at the injection site represents any grade of these local reactions among mild, moderate or severe.

  3. Percentage of Participants With Systemic Reactions Within 10 Days After Vaccination [ Time Frame: Within 10 days after Vaccination ]
    Systemic reactions included fever, fatigue, headache, diarrhea, vomiting, muscle pain and joint pain, were recorded using an e-diary. Fever was graded as 38.0 to 38.4 degree Celsius (C), 38.5 to 38.9 degree C, 39.0 to 40.0 degree C and greater than (>) 40.0 degree C. Vomiting was graded as mild (1-2 times in 24 hours), moderate (>2 times in 24 hours) and severe (required intravenous hydration). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours) and severe (>=6 loose stools in 24 hours). Headache, fatigue, muscle pain and joint pain were graded as mild (no interference with activity), moderate (some interference with activity) and severe (prevented daily routine activity). Participants may be represented in more than 1 row. Here "any" for fever, fatigue, headache, vomiting, diarrhea, muscle pain, joint pain represents any grade of these systemic reactions among mild, moderate or severe.

  4. Number of Participants With Adverse Events (AEs) From Vaccination Until The Day of Surgery (Day 1) [ Time Frame: From vaccination up to Day of surgery (Day 1) (10-60 days after vaccination) ]
    An adverse event (AE) was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. AEs including serious as well non-serious AEs.

  5. Number of Participants With Adverse Events (AEs) From Vaccination Until First Postoperative Evaluation on Day 42 [ Time Frame: From vaccination until Day 42 after surgery (52-102 days after vaccination) ]
    An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. AEs including serious as well non-serious AEs.

  6. Number of Participants With Adverse Events (AEs) From The Day of Surgery (Day 1) Until First Postoperative Evaluation on Day 42 [ Time Frame: Day of surgery (Day 1) up to Day 42 after surgery ]
    An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. AEs including serious as well non-serious AEs.

  7. Number of Participants With Newly Diagnosed Chronic Medical Disorders From First Postoperative Evaluation on Day 42 Until Last Postoperative Evaluation on Day 180 [ Time Frame: Day 42 up to Day 180 (up to 138 days) ]
    A newly diagnosed chronic medical disorder was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.

  8. Number of Participants With Serious Adverse Events (SAEs) From Vaccination Until Last Postoperative Evaluation on Day 180 [ Time Frame: From vaccination up to Day 180 after surgery (190-240 days after vaccination) ]
    An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly.

  9. Number of Participants With Serious Adverse Events (SAEs) From Vaccination Until Day of Surgery (Day 1) [ Time Frame: From vaccination up to Day of surgery (Day 1) (10-60 days after vaccination) ]
    An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly.

  10. Number of Participants With Serious Adverse Events (SAEs) From The Day of Surgery (Day 1) Until Last Postoperative Evaluation on Day 180 [ Time Frame: Day of surgery (Day 1) up to Day 180 after surgery ]
    An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly.


Secondary Outcome Measures :
  1. Number of Participants With Postoperative S. Aureus Blood Stream Infection (BSI) And/or Surgical-site Infection (SSI-Including Deep Incisional or Organ/Space) Occurred Within 180 Days After Surgery [ Time Frame: Day of surgery (Day 1) up to Day 180 after surgery ]
    BSI: clinical infection involved a recognized pathogen (S. aureus) cultured from 1 or more blood cultures or a commensal organism cultured from 2 or more blood cultures whether primary or secondary to infection at another site. SSI: infection at a surgical incision. Types of SSI in this outcome measure: Deep incisional SSI: infection involved deep soft tissues of incision (e.g. fascial and muscle layers), Organ/space SSI: infection involved any part of body excluding skin incision, fascia or muscle layers, that was opened or manipulated during operative procedure. Overall number of participants with postoperative BSI and/or SSI (including deep incisional or organ/space), caused by S. aureus, occurred within 180 days of post elective open posterior spinal fusion surgery with multilevel instrumentation, as confirmed by EAC have been reported. A participant may have met criteria for both BSI and SSI (deep incisional or organ/space).

  2. Number of Participants With Any Postoperative S. Aureus Surgical-site Infection (SSI-Superficial, Deep Incisional or Organ/Space) Occurred Within 90 Days After Surgery [ Time Frame: Day of surgery (Day 1) up to Day 90 after surgery ]
    SSI: infection at a surgical incision. Types of SSI in this outcome measure: Superficial SSI: Infection involved only skin and subcutaneous tissue of the incision, Deep incisional SSI: infection involved deep soft tissues of incision (e.g. fascial and muscle layers), Organ/space SSI: infection involved any part of body, excluding skin incision, fascia, or muscle layers, that was opened or manipulated during operative procedure. Overall number of participants with postoperative SSI (including superficial, deep incisional and/or organ/space SSI) caused by S. aureus, occurred within 90 days after elective open posterior spinal fusion surgery with multilevel instrumentation as confirmed by EAC have been reported.

  3. Number of Participants With Any Postoperative S. Aureus Surgical-site Infection (SSI-Superficial, Deep Incisional or Organ/Space) Occurred Within 180 Days After Surgery [ Time Frame: Day of surgery (Day 1) up to Day 180 after surgery ]
    SSI: infection at a surgical incision. Types of SSI in this outcome measure: Superficial SSI: Infection involved only skin and subcutaneous tissue of the incision, Deep incisional SSI: infection involved deep soft tissues of incision (e.g. fascial and muscle layers), Organ/space SSI: infection involved any part of body, excluding skin incision, fascia, or muscle layers, that was opened or manipulated during operative procedure. Overall number of participants with postoperative SSI (including superficial, deep incisional and/or organ/space SSI) caused by S. aureus, occurred within 180 days after elective open posterior spinal fusion surgery with multilevel instrumentation as confirmed by EAC have been reported.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject must be scheduled to undergo an elective open posterior spinal fusion procedures with multilevel instrumentation, 10 to 60 days after study vaccination.
  • Subject must be available for the entire duration of the study, and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures including completion of the electronic diary for 10 days after study vaccination.
  • Aged 18 to <86 years old

Exclusion Criteria:

  • Planned spinal fusion procedure requiring separate operations performed on separate days (ie, staged procedure).
  • Surgical indication of malignancy, infection or acute or emergency trauma.
  • History of major surgery within 3 months prior to enrollment, or anticipated major surgery other than the Index Surgical Procedure between study enrollment and completion of study participation.
  • History of any spinal surgery performed within 6 months prior to study enrollment.
  • History of any previous spinal surgery resulting in postoperative BSI or SSI.
  • Congenital or acquired immunodeficiency disorder, rheumatologic disorder or other illness requiring chronic treatment with known immunosuppressant medications, including monoclonal antibodies within a year of enrollment or the use of systemic corticosteroids for > 14 days within 30 days prior to enrollment.
  • History of leukemia, lymphoma, underlying bone marrow disorder or history of bone marrow transplant.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02388165


Locations
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Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
  Study Documents (Full-Text)

Documents provided by Pfizer:
Study Protocol  [PDF] February 5, 2018
Statistical Analysis Plan  [PDF] August 22, 2019

More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02388165    
Other Study ID Numbers: B3451002
2014-002644-40 ( EudraCT Number )
6123K1-2001 ( Other Identifier: Alias Study Number )
STRIVE ( Other Identifier: Alias Study Number )
First Posted: March 13, 2015    Key Record Dates
Results First Posted: September 2, 2020
Last Update Posted: January 5, 2021
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pfizer:
Staphylococcal Vaccine
Post-operative Surgical Site Infection
Spinal Surgery
MRSA
Staphylococcus aureus
Additional relevant MeSH terms:
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Vaccines
Immunologic Factors
Physiological Effects of Drugs