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A Phase IIb, Open-Label, Dose Ranging Study of 13-Valent Pneumococcal Conjugate Vaccine in Adults 55 Through 74 Years of Age Previously Vaccinated With 23-Valent Pneumococcal Polysaccharide Vaccine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT01654263
First received: July 19, 2012
Last updated: February 23, 2017
Last verified: April 15, 2016
July 19, 2012
February 23, 2017
October 10, 2012
August 21, 2015   (Final data collection date for primary outcome measure)
  • Number of Participants Reporting Solicited Local and Systemic Adverse Events [ Time Frame: Days 0 to Day 7 post vaccination ]
    Participants maintained a memory aid to record daily the occurrence of local injection site reactions and systemic reactions for 8 days after vaccination based on their interference with daily activities for subjective symptoms or quantitative measurement of the reaction. All participants reporting events of any severity (mild, moderate, or severe) are counted. For measured reactions, participants are included if the reaction is >0mm.
  • Number of Participants Reporting Unsolicited Vaccine-related Adverse Events. [ Time Frame: Up to Day 28 post vaccination ]
    Association with PCV13 was determined by the investigator and defined as "Related", meaning there was a known temporal relationship, or the event was known to occur in association with study product or with a product in a similar class of study products and no alternate etiology was identified.
  • Number of Participants Reporting Vaccine-related Serious Adverse Events. [ Time Frame: Up to Day 180 post vaccination ]
    Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required inpatient hospitalization or prolongation thereof; was a congenital anomaly/birth defect; or may have jeopardized the participant, or required intervention to prevent one of the outcomes. Association with PCV13 was determined by the investigator and defined as "Related", meaning there was a known temporal relationship, or the event was known to occur in association with study product or with a product in a similar class of study products and no alternate etiology was identified.
  • Geometric Mean Titers of Serotype-specific Opsonophagocytic Antibody (OPA) to 12 Vaccine Serotypes at Days 0 and 28 Post Vaccination. [ Time Frame: Day 0 and Day 28 post vaccination ]
    Blood was collected from all participants at Day 0 and Day 28 after receipt of vaccination. The geometric mean for each group was then assessed by serotype-specific opsonophagocytic antibody (OPA).
  • Safety: Unsolicited vaccine related adverse events with onset on days 0 through 28 post vaccination. [ Time Frame: Up to Day 28 post vaccination ]
  • Safety: Vaccine related serious adverse events with onset on days 0 through 180 post vaccination. [ Time Frame: Up to Day 28 post vaccination ]
  • Immunogenicity: serotype-specific opsonophagocytic antibody (OPA) titer for each of the 13 vaccine serotypes at day 28 post vaccination. [ Time Frame: Day 28 post vaccination ]
  • Immunogenicity: OPA serotype-specific Geometric Mean Titers (GMTs) at Day 28. [ Time Frame: Day 28 ]
  • Safety: Solicited local and systemic adverse events with onset on days 0 through 7 post vaccination. [ Time Frame: Up to Day 7 post vaccination ]
Complete list of historical versions of study NCT01654263 on ClinicalTrials.gov Archive Site
Immunogenicity: Serotype-specific OPA Titer to 12 Vaccine Serotypes at Days 0 and 180 Post Vaccination. [ Time Frame: Day 0 and Day 180 post vaccination ]
Blood was collected from all participants at Days 0 and 180 after receipt of vaccination. The geometric mean for each group was then assessed by serotype-specific opsonophagocytic antibody (OPA).
  • Immunogenicity: serotype-specific OPA titer for each of the 13 vaccine serotypes at day 180 post vaccination. [ Time Frame: Day 180 post vaccination ]
  • Immunogenicity: Serotype specific ELISA concentration to each of the 13 vaccine serotypes at day 28 and day 180 post vaccination. [ Time Frame: Day 28 and Day 180 post vaccination ]
Not Provided
Not Provided
 
A Phase IIb, Open-Label, Dose Ranging Study of 13-Valent Pneumococcal Conjugate Vaccine in Adults 55 Through 74 Years of Age Previously Vaccinated With 23-Valent Pneumococcal Polysaccharide Vaccine
A Phase IIb, Open-Label, Dose-Ranging Study of 13-Valent Pneumococcal Conjugate Vaccine in Adults 55 Through 74 Years of Age Previously Vaccinated With 23-Valent Pneumococcal Polysaccharide Vaccine
The proposed phase IIb randomized, open label, dose ranging, safety and immunogenicity study will evaluate two different doses of 13-valent pneumococcal conjugate vaccine (PCV13) in two groups of participants (55 through 74 years of age). First group vaccine naïve participants will be open-label to receive a single injection of 0.5 mL PCV13. Second group of participant previously vaccinated with 23-valent pneumococcal polysaccharide vaccine (PPSV23) will be randomized 1:1 to receive two injections of 0.5 mL PCV13, one dose in each arm (Group IIA or Group IIB). Blood samples will be obtained at baseline, at one month and six months post-vaccination. The primary objectives are: to determine if two 0.5 mL doses of PCV13 are statistically significantly more immunogenic than a single 0.5 mL dose of PCV13 for at least some of the vaccine serotypes among participants 55 through 74 years of age previously vaccinated with PPSV23, as measured by serotype-specific OPA titers 28 days after study
This is a phase IIb open-label immunogenicity and safety study to evaluate dosages of 0.5 mL and 1.0 mL (given as two 0.5 mL injections in separate arms) of PCV13 in adults 55 through 74 years of age previously vaccinated with PPSV23. The study will enroll two groups of participants. Group I participants will all receive an open-label dose of 0.5 mL PCV13 and will include 294 adults 55-74 years of age who have not previously received 23-valent pneumococcal polysaccharide vaccine (PPSV23). Group II will be randomized 1:1 to receive 0.5 mL PCV13 (Group IIA) or 0.5 mL PCV13 in the right arm and 0.5 mL PCV 13 in the left arm (Group IIB). Group II will include 588 adults 55 through 74 years of age who previously received a single dose of PPSV23 > /=3 years and < /=7 years prior to enrollment. Enrollment in both groups will be stratified by age group (55 through 64 years and 65 through 74 years).The study duration is approximately 18 months. The primary objectives are: to determine if two 0.5 mL doses of PCV13 are statistically significantly more immunogenic than a single 0.5 mL dose of PCV13 for at least some of the vaccine serotypes among participants 55 through 74 years of age previously vaccinated with PPSV23, as measured by serotype-specific OPA titers 28 days after study vaccination, and is non-inferior to 12 vaccine serotypes; and determine if two 0.5 mL doses of PCV13 administered to participants previously vaccinated with PPSV23 are non-inferior to a single dose of 0.5 mL of PCV13 administered to vaccine-naïve adults 55 through 74 years of age for the 12 vaccine serotypes, as measured by serotype-specific OPA titers 28 days after study vaccination. The secondary objectives of this study are to: determine if two x 0.5mL doses of PCV13 is statistically significantly more immunogenic than a single 0.5 mL dose of PCV13 for at least some of the vaccine serotypes among participants 55 through 74 years of age previously vaccinated with PPSV23, as measured by serotype-specific OPA titers 180 days after study vaccination, and is non-inferior to 12 vaccine serotypes; to determine if two x 0.5mL doses of PCV13 administered to participants previously vaccinated with PPSV23 is non-inferior to a single dose of 0.5 mL of PCV13 administered to vaccine-naïve adults 55 through 74 years of age for 12 vaccine serotypes, as measured by serotype-specific OPA titers 180 days after study vaccination. Parent protocol to sub-study 12-0031.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
Pneumococcal Infection
Biological: Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]
Prevnar 13 (PCV13) 13-valent pneumococcal conjugate vaccine. All doses given on Day 0. Group IA and IB (open-label): 0.5 mL intramuscular (IM) injection; Group IIA (open-label, randomized): 0.5 mL IM injection; Group IIB (open-label, randomized): 0.5 mL IM injection in the right arm and 0.5 mL IM in the left arm.
  • Experimental: Group IA: Pneumococcal vaccine-naive, age 55 - 64
    Open- label, 13-valent pneumococcal conjugate vaccine (PCV13) given as 0.5 mL intramuscular (IM) injection to 147 subjects vaccine-naive adults
    Intervention: Biological: Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]
  • Experimental: Group IB: Pneumococcal vaccine-naive, age 65 - 74
    Open- label, PCV13 given as 0.5 mL IM injection to 147 subjects vaccine-naive adults
    Intervention: Biological: Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]
  • Experimental: Group IIA: age 55 - 64, previous PPSV23
    Open-label, randomized PCV13 given as a 0.5 mL IM injection to 147 subjects with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment
    Intervention: Biological: Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]
  • Experimental: Group IIAA: age 55 - 64, previous PPSV23
    Open-label, randomized PCV13 given as a 0.5 mL IM injection in the right arm and 0.5 mL PCV 13 IM in the left arm, to 147 subjects with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment
    Intervention: Biological: Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]
  • Experimental: Group IIB: age 65 - 74, previous PPSV23
    Open-label, randomized PCV13 given as a 0.5 mL IM injection in the right arm and 0.5 mL PCV 13 IM in the left arm, to 147 subjects with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment
    Intervention: Biological: Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]
  • Experimental: Group IIBB: age 65 - 74, previous PPSV23
    Open-label, randomized PCV13 given as a 0.5 mL IM injection to 147 subjects with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment
    Intervention: Biological: Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
884
August 21, 2015
August 21, 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

1. Male or female adults 55 through 74 years of age at the time of enrollment who are able to provide informed consent. 2. For the pneumococcal vaccine-naïve group (Group I), no pneumococcal vaccine received prior to enrollment, as documented by participant report and review of available vaccine records. For the previously vaccinated group (Group II), documented vaccination with exactly one dose of PPSV23 administered >/=3 and </=7 years prior to enrollment and no other lifetime doses of PPSV23. (History of receipt or non-receipt of a pneumococcal vaccine may be presumptively ascertained by participant report but must be confirmed by review of primary source information, including but not limited to medical records, primary care or other provider report, and health department records. Medical records should be reviewed and/or primary care or other providers queried to identify pneumococcal vaccinations administered for a period of not less than 10 years prior to enrollment.) 3. Determined by medical history, targeted physical examination (if indicated), and clinical judgment to be eligible for the study. Subjects with preexisting stable disease, defined as disease not requiring significant change in therapy (A change in dose or therapy within a category (e.g., change from one nonsteroidal anti-inflammatory drug to another) is allowed. A change to a new therapy category (e.g. surgery or addition of a new pharmacological class) is only allowed if it is not caused by worsening disease.) or hospitalization for worsening disease 12 weeks prior to enrollment, are eligible. 4. Agree not to receive a live virus vaccine (for example, zoster vaccine) before the Day 28 (Visit 03) blood specimen collection and not to receive an inactivated vaccine (for example, inactivated influenza vaccine) within 14 days after enrollment. 5. The subject is able to understand and comply with the planned study procedures including being available for all study visits. 6. The subject has provided informed consent prior to any study procedures.

Exclusion Criteria:

1. Receipt of any PCV or investigational pneumococcal vaccine prior to enrollment. 2. Receipt of any inactivated vaccine within 14 days prior to enrollment or receipt of any live vaccine within 30 days prior to enrollment. 3. Receipt of an allergy desensitization injection within 14 days prior to enrollment or planned receipt of an allergy desensitization injection within 7 days following enrollment. 4. Receipt of a diphtheria toxoid containing vaccine (for example, tetanus and diphtheria toxoid [Td] or tetanus and diphtheria toxoid and acellular pertussis [TdaP] vaccine) within six months prior to enrollment. 5. Known or suspected immunodeficiency, receipt of cancer chemotherapy or radiation therapy within the preceding 36 months, or receiving treatment with immunosuppressive therapy, including systemic corticosteroids, e.g., for cancer, HIV or autoimmune disease. If any systemic (oral, parenteral) corticosteroids have been administered for treatment of acute illness within 30 days of vaccination, and any long term use (>2 weeks) in the 30 through 59 days before vaccination should be excluded. (Topical, intranasal, and inhaled corticosteroids are allowed.) 6. Serious chronic disorders including active or metastatic malignancy, hematologic malignancy, severe chronic obstructive pulmonary disease or clinically significant congestive heart failure, requirement for supplemental oxygen, end stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that in the opinion of the investigator precludes the subject's participation. 7. Known HIV, hepatitis B or hepatitis C infection. 8. Residence in a nursing home or other skilled nursing facility or requirement for skilled nursing care. An ambulatory subject who does not require skilled nursing care and is a resident of a retirement home or community is eligible for the trial. 9. Inability to provide informed consent or complete study activities, for example, due to dementia or other impairment. 10. Poor or missing eyesight, requiring third party support to read. 11. Receipt of any blood products, including immunoglobulin, within three months prior to enrollment. 12. Heart rate less than 40 bpm or greater than 120 bpm as measured at the enrollment visit and prior to vaccination. 13. Systolic blood pressure less than 90 mm Hg or greater than 170 mm Hg as measured at the enrollment visit and prior to vaccination. 14. Diastolic blood pressure greater than 110 mm Hg as measured at the enrollment visit and prior to vaccination. 15. For Group I, unable to receive a vaccination in the deltoid muscle of the right arm and unable to receive a vaccination in the deltoid muscle of the left arm because of insufficient muscle mass, need to avoid injections due to prior lymph node dissection or radiation, or other factor. For Group II, unable to receive a vaccination in the deltoid muscle of one or both arms because of insufficient muscle mass, need to avoid injections due to prior lymph node dissection or radiation, or other factor. 16. Currently on anticoagulant therapy (for example, warfarin, heparin [IV or SQ], or dabigatran) or a history of bleeding diathesis that would contraindicate intramuscular injection. (Aspirin, clopidogrel, dipyridamole, and nonsteroidal anti-inflammatory agents are allowed). 17. Known clinically significant allergic reaction to prior pneumococcal vaccination (for Group II participants) or to a component of PCV13 vaccine (PCV13 is latex free). 18. Current known abuse of alcohol or drug addiction that in the opinion of the Investigator may interfere with the subject's ability to comply with trial procedures. 19. Rec eipt of any other investigational vaccine or agent within one month before enrollment or intent to receive any other investigational vaccine or agent prior to the conclusion of the study. 20. Any medical condition that would, in the opinion of the investigator, place the participant at an unacceptable risk of an adverse event or interfere with the evaluation of the study objectives.

Sexes Eligible for Study: All
55 Years to 74 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01654263
11-0034
HHSN272201300018I
Not Provided
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Not Provided
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
Not Provided
Not Provided
National Institute of Allergy and Infectious Diseases (NIAID)
April 15, 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP