Trial Outcomes & Findings for Study Response of 13-valent Conjugate Pneumococcal Vaccine in Patients With End Stage Renal Disease (NCT NCT01974817)

NCT ID: NCT01974817

Last Updated: 2016-11-17

Results Overview

Study the immunologic response after administration of single dose 13-valent conjugate pneumococcal vaccine in patients 50 years or older with end stage renal disease on dialysis.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 25 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2016-11-17

Participant Flow

Participant milestones

Measure	Vaccine Patients will receive one dose of 0.5 ml 13-valent conjugate pneumococcal vaccine (Prevnar-13) intra-muscularly. 13-valent conjugate pneumococcal vaccine: 0.5ml IM for one dose
Overall Study STARTED	25
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Measure	Vaccine Patients will receive one dose of 0.5 ml 13-valent conjugate pneumococcal vaccine (Prevnar-13) intra-muscularly. 13-valent conjugate pneumococcal vaccine: 0.5ml IM for one dose
Overall Study Death	4
Overall Study Lost to Follow-up	2
Overall Study Protocol Violation	2

Baseline Characteristics

Study Response of 13-valent Conjugate Pneumococcal Vaccine in Patients With End Stage Renal Disease

Baseline characteristics by cohort

Measure	Vaccine n=25 Participants Patients will receive one dose of 0.5 ml 13-valent conjugate pneumococcal vaccine (Prevnar-13) intra-muscularly. 13-valent conjugate pneumococcal vaccine: 0.5ml IM for one dose
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=93 Participants
Age, Categorical >=65 years	12 Participants n=93 Participants
Sex: Female, Male Female	13 Participants n=93 Participants
Sex: Female, Male Male	12 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=93 Participants
Race (NIH/OMB) Black or African American	9 Participants n=93 Participants
Race (NIH/OMB) White	14 Participants n=93 Participants
Race (NIH/OMB) More than one race	1 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	25 participants n=93 Participants

PRIMARY outcome

Timeframe: 12 months

Study the immunologic response after administration of single dose 13-valent conjugate pneumococcal vaccine in patients 50 years or older with end stage renal disease on dialysis.

Outcome measures

Measure	Vaccine Arm n=17 Participants A total of 17 patients received 1 dose of 13-valent pneumococcal conjugate vaccine.
Change From Baseline in Antibody Concentrations After 13-valent Conjugate Pneumococcal Vaccination in in Patients 50 Years or Older With End Stage Renal Disease on Dialysis Serotype 1	1.46 µg/ml Interval 0.8 to 2.64
Change From Baseline in Antibody Concentrations After 13-valent Conjugate Pneumococcal Vaccination in in Patients 50 Years or Older With End Stage Renal Disease on Dialysis Serotype 3	0.79 µg/ml Interval 0.43 to 1.46
Change From Baseline in Antibody Concentrations After 13-valent Conjugate Pneumococcal Vaccination in in Patients 50 Years or Older With End Stage Renal Disease on Dialysis Serotype 4	0.57 µg/ml Interval 0.37 to 0.87
Change From Baseline in Antibody Concentrations After 13-valent Conjugate Pneumococcal Vaccination in in Patients 50 Years or Older With End Stage Renal Disease on Dialysis Serotype 5	2.80 µg/ml Interval 1.3 to 6.01
Change From Baseline in Antibody Concentrations After 13-valent Conjugate Pneumococcal Vaccination in in Patients 50 Years or Older With End Stage Renal Disease on Dialysis Serotype 6A	1.93 µg/ml Interval 0.86 to 4.32
Change From Baseline in Antibody Concentrations After 13-valent Conjugate Pneumococcal Vaccination in in Patients 50 Years or Older With End Stage Renal Disease on Dialysis Serotype 14	5.95 µg/ml Interval 3.07 to 11.52
Change From Baseline in Antibody Concentrations After 13-valent Conjugate Pneumococcal Vaccination in in Patients 50 Years or Older With End Stage Renal Disease on Dialysis Serotype 19F	4.56 µg/ml Interval 2.9 to 7.18
Change From Baseline in Antibody Concentrations After 13-valent Conjugate Pneumococcal Vaccination in in Patients 50 Years or Older With End Stage Renal Disease on Dialysis Serotype 23F	2.24 µg/ml Interval 1.11 to 4.52
Change From Baseline in Antibody Concentrations After 13-valent Conjugate Pneumococcal Vaccination in in Patients 50 Years or Older With End Stage Renal Disease on Dialysis Serotype 6B	3.08 µg/ml Interval 1.49 to 6.36
Change From Baseline in Antibody Concentrations After 13-valent Conjugate Pneumococcal Vaccination in in Patients 50 Years or Older With End Stage Renal Disease on Dialysis Serotype 7F	2.48 µg/ml Interval 1.29 to 4.77
Change From Baseline in Antibody Concentrations After 13-valent Conjugate Pneumococcal Vaccination in in Patients 50 Years or Older With End Stage Renal Disease on Dialysis Serotype 18C	4.23 µg/ml Interval 2.48 to 7.19
Change From Baseline in Antibody Concentrations After 13-valent Conjugate Pneumococcal Vaccination in in Patients 50 Years or Older With End Stage Renal Disease on Dialysis Serotype 19A	3.11 µg/ml Interval 1.38 to 6.99
Change From Baseline in Antibody Concentrations After 13-valent Conjugate Pneumococcal Vaccination in in Patients 50 Years or Older With End Stage Renal Disease on Dialysis Serotype 9V	1.36 µg/ml Interval 0.88 to 2.09

Adverse Events

Vaccine Arm

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Vaccine Arm n=25 participants at risk A total of 17 patients received 1 dose of 13-valent pneumococcal conjugate vaccine.
General disorders Pain	8.0% 2/25
General disorders Muscle pain	8.0% 2/25

Additional Information

Dr Subhashis Mitra

Michigan State University

Phone: 517-353-3128

Email: mitrasub@msu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place