Trial Outcomes & Findings for A Study to Assess Immune Response in Pediatric Kidney Transplant Recipients Treated With Daclizumab (Zenapax) (NCT NCT02576145)

NCT ID: NCT02576145

Last Updated: 2016-01-13

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

11 participants

Primary outcome timeframe

Baseline and Day 43 or Day 57

Results posted on

2016-01-13

Participant Flow

Participant milestones

Participant milestones
Measure	Group A (With Daclizumab Therapy) Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.	Group B (Post Daclizumab Therapy) Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
Overall Study STARTED	6	5
Overall Study COMPLETED	3	4
Overall Study NOT COMPLETED	3	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Group A (With Daclizumab Therapy) Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.	Group B (Post Daclizumab Therapy) Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
Overall Study Adverse Event	1	0
Overall Study Withdrawal by Subject	1	0
Overall Study Acute rejection	1	0
Overall Study Tetanus Titers Decreased	0	1

Baseline Characteristics

A Study to Assess Immune Response in Pediatric Kidney Transplant Recipients Treated With Daclizumab (Zenapax)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group A (With Daclizumab Therapy) n=6 Participants Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.	Group B (Post Daclizumab Therapy) n=5 Participants Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.	Total n=11 Participants Total of all reporting groups
Age, Continuous	11.8 years STANDARD_DEVIATION 5.78 • n=5 Participants	12.6 years STANDARD_DEVIATION 4.16 • n=7 Participants	12.2 years STANDARD_DEVIATION 4.87 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Day 43 or Day 57

Population: All patient population: All participants who were enrolled in the study and received at least 2 vaccine doses and had Day 43 and 57 assessments were included in this population.

Outcome measures

Outcome measures
Measure	Group A (With Daclizumab Therapy) n=5 Participants Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.	Group B (Post Daclizumab Therapy) n=5 Participants Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
Number of Participants Who Developed a Positive Antibody Response (IgG) to Keyhole Limpet Hemocyanin (KLH) Immunization	2 participants	2 participants

SECONDARY outcome

Timeframe: Baseline, Day 22, Day 29, Day 43, and Day 57

Population: All patient population: All participants who were enrolled in the study and received at least 1 vaccine dose were included in this population.

Positive cellular response was defined as an increase in the 5-bromo-2-deoxyuridine (BrdU) percent total net of at least 1.5-fold compared with baseline, where baseline was assigned a value of 0.5 if \<=0, on at least one time point on Days 22, 29, 43 or 57. All cellular responses were assessed by BrdU proliferation assay.

Outcome measures

Outcome measures
Measure	Group A (With Daclizumab Therapy) n=2 Participants Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.	Group B (Post Daclizumab Therapy) n=5 Participants Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
Number of Participants Who Developed a Positive Cellular Response to KLH Immunization	1 participants	4 participants

SECONDARY outcome

Timeframe: Baseline, Day 22, Day 29, Day 43 and Day 57

Population: All patient population: All participants who were enrolled in the study and received at least 1 vaccine dose were included in this population.

Positive antibody response was defined as at least a 2-fold increase in antibody concentration on either Day 43 or Day 57 compared with baseline where baseline was assigned a value of 1 if it was below the limit of quantification. Positive cellular response was defined as an increase in the 5-bromo-2-deoxyuridine (BrdU) percent total net of at least 1.5-fold compared with baseline, where baseline was assigned a value of 0.5 if \<=0, on at least one time point on Days 22, 29, 43 or 57. All humoral responses were assessed by ELISA and all cellular responses were assessed by BrdU proliferation assay.

Outcome measures

Outcome measures
Measure	Group A (With Daclizumab Therapy) n=2 Participants Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.	Group B (Post Daclizumab Therapy) n=5 Participants Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
Number of Participants Who Developed Both a Positive Antibody Response and a Positive Cellular Response to KLH Immunization	1 participants	1 participants

SECONDARY outcome

Timeframe: Baseline, Day 22, Day 29, Day 43 and Day 57

Population: All patient population: All participants who were enrolled in the study and received at least 1 vaccine dose were included in this population.

Humoral response to TT was defined as \>=1.5 fold increase in antibody concentration from baseline in participants with protective anti-TT IgG level \>=0.1 IU/mL. All humoral responses were assessed by ELISA.

Outcome measures

Outcome measures
Measure	Group A (With Daclizumab Therapy) n=5 Participants Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.	Group B (Post Daclizumab Therapy) n=4 Participants Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
Number of Participants Who Developed a Positive Humoral Response to Tetanus Toxoid (TT)	3 participants	3 participants

SECONDARY outcome

Timeframe: Baseline, Day 22, Day 29, Day 43 and Day 57

Population: All patient population: All participants who were enrolled in the study and received at least 1 vaccine dose were included in this population.

Positive cellular response was defined as an increase in the BrdU percent total net of at least 1.5-fold compared with baseline, where baseline was assigned a value of 0.5 if \<=0, on at least one time point on days 22, 29, 43 or 57. All cellular responses were assessed by BrdU proliferation assay.

Outcome measures

Outcome measures
Measure	Group A (With Daclizumab Therapy) n=3 Participants Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.	Group B (Post Daclizumab Therapy) n=4 Participants Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
Number of Participants Who Developed a Positive Cellular Response to Tetanus Toxoid (TT)	2 participants	3 participants

SECONDARY outcome

Timeframe: Baseline, Day 22, Day 29, Day 43 and Day 57

Population: All patient population: All participants who were enrolled in the study and received at least 1 vaccine dose were included in this population.

Outcome measures

Outcome measures
Measure	Group A (With Daclizumab Therapy) n=1 Participants Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.	Group B (Post Daclizumab Therapy) n=2 Participants Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
Number of Participants Who Developed a Positive Antibody Response to KLH and Positive Cellular Responses to Both KLH and TT Immunizations	0 participants	1 participants

SECONDARY outcome

Timeframe: Up to Day 252

Population: All patient population: All participants who were enrolled in the study and received at least 2 vaccine doses were included in this population. Only participants who were KLH cellular nonresponders were evaluated.

Nonresponders (participants who failed to mount cellular responses to KLH) were rechallenged with KLH 6 months after Day 29 (Day 196). For nonresponders, positive cellular response to KLH was defined as an increase in the 5-bromo-2-deoxyuridine (BrdU) percent total net of at least 1.5-fold compared with baseline, where baseline was assigned a value of 0.5 if \<=0, on at least one time point up to Day 252. All cellular responses were assessed by BrdU proliferation assay.

Outcome measures

Outcome measures
Measure	Group A (With Daclizumab Therapy) n=1 Participants Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.	Group B (Post Daclizumab Therapy) n=1 Participants Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
Number of KLH Cellular Nonresponders Who Were Rechallenged and Mounted a Cellular Response to KLH Immunization	0 participants	0 participants

SECONDARY outcome

Timeframe: up to Day 252

Nonresponders (participants who mount humoral responses but no cellular responses to tetanus vaccination) were rechallenged with TT 6 months after Day 29 (Day 196). For nonresponders, positive cellular response to TT was defined as an increase in the BrdU percent total net of at least 1.5-fold compared with baseline, where baseline was assigned a value of 0.5 if \<=0, at any time point up to Day 252. All cellular responses were assessed by BrdU proliferation assay.

Outcome measures

Outcome measures
Measure	Group A (With Daclizumab Therapy) n=1 Participants Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.	Group B (Post Daclizumab Therapy) n=1 Participants Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
Number of Tetanus Cellular Nonresponders Who Were Rechallenged and Mounted a Cellular Tetanus Response	0 participants	0 participants

SECONDARY outcome

Timeframe: Screening, Day 22, Day 29, Day 43 and Day 57

Due to the small number of participants enrolled in the study, geometric means at Baseline and on Days 22, 29, 43 and 57 were not reported.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Screening, Day 29, Day 57 and Day 168

Population: All patient population: All participants who were enrolled in the study and received at least 1 vaccine dose were included in this population. Only participants with data available at a particular time point were analyzed.

CD25 is an antigen that is present on a subset of peripheral blood lymphocytes. The expression of CD25+ on T cell was investigated using antibody 2A3. Blood samples were drawn for evaluation of CD25+ at screening and on Days 29, 57, and 168.

Outcome measures

Outcome measures
Measure	Group A (With Daclizumab Therapy) n=6 Participants Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.	Group B (Post Daclizumab Therapy) n=5 Participants Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
Mean Percent Expression of 2A3/CD25+ Antibody Screening, n=1, 5	0.10 Percent expression Standard Deviation NA Dispersion is not available as only 1 participant was analysed	9.44 Percent expression Standard Deviation 3.023
Mean Percent Expression of 2A3/CD25+ Antibody Day 29, n=5, 3	0.12 Percent expression Standard Deviation 0.084	8.53 Percent expression Standard Deviation 2.003
Mean Percent Expression of 2A3/CD25+ Antibody Day 57, n=5, 5	0.06 Percent expression Standard Deviation 0.055	10.18 Percent expression Standard Deviation 2.479
Mean Percent Expression of 2A3/CD25+ Antibody Day 168, n=6, 3	8.33 Percent expression Standard Deviation 2.670	12.53 Percent expression Standard Deviation 4.888

SECONDARY outcome

Timeframe: Days 1, 22, 29, 43 and 57

Blood samples were obtained for flow activated cell sorter (FACS) analyses of T cell subsets (CD3, CD4, and CD8) on Days 1, 22, 29, 43, and 57. These cells are present on white blood cells and are used as markers to associate cells with immune functions.

Outcome measures

SECONDARY outcome

Timeframe: Days 1, 29 and 57

Population: All patient population: All participants who were enrolled in the study and received at least 1 vaccine dose were included in this population.Only participants with data available at a particular time point were analyzed.

Blood samples were obtained for flow activated cell sorter (FACS) analyses of HLA-DR+, CD45RO+ and CD45RA+ on Days 1, 29, and 57. These cells are present on white blood cells and are used as markers to associate cells with immune functions.

Outcome measures

Outcome measures
Measure	Group A (With Daclizumab Therapy) n=6 Participants Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.	Group B (Post Daclizumab Therapy) n=5 Participants Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
Mean Percent Expression of HLA-DR+, CD45RO+ and CD45RA+ HLADR+, Day 1, n=6, 2	2.58 Percent expression Standard Deviation 1.098	5.80 Percent expression Standard Deviation 3.394
Mean Percent Expression of HLA-DR+, CD45RO+ and CD45RA+ HLADR +, Day 29, n=5, 2	5.04 Percent expression Standard Deviation 7.720	5.10 Percent expression Standard Deviation 4.101
Mean Percent Expression of HLA-DR+, CD45RO+ and CD45RA+ HLADR +, Day 57, n=5, 2	4.16 Percent expression Standard Deviation 5.126	4.55 Percent expression Standard Deviation 3.182
Mean Percent Expression of HLA-DR+, CD45RO+ and CD45RA+ CD45RO +, Day 1, n=6, 2	22.85 Percent expression Standard Deviation 3.690	39.45 Percent expression Standard Deviation 3.889
Mean Percent Expression of HLA-DR+, CD45RO+ and CD45RA+ CD45RO +, Day 29, n=5, 2	27.04 Percent expression Standard Deviation 4.779	39.45 Percent expression Standard Deviation 8.556
Mean Percent Expression of HLA-DR+, CD45RO+ and CD45RA+ CD45RO +, Day 57, n=5, 2	26.90 Percent expression Standard Deviation 7.027	34.45 Percent expression Standard Deviation 3.323
Mean Percent Expression of HLA-DR+, CD45RO+ and CD45RA+ CD45RA +, Day 1, n=6, 2	69.85 Percent expression Standard Deviation 4.359	50.50 Percent expression Standard Deviation 4.384
Mean Percent Expression of HLA-DR+, CD45RO+ and CD45RA+ CD45RA +, Day 29, n=5, 2	66.86 Percent expression Standard Deviation 5.663	52.70 Percent expression Standard Deviation 10.041
Mean Percent Expression of HLA-DR+, CD45RO+ and CD45RA+ CD45RA +, Day 57, n=5, 2	62.84 Percent expression Standard Deviation 5.999	56.15 Percent expression Standard Deviation 5.869

SECONDARY outcome

Timeframe: Month 6

Positive antibody response was defined as at least a 2-fold increase in antibody concentration on Month 6 compared with baseline where baseline was assigned a value of 1 if it was below the limit of quantification. All humoral responses were assessed by enzyme-linked immunosorbent assay (ELISA). Due to the small number of participants enrolled in the study, percentage of participants with positive antibody response to KLH immunization at Month 6 was not reported.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to Day 252

Nonresponders (participants who failed to mount antibody responses to KLH) were rechallenged with KLH 6 months after Day 29 (Day 196). For nonresponders, positive antibody response to KLH was defined as at least a 2-fold increase in antibody concentration at any time point up to Day 252 compared with baseline where baseline was assigned a value of 1 if it was below the limit of quantification. All humoral responses were assessed by enzyme-linked immunosorbent assay (ELISA).

Outcome measures

Outcome measures
Measure	Group A (With Daclizumab Therapy) n=2 Participants Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.	Group B (Post Daclizumab Therapy) n=1 Participants Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
Number of KLH Antibody Nonresponders Who Underwent Rechallenge and Mounted a KLH Antibody Response	1 participants	1 participants

SECONDARY outcome

Timeframe: Day 1 and Day 29

Population: All patient population: All participants who were enrolled in the study and received at least 1 vaccine dose were included in this population.

DTH skin reactions were assessed 48 hours after each KLH immunization given on Day 1 and on Day 29. A positive response was defined as an induration \>=5 mm.

Outcome measures

Outcome measures
Measure	Group A (With Daclizumab Therapy) n=6 Participants Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.	Group B (Post Daclizumab Therapy) n=5 Participants Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
Number of Participants With a Positive Delayed Type Hypersensitivity (DTH) Response After KLH Immunization	0 participants	1 participants

SECONDARY outcome

Timeframe: Up to Month 12

Population: All patient population: All participants who were enrolled in the study and received at least 1 vaccine dose were included in this population.

An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator's judgment or requires intervention to prevent one or other of these outcomes

Outcome measures

Outcome measures
Measure	Group A (With Daclizumab Therapy) n=6 Participants Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.	Group B (Post Daclizumab Therapy) n=5 Participants Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) Any AE	6 participants	4 participants
Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) Any SAE	3 participants	2 participants

Adverse Events

Group A (With Daclizumab Therapy)

Serious events: 3 serious events

Other events: 6 other events

Deaths: 0 deaths

Group B (Post Daclizumab Therapy)

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Group A (With Daclizumab Therapy) n=6 participants at risk Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.	Group B (Post Daclizumab Therapy) n=5 participants at risk Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
Infections and infestations BK virus infection	16.7% 1/6 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.	0.00% 0/5 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.
Infections and infestations Epstein-Barr virus infection	16.7% 1/6 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.	0.00% 0/5 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.
Infections and infestations Gastroenteritis	0.00% 0/6 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.	20.0% 1/5 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.
Infections and infestations Viral infection	0.00% 0/6 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.	20.0% 1/5 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.
Renal and urinary disorders Haematuria	16.7% 1/6 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.	0.00% 0/5 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.

Other adverse events

Additional Information

Roche Trial Information Hotline

F. Hoffmann-La Roche AG

Phone: +41 61 6878333

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER

Measure	Group A (With Daclizumab Therapy) n=6 Participants Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.	Group B (Post Daclizumab Therapy) n=5 Participants Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
Mean Percent Expression of CD3, CD4, and CD8 CD3+, Day 1, n=6, 2	76.97 Percent expression Standard Deviation 4.069	79.50 Percent expression Standard Deviation 1.414
Mean Percent Expression of CD3, CD4, and CD8 CD3+, Day 22, n=6, 2	78.70 Percent expression Standard Deviation 7.211	77.25 Percent expression Standard Deviation 1.202
Mean Percent Expression of CD3, CD4, and CD8 CD3+, Day 29, n=5, 2	79.82 Percent expression Standard Deviation 9.116	78.80 Percent expression Standard Deviation 1.131
Mean Percent Expression of CD3, CD4, and CD8 CD3+, Day 43, n=5, 2	76.74 Percent expression Standard Deviation 10.126	78.65 Percent expression Standard Deviation 0.778
Mean Percent Expression of CD3, CD4, and CD8 CD3+, Day 57, n=5, 2	77.80 Percent expression Standard Deviation 8.460	79.20 Percent expression Standard Deviation 3.960
Mean Percent Expression of CD3, CD4, and CD8 CD4+, Day 1, n=6, 2	48.87 Percent expression Standard Deviation 7.153	36.90 Percent expression Standard Deviation 7.212
Mean Percent Expression of CD3, CD4, and CD8 CD4+, Day 22, n=6, 2	48.98 Percent expression Standard Deviation 7.743	34.20 Percent expression Standard Deviation 9.051
Mean Percent Expression of CD3, CD4, and CD8 CD4+, Day 29, n=5, 2	51.16 Percent expression Standard Deviation 8.830	34.85 Percent expression Standard Deviation 7.566
Mean Percent Expression of CD3, CD4, and CD8 CD4+, Day 43, n=5, 2	47.08 Percent expression Standard Deviation 8.685	34.75 Percent expression Standard Deviation 6.435
Mean Percent Expression of CD3, CD4, and CD8 CD4+, Day 57, n=5, 2	47.58 Percent expression Standard Deviation 8.404	36.85 Percent expression Standard Deviation 6.718
Mean Percent Expression of CD3, CD4, and CD8 CD8+, Day 1, n=6, 2	24.07 Percent expression Standard Deviation 5.452	37.30 Percent expression Standard Deviation 9.758
Mean Percent Expression of CD3, CD4, and CD8 CD8+, Day 22, n=6, 2	25.15 Percent expression Standard Deviation 6.806	38.25 Percent expression Standard Deviation 11.526
Mean Percent Expression of CD3, CD4, and CD8 CD8+, Day 29, n=5, 2	24.06 Percent expression Standard Deviation 7.790	38.75 Percent expression Standard Deviation 10.394
Mean Percent Expression of CD3, CD4, and CD8 CD8+, Day 43, n=5, 2	24.00 Percent expression Standard Deviation 8.405	39.00 Percent expression Standard Deviation 8.768
Mean Percent Expression of CD3, CD4, and CD8 CD8+, Day 57, n=5, 2	24.86 Percent expression Standard Deviation 7.110	38.55 Percent expression Standard Deviation 11.243

Measure	Group A (With Daclizumab Therapy) n=6 participants at risk Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.	Group B (Post Daclizumab Therapy) n=5 participants at risk Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
Infections and infestations Hordeolum	16.7% 1/6 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.	0.00% 0/5 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.
Infections and infestations Upper respiratory tract Infection	0.00% 0/6 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.	20.0% 1/5 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.
Infections and infestations Bronchitis	16.7% 1/6 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.	0.00% 0/5 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.
Infections and infestations Gastroenteritis	16.7% 1/6 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.	0.00% 0/5 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.
Infections and infestations Pneumonia	0.00% 0/6 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.	20.0% 1/5 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.
Infections and infestations Rhinitis	0.00% 0/6 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.	20.0% 1/5 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.
Infections and infestations Sepsis	16.7% 1/6 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.	0.00% 0/5 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.
Infections and infestations Urinary tract infection	16.7% 1/6 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.	0.00% 0/5 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.
Infections and infestations Nasopharyngitis	16.7% 1/6 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.	0.00% 0/5 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.
Gastrointestinal disorders Vomiting	16.7% 1/6 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.	20.0% 1/5 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.
Gastrointestinal disorders Abdominal pain	0.00% 0/6 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.	20.0% 1/5 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.
Gastrointestinal disorders Diarrhoea	16.7% 1/6 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.	0.00% 0/5 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.
Gastrointestinal disorders Gastrooesophageal reflux disease	16.7% 1/6 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.	0.00% 0/5 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.
Gastrointestinal disorders Ileus	0.00% 0/6 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.	20.0% 1/5 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.
Gastrointestinal disorders Nausea	16.7% 1/6 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.	0.00% 0/5 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.
Respiratory, thoracic and mediastinal disorders Atelectasis	16.7% 1/6 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.	0.00% 0/5 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/6 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.	20.0% 1/5 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/6 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.	20.0% 1/5 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	16.7% 1/6 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.	0.00% 0/5 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.
Respiratory, thoracic and mediastinal disorders Respiratory tract congestion	0.00% 0/6 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.	20.0% 1/5 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/6 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.	20.0% 1/5 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.
Blood and lymphatic system disorders Leukopenia	50.0% 3/6 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.	0.00% 0/5 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.
Blood and lymphatic system disorders Anaemia	0.00% 0/6 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.	20.0% 1/5 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.
Metabolism and nutrition disorders Acidosis	0.00% 0/6 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.	20.0% 1/5 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.
Metabolism and nutrition disorders Anorexia	0.00% 0/6 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.	20.0% 1/5 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/6 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.	20.0% 1/5 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.
Metabolism and nutrition disorders Hypomagnesaemia	16.7% 1/6 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.	0.00% 0/5 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.
Renal and urinary disorders Haematuria	33.3% 2/6 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.	0.00% 0/5 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.
Renal and urinary disorders Dysuria	16.7% 1/6 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.	0.00% 0/5 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.
Investigations Blood creatinine increased	16.7% 1/6 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.	20.0% 1/5 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.
Investigations Urinary sediment present	16.7% 1/6 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.	0.00% 0/5 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.
Nervous system disorders Dizziness	0.00% 0/6 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.	20.0% 1/5 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.
Nervous system disorders Headache	0.00% 0/6 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.	20.0% 1/5 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.
Nervous system disorders Tremor	16.7% 1/6 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.	0.00% 0/5 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.
Vascular disorders Hypertension	0.00% 0/6 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.	20.0% 1/5 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.
Vascular disorders Hypotension	16.7% 1/6 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.	0.00% 0/5 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.
Vascular disorders Orthostatic hypotension	16.7% 1/6 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.	0.00% 0/5 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.
General disorders Injection site induration	0.00% 0/6 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.	20.0% 1/5 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.
General disorders Oedema peripheral	16.7% 1/6 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.	0.00% 0/5 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.
General disorders Pyrexia	0.00% 0/6 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.	20.0% 1/5 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.
Endocrine disorders Hyperparathyroidism	16.7% 1/6 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.	0.00% 0/5 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.
Injury, poisoning and procedural complications Sunburn	16.7% 1/6 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.	0.00% 0/5 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/6 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.	20.0% 1/5 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.
Skin and subcutaneous tissue disorders Acne	0.00% 0/6 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.	20.0% 1/5 • Up to Month 12 SAEs and AEs were collected in members of All Patient Population, comprised of all participants who were enrolled in the study and received at least 1 vaccine dose.