Trial Outcomes & Findings for Prospective Trial of Vaccine Responses in Childhood Cancer Survivors (NCT NCT00505063)
NCT ID: NCT00505063
Last Updated: 2026-07-29
Results Overview
To prospectively determine the response rate and duration of protective titers following revaccination with routine childhood immunizations in pediatric survivors of childhood cancer.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
75 participants
Primary outcome timeframe
Up to 2 years
Results posted on
2026-07-29
Participant Flow
Participant milestones
| Measure |
Cohort A
Immunization Schedule patients \<7 years.
Immunization Schedule patients \<7 years.: • Time 0 months: Prevnar 13 #1, Hib #1
* Time 1 months: Pediarix #1
* Time 2 months: Prevnar 13 #2, Hib #2
* Time 3-4 months: Pediarix #2
* Time 4-6 months: Draw post vaccine titers
* Time 6-12 months: Administer Hepatitis #3 to patients not immunized prior to treatment for cancer, or with negative Hepatitis B titers after two immunizations.
|
Cohort B
Immunization Schedule patients \> or = to 7 years and \<11 years of age
Immunization Schedule patients \> or = to 7 years and \<11 years of age: • Time 0 months: Hib #1, Prevnar 13 #1, Hepatitis B #1
* Time 1 month: Td#1, IPV #1(inactivated polio virus vaccine), Hepatitis B #2
* Time 2-3 months: Prevnar 13 #2, Hib #2
* Time 3-6 months: Td #2, Draw post vaccine titers Time 6-12 months: Administer Hepatitis #3 to patients not immunized prior to treatment for cancer, or with negative Hepatitis B titers after two immunizations.
|
Cohort C
Immunization Schedule patients \> or = to 11 years of age
Immunization Schedule patients \> or = to 11 years of age: • Time 0 month: Hib#1, Prevnar 13#1, Hepatitis B #1
* Time 1 month: Tdap(BOOSTRIX), Hepatitis B #2
* Time 2-3 months: Hib #2, Prevnar 13#2, Menactra
* Time 3-6 months: IPV, Draw post vaccine titers
* Time 6-12 months: Gardasil (dose #2 given 2 months after first dose, and dose #3 given 6 months after first dose)
|
|---|---|---|---|
|
Overall Study
STARTED
|
26
|
13
|
36
|
|
Overall Study
COMPLETED
|
15
|
11
|
31
|
|
Overall Study
NOT COMPLETED
|
11
|
2
|
5
|
Reasons for withdrawal
| Measure |
Cohort A
Immunization Schedule patients \<7 years.
Immunization Schedule patients \<7 years.: • Time 0 months: Prevnar 13 #1, Hib #1
* Time 1 months: Pediarix #1
* Time 2 months: Prevnar 13 #2, Hib #2
* Time 3-4 months: Pediarix #2
* Time 4-6 months: Draw post vaccine titers
* Time 6-12 months: Administer Hepatitis #3 to patients not immunized prior to treatment for cancer, or with negative Hepatitis B titers after two immunizations.
|
Cohort B
Immunization Schedule patients \> or = to 7 years and \<11 years of age
Immunization Schedule patients \> or = to 7 years and \<11 years of age: • Time 0 months: Hib #1, Prevnar 13 #1, Hepatitis B #1
* Time 1 month: Td#1, IPV #1(inactivated polio virus vaccine), Hepatitis B #2
* Time 2-3 months: Prevnar 13 #2, Hib #2
* Time 3-6 months: Td #2, Draw post vaccine titers Time 6-12 months: Administer Hepatitis #3 to patients not immunized prior to treatment for cancer, or with negative Hepatitis B titers after two immunizations.
|
Cohort C
Immunization Schedule patients \> or = to 11 years of age
Immunization Schedule patients \> or = to 11 years of age: • Time 0 month: Hib#1, Prevnar 13#1, Hepatitis B #1
* Time 1 month: Tdap(BOOSTRIX), Hepatitis B #2
* Time 2-3 months: Hib #2, Prevnar 13#2, Menactra
* Time 3-6 months: IPV, Draw post vaccine titers
* Time 6-12 months: Gardasil (dose #2 given 2 months after first dose, and dose #3 given 6 months after first dose)
|
|---|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
1
|
|
Overall Study
Participant relapse prior to initiation of vaccines
|
2
|
0
|
1
|
|
Overall Study
Participant relapse during course of study
|
6
|
1
|
0
|
|
Overall Study
Participant not evaluable pre vaccines
|
0
|
0
|
1
|
Baseline Characteristics
Prospective Trial of Vaccine Responses in Childhood Cancer Survivors
Baseline characteristics by cohort
| Measure |
Cohort A
n=26 Participants
Immunization Schedule patients \<7 years.
Immunization Schedule patients \<7 years.: • Time 0 months: Prevnar 13 #1, Hib #1
* Time 1 months: Pediarix #1
* Time 2 months: Prevnar 13 #2, Hib #2
* Time 3-4 months: Pediarix #2
* Time 4-6 months: Draw post vaccine titers
* Time 6-12 months: Administer Hepatitis #3 to patients not immunized prior to treatment for cancer, or with negative Hepatitis B titers after two immunizations.
|
Cohort B
n=13 Participants
Immunization Schedule patients \> or = to 7 years and \<11 years of age
Immunization Schedule patients \> or = to 7 years and \<11 years of age: • Time 0 months: Hib #1, Prevnar 13 #1, Hepatitis B #1
* Time 1 month: Td#1, IPV #1(inactivated polio virus vaccine), Hepatitis B #2
* Time 2-3 months: Prevnar 13 #2, Hib #2
* Time 3-6 months: Td #2, Draw post vaccine titers Time 6-12 months: Administer Hepatitis #3 to patients not immunized prior to treatment for cancer, or with negative Hepatitis B titers after two immunizations.
|
Cohort C
n=36 Participants
Immunization Schedule patients \> or = to 11 years of age
Immunization Schedule patients \> or = to 11 years of age: • Time 0 month: Hib#1, Prevnar 13#1, Hepatitis B #1
* Time 1 month: Tdap(BOOSTRIX), Hepatitis B #2
* Time 2-3 months: Hib #2, Prevnar 13#2, Menactra
* Time 3-6 months: IPV, Draw post vaccine titers
* Time 6-12 months: Gardasil (dose #2 given 2 months after first dose, and dose #3 given 6 months after first dose)
|
Total
n=75 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
4.4 years
n=9 Participants
|
9.1 years
n=27 Participants
|
15.3 years
n=267 Participants
|
10.5 years
n=265 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=9 Participants
|
7 Participants
n=27 Participants
|
18 Participants
n=267 Participants
|
39 Participants
n=265 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=9 Participants
|
6 Participants
n=27 Participants
|
18 Participants
n=267 Participants
|
36 Participants
n=265 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
4 Participants
n=265 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=9 Participants
|
12 Participants
n=27 Participants
|
28 Participants
n=267 Participants
|
57 Participants
n=265 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
6 Participants
n=267 Participants
|
14 Participants
n=265 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
2 Participants
n=265 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
6 Participants
n=265 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=9 Participants
|
10 Participants
n=27 Participants
|
31 Participants
n=267 Participants
|
63 Participants
n=265 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
4 Participants
n=265 Participants
|
|
Region of Enrollment
United States
|
26 Participants
n=9 Participants
|
13 Participants
n=27 Participants
|
36 Participants
n=267 Participants
|
75 Participants
n=265 Participants
|
PRIMARY outcome
Timeframe: Up to 2 yearsTo prospectively determine the response rate and duration of protective titers following revaccination with routine childhood immunizations in pediatric survivors of childhood cancer.
Outcome measures
| Measure |
Cohort A
n=22 Participants
Immunization Schedule patients \<7 years.
Immunization Schedule patients \<7 years.: • Time 0 months: Prevnar 13 #1, Hib #1
* Time 1 months: Pediarix #1
* Time 2 months: Prevnar 13 #2, Hib #2
* Time 3-4 months: Pediarix #2
* Time 4-6 months: Draw post vaccine titers
* Time 6-12 months: Administer Hepatitis #3 to patients not immunized prior to treatment for cancer, or with negative Hepatitis B titers after two immunizations.
|
Cohort B
n=11 Participants
Immunization Schedule patients \> or = to 7 years and \<11 years of age
Immunization Schedule patients \> or = to 7 years and \<11 years of age: • Time 0 months: Hib #1, Prevnar 13 #1, Hepatitis B #1
* Time 1 month: Td#1, IPV #1(inactivated polio virus vaccine), Hepatitis B #2
* Time 2-3 months: Prevnar 13 #2, Hib #2
* Time 3-6 months: Td #2, Draw post vaccine titers Time 6-12 months: Administer Hepatitis #3 to patients not immunized prior to treatment for cancer, or with negative Hepatitis B titers after two immunizations.
|
Cohort C
n=32 Participants
Immunization Schedule patients \> or = to 11 years of age
Immunization Schedule patients \> or = to 11 years of age: • Time 0 month: Hib#1, Prevnar 13#1, Hepatitis B #1
* Time 1 month: Tdap(BOOSTRIX), Hepatitis B #2
* Time 2-3 months: Hib #2, Prevnar 13#2, Menactra
* Time 3-6 months: IPV, Draw post vaccine titers
* Time 6-12 months: Gardasil (dose #2 given 2 months after first dose, and dose #3 given 6 months after first dose)
|
|---|---|---|---|
|
Percentage of Participants With Protective Antibody Titers After Vaccination
|
93.5 percentage of pts
|
93.5 percentage of pts
|
93.5 percentage of pts
|
SECONDARY outcome
Timeframe: BaselineThe Absolute Lymphocyte Count (ALC), the absolute CD4+ T cell count, and the absolute CD8+ T cell count at baseline were the in-vitro parameters of lymphoid reconstitution.
Outcome measures
| Measure |
Cohort A
n=22 Participants
Immunization Schedule patients \<7 years.
Immunization Schedule patients \<7 years.: • Time 0 months: Prevnar 13 #1, Hib #1
* Time 1 months: Pediarix #1
* Time 2 months: Prevnar 13 #2, Hib #2
* Time 3-4 months: Pediarix #2
* Time 4-6 months: Draw post vaccine titers
* Time 6-12 months: Administer Hepatitis #3 to patients not immunized prior to treatment for cancer, or with negative Hepatitis B titers after two immunizations.
|
Cohort B
n=11 Participants
Immunization Schedule patients \> or = to 7 years and \<11 years of age
Immunization Schedule patients \> or = to 7 years and \<11 years of age: • Time 0 months: Hib #1, Prevnar 13 #1, Hepatitis B #1
* Time 1 month: Td#1, IPV #1(inactivated polio virus vaccine), Hepatitis B #2
* Time 2-3 months: Prevnar 13 #2, Hib #2
* Time 3-6 months: Td #2, Draw post vaccine titers Time 6-12 months: Administer Hepatitis #3 to patients not immunized prior to treatment for cancer, or with negative Hepatitis B titers after two immunizations.
|
Cohort C
n=32 Participants
Immunization Schedule patients \> or = to 11 years of age
Immunization Schedule patients \> or = to 11 years of age: • Time 0 month: Hib#1, Prevnar 13#1, Hepatitis B #1
* Time 1 month: Tdap(BOOSTRIX), Hepatitis B #2
* Time 2-3 months: Hib #2, Prevnar 13#2, Menactra
* Time 3-6 months: IPV, Draw post vaccine titers
* Time 6-12 months: Gardasil (dose #2 given 2 months after first dose, and dose #3 given 6 months after first dose)
|
|---|---|---|---|
|
Median Absolute Lymphocyte Count (ALC), the Absolute CD4+ T Cell Count, and the Absolute CD8+ T Cell Count at Baseline
Absolute CD8+ T cell count
|
479 cells/mcL
Interval 101.0 to 1909.0
|
479 cells/mcL
Interval 101.0 to 1909.0
|
479 cells/mcL
Interval 101.0 to 1909.0
|
|
Median Absolute Lymphocyte Count (ALC), the Absolute CD4+ T Cell Count, and the Absolute CD8+ T Cell Count at Baseline
Absolute Lymphocyte Count (ALC)
|
1500 cells/mcL
Interval 500.0 to 6300.0
|
1500 cells/mcL
Interval 500.0 to 6300.0
|
1500 cells/mcL
Interval 500.0 to 6300.0
|
|
Median Absolute Lymphocyte Count (ALC), the Absolute CD4+ T Cell Count, and the Absolute CD8+ T Cell Count at Baseline
Absolute CD4+ T cell count
|
556 cells/mcL
Interval 201.0 to 2880.0
|
556 cells/mcL
Interval 201.0 to 2880.0
|
556 cells/mcL
Interval 201.0 to 2880.0
|
Adverse Events
Cohort A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort B
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort C
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort A
n=26 participants at risk
Immunization Schedule patients \<7 years.
Immunization Schedule patients \<7 years.: • Time 0 months: Prevnar 13 #1, Hib #1
* Time 1 months: Pediarix #1
* Time 2 months: Prevnar 13 #2, Hib #2
* Time 3-4 months: Pediarix #2
* Time 4-6 months: Draw post vaccine titers
* Time 6-12 months: Administer Hepatitis #3 to patients not immunized prior to treatment for cancer, or with negative Hepatitis B titers after two immunizations.
|
Cohort B
n=13 participants at risk
Immunization Schedule patients \> or = to 7 years and \<11 years of age
Immunization Schedule patients \> or = to 7 years and \<11 years of age: • Time 0 months: Hib #1, Prevnar 13 #1, Hepatitis B #1
* Time 1 month: Td#1, IPV #1(inactivated polio virus vaccine), Hepatitis B #2
* Time 2-3 months: Prevnar 13 #2, Hib #2
* Time 3-6 months: Td #2, Draw post vaccine titers Time 6-12 months: Administer Hepatitis #3 to patients not immunized prior to treatment for cancer, or with negative Hepatitis B titers after two immunizations.
|
Cohort C
n=36 participants at risk
Immunization Schedule patients \> or = to 11 years of age
Immunization Schedule patients \> or = to 11 years of age: • Time 0 month: Hib#1, Prevnar 13#1, Hepatitis B #1
* Time 1 month: Tdap(BOOSTRIX), Hepatitis B #2
* Time 2-3 months: Hib #2, Prevnar 13#2, Menactra
* Time 3-6 months: IPV, Draw post vaccine titers
* Time 6-12 months: Gardasil (dose #2 given 2 months after first dose, and dose #3 given 6 months after first dose)
|
|---|---|---|---|
|
Nervous system disorders
CNS Toxicity
|
0.00%
0/26 • Up to 2 years
|
0.00%
0/13 • Up to 2 years
|
2.8%
1/36 • Up to 2 years
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Nancy Kernan, MD
Memorial Sloan Kettering Cancer Center
Phone: 212-639-7250
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place