Primary Objective: *To evaluate the immune responses 1 month after 3 doses of 13vPnC as measured by fold rises of serotype-specific immunoglobulin G (IgG) geometric mean concentrations (GMCs) in subjects *2 years of age. Secondary Objectives: *To…
ID
Source
Brief title
Condition
- Bacterial infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary Objective: *To evaluate the immune responses 1 month after 3 doses of
13vPnC as measured by fold rises of serotype-specific immunoglobulin G (IgG)
geometric mean concentrations (GMCs) in subjects *2 years of age.
Secondary outcome
Secondary Objectives: *To evaluate the immune responses 1 month after 3 doses
of 13vPnC as measured by serotype-specific IgG GMCs in subjects *2 years of
age. *To evaluate the immune responses 1 month after 4 doses of 13vPnC as
measured by serotype-specific IgG GMCs and fold rises of IgG GMCs in subjects
*2 years of age. *To evaluate the immune responses 1 month after 3 doses and 1
month after 4 doses of 13vPnC as measured by IgG GMCs and fold rise IgG GMCs in
the pediatric subgroup (*2 to <18 years) and by serotype-specific IgG GMCs and
fold rise IgG GMCs in the adult subgroup (*18 years). Exploratory Objectives:
*To evaluate the immune responses measured by serotype-specific IgG GMCs and
fold rise IgG GMCs in subjects *2 years of age, in the pediatric subgroup (*2
to <18 years) and in the adult subgroup (*18 years). -1 month after dose 1 and
1 month after dose 2 of 13vPnC. (Fold rise IgG GMCs: 1 month after dose 1 and 1
month after dose 2 relative to before dose 1). -Before and 1 month after dose 4
of 13vPnC. (Fold rise IgG GMCs: 1 month after dose 4 relative to before dose
4). -1 month after dose 4 of 13vPnC compared with 1 month after dose 3 of
13vPnC. (Fold rise IgG GMCs: 1 month after dose 4 relative to 1 month after
dose 3). -1 month after 23vPS for the 12 common serotypes and 6A. (Fold rise
IgG GMCs: 1 month after 23vPS relative to before 23vPS, 1 month after 23vPS
relative to before dose 1 of 13vPnC). *To evaluate the immune response 1 month
after 3 and 1 month after 4 doses of 13vPnC as measured by proportion of
subjects achieving a serotype-specific IgG GMC *0.35 *g/mL in subjects *2 years
of age, in the pediatric subgroup (*2 to <18 years) and in the adult subgroup
(*18 years). Safety Objective: *To evaluate the acceptability of the safety
profile of 13vPnC as measured by the incidence rates of local reactions,
systemic events, and adverse events (AEs).
Background summary
Streptococcus pneumoniae is a significant cause of morbidity after
hematopoietic stem cell transplantation (HSCT), especially after allogeneic
HSCT, and particularly when complicated by graft-versus-host disease (GVHD).
Current guidelines from the United States Centers for Disease Control and
Prevention (CDC) and the Infectious Diseases Working Party of the European
Group for Blood and Marrow Transplantation (EBMT) recommend vaccinating HSCT
recipients with 23-valent pneumococcal polysaccharide vaccine (23vPS) as a
single dose at 12 months (EBMT) or as sequential doses at 12 months and 24
months (CDC) after HSCT, because antibody responses to these vaccines are
impaired after HSCT. Current EBMT recommendations have been further updated to
include 3 doses of 7-valent pneumococcal conjugate vaccine (7vPnC) starting as
early as 3 to 6 months, to protect against pneumococcal disease caused by the
serotypes in 7vPnC during the first year after HSCT. Based on current knowledge
it is anticipated that future recommendations for vaccination against
pneumococcal disease will include 3 doses of 7vPnC, starting as early as 3 to 6
months after HSCT and followed later by a fourth dose of 7vPnC or 1 dose of
23vPS in the second year after HSCT. Three (3) doses of 13vPnC will be
administered at intervals of 1 month, starting at approximately 3 months after
HSCT, followed by a fourth dose of 13vPnC at approximately 6 months after the
third dose. Some patients receive immunoglobulins after HSCT; thus, the
proposed start of vaccination in this study is 3 to 6 months (91 to 203 days)
after HSCT, provided that the immunoglobulin administration has been stopped
for at least 60 days to avoid confounding the immunogenicity results. 23vPS
will be administered approximately 1 month after the fourth dose of 13vPnC
because of the extended serotype coverage of 23vPS.
Study objective
Primary Objective: *To evaluate the immune responses 1 month after 3 doses of
13vPnC as measured by fold rises of serotype-specific immunoglobulin G (IgG)
geometric mean concentrations (GMCs) in subjects *2 years of age.
Secondary Objectives: *To evaluate the immune responses 1 month after 3 doses
of 13vPnC as measured by serotype-specific IgG GMCs in subjects *2 years of
age. *To evaluate the immune responses 1 month after 4 doses of 13vPnC as
measured by serotype-specific IgG GMCs and fold rises of IgG GMCs in subjects
*2 years of age. *To evaluate the immune responses 1 month after 3 doses and 1
month after 4 doses of 13vPnC as measured by IgG GMCs and fold rise IgG GMCs in
the pediatric subgroup (*2 to <18 years) and by serotype-specific IgG GMCs and
fold rise IgG GMCs in the adult subgroup (*18 years). Exploratory Objectives:
*To evaluate the immune responses measured by serotype-specific IgG GMCs and
fold rise IgG GMCs in subjects *2 years of age, in the pediatric subgroup (*2
to <18 years) and in the adult subgroup (*18 years). -1 month after dose 1 and
1 month after dose 2 of 13vPnC. (Fold rise IgG GMCs: 1 month after dose 1 and 1
month after dose 2 relative to before dose 1). -Before and 1 month after dose 4
of 13vPnC. (Fold rise IgG GMCs: 1 month after dose 4 relative to before dose
4). -1 month after dose 4 of 13vPnC compared with 1 month after dose 3 of
13vPnC. (Fold rise IgG GMCs: 1 month after dose 4 relative to 1 month after
dose 3). -1 month after 23vPS for the 12 common serotypes and 6A. (Fold rise
IgG GMCs: 1 month after 23vPS relative to before 23vPS, 1 month after 23vPS
relative to before dose 1 of 13vPnC). *To evaluate the immune response 1 month
after 3 and 1 month after 4 doses of 13vPnC as measured by proportion of
subjects achieving a serotype-specific IgG GMC *0.35 *g/mL in subjects *2 years
of age, in the pediatric subgroup (*2 to <18 years) and in the adult subgroup
(*18 years). Safety Objective: *To evaluate the acceptability of the safety
profile of 13vPnC as measured by the incidence rates of local reactions,
systemic events, and adverse events (AEs).
Study design
A Phase 3, Open-label Trial to Evaluate the Safety, Tolerability, and
Immunogenicity of 13-valent Pneumococcal Conjugate Vaccine Followed by
23-valent Pneumococcal Polysaccharide Vaccine in Recipients of Allogeneic
Hematopoietic Stem Cell Transplant Aged 2 Years and Older .
Intervention
The subjects should/ will come to the hospital 7 times. There are 2 types of
requests, a vaccination visit and an inspection visit. At each visit blood
samples will be taken. About 4 months after the last visit, the study doctor or
nurse will call the subjects to ask how she / he feel. For 14 days after each
13vPnC vaccination the subject will answer some questions in an electronic
diary. The subjects given a digital thermometer and a measurement device to
take home to measure the redness or swelling that may occur at the spot where
the vaccine was 13vPnC was given. Visit 1, 2, 3 and 5 are 13vPnC vaccination
visits. Visit 6 is a 23vPS vaccination visit. Visit 4 and 7 are check up
visits. During this visit the physical examination and vital signs will be
determined.
Study burden and risks
The risk associated with the participation is not different from the standard
therapy.
Rivium Westlaan 142
2909 LD Capelle aan den IJssel
NL
Rivium Westlaan 142
2909 LD Capelle aan den IJssel
NL
Listed location countries
Age
Inclusion criteria
*Male or female subject *2 years of age. *Allogeneic HSCT for hematologic disorder. *Allogeneic HSCT with full myeloablative conditioning or reduced intensity conditioning. *Allogeneic HSCT approximately 3 to 6 months (91 days to 203 days) before enrollment. *Stable engraftment (absolute neutrophil count (ANC) >1000/µl; platelet count >50,000/µl). *Complete hematologic remission of underlying disease. *Subject or parent/legal guardian expected to be available for the entire study and can be contacted by telephone. *Subject or parent/legal guardian must be able to complete an electronic diary (e-diary) and complete all relevant study procedures during study participation. * All female and male subjects who are biologically capable of having children must agree to abstinence or commit to the use of a reliable method of birth control for 3 months after the last vaccination. * Negative urine pregnancy test for all female subjects of child bearing potential.
Exclusion criteria
*Autologous HSCT. *Receipt of donor lymphocyte infusions during the 28 days preceding enrollment. *Uncontrolled GVHD that in the opinion of the investigator would prevent the subject from participating in the study. *Lansky/Karnofsky Score *60%. *Receipt of plasma products or immunoglobulins during the 60 days preceding enrollment. *Receipt of rituximab since HSCT. *Receipt of chemotherapy since HSCT. *Human immunodeficiency virus (HIV) infection. *Lymphoproliferative disorder since HSCT. *Chronic illnesses with cardiac, pulmonary, renal, or liver failure that in the opinion of the investigator would prevent the subject participating in the study. *Vaccination with any licensed or experimental pneumococcal vaccine since HSCT. *Previous anaphylactic reaction to any vaccine or vaccine-related component. *Bleeding diathesis or condition associated with prolonged bleeding time that would in the opinion of the investigator contraindicate intramuscular injection. *Participation in another study with ongoing use of an unlicensed investigational product from 28 days before study enrollment until the end of the study. *Participation in another study with ongoing use of a licensed investigational product that in the opinion of the investigator would interfere with the evaluation of the study objectives. *Permanent residence in a nursing home or other residential care facility. *Pregnant or breastfeeding female subject. *Subject who is a direct relative (child, grandchild, parent, or grandparent) of study personnel, or is a member of the study personnel.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2009-012087-13-NL |
| ClinicalTrials.gov | NCT00980655 |
| CCMO | NL30456.000.09 |