Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00168662
Status:
COMPLETED
Last Update Posted:
2008-02-26
First Post:
2005-09-09
Brief Title:
Non-Specific Effects of Standard Titre Measles Vaccination
Sponsor:
Bandim Health Project
Organization:
Bandim Health Project
Study Overview
Official Title:
Trial of Two-Dose Standard Measles Vaccination Schedule Long-Term Impact on Morbidity and Mortality of a Two-Dose Vaccination Schedule at 6 and 9 Months of Age Compared With a Standard Regimen of One Dose at 9 Months of Age
Status:
COMPLETED
Status Verified Date:
2008-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The general objectives of the proposed research work are
A1 to reduce childhood mortality in developing countries through better control of measles infection by finding the best immunization strategy and A2 to investigate the hypothesis that standard titre measles immunization is associated with non targeted beneficial effects on childhood morbidity and mortality in developing countries
The measurable specific objectives of the present proposal are
B1 to examine whether a two-dose strategy for measles immunization at 6 and 9 months of age can reduce measles incidence by 50 through better coverage or improved seroconversion and B2 to examine whether a two-dose strategy for measles immunization at 6 and 9 months of age can reduce childhood mortality by 20 through better coverage better protection against measles or non targeted beneficial effects and B3 to determine the magnitude and duration of non-measles related changes in morbidity patterns after standard titre measles immunization in particular to test whether measles immunization is associated with a 15 reduction in the risk of diarrhoea and B4 to determine non-measles related immunological changes among recipients of measles vaccine in order to establish possible pathways for the non targeted effects of standard titre measles immunization
A1 to reduce childhood mortality in developing countries through better control of measles infection by finding the best immunization strategy and A2 to investigate the hypothesis that standard titre measles immunization is associated with non targeted beneficial effects on childhood morbidity and mortality in developing countries
The measurable specific objectives of the present proposal are
B1 to examine whether a two-dose strategy for measles immunization at 6 and 9 months of age can reduce measles incidence by 50 through better coverage or improved seroconversion and B2 to examine whether a two-dose strategy for measles immunization at 6 and 9 months of age can reduce childhood mortality by 20 through better coverage better protection against measles or non targeted beneficial effects and B3 to determine the magnitude and duration of non-measles related changes in morbidity patterns after standard titre measles immunization in particular to test whether measles immunization is associated with a 15 reduction in the risk of diarrhoea and B4 to determine non-measles related immunological changes among recipients of measles vaccine in order to establish possible pathways for the non targeted effects of standard titre measles immunization
Detailed Description:
Background Measles is the major killer among vaccine preventable diseases with an estimated one million deathsyear in developing countries Though a good vaccine exists the current immunization strategy of one dose at 9 months is far from optimal too many children get measles before the age of immunization coverage is too low when immunization has to wait until 9 months of age and the protective efficacy is insufficient with the current vaccine given at 9 months of age There is therefore a need for alternative immunization strategies or new vaccines
Evaluations of vaccines have usually been based on a disease specific perspective ie evaluation of specific immunity and protective efficacy against the specific disease its complications and mortality However our research from Guinea-Bissau Senegal and Bangladesh has indicated that measles immunization and measles infection may have non-specific beneficial effects The present protocol is an attempt to assess the magnitude and possible mechanisms of the non targeted beneficial effects of measles immunization and measles infection as well as an attempt to assess some of the practical implications of the hypothesis about non-specific beneficial effects
Approach and methodologies We tested a two dose measles immunization strategy at 6 and 9 months compared with the currently recommended strategy of one dose at 9 months The children were be randomized to receive measles immunization at 6 and 9 months of age or inactivated polio at 6 months and measles at 9 months of age
The non targeted effects of measles immunization on mortality and morbidity are best studied within a randomized trial comparing immunized and unimmunized children In order to study the impact on non-measles related morbidity some children recruited for the immunization trial will be included in weekly morbidity surveillance for diarrhoea respiratory infections and malaria which are the most important disease complexes for childhood mortality in Guinea-Bissau
Possible immunological differences between measles immunized and unimmunized children will be examined through measurements of T-lymphocyte levels neopterin beta2-microglobulin delayed hypersensitivity Multitest allergic reactions skin prick tests antibody responses to other antigens tetanus and thymus growth by sonography Functional differences will be tested by response to a second vaccine antigen HBV at 7½ and 9 months of age when only one group has received measles vaccine
Evaluations of vaccines have usually been based on a disease specific perspective ie evaluation of specific immunity and protective efficacy against the specific disease its complications and mortality However our research from Guinea-Bissau Senegal and Bangladesh has indicated that measles immunization and measles infection may have non-specific beneficial effects The present protocol is an attempt to assess the magnitude and possible mechanisms of the non targeted beneficial effects of measles immunization and measles infection as well as an attempt to assess some of the practical implications of the hypothesis about non-specific beneficial effects
Approach and methodologies We tested a two dose measles immunization strategy at 6 and 9 months compared with the currently recommended strategy of one dose at 9 months The children were be randomized to receive measles immunization at 6 and 9 months of age or inactivated polio at 6 months and measles at 9 months of age
The non targeted effects of measles immunization on mortality and morbidity are best studied within a randomized trial comparing immunized and unimmunized children In order to study the impact on non-measles related morbidity some children recruited for the immunization trial will be included in weekly morbidity surveillance for diarrhoea respiratory infections and malaria which are the most important disease complexes for childhood mortality in Guinea-Bissau
Possible immunological differences between measles immunized and unimmunized children will be examined through measurements of T-lymphocyte levels neopterin beta2-microglobulin delayed hypersensitivity Multitest allergic reactions skin prick tests antibody responses to other antigens tetanus and thymus growth by sonography Functional differences will be tested by response to a second vaccine antigen HBV at 7½ and 9 months of age when only one group has received measles vaccine
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU grant IC18-CT95-0011 | None | None | None |