Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00452088
Status:
UNKNOWN
Last Update Posted:
2008-05-07
First Post:
2007-03-23
Brief Title:
A Phase Ib Trial of MSP 3 LSP in 1-2 Year Old Children in Burkina Faso
Sponsor:
African Malaria Network Trust
Organization:
African Malaria Network Trust
Study Overview
Official Title:
Randomized Controlled Dose Escalation Phase Ib Trial of MSP 3 LSP Adjuvanted in Aluminium Hydroxide Versus Hepatitis Bin 12 to 24 Month Old Children in Burkina Faso
Status:
UNKNOWN
Status Verified Date:
2007-11
Last Known Status:
RECRUITING
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:
MSP3LSP
Brief Summary:
This will be a study of the safety of MSP 3 LSP candidate malaria vaccine in children aged 1-2 years in Burkina Faso Three imminizations at 28 day intervals will be administratered subcuteneously on the shoulder region The study will compare MSP3 with Engerix B vaccine to evaluate whether it is just as safe to give to children in malaria endemic country The study will also evaluate whether the vaccine induces the expected immune responses Two dose levels of MSP 3 will be evaluated 15µg and 30µg to determine the one with the best safety and immune response profile
Detailed Description:
The study is a single centre randomized controlled and blinded study observer blind It will be conducted at the CNRFP Vaccinology unit located in Balonghin Children in the catchments area within the 1-2 years age group whose parents consent will be screened to randomise 45 eligible participants Two MSP 3 dose levels will be evaluated 15µg and 30µg The study will start with immunizing older children with the lowest dose observing safety parameters closely then proceed to to the higher dose with a two week of observation apart
Clinical biological and immune response data gathered after vaccination with 15µg and 30µg MSP 3 LSP will be compared to
The childrens baseline data before vaccinations and
The post vaccination data of children in the control group
Randomization will ensure that the comparison groups are similar in relevant characteristics at baseline The concealment of allocation before enrolment will further enforce the randomisation Individuals who will make the assessment of the study end points will be completely blinded of the vaccine administered This will ensure that there is no observer bias Further reporting or information bias will be minimised because the recipients will also not be aware of which vaccine they have been administered This is possible because the selected control vaccine has not been in routine use in this area and has only now been recommended by the Ministry of Health Cross over immunisation at the end of the trial will involve only those children who will received the study vaccine they will be administered the control vaccine in the interest of public health benefits for them
The schedule of vaccination at 0 1 and 2 months has been adopted because it is suitable for the target group The idea is to eventually deploy the vaccine through the expanded programme on immunisation should the vaccine become registered for public use For the EPI age group it is not only an efficient delivery mechanism but they are also the most vulnerable group to malaria
In brief the groups will be allocated as follows
Group 1 23 participants 15 receiving MSP-3 vaccine 15 µg and 8 receiving Hepatitis B vaccine
Group 2 22 participants 15 receiving MSP-3 vaccine 30 µg and 7 receiving Hepatitis B vaccine
Immunization schedule will be 0 1 and 2 months for all cohorts and provisionally as following for each group
Study days 0 28 and 56 for group 1 and Study days 14 42 70 for group 2 Vaccinations of groups 1 and 2 will be staggered immunization in group 2 will start 2 weeks after group 1 This interval may be extended if deemed necessary due to SAEs or other safety concernsRandomization will be done for each group at the times of first vaccinationsRoute of inoculation will be by subcutaneous injection into right or left deltoid alternately
Each child will be observed for at least 60 minutes after vaccination to evaluate and treat any acute adverse events AEs Study duration will be approximately 13 months per participant There will be a seven 7 day follow-up period for solicited adverse events day of vaccination plus 6 subsequent days and twenty eight 28 day follow-up period for unsolicited adverse events Vaccination day plus 27 subsequent days The follow-up for serious adverse events SAEs will be for 12 months following the first dose of study vaccine 9 months after dose 3
At the end of the follow-up period for unsolicited AEs ie one month after the third dose participants will be followed by field workers at home at monthly intervals to record SAEs For data collection conventional paper Case Report Forms in triplicate copies will be used
An interim analysis is foreseen after day 84 of follow up At this stage decision will be considered whether to proceed to a phase 2b study or not and with which dosage of MSP 3 based on the safety and immunogenicity profile
Clinical biological and immune response data gathered after vaccination with 15µg and 30µg MSP 3 LSP will be compared to
The childrens baseline data before vaccinations and
The post vaccination data of children in the control group
Randomization will ensure that the comparison groups are similar in relevant characteristics at baseline The concealment of allocation before enrolment will further enforce the randomisation Individuals who will make the assessment of the study end points will be completely blinded of the vaccine administered This will ensure that there is no observer bias Further reporting or information bias will be minimised because the recipients will also not be aware of which vaccine they have been administered This is possible because the selected control vaccine has not been in routine use in this area and has only now been recommended by the Ministry of Health Cross over immunisation at the end of the trial will involve only those children who will received the study vaccine they will be administered the control vaccine in the interest of public health benefits for them
The schedule of vaccination at 0 1 and 2 months has been adopted because it is suitable for the target group The idea is to eventually deploy the vaccine through the expanded programme on immunisation should the vaccine become registered for public use For the EPI age group it is not only an efficient delivery mechanism but they are also the most vulnerable group to malaria
In brief the groups will be allocated as follows
Group 1 23 participants 15 receiving MSP-3 vaccine 15 µg and 8 receiving Hepatitis B vaccine
Group 2 22 participants 15 receiving MSP-3 vaccine 30 µg and 7 receiving Hepatitis B vaccine
Immunization schedule will be 0 1 and 2 months for all cohorts and provisionally as following for each group
Study days 0 28 and 56 for group 1 and Study days 14 42 70 for group 2 Vaccinations of groups 1 and 2 will be staggered immunization in group 2 will start 2 weeks after group 1 This interval may be extended if deemed necessary due to SAEs or other safety concernsRandomization will be done for each group at the times of first vaccinationsRoute of inoculation will be by subcutaneous injection into right or left deltoid alternately
Each child will be observed for at least 60 minutes after vaccination to evaluate and treat any acute adverse events AEs Study duration will be approximately 13 months per participant There will be a seven 7 day follow-up period for solicited adverse events day of vaccination plus 6 subsequent days and twenty eight 28 day follow-up period for unsolicited adverse events Vaccination day plus 27 subsequent days The follow-up for serious adverse events SAEs will be for 12 months following the first dose of study vaccine 9 months after dose 3
At the end of the follow-up period for unsolicited AEs ie one month after the third dose participants will be followed by field workers at home at monthly intervals to record SAEs For data collection conventional paper Case Report Forms in triplicate copies will be used
An interim analysis is foreseen after day 84 of follow up At this stage decision will be considered whether to proceed to a phase 2b study or not and with which dosage of MSP 3 based on the safety and immunogenicity profile
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 |
|---|---|---|---|
| MSP3_BF_0302 | None | None | None |