Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00121771
Status:
COMPLETED
Last Update Posted:
2017-01-12
First Post:
2005-07-18
Brief Title:
Malaria Candidate Vaccines FP9 Circumsporozoite CS and MVA CS in Adult Gambian Men
Sponsor:
London School of Hygiene and Tropical Medicine
Organization:
London School of Hygiene and Tropical Medicine
Study Overview
Official Title:
A Phase 1 Trial of the Malaria Candidate Vaccines FP9 CS and MVA CS in Adult Gambian Men Aged 18 - 45 Years
Status:
COMPLETED
Status Verified Date:
2017-01
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:
Animal and human studies have shown that the prime-boost immunization strategy using malaria antigens expressed in plasmid or viral vectors induces strong cellular immune responses An immunization regimen with the malaria vaccines DNA ME-TRAP followed by MVA ME-TRAP induced strong T cell responses in adults in the United Kingdom UK and in the Gambia but did not provide significant clinical protection against infection The investigators assessed two new vaccines which utilize a similar immunization strategy but a different malaria antigen a circumsporozoite CS protein The entire CS protein was expressed either in a modified vaccinia virus Ankara MVA CS or an attenuated fowlpox virus strain FP9 CS
Detailed Description:
Objectives
The primary aim was the assessment of safety and reactogenicity of these vaccines in Gambian adults The secondary aim was the assessment of immunogenicity and comparison with UK adults given the same vaccines
Study Area
The study was conducted in the town of Farafenni about 200km east of the capital city Banjul In this area malaria is highly seasonal with an entomological inoculation rate between 10-50 bites per year This study was carried out from January to June when the incidence of malaria is low
Study Population
The study involved 32 healthy Gambian adults aged 18-45 years Volunteers were subjected to a thorough physical and medical examination Exclusion criteria included a low PCV 30 raised plasma creatinine or ALT levels and HIV positivity as determined by ELISA assays
Study Procedure
After prior consultations with community leaders public meetings were held to inform the community of the planned study Volunteers aged 18-45 years were then invited to take part in the study after written informed consent was obtained in the presence of the principal investigator Prior to the start of the screening exercise the investigators checked the age and identity of each volunteer and conducted pre-HIV test counselling Screening involved a thorough physical examination blood sampling for haematological full blood count packed cell volume PCV renal plasma creatinine and hepatic alanine aminotransferase tests and HIV 1 and 2 testing by ELISA All eligible volunteers were issued unique study numbers and photo identification cards
The initial part of the study was designed to determine the dose and safety of the individual vaccines using an open-label dose escalation method Study volunteers were randomly allocated to two groups of four that received 5 x 107 pfu id of either FP9 CS or MVA CS When a good safety profile was evident one week after this dose another set of four volunteers per group received a higher dose 1 x 108 pfu id of FP9 CS or MVA CS After the investigators had achieved a satisfactory safety profile with a higher dose of both vaccines given alone they proceeded to administer the vaccines in combination using the heterologous prime-boost regime The vaccines were administered at 4-week intervals Eight volunteers received FP9 CS at week 0 followed by MVA CS at week 4 FM group Another set of 8 volunteers received FP9 CS at weeks 0 and 4 followed by MVA CS at week 8 FFM Following vaccination volunteers were observed for 1 hour and given a course of antipyretic paracetamol to take if required A physician and a study nurse could be contacted by the volunteers at anytime during the course of the study In addition home visits were made by field workers on days 1 2 7 and 28 after each vaccination to record adverse events using a standard questionnaire
Sample Size
Sample size was determined by the requirement to make a preliminary evaluation of inter-group and inter-individual variability to avoid excessive risk and to allow for a realistic workload Statistical significance may not be reached in this study with low power but a non-significant finding would provide justification for the need for a study with greater power
Data Safety Monitoring Board DSMB
An international DSMB was established to monitor the conduct of the trial and to approve the analytical plan The trial was conducted in line with the ICH Good Clinical Practices guidelines and with the Medical Research Council MRC rules and regulations for the conduct of clinical trials
The primary aim was the assessment of safety and reactogenicity of these vaccines in Gambian adults The secondary aim was the assessment of immunogenicity and comparison with UK adults given the same vaccines
Study Area
The study was conducted in the town of Farafenni about 200km east of the capital city Banjul In this area malaria is highly seasonal with an entomological inoculation rate between 10-50 bites per year This study was carried out from January to June when the incidence of malaria is low
Study Population
The study involved 32 healthy Gambian adults aged 18-45 years Volunteers were subjected to a thorough physical and medical examination Exclusion criteria included a low PCV 30 raised plasma creatinine or ALT levels and HIV positivity as determined by ELISA assays
Study Procedure
After prior consultations with community leaders public meetings were held to inform the community of the planned study Volunteers aged 18-45 years were then invited to take part in the study after written informed consent was obtained in the presence of the principal investigator Prior to the start of the screening exercise the investigators checked the age and identity of each volunteer and conducted pre-HIV test counselling Screening involved a thorough physical examination blood sampling for haematological full blood count packed cell volume PCV renal plasma creatinine and hepatic alanine aminotransferase tests and HIV 1 and 2 testing by ELISA All eligible volunteers were issued unique study numbers and photo identification cards
The initial part of the study was designed to determine the dose and safety of the individual vaccines using an open-label dose escalation method Study volunteers were randomly allocated to two groups of four that received 5 x 107 pfu id of either FP9 CS or MVA CS When a good safety profile was evident one week after this dose another set of four volunteers per group received a higher dose 1 x 108 pfu id of FP9 CS or MVA CS After the investigators had achieved a satisfactory safety profile with a higher dose of both vaccines given alone they proceeded to administer the vaccines in combination using the heterologous prime-boost regime The vaccines were administered at 4-week intervals Eight volunteers received FP9 CS at week 0 followed by MVA CS at week 4 FM group Another set of 8 volunteers received FP9 CS at weeks 0 and 4 followed by MVA CS at week 8 FFM Following vaccination volunteers were observed for 1 hour and given a course of antipyretic paracetamol to take if required A physician and a study nurse could be contacted by the volunteers at anytime during the course of the study In addition home visits were made by field workers on days 1 2 7 and 28 after each vaccination to record adverse events using a standard questionnaire
Sample Size
Sample size was determined by the requirement to make a preliminary evaluation of inter-group and inter-individual variability to avoid excessive risk and to allow for a realistic workload Statistical significance may not be reached in this study with low power but a non-significant finding would provide justification for the need for a study with greater power
Data Safety Monitoring Board DSMB
An international DSMB was established to monitor the conduct of the trial and to approve the analytical plan The trial was conducted in line with the ICH Good Clinical Practices guidelines and with the Medical Research Council MRC rules and regulations for the conduct of clinical trials
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 |
|---|---|---|---|
| VAC 026 | None | None | None |