Ignite Creation Date:
2024-05-05 @ 5:17 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00427167
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2007-01-25
Brief Title:
Phase I Study of AMA1-C1Alhydrogel Registered Trademark CPG 7909 Malaria Vaccine
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Phase I Study of the Safety and Immunogenicity of AMA1-C1Alhydrogel CPG 7909 an Asexual Blood Stage Vaccine for Plasmodium Falciparum Malaria
Status:
COMPLETED
Status Verified Date:
2009-08-03
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:
This study will evaluate the safety and immune response of healthy volunteers to an experimental malaria vaccine called AMA1-C1Alhydrogel Registered Trademark CPG 7909 Malaria is an infection of red blood cells caused by a parasite Plasmodium falciparum that is spread by certain kinds of mosquitoes Each year about 1 million people are killed by malaria worldwide most of them young children in Africa AMA1 C1 may help block the malaria parasite from getting into red blood cells The vaccine is mixed with Alhydrogel Registered Trademark a material that is commonly added to vaccines to make them work better also called an adjuvant Besides evaluating the vaccine this study will also test two solutions of an experimental adjuvant CPG 7909-P and CPG 7909-S
Healthy people between 18 and 50 years of age may be eligible for this 7-month study Participants are randomly assigned to one of four treatment groups A B C or D below All receive two vaccinations given as a shot in the upper arm either 1 or 2 months apart as shown
Group A AMA1 CIAlhydrogel Registered TrademarkCPG 7909-P at Day 0 and Day 28 1-month interval
Group B AMA1 CIAlhydrogel Registered TrademarkCPG 7909-S at Day 0 and Day 28 1-month interval
Group C AMA1 CIAlhydrogel Registered TrademarkCPG 7909-P at Day 0 and Day 56 2-month interval
Group D AMA1 CIAlhydrogel Registered TrademarkCPG 7909-S at Day 0 and Day 56 2-month interval
Group A and B participants return to the clinic for checkups at 3 7 and 14 days after each vaccination and again at months 2 3 4 5 and 7 Group C and D participants come to the clinic at 3 7 and 14 days after each vaccination and again at months 3 4 5 and 7
In addition to the vaccinations the study includes the following procedures
Photographs of the subjects arm where the vaccination is given if a rash develops
Daily temperature and symptoms record for the first 6 days after each of the 2 vaccinations and at any other time there is concern about fever or other symptoms
Blood draws about 12 times during the study to check for safety and to measure the antibody response and the effect of the study vaccine
Some participants may be asked to undergo plasmapheresis a procedure for collecting plasma the liquid part of the blood This is done by using a machine called a blood cell separator Blood is collected through a needle place
Healthy people between 18 and 50 years of age may be eligible for this 7-month study Participants are randomly assigned to one of four treatment groups A B C or D below All receive two vaccinations given as a shot in the upper arm either 1 or 2 months apart as shown
Group A AMA1 CIAlhydrogel Registered TrademarkCPG 7909-P at Day 0 and Day 28 1-month interval
Group B AMA1 CIAlhydrogel Registered TrademarkCPG 7909-S at Day 0 and Day 28 1-month interval
Group C AMA1 CIAlhydrogel Registered TrademarkCPG 7909-P at Day 0 and Day 56 2-month interval
Group D AMA1 CIAlhydrogel Registered TrademarkCPG 7909-S at Day 0 and Day 56 2-month interval
Group A and B participants return to the clinic for checkups at 3 7 and 14 days after each vaccination and again at months 2 3 4 5 and 7 Group C and D participants come to the clinic at 3 7 and 14 days after each vaccination and again at months 3 4 5 and 7
In addition to the vaccinations the study includes the following procedures
Photographs of the subjects arm where the vaccination is given if a rash develops
Daily temperature and symptoms record for the first 6 days after each of the 2 vaccinations and at any other time there is concern about fever or other symptoms
Blood draws about 12 times during the study to check for safety and to measure the antibody response and the effect of the study vaccine
Some participants may be asked to undergo plasmapheresis a procedure for collecting plasma the liquid part of the blood This is done by using a machine called a blood cell separator Blood is collected through a needle place
Detailed Description:
AMA1-C1 CPG 7909 is a blood stage malaria vaccine candidate The objectives of this Phase 1 study are to confirm the previously demonstrated safety and immunogenicity of AMA1-C1 CPG 7909 formulated in a phosphate buffer In addition this study will evaluate the safety and immunogenicity of AMA1-C1 CPG 7909 formulated in a saline buffer and determine if the addition of CPG 7909 in a saline buffer enhances the immune response to AMA1-C1 in a manner similar to that seen with the addition of CPG 7909 in a phosphate buffer The immunological effect of giving a second dose of vaccine at 1 or 2 months will also be evaluated The study is a double blind Phase 1 clinical trial in healthy adult volunteers Volunteers will be screened and 24 participants will be enrolled and randomly assigned to 1 of 4 groups in a 2x2 design 6 volunteers will receive 2 doses of 80 micrograms AMA1-C1Alhydrogel 500 micrograms CPG 7909 phosphate at a 1-month dosing interval 6 volunteers will receive 2 doses of 80 micrograms AMA1-C1Alhydrogel 500 micrograms CPG 7909 saline at a 1 month dosing interval 6 volunteers will receive 2 doses of 80 micrograms AMA1-C1Alhydrogel 500 micrograms CPG 7909 phosphate at a 2-month dosing interval and 6 volunteers will receive 2 doses of 80 micrograms AMA1-C1Alhydrogel 500 micrograms CPG 7909 saline at a 2 month dosing interval Safety outcome measures are local and systemic including laboratory adverse events Immune responses to vaccination will be measured by enzyme-linked immunosorbent assay ELISA and parasite growth inhibition assay GIA and will be compared among groups
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 |
|---|---|---|---|
| 07-I-0083 | None | None | None |