Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00340574
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2006-06-19
Brief Title:
Improving the Efficacy of Experimental Malaria Vaccine AMA1-C1Alhydrogel Registered Trademark
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 AMA-1-C1Alhydrogel CPG 7909 An Asexual Blood Stage Vaccine for Plasmodium Falciparum Malaria
Status:
COMPLETED
Status Verified Date:
2008-07-02
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:
This study will evaluate the safety and efficacy of the experimental malaria vaccine AMA1-C1Alhydrogel Registered Trademark and determine whether a new additional component of the vaccine may increase its effectiveness Malaria is a debilitating and potentially fatal blood disease transmitted by a parasite found in certain mosquitoes The AMA1-C1 vaccine has been designed to create an immune response against the parasite and prevent the disease The purpose of the study is to determine whether the additional component-protein pieces known as CpG- improves the immune response to the vaccine without causing problematic side effects
Volunteers must be healthy adults between 18 and 45 years old Individuals who have had malaria in the past or have recently traveled to areas where malaria is endemic will be excluded from the study Candidates will be screened with a physical examination blood tests and medical history
Participants will be involved in a three-stage study In the first stage a group of participants will receive either a high dose of the vaccine alone or a low dose combined with the CpG protein In the second stage a different group of participants will receive a high dose of the vaccine alone or a high dose combined with CpG In the third stage a larger group of participants will receive a high dose of the vaccine alone or a high dose combined with CpG The vaccine will be injected into the muscle of the upper arm and all participants will receive three doses of the vaccine with 28 days between doses to monitor possible reactions and side effects Participants will be monitored for 30 minutes after each injection and will record any symptoms they experience over the six days after receiving their dose In addition participants will be examined over the course of six months during and after the trial with physical exams and blood and urine tests
Volunteers must be healthy adults between 18 and 45 years old Individuals who have had malaria in the past or have recently traveled to areas where malaria is endemic will be excluded from the study Candidates will be screened with a physical examination blood tests and medical history
Participants will be involved in a three-stage study In the first stage a group of participants will receive either a high dose of the vaccine alone or a low dose combined with the CpG protein In the second stage a different group of participants will receive a high dose of the vaccine alone or a high dose combined with CpG In the third stage a larger group of participants will receive a high dose of the vaccine alone or a high dose combined with CpG The vaccine will be injected into the muscle of the upper arm and all participants will receive three doses of the vaccine with 28 days between doses to monitor possible reactions and side effects Participants will be monitored for 30 minutes after each injection and will record any symptoms they experience over the six days after receiving their dose In addition participants will be examined over the course of six months during and after the trial with physical exams and blood and urine tests
Detailed Description:
Purpose This study will evaluate the safety and immunogenicity of the experimental malaria vaccine AMA1-C1Alhydrogel Registered Trademark and the ability of the TLR-9 agonist CPG 7909 oligodexoynucleotide ODN to augment antibody response to the vaccine and alter the Th1Th2 bias The vaccine preparations to be studied contain an equal mixture of AMA1 from two different clones of Plasmodium falciparum FVO and 3D7 both produced separately as recombinant proteins expressed by Pichia pastoris PpAMA-1 FVO and PpAMA-1 3D7 Bulk PpAMA-1 antigens were purified from culture medium of transformed yeast grown in a 60L fermenter The correctly folded PpAMA-1 was purified from this mixture by a combination of affinity ionic hydrophobic and gel filtration chromatography Purified PpAMA-1 FVO and PpAMA-1 3D7 were subsequently mixed and adsorbed onto aluminum hydroxide gel Alhydrogel Registered Trademark The CPG 7909 ODN formulation used in this study CPG 7909 is manufactured by Coley Pharmaceutical Group Subjects will be randomly assigned to receive Alhydrogel Registered Trademark formulated vaccine with or without CPG 7909 in a point of use formulation
Research Environment The study will be conducted at the University of Rochester Vaccine and Treatment Evaluation Unit VTEU
Subjects Subjects for this study will be healthy adults between the ages of 18 and 45 years with no history of malaria or of recent travel to malaria-endemic areas Subjects will be enrolled in three consecutive dose-escalation cohorts with review by a Safety Monitoring Committee between cohorts
Subject participation Subjects will receive three vaccinations with the AMA1-C1Alhydrogel Registered Trademark vaccine formulated in Alhydrogel Registered Trademark with or without CPG 7909 adjuvant over 2 months 0 1 2 months by intramuscular IM injection Subjects will have multiple blood samples obtained over the next 6 months
Variables to be Investigated Samples will be tested for binding antibody to AMA1 and for ability to inhibit the growth of plasmodia in vitro In addition antigen-specific activated B cells in peripheral blood will be enumerated as well as the relative ratio of antigen-specific Th1-like and Th2-like T cells
RiskBenefits The risks of participating in this study are those associated with administration of AMA1-C1Alhydrogel Registered Trademark and of CPG 7909 and include local pain systemic inflammatory responses including fever and influenza-like symptoms and induction of autoimmune responses As with any other investigational vaccine there are unknown risks Subjects may derive no benefit from participation in this study Development of effective vaccines to prevent malaria is an important societal benefit
Confidentiality Volunteers will have code numbers and will not be identified by name
Research Environment The study will be conducted at the University of Rochester Vaccine and Treatment Evaluation Unit VTEU
Subjects Subjects for this study will be healthy adults between the ages of 18 and 45 years with no history of malaria or of recent travel to malaria-endemic areas Subjects will be enrolled in three consecutive dose-escalation cohorts with review by a Safety Monitoring Committee between cohorts
Subject participation Subjects will receive three vaccinations with the AMA1-C1Alhydrogel Registered Trademark vaccine formulated in Alhydrogel Registered Trademark with or without CPG 7909 adjuvant over 2 months 0 1 2 months by intramuscular IM injection Subjects will have multiple blood samples obtained over the next 6 months
Variables to be Investigated Samples will be tested for binding antibody to AMA1 and for ability to inhibit the growth of plasmodia in vitro In addition antigen-specific activated B cells in peripheral blood will be enumerated as well as the relative ratio of antigen-specific Th1-like and Th2-like T cells
RiskBenefits The risks of participating in this study are those associated with administration of AMA1-C1Alhydrogel Registered Trademark and of CPG 7909 and include local pain systemic inflammatory responses including fever and influenza-like symptoms and induction of autoimmune responses As with any other investigational vaccine there are unknown risks Subjects may derive no benefit from participation in this study Development of effective vaccines to prevent malaria is an important societal benefit
Confidentiality Volunteers will have code numbers and will not be identified by name
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 |
|---|---|---|---|
| 05-I-N117 | None | None | None |