Ignite Creation Date:
2024-05-05 @ 5:02 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00371189
Status:
COMPLETED
Last Update Posted:
2014-09-22
First Post:
2006-08-31
Brief Title:
Adenovirus Vaccine for Malaria
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase I Randomized Controlled Dosage-Escalation Trial to Evaluate the Immunogenicity Safety and Reactogenicity of an Adenovirus Type 35 Based Circumsporozoite Malaria Vaccine in Healthy Adults 18 to 45 Years of Age
Status:
COMPLETED
Status Verified Date:
2014-06
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:
Malaria is caused by a parasite carried by a mosquito Currently there is no vaccine licensed to prevent malaria The purpose of this study is to find the most effective and safest dose of an experimental vaccine for the treatment of malaria Participants will include 72 healthy adults ages18 to 45 enrolled at Vanderbilt University Medical Center and Stanford University Volunteers will receive 3 doses of either the malaria vaccine or placebo contains no vaccine by injection into a muscle at 0 1 and 6 months Investigators will evaluate how the body responds to increasing dosage strengths of the vaccine Study procedures include physical exam multiple blood draws and completion of a memory aid diary Each participant will be actively involved in the study for about 12 months Then an annual phone call will be made to check for any serious illness events for a period of 5 years
Detailed Description:
Malaria currently represents one of the most prevalent infections in tropical and subtropical areas throughout the world Each year malaria affects around 300 million people and kills 1 to 3 million people in developing countries The widespread occurrence and the growing incidence of malaria are a consequence of the increasing numbers of drug-resistant parasites and insecticide-resistant parasite vectors Other factors include environmental and climatic changes civil disturbances and increased mobility of populations It is hypothesized that the Ad35CS01 vaccine will prevent the Plasmodium P falciparum parasite which causes malaria from entering and developing within the liver of those who become infected Ad35CS01 would therefore be expected to reduce malaria-attributable morbidity and mortality The purpose of this phase I randomized controlled dosage-escalation trial is to evaluate the immunogenicity safety and reactogenicity of an Adenovirus Type 35 based circumsporozoite malaria vaccine in 72 healthy adults 18 to 45 years of age in the United States Subjects will be randomized in a 51 ratio to receive 3 doses of the Adenovirus Type 35 circumsporozoite malaria vaccine Ad35CS01 or normal saline placebo control by the intramuscular route at 0 1 and 6 months The safety reactogenicity and immunogenicity of ascending dosages of the vaccine will be assessed Fifteen subjects will receive vaccine at each of the following dosage levels 108 viral particles vpmilliliters ml 109 vpml 1010 vpml and 1011 vpml with 3 subjects receiving control at each of these dosage levels Dosage escalation will proceed only after review of the safety data by the Safety Monitoring Committee of the prior dosage level The primary objective is to assess the safety and reactogenicity of ascending dosages of Adenovirus Type 35 based circumsporozoite malaria vaccine among healthy subjects given in 3 intramuscular doses at 0 1 and 6 months The secondary objective is to evaluate the immunogenicity of the Adenovirus Type 35 based circumsporozoite malaria vaccine through performance of Humoral Immune Assays ELISA enzyme-linked immunosorbent assay for antibodies to circumsporozoite antigen and Adenovirus Neutralization Assay for neutralizing antibodies to Adenovirus type 35 and Cellular Immune Assays enzyme-linked immunosorbent spot ELISPOT and Flow Cytometry for circumsporozoite CS-specific cluster of differentiation CD4 and CD8 T cell responses
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 |
|---|---|---|---|
| N01AI80007C | None | None | None |