Ignite Creation Date:
2024-05-05 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00347555
Status:
COMPLETED
Last Update Posted:
2013-04-12
First Post:
2006-06-29
Brief Title:
Safety and Immunogenicity of EBA-175 RII-NG Malaria Vaccine Administered Intramuscularly
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Phase I Double-Blinded Placebo-Controlled Dosage-Escalation Study of the Safety and Immunogenicity of EBA-175 RII-NG Malaria Vaccine Administered Intramuscularly
Status:
COMPLETED
Status Verified Date:
2012-05
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 an illness caused by a parasite an animal or plant that lives in or on a host that enters the human body through the bite of an infected mosquito The purpose of this study is to find out about the safety of an experimental malaria vaccine and whether the vaccine causes humans to produce antibodies proteins made by the bodys immune system to help control or prevent infection Four strengths of the vaccine will be tested The lowest strength of the vaccine will be tested before the next higher strength is tested Each dosage shot of vaccine will be given to 18 people in 4 dosage groups on Day 0 at 1 month and at 6 months Two people in each dosage group will receive injections of a placebo contains no medication Participants will include 80 healthy adults between 18 and 40 years of age Multiple blood draws will occur over the duration of the study Participants will be involved in study related procedures for approximately 13 months
Detailed Description:
This study is a phase I double-blinded placebo-controlled dosage-escalation study of the safety and immunogenicity of EBA-175 RII-NG malaria vaccine administered intramuscularly The vaccine is a recombinant Plasmodium falciparum Pf erythrocyte-binding antigen 175 kDa Region II-nonglycosylated EBA-175 RII-NG adsorbed to aluminum phosphate adjuvant The study is being conducted at Baylor College of Medicine Houston Texas Eighty healthy subjects between the ages of 18 and 40 years males and females will be recruited from Houston Texas and will participate in the study for approximately 13 months Subjects will be randomized to receive 3 doses of the vaccine or saline placebo by the intramuscular route in a 91 ratio at 0 1 and 6 months The safety and immunogenicity of ascending dosages of the vaccine will be assessed Eighteen subjects will receive vaccine at each of the following dosage levels 5 20 80 and 160 micrograms Two subjects will receive placebo for each dosage level Dosage escalation will proceed only after review of the 2-week safety data of the 2 initial doses of the prior dosage level The primary study objective is to assess the safety and reactogenicity tolerability of ascending dosages of EBA-175 RII-NG vaccine among healthy subjects given in 3 intramuscular doses at 0 1 and 6 months The secondary study objective is to evaluate the immunogenicity of the EBA-175 RII-NG vaccine by measuring anti-EBA-175 RII-NG antibodies using enzyme-linked immunosorbent assay ELISA anti-parasite antibodies by indirect fluorescence antibody test IFAT inhibition of binding of EBA-175 RII-NG to red blood cells RBCs and inhibition of Pf growth in vitro
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 |
|---|---|---|---|
| N01AI80002C | None | None | None |