Ignite Creation Date:
2024-05-05 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00392015
Status:
COMPLETED
Last Update Posted:
2021-05-21
First Post:
2006-10-24
Brief Title:
NMRC-M3V-Ad-PfCA Vaccine - Clinical Trial 1
Sponsor:
US Army Medical Research and Development Command
Organization:
US Army Medical Research and Development Command
Study Overview
Official Title:
A Two Part Clinical Trial Assessing the Safety Tolerability Immunogenicity and Protective Efficacy of NMRC-M3V-Ad-PfCA a Multivalent Adenovirus-Vectored Plasmodium Falciparum Malaria Vaccine in Healthy Malaria-Naïve Adults
Status:
COMPLETED
Status Verified Date:
2021-04
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:
The purpose of this study is to determine whether a new investigational malaria vaccine is safe well tolerated and effective against experimental exposure to malaria when given to healthy people with no previous exposure to malaria The vaccine consists of a modified form of a relatively common virus adenovirus that has been rendered incapable of replicating itself and modified to deliver the malaria gene of interest to the bodys cells allowing the cell to manufacture the protein encoded by the gene and present it to the bodys immune system in a more natural and presumably effective way
Detailed Description:
The vaccine called NMRC-M3V-Ad-PfCA key NMRC Multi-antigen Multi-stage Malaria Vaccine Adenovectored P falciparum CSP AMA1 antigens is a combination of two recombinant adenovirus-derived constructs adenovectors one expressing the pre-erythrocytic stage antigen circumsporozoite protein CSP and the other expressing the erythrocytic stage antigen Apical Membrane Antigen 1 AMA1 both from the 3D7 strain of P falciparum The vector is an attenuated replication-deficient adenovirus derived from wildtype serotype 5 adenovirus through the deletion of several genes The vaccine is formulated in a buffered saline solution Final Formulation Buffer FFB
This is a Phase 12a randomized open-label dose-escalating trial of the NMRC-M3V-Ad-PfCA vaccine administered intramuscularly to healthy malaria-naïve adult volunteers All volunteers will be seronegative 1500 by a luciferase-based neutralizing antibody assay VRC Bethesda for adenovirus serotype 5 In the first part of the study dose-escalation phase Part A 1 x 1010 particle units pu per construct or 2 x 1010 pu total will be administered to six volunteers as a single dose to assess safety and 4 weeks later 5 x 1010 pu per construct or 1 x 1011 pu total dose five-fold dose escalation will be administered to six additional volunteers In the second part of the study regimen-comparison phase Part B three regimens for administration will be compared one dose two doses administered ten days apart and two doses administered 16 weeks apart Separate groups will receive one dose of the individual components of the vaccine NMRC-MV-Ad-PfC and NMRC-MV-Ad-PfA Following immunization volunteers participating in the regimen-comparison phase as well as several non-immunized control volunteers serving as infectivity controls will be challenged with P falciparum sporozoites in order to assess vaccine efficacy against non-immunized controls challenged at the same time The proposed design of the regimen-comparison phase will provide information to direct selection of an appropriate dosing regimen for subsequent studies and will also indicate whether the two constituent antigens when co-formulated act synergistically independently or interfere with each other in the induction of antigen-specific immune responses and protective immunity
This is a Phase 12a randomized open-label dose-escalating trial of the NMRC-M3V-Ad-PfCA vaccine administered intramuscularly to healthy malaria-naïve adult volunteers All volunteers will be seronegative 1500 by a luciferase-based neutralizing antibody assay VRC Bethesda for adenovirus serotype 5 In the first part of the study dose-escalation phase Part A 1 x 1010 particle units pu per construct or 2 x 1010 pu total will be administered to six volunteers as a single dose to assess safety and 4 weeks later 5 x 1010 pu per construct or 1 x 1011 pu total dose five-fold dose escalation will be administered to six additional volunteers In the second part of the study regimen-comparison phase Part B three regimens for administration will be compared one dose two doses administered ten days apart and two doses administered 16 weeks apart Separate groups will receive one dose of the individual components of the vaccine NMRC-MV-Ad-PfC and NMRC-MV-Ad-PfA Following immunization volunteers participating in the regimen-comparison phase as well as several non-immunized control volunteers serving as infectivity controls will be challenged with P falciparum sporozoites in order to assess vaccine efficacy against non-immunized controls challenged at the same time The proposed design of the regimen-comparison phase will provide information to direct selection of an appropriate dosing regimen for subsequent studies and will also indicate whether the two constituent antigens when co-formulated act synergistically independently or interfere with each other in the induction of antigen-specific immune responses and protective immunity
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 |
|---|---|---|---|
| NMRC20060001 | OTHER | NMRC | None |
| HSRRB A-13453 | OTHER | None | None |