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Phase I/II Trial of a Malaria Vaccine in Adults Living in the United States of America

Primary Purpose

Plasmodium Falciparum Malaria

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Falciparum Malaria Protein 11 with AS01B adjuvant.
Sponsored by
U.S. Army Medical Research and Development Command
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Plasmodium Falciparum Malaria focused on measuring Vaccine, Phase I/II, Malaria, Liver Stage Antigen -1, Falciparum Malaria Protein -11, AS01B, adjuvant

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: A male or non-pregnant female 18 to 50 years of age (inclusive) at the time of screening. Written informed consent obtained from the subject before screening procedures. Free of obvious health problems as established by medical history and clinical examination before entering into the study.* Available to participate for duration of study (approximately 15 months). If the subject is female, she must be currently using birth control, must be surgically sterilized, or must be at least 1-year post menopausal. Pass a comprehension assessment test. Exclusion Criteria: Prior receipt of an investigational malaria vaccine. Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 28 days preceding the first dose of study vaccine, or planned use during the study period. Administration of chronic immunosuppressants or other immune modifying drugs within six months of vaccination. Chronic use of antibiotics with anti-malarial effects. Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine(s). History of use of anti-malarial medication within 60 days prior to vaccination. Any history of malaria. Known exposure to malaria within the previous 12 months. Planned travel to malarious areas during the study period. Any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV infection. A family history of congenital or hereditary immunodeficiency. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. Chronic or active neurologic disease including seizures, but not including a single febrile seizure as a child. History of splenectomy. Acute disease at the time of enrollment. Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests. Personal history of autoimmune disease or subjects who describe a first-degree relative with clearly documented autoimmune disease. Seropositive for hepatitis B surface antigen. Seropositive for Hepatitis C virus (antibodies to HCV). Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned. administration during the study period Pregnant or lactating female. Suspected or known current alcohol abuse as defined by the American Psychiatric Association in DSM IV. Chronic or active intravenous drug use. History of severe reactions to mosquito bites as defined as anaphylaxis. Female who intends to become pregnant during the study. Any history of anaphylaxis in reaction to vaccination. A clinical history of sickle cell disease or sickle cell trait. Any other significant finding that in the opinion of the investigator would increase the risk of having an adverse outcome from participating in this study.

Sites / Locations

  • Walter Reed Army Institute of Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

10ug dose FMP011

50ug dose FMP011

Arm Description

Falciparum Malaria Protein 11 with AS01B adjuvant

Falciparum Malaria Protein 11 with AS01B adjuvant

Outcomes

Primary Outcome Measures

Safety - Most Frequently Reported Adverse Events and Grade
An AE was defined as any reaction, side effect, or untoward event that occurred during the course of the trial whether or not the event was considered related to the study drug or clinically significant. Grade 1: Mild Grade 2: Moderate Grade 3: Severe

Secondary Outcome Measures

Anti-LSA-1 Antibody Response in Titer Units on Days 0, 28, 42, and 84
Anti-LSA-1 Antibody Response in Titer Units on Days 0, 28, 42, and 84

Full Information

First Posted
April 6, 2006
Last Updated
May 3, 2018
Sponsor
U.S. Army Medical Research and Development Command
Collaborators
GlaxoSmithKline, The PATH Malaria Vaccine Initiative (MVI), Walter Reed Army Institute of Research (WRAIR)
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1. Study Identification

Unique Protocol Identification Number
NCT00312663
Brief Title
Phase I/II Trial of a Malaria Vaccine in Adults Living in the United States of America
Official Title
A Phase I/IIa Controlled Study of the Safety, Immunogenicity and Preliminary Efficacy of FMP011/AS01B Candidate Malaria Vaccine in Malaria-naive Adults Living in the United States
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
April 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
U.S. Army Medical Research and Development Command
Collaborators
GlaxoSmithKline, The PATH Malaria Vaccine Initiative (MVI), Walter Reed Army Institute of Research (WRAIR)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Phase I/II Trial of a Malaria Vaccine, FMP011/AS01B, in Adults Living in the United States of America.
Detailed Description
Controlled challenge, Phase I/IIa WRAIR study. Healthy, malaria-naive adults aged 18 - 50 years. 2 groups, 5 subjects in group A (10µg dose) and 13 subjects in group B(50µg dose). Control: none for immunization phase; infectivity controls for challenge and rechallenge phases. Six infectivity controls per day of challenge will be enrolled for the challenge phases, with 3 alternates available for challenge if needed. Vaccination schedule of 0, 1 months. Challenge of up to 13 subjects in Group B. Contingent upon short term efficacy, rechallenge of initially protected subjects 6 months (+/- 2 months) after second dose of vaccine. Self-contained study. Duration of the study, per subject: approximately 15 months (screening, enrollment, vaccination, challenge and rechallenge). Data collection will be by done onsite.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plasmodium Falciparum Malaria
Keywords
Vaccine, Phase I/II, Malaria, Liver Stage Antigen -1, Falciparum Malaria Protein -11, AS01B, adjuvant

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
10ug dose FMP011
Arm Type
Experimental
Arm Description
Falciparum Malaria Protein 11 with AS01B adjuvant
Arm Title
50ug dose FMP011
Arm Type
Experimental
Arm Description
Falciparum Malaria Protein 11 with AS01B adjuvant
Intervention Type
Biological
Intervention Name(s)
Falciparum Malaria Protein 11 with AS01B adjuvant.
Intervention Description
malaria experimental vaccine
Primary Outcome Measure Information:
Title
Safety - Most Frequently Reported Adverse Events and Grade
Description
An AE was defined as any reaction, side effect, or untoward event that occurred during the course of the trial whether or not the event was considered related to the study drug or clinically significant. Grade 1: Mild Grade 2: Moderate Grade 3: Severe
Time Frame
30 days post vaccination
Secondary Outcome Measure Information:
Title
Anti-LSA-1 Antibody Response in Titer Units on Days 0, 28, 42, and 84
Description
Anti-LSA-1 Antibody Response in Titer Units on Days 0, 28, 42, and 84
Time Frame
Days 0, 28, 42, and 84

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: A male or non-pregnant female 18 to 50 years of age (inclusive) at the time of screening. Written informed consent obtained from the subject before screening procedures. Free of obvious health problems as established by medical history and clinical examination before entering into the study.* Available to participate for duration of study (approximately 15 months). If the subject is female, she must be currently using birth control, must be surgically sterilized, or must be at least 1-year post menopausal. Pass a comprehension assessment test. Exclusion Criteria: Prior receipt of an investigational malaria vaccine. Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 28 days preceding the first dose of study vaccine, or planned use during the study period. Administration of chronic immunosuppressants or other immune modifying drugs within six months of vaccination. Chronic use of antibiotics with anti-malarial effects. Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine(s). History of use of anti-malarial medication within 60 days prior to vaccination. Any history of malaria. Known exposure to malaria within the previous 12 months. Planned travel to malarious areas during the study period. Any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV infection. A family history of congenital or hereditary immunodeficiency. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. Chronic or active neurologic disease including seizures, but not including a single febrile seizure as a child. History of splenectomy. Acute disease at the time of enrollment. Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests. Personal history of autoimmune disease or subjects who describe a first-degree relative with clearly documented autoimmune disease. Seropositive for hepatitis B surface antigen. Seropositive for Hepatitis C virus (antibodies to HCV). Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned. administration during the study period Pregnant or lactating female. Suspected or known current alcohol abuse as defined by the American Psychiatric Association in DSM IV. Chronic or active intravenous drug use. History of severe reactions to mosquito bites as defined as anaphylaxis. Female who intends to become pregnant during the study. Any history of anaphylaxis in reaction to vaccination. A clinical history of sickle cell disease or sickle cell trait. Any other significant finding that in the opinion of the investigator would increase the risk of having an adverse outcome from participating in this study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James F. Cummings, MD
Organizational Affiliation
Walter Reed Army Institute of Research (WRAIR)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Walter Reed Army Institute of Research
City
Silver Spring
State/Province
Maryland
ZIP/Postal Code
20910
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
GlaxoSmithKline, The PATH Malaria Vaccine Initiative (MVI), Walter Reed Army Institute of Research (WRAIR)

Learn more about this trial

Phase I/II Trial of a Malaria Vaccine in Adults Living in the United States of America

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