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

NCT00312663 | Completed Phase 1 Results DMC

• 2 other identifiers: WRAIR 1250HSRRB A-13734
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Phase I/II Trial of a Malaria Vaccine, FMP011/AS01B, in Adults Living in the United States of America.

Conditions

Plasmodium Falciparum Malaria

Keywords

Vaccine; Phase I/II; Malaria; Liver Stage Antigen -1; Falciparum Malaria Protein -11; AS01B; adjuvant

Outcome Measures

Primary Outcomes (1)

• 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

  30 days post vaccination

Secondary Outcomes (1)

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

  Days 0, 28, 42, and 84

Study Arms (2)

10ug dose FMP011

EXPERIMENTAL

Falciparum Malaria Protein 11 with AS01B adjuvant

Biological: Falciparum Malaria Protein 11 with AS01B adjuvant.

50ug dose FMP011

EXPERIMENTAL

Falciparum Malaria Protein 11 with AS01B adjuvant

Biological: Falciparum Malaria Protein 11 with AS01B adjuvant.

Interventions

Falciparum Malaria Protein 11 with AS01B adjuvant. BIOLOGICAL

malaria experimental vaccine

10ug dose FMP011; 50ug dose FMP011

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• U.S. Army Medical Research and Development Command: lead
• GlaxoSmithKline: collaborator
• The PATH Malaria Vaccine Initiative (MVI): collaborator
• Walter Reed Army Institute of Research (WRAIR): collaborator

Study Sites (1)

Walter Reed Army Institute of Research

Silver Spring, Maryland, 20910, United States

Location

MeSH Terms

Conditions

Malaria, Falciparum; Malaria

Interventions

AS01B adjuvant

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Results Point of Contact

• Title: James Cummings, MD
• Organization: WRAIR

james.cummings@us.army.mil

301-319-9312

Study Officials

• James F. Cummings, MD

  Walter Reed Army Institute of Research (WRAIR)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2006
• First Posted: April 10, 2006
• Study Start: April 1, 2006
• Primary Completion: October 1, 2006
• Study Completion: April 1, 2007
• Last Updated: November 26, 2018
• Results First Posted: November 26, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)