Evaluate the Safety and Efficacy of Plasmodium Falciparum Malaria Protein 010 (FMP010) Administered With Adjuvant AS01B

NCT02458092 | Completed Phase 1 Results DMC

• 2 other identifiers: A-14620.bWRAIR 1417
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine whether an investigational malaria vaccine is safe and induces an immune response against malaria when tested in adults living in the United States.

Conditions

Malaria

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Solicited Adverse Events With Each Vaccination by Grade

  Vaccinations were given at 0-, 1-, 2-month interval, occurrence and intensity of solicited symptoms on day of vaccination (Day 0) and Days 1-7 after each vaccination Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe

  After each vaccination (Day 0), follow-up visits were scheduled on Days 1, 2, 3, and 7

• Number of Subjects With Unsolicited Adverse Events at Specified Grades

  Vaccinations were given at 0-, 1-, 2-month interval, number of subjects reporting unsolicited symptoms at specified grades over a 30-day follow-up period (day of vaccination and 29 subsequent days) after each vaccination Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe

  After each vaccination (Day 0), 30 day f/u period post vaccination

• Number of Subjects With the Occurrence of Serious Adverse Events

  Vaccinations were given at 0-, 1-, 2-month interval, number of subjects with the occurrence of serious adverse events at days 0-7 post vaccination

  After each vaccination (Day 0), follow-up visits were scheduled on Days 1, 2, 3, and 7 post vaccination

Secondary Outcomes (2)

• Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group

  After each vaccination, blood draws performed on Days 0, 14, 28, 42, 56, 70 and 112

• Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group

  After each vaccination, blood draws performed on Days 0, 14, 28, 42, 56, 70 and 112

Study Arms (2)

50 µg of FMP010 antigen in 0.5 mL AS01B adjuvant

EXPERIMENTAL

50 µg of FMP010 antigen in 0.5 mL AS01B adjuvant given intramuscularly in the deltoid muscle of the non-dominant arm.

Biological: Plasmodium falciparum Malaria Protein 010 (FMP010)

Rabies Vaccine Rabipur

EXPERIMENTAL

Rabies Vaccine Rabipur given intramuscularly in the deltoid muscle of the non-dominant arm.

Biological: Rabipur

Interventions

Plasmodium falciparum Malaria Protein 010 (FMP010) BIOLOGICAL

Vaccine antigen is a recombinant protein based on merozoite surface protein-1 (MSP-1) of FVO strain of Plasmodium falciparum, and adjuvant AS01B is a proprietary adjuvant of GSK

50 µg of FMP010 antigen in 0.5 mL AS01B adjuvant

Rabipur BIOLOGICAL

Rabipur is a licensed rabies vaccine.

Rabies Vaccine Rabipur

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-lactating female 18 to 50 years of age (inclusive) at the time of screening
• Free of significant health problems as established by medical history and clinical examination before entering into the study
• Available to participate for duration of study (approximately seven months)
• If the subject is female, she must be of non-childbearing potential (either surgically sterilized or one year post-menopausal) or, if of childbearing potential, she must have a negative pregnancy test at the time of vaccination, be capable of preventing pregnancy for at least one month prior to determination of eligibility (to include abstinence or contraceptives (for example intrauterine contraceptive device; oral contraceptives; Norplant® or Depo-Provera® ), and must agree to continue such precautions for two months after completion of the vaccination series.
• Written informed consent must be obtained from the subject before screening procedures.

You may not qualify if:

• Prior receipt of any investigational malaria vaccine
• Prior receipt of a vaccine containing either QS-21, MPL or AS02A or AS01B
• Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period
• Administration of chronic (defined as more than 14 days) immunosuppressants or other immune modifying drugs within six months of vaccination. For corticosteroids, this is defined as prednisone, or equivalent, 0.5 mg/kg/day. Inhaled and topical steroids are allowed.
• Planned administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of the study vaccine.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
• A family history of congenital or hereditary immunodeficiency
• Chronic or active neurologic disease including seizure disorder
• History of splenectomy
• Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or abnormal baseline laboratory screening tests
• ALT above normal range
• Creatinine above normal range
• Hemoglobin below normal range
• Platelet count below normal range
• Total white cell count below normal

Sponsors & Collaborators

• U.S. Army Medical Research and Development Command: lead
• GlaxoSmithKline: collaborator
• United States Agency for International Development (USAID): collaborator
• Walter Reed Army Institute of Research (WRAIR): collaborator
• Kenya Medical Research Institute: collaborator

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Nekoye Otsyula
• Organization: US Army Medical Research Unit - Kenya

notsyula@wrp-ksm.org

254-722-239-828

Study Officials

• Nekoye Otsyula

  US Army Medical Research Unit - Kenya

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2015
• First Posted: May 29, 2015
• Study Start: April 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: June 1, 2009
• Last Updated: June 28, 2023
• Results First Posted: June 9, 2020

Record last verified: 2023-06