Clinical trial NCT02458092: Evaluate the Safety and Efficacy of Plasmodium Falciparum Malaria Protein 010 (FMP010) Administered With Adjuvant AS01B
Official title: Phase 1b Controlled Double Blind Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of the Candidate Plasmodium Falciparum Malaria Protein 010 (FMP010) Administered Intramuscularly With Glaxo Smith Kline (GSK) Biologicals' Adjuvant AS01B
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Malaria
Lead sponsor: U.S. Army Medical Research and Development Command
Sponsor class: FED
Collaborators: name: GlaxoSmithKline
name: United States Agency for International Development (USAID)
name: Walter Reed Army Institute of Research (WRAIR)
name: Kenya Medical Research Institute
First posted: 2015-05-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: Study is to evaluate the safety, reactogenicity, and immunogenicity fo the candidate Plasmodium falciparum malaria protein 10 (FMP010). Malaria-experienced adults will be enrolled and randomized into 2 groups. Subjects will receive full dose FMP010 antigen (approximately 50 μg) in 0.5 mL AS01B adjuvant or licensed rabies vaccine Rabipur (by Novartis) supplied in single dose vials containing lyophilized antigen with 1.0 mL of diluent (sterile water) for injection.

Eligibility criteria: Inclusion Criteria:

* • 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.

Exclusion Criteria:

* • 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
  * Acute disease at the time of enrollment (acute disease is defined as the presence of a moderate or severe illness with or without fever). All vaccines can be administered to persons with a minor illness, such as diarrhea or mild upper respiratory infection without fever, i.e. Oral temperature \< 37.5°C.
  * Hepatomegaly, right upper quadrant abdominal pain or tenderness
  * 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/drug abuse as obtained by history and physical examination
  * Female who is willing or intends to become pregnant during the study
  * Any history of allergic reaction or anaphylaxis to previous vaccination
  * Unwilling to allow blood samples to be stored for future use
  * Inability to make follow up visits
  * Allergy to kanamycin, nickel, or imidazole
  * 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
  * Previous allergy to Rabies Vaccine
  * Allergy to chicken and chicken products

Primary outcomes:
measure: Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
timeFrame: After each vaccination (Day 0), follow-up visits were scheduled on Days 1, 2, 3, and 7
measure: Number of Subjects With Unsolicited Adverse Events at Specified Grades
timeFrame: After each vaccination (Day 0), 30 day f/u period post vaccination
measure: Number of Subjects With the Occurrence of Serious Adverse Events
timeFrame: After each vaccination (Day 0), follow-up visits were scheduled on Days 1, 2, 3, and 7 post vaccination
Secondary outcomes:
measure: Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
timeFrame: After each vaccination, blood draws performed on Days 0, 14, 28, 42, 56, 70 and 112
measure: Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in Rabies Vaccine Group
timeFrame: After each vaccination, blood draws performed on Days 0, 14, 28, 42, 56, 70 and 112
Other outcomes:
Locations:
Study officials:
affiliation: US Army Medical Research Unit - Kenya
name: Nekoye Otsyula
role: PRINCIPAL_INVESTIGATOR
References: