Phase I Pediatric FMP2.1/AS02A Trial in Mali

NCT00358332 | Completed Phase 1 Results

• 4 other identifiers: 05-0146U19AI0656832U01AI065683-06GSKBio: Malaria 051 (106874)
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test the safety and dosages of a malaria vaccine in 100 children, 1-6 years old, in Bandiagara, Mali. The study is testing the safety of the vaccine when it is given to people who are regularly exposed to malaria and it will provide information regarding optimal vaccine dosage. This study will compare 3 injections of different vaccine doses to a rabies vaccine that is already approved. During the study, the child's health will be checked in the clinic and during home visits. Children may participate for about 14 months, and blood will be taken from each child throughout the study. If the child becomes sick from malaria, he/she will be treated. Information from this study may be used to develop a malaria vaccine that will help control the disease.

Conditions

Plasmodium Falciparum Malaria

Keywords

malaria, vaccine, Mali, children

Outcome Measures

Primary Outcomes (4)

• Occurrence of Solicited Systemic Symptoms During a 7-day Surveillance Period (Systematically Collected) Following Vaccinations at Days 0, 30, and 60.

  The number of participants reporting drowsiness irritability/fussiness, loss of appetite, vomiting, and feverishness. Participants are counted only once but may have experienced symptoms on multiple occasions.

  7 Days following any vaccination

• Occurrence of Unsolicited Symptoms During a 30-day Surveillance Period Following Vaccinations at Days 0, 30, and 60.

  The number of participants spontaneously reporting any symptom (defined as any Adverse Event considered associated with the product) within 30 days of any vaccination. Participants are counted only once but may have experienced events on multiple occasions.

  Day of vaccination and 30 subsequent days.

• Number of Subjects Spontaneously Reporting Any Serious Adverse Event.

  Any untoward medical occurrence that resulted in death, persistent/significant disability/incapacity, required in-patient hospitalization or prolongation thereof, was life threatening or a congenital anomaly/birth defect in offspring of a study subject; or may have jeopardized the participant or required intervention to prevent one of the outcomes.

  1 year after the last vaccination.

• Occurrence of Solicited Local Symptoms During a 7-day Surveillance Period (Systematically Collected) Following Vaccinations at Days 0, 30, and 60.

  The number of participants reporting pain, swelling and erythema. Participants are counted only once but may have experienced symptoms on multiple occasions.

  7 Days following any vaccination

Secondary Outcomes (7)

• Anti-FMP2.1 Antibody Titers Measured by ELISA, at Day 0

  Day 0

• Anti-FMP2.1 Antibody Titers Measured by ELISA, at Day 30

  Day 30 +/- 7 days

• Anti-FMP2.1 Antibody Titers Measured by ELISA, at Day 60

  Day 60 +/- 7 days

• Anti-FMP2.1 Antibody Titers Measured by ELISA, at Day 90

  Day 90 +/- 10 days

• Anti-FMP2.1 Antibody Titers Measured by ELISA, at Day 180

  Day 180 +/- 14 days

Study Arms (3)

Group 1: FMP2.1/AS02A 10 mcg dose or rabies vaccine.

EXPERIMENTAL

20 children will be randomized to receive either the 10 mcg dose of FMP2.1/AS02A (n=15) or rabies vaccine (n=5) on study days 0, 30 +/- 7, and 60 +/- 7.

Biological: FMP2.1/AS02A; Biological: Rabies vaccine (RabAvert)

Group 2: FMP2.1/AS02A 25 mcg dose or rabies vaccine.

EXPERIMENTAL

40 children will be randomized to receive either the 25 mcg dose of FMP2.1/AS02A (n=30) or rabies vaccine (n=10) on study days 0, 30 +/- 7, and 60 +/- 7.

Biological: FMP2.1/AS02A; Biological: Rabies vaccine (RabAvert)

Group 3: FMP2.1/AS02A 50 mcg dose or rabies vaccine.

EXPERIMENTAL

40 children will be randomized to receive either the 50 mcg dose of FMP2.1/AS02A (n=30) or rabies vaccine (n=10) on study days 0, 30 +/- 7, and 60 +/- 7.

Biological: FMP2.1/AS02A; Biological: Rabies vaccine (RabAvert)

Interventions

FMP2.1/AS02A BIOLOGICAL

FMP2.1 will be reconstituted in AS02A adjuvant. Dosages: 10, 25, or 50 mcg of FMP2.1 or 0.1, 0.25 or 0.5 mL of FMP2.1/AS02A administered by intramuscular injection.

Group 1: FMP2.1/AS02A 10 mcg dose or rabies vaccine.; Group 2: FMP2.1/AS02A 25 mcg dose or rabies vaccine.; Group 3: FMP2.1/AS02A 50 mcg dose or rabies vaccine.

Rabies vaccine (RabAvert) BIOLOGICAL

RabAvert, white, freeze-dried vaccine for reconstitution with diluent. Dosage: 1.0 mL of rabies vaccine.

Group 1: FMP2.1/AS02A 10 mcg dose or rabies vaccine.; Group 2: FMP2.1/AS02A 25 mcg dose or rabies vaccine.; Group 3: FMP2.1/AS02A 50 mcg dose or rabies vaccine.

Eligibility Criteria

• Age: 1 Year - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age 1-6 years inclusive at the time of screening.
• Residing in Bandiagara town.
• Appear to be in generally good health based on clinical and laboratory investigation.
• Separate written informed consent obtained from the parent/guardian before screening and study start, respectively.
• Available to participate in follow-up for the duration of study (14 months).

You may not qualify if:

• Previous vaccination with an investigational vaccine or a rabies vaccine.
• Use of a investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first study immunization, or planned use up to 30 days after the third immunization.
• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first immunization. This includes any dose level of oral steroids or inhaled steroids, but not topical steroids.
• Confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
• Confirmed or suspected autoimmune disease.
• History of allergic reactions or anaphylaxis to immunizations or to any vaccine component.
• History of serious allergic reactions to any substance, requiring hospitalization or emergent medical care.
• History of allergy to tetracycline, doxycycline, nickel or Imidazole.
• History of splenectomy.
• Laboratory evidence of liver disease (alanine aminotransferase \[ALT\] greater than the upper limit of normal of the testing laboratory = 49.6 U/L).
• Laboratory evidence of renal disease (serum creatinine greater than the upper limit of normal of the testing laboratory = 0.5 mg/dL (44.2 micromol/L), or more than trace protein or blood on urine dipstick testing).
• Laboratory evidence of hematologic disease (absolute leukocyte count \<5,300/mm\^3 or \>15,300/mm\^3, absolute lymphocyte count \<2,300 mm\^3, platelet count \<133,000/mm\^3, or hemoglobin \<9.0 g/dL).
• Chronic skin condition that could interfere with vaccine site reactogenicity assessment.
• Administration of immunoglobulins and/or any blood products within the three months preceding the first study immunization or planned administration during the study period.
• Simultaneous participation in any other interventional clinical trial.

Sponsors & Collaborators

• U.S. Army Medical Research and Development Command: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• Walter Reed Army Institute of Research (WRAIR): collaborator
• GlaxoSmithKline: collaborator
• University of Maryland, Baltimore: collaborator

Study Sites (1)

University of Bamako, Malaria Research and Training Center

Bamako, Mali

Location

Related Publications (1)

• Thera MA, Doumbo OK, Coulibaly D, Laurens MB, Kone AK, Guindo AB, Traore K, Sissoko M, Diallo DA, Diarra I, Kouriba B, Daou M, Dolo A, Baby M, Sissoko MS, Sagara I, Niangaly A, Traore I, Olotu A, Godeaux O, Leach A, Dubois MC, Ballou WR, Cohen J, Thompson D, Dube T, Soisson L, Diggs CL, Takala SL, Lyke KE, House B, Lanar DE, Dutta S, Heppner DG, Plowe CV. Safety and immunogenicity of an AMA1 malaria vaccine in Malian children: results of a phase 1 randomized controlled trial. PLoS One. 2010 Feb 4;5(2):e9041. doi: 10.1371/journal.pone.0009041.

  PMID: 20140214 RESULT

MeSH Terms

Conditions

Malaria, Falciparum; Malaria

Interventions

Rabies Vaccines

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Christopher V. Plowe
• Organization: University of Maryland School of Medicine

cplowe@medicine.umaryland.edu

410-706-3082

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED

Study Record Dates

• First Submitted: July 27, 2006
• First Posted: July 31, 2006
• Study Start: November 1, 2006
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: October 24, 2011
• Results First Posted: March 4, 2009

Record last verified: 2011-10

Locations

MA (1)