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Plasmodium Falciparum MalariaPhase 1NCT00358332

Phase I Pediatric FMP2.1/AS02A Trial in Mali

A Phase 1 study testing FMP2.1/AS02A and Rabies vaccine (RabAvert) in people with Plasmodium Falciparum Malaria, run by U.S. Army Medical Research and Development Command at 1 site in Mali.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 1 year to 6 yearsHealthy volunteers can take part
Conditions the study is for
Plasmodium Falciparum Malaria
What is being tested?
FMP2.1/AS02A and Rabies vaccine (RabAvert)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteMali
Study dates
Nov 2006to Dec 2007
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 6 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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).

Who cannot join

  • 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.
Show all 17Show fewer
  • 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.
  • Acute or chronic pulmonary, cardiovascular, hepatic, renal or neurological condition, severe malnutrition, or any other clinical findings that in the opinion of the Principal Investigator (PI) may increase the risk of participating in the study.
  • Other condition that in the opinion of the PI would jeopardize the safety or rights of a participant in the trial or would render the participant unable to comply with the protocol.

Trial locations and contacts

1 site in 1 country.

Mali1 site

  • University of Bamako, Malaria Research and Training Center

    Bamako

Other trials in Mali

About this study

Official title: Randomized, Controlled, Dose Escalation Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of WRAIR's AMA-1 Malaria Vaccine (FMP2.1) Adjuvanted in GSKBio's AS02A Vs. Rabies Vaccine in 1-6 Year Old Children in Bandiagara, Mali

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.

Read the detailed description

This study is a randomized, controlled, dose-escalation, phase I trial of the FMP2.1/AS02A malaria vaccine, using rabies vaccine as a control. This study is linked to DMID protocol 07-0003. The primary objective of this study is to evaluate the safety and reactogenicity of FMP2.1/AS02A in children naturally exposed to P. falciparum malaria infection. The secondary objective is to measure the magnitude and duration of antibody response to FMP2.1 by enzyme-linked immunosorbent assay (ELISA). One hundred healthy children aged 1-6 years in Bandiagara, Mali, will be randomized to 1 of 3 possible groups. Twenty subjects will be enrolled in cohort 1 and 40 subjects each in cohorts 2 and 3. Children within each cohort will be randomized in a 3:1 ratio to receive 10, 25 or 50 micrograms of FMP2.1 (in cohorts 1, 2 and 3, respectively) adjuvanted with a proportionate volume of the AS02A, or rabies vaccine. Thus a total of 75 children will receive the malaria vaccine and 25 the rabies vaccine. Immunizations will be given on days 0, 30 and 60 in a staggered fashion, with the first administrations of the 25 and 50 microgram dose levels of FMP2.1 following the first administration of the 10 and 25 microgram dose levels, respectively, by 2-3 weeks. Solicited adverse events will be recorded on the days of immunization and days 1, 2, 3 and 7 after each immunization, and unsolicited adverse events will be recorded for 30 days after each immunization. Children will be followed for 1 year after the last immunization. Sera will be collected for anti-FMP2.1 antibody titers on the days of immunization and 14 days after each immunization as well as 3, 6, 9 and 12 months after the first immunization. Each child will participate in the study for up to 414 days, which includes the screening period. The primary outcome measures include: occurrence of solicited symptoms after each vaccination during a 7-day surveillance period (day of vaccination and days 1, 2, 3 and 7 after vaccination), occurrence of unsolicited symptoms after each vaccination during a 30-day surveillance period (day of vaccination and 30 subsequent days); and occurrence of serious adverse events throughout the study period. The secondary outcome measure is titers and activity of anti-FMP2.1 antibody at each time point where serology samples are analyzed, measured by ELISA.

Being tested
FMP2.1/AS02A, Rabies vaccine (RabAvert)
Keywords
malaria, vaccine, Mali, children
Medical subject headings
Malaria, Falciparum, Malaria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FMP2.1/AS02ABiological

    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.

  • Rabies vaccine (RabAvert)Biological

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

Study groups in NCT00358332
Study groupRoleWhat they receive
Group 1: FMP2.1/AS02A 10 mcg dose or rabies vaccine.Experimental20 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.
Receives: Biological: FMP2.1/AS02A; Biological: Rabies vaccine (RabAvert)
Group 2: FMP2.1/AS02A 25 mcg dose or rabies vaccine.Experimental40 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.
Receives: Biological: FMP2.1/AS02A; Biological: Rabies vaccine (RabAvert)
Group 3: FMP2.1/AS02A 50 mcg dose or rabies vaccine.Experimental40 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.
Receives: Biological: FMP2.1/AS02A; Biological: Rabies vaccine (RabAvert)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 7 Days following any vaccination

  2. 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.

    Measured: Day of vaccination and 30 subsequent days.

  3. 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.

    Measured: 1 year after the last vaccination.

  4. 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.

    Measured: 7 Days following any vaccination

Secondary outcomes (7)

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

    This outcome is the mean of the log anti-FMP2.1 antibody response measured by ELISA.

    Measured: Day 0

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

    This outcome is the mean of the log anti-FMP2.1 antibody response measured by ELISA.

    Measured: Day 30 +/- 7 days

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

    This outcome is the mean of the log anti-FMP2.1 antibody response measured by ELISA.

    Measured: Day 60 +/- 7 days

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

    This outcome is the mean of the log anti-FMP2.1 antibody response measured by ELISA.

    Measured: Day 90 +/- 10 days

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

    This outcome is the mean of the log anti-FMP2.1 antibody response measured by ELISA.

    Measured: Day 180 +/- 14 days

  6. Anti-FMP2.1 Antibody Titers Measured by ELISA, at Day 272.

    This outcome is the mean of the log anti-FMP2.1 antibody response measured by ELISA.

    Measured: Day 272 +/- 14 days

  7. Anti-FMP2.1 Antibody Titers Measured by ELISA, at Day 364

    This outcome is the mean of the log anti-FMP2.1 antibody response measured by ELISA.

    Measured: Day 364 +/- 14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jul 2006 (estimated)
  2. Study startNov 2006
  3. Primary completionDec 2007
  4. Study completionDec 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00358332
Sponsor's protocol ID
05-0146
Other IDs
U19AI065683, 2U01AI065683-06, GSKBio: Malaria 051 (106874)
Status last verified
Oct 2011
First submitted
27 Jul 2006
Last updated
24 Oct 2011

Publications

  • 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.

    PubMed 20140214

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing FMP2.1/AS02A and Rabies vaccine (RabAvert) in people with Plasmodium Falciparum Malaria, run by U.S. Army Medical Research and Development Command at 1 site in Mali.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mali. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Mar 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of Solicited Systemic Symptoms During a 7-day Surveillance Period (Systematically Collected) Following Vaccinations at Days 0, 30, and 60. (time frame: 7 Days following any vaccination). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00358332, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2011; AzTrials last refreshed its copy on 7 Nov 2026.

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