Plasmodium Falciparum MalariaPhase 1/2NCT00312663
Phase I/II Trial of a Malaria Vaccine in Adults Living in the United States of America
A Phase 1/2 study testing Falciparum Malaria Protein 11 with AS01B adjuvant. in people with Plasmodium Falciparum Malaria, run by U.S. Army Medical Research and Development Command at 1 site in United States.
Trial summary
Phase I/II Trial of a Malaria Vaccine, FMP011/AS01B, in Adults Living in the United States of America. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Plasmodium Falciparum Malaria
- What is being tested?
- Falciparum Malaria Protein 11 with AS01B adjuvant.
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2006to Apr 2007
- Phase
- Phase 1/2
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- Personal history of autoimmune disease or subjects who describe a first-degree relative with clearly documented autoimmune disease.
- Seropositive for hepatitis B surface antigen.
- Seropositive for Hepatitis C virus (antibodies to HCV).
- 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 as defined by the American Psychiatric Association in DSM IV.
- Chronic or active intravenous drug use.
- History of severe reactions to mosquito bites as defined as anaphylaxis.
- Female who intends to become pregnant during the study.
- Any history of anaphylaxis in reaction to vaccination.
- A clinical history of sickle cell disease or sickle cell trait.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Walter Reed Army Institute of Research
Silver Spring, Maryland, 20910
About this study
Official title: A Phase I/IIa Controlled Study of the Safety, Immunogenicity and Preliminary Efficacy of FMP011/AS01B Candidate Malaria Vaccine in Malaria-naive Adults Living in the United States
Phase I/II Trial of a Malaria Vaccine, FMP011/AS01B, in Adults Living in the United States of America.
Read the detailed description
- Controlled challenge, Phase I/IIa WRAIR study.
- Healthy, malaria-naive adults aged 18 - 50 years.
- 2 groups, 5 subjects in group A (10µg dose) and 13 subjects in group B(50µg dose).
- Control: none for immunization phase; infectivity controls for challenge and rechallenge phases. Six infectivity controls per day of challenge will be enrolled for the challenge phases, with 3 alternates available for challenge if needed.
- Vaccination schedule of 0, 1 months.
- Challenge of up to 13 subjects in Group B.
- Contingent upon short term efficacy, rechallenge of initially protected subjects 6 months (+/- 2 months) after second dose of vaccine.
- Self-contained study.
- Duration of the study, per subject: approximately 15 months (screening, enrollment, vaccination, challenge and rechallenge).
- Data collection will be by done onsite.
- Conditions
- Plasmodium Falciparum Malaria
- Being tested
- Falciparum Malaria Protein 11 with AS01B adjuvant.
- Keywords
- Vaccine, Phase I/II, Malaria, Liver Stage Antigen -1, Falciparum Malaria Protein -11, AS01B, adjuvant
- 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.
Falciparum Malaria Protein 11 with AS01B adjuvant.Biological
malaria experimental vaccine
| Study group | Role | What they receive |
|---|---|---|
| 10ug dose FMP011 | Experimental | Falciparum Malaria Protein 11 with AS01B adjuvant Receives: Biological: Falciparum Malaria Protein 11 with AS01B adjuvant. |
| 50ug dose FMP011 | Experimental | Falciparum Malaria Protein 11 with AS01B adjuvant Receives: Biological: Falciparum Malaria Protein 11 with AS01B adjuvant. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days post vaccination
Secondary outcomes (1)
Anti-LSA-1 Antibody Response in Titer Units on Days 0, 28, 42, and 84
Anti-LSA-1 Antibody Response in Titer Units on Days 0, 28, 42, and 84
Measured: Days 0, 28, 42, and 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2006 (estimated)
- Study startApr 2006
- Primary completionOct 2006
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Plasmodium Falciparum MalariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- U.S. Army Medical Research and Development Command
- Sponsor type
- US federal agency
- Collaborators
- GlaxoSmithKline, The PATH Malaria Vaccine Initiative (MVI), Walter Reed Army Institute of Research (WRAIR)
- Responsible party
- Sponsor
- Investigators
- James F. Cummings, MD, Principal investigator, Walter Reed Army Institute of Research (WRAIR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00312663
- Sponsor's protocol ID
- WRAIR 1250
- Other IDs
- HSRRB A-13734
- Status last verified
- May 2018
- First submitted
- 6 Apr 2006
- Last updated
- 26 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: GlaxoSmithKline, The PATH Malaria Vaccine Initiative (MVI), Walter Reed Army Institute of Research (WRAIR)
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/IIa Controlled Study of the Safety, Immunogenicity and Preliminary Efficacy of FMP011/AS01B Candidate Malaria Vaccine in Malaria-naive Adults Living in the United States
- ClinicalTrials.gov ID
- NCT00312663
- Acronym / sponsor ID
- WRAIR 1250
- Conditions
- Plasmodium Falciparum Malaria
- Keywords
- Vaccine, Phase I/II, Malaria, Liver Stage Antigen -1, Falciparum Malaria Protein -11, AS01B, adjuvant
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- U.S. Army Medical Research and Development CommandUS federal agency
- Collaborators
- GlaxoSmithKline, The PATH Malaria Vaccine Initiative (MVI), Walter Reed Army Institute of Research (WRAIR)
- Study start
- Apr 2006
- Primary completion
- Oct 2006 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 10 Apr 2006 (estimated)
- Results
- Posted 26 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase I/II Trial of a Malaria Vaccine, FMP011/AS01B, in Adults Living in the United States of America.
Detailed description
- Controlled challenge, Phase I/IIa WRAIR study.
- Healthy, malaria-naive adults aged 18 - 50 years.
- 2 groups, 5 subjects in group A (10µg dose) and 13 subjects in group B(50µg dose).
- Control: none for immunization phase; infectivity controls for challenge and rechallenge phases. Six infectivity controls per day of challenge will be enrolled for the challenge phases, with 3 alternates available for challenge if needed.
- Vaccination schedule of 0, 1 months.
- Challenge of up to 13 subjects in Group B.
- Contingent upon short term efficacy, rechallenge of initially protected subjects 6 months (+/- 2 months) after second dose of vaccine.
- Self-contained study.
- Duration of the study, per subject: approximately 15 months (screening, enrollment, vaccination, challenge and rechallenge).
- Data collection will be by done onsite.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 10ug dose FMP011 | Experimental | Biological: Falciparum Malaria Protein 11 with AS01B adjuvant.Falciparum Malaria Protein 11 with AS01B adjuvant |
| 50ug dose FMP011 | Experimental | Biological: Falciparum Malaria Protein 11 with AS01B adjuvant.Falciparum Malaria Protein 11 with AS01B adjuvant |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (28 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Falciparum Malaria Protein 11 with AS01B adjuvant.malaria experimental vaccine | Biological | 10ug dose FMP011, 50ug dose FMP011 |
Primary outcome
Safety - Most Frequently Reported Adverse Events and Grade
Time frame: 30 days post vaccination
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
1 secondary outcome
Anti-LSA-1 Antibody Response in Titer Units on Days 0, 28, 42, and 84
Time frame: Days 0, 28, 42, and 84
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. GlaxoSmithKline, The PATH Malaria Vaccine Initiative (MVI), Walter Reed Army Institute of Research (WRAIR)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James F. Cummings, MD principal investigator
Walter Reed Army Institute of Research (WRAIR)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Falciparum Malaria Protein 11 with AS01B adjuvant. in people with Plasmodium Falciparum Malaria, run by U.S. Army Medical Research and Development Command at 1 site in United States.
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 6 inclusion and 28 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 26 Nov 2018. 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 United States. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 26 Nov 2018). 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?
Safety - Most Frequently Reported Adverse Events and Grade (time frame: 30 days post vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Nov 2018.