MalariaPhase 1NCT02458092
Evaluate the Safety and Efficacy of Plasmodium Falciparum Malaria Protein 010 (FMP010) Administered With Adjuvant AS01B
A Phase 1 study testing Plasmodium falciparum Malaria Protein 010 (FMP010) and Rabipur in people with Malaria, run by U.S. Army Medical Research and Development Command.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- Plasmodium falciparum Malaria Protein 010 (FMP010) and Rabipur
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Apr 2008to Jun 2009
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- • 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.
Who cannot join
- • 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
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- 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
About this study
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
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.
Read the 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.
- Conditions
- Malaria
- Being tested
- Plasmodium falciparum Malaria Protein 010 (FMP010), Rabipur
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
RabipurBiological
Rabipur is a licensed rabies vaccine.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Biological: Rabipur |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Antibody concentrations will be presented by reporting the summarized Geometric Mean Titer (GMT) values with 95% Confidence Interval (CI) (not presented in results), at each time point at which blood samples are taken for serology.
Peak responses (Day 70) will be compared by Student's T test on data normalized by log transformation to ascertain presence or absence of significant dose response difference. GMTs are presented without CI data.
Measured: 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
Antibody concentrations will be presented by reporting the summarized Geometric Mean Titer (GMT) values with 95% Confidence Interval (CI) at each time point at which blood samples are taken for serology.
Peak responses (Day 70) will be compared by Student's T test on data normalized by log transformation to ascertain presence or absence of significant dose response difference. GMTs are presented without CI data.
Measured: After each vaccination, blood draws performed on Days 0, 14, 28, 42, 56, 70 and 112
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2015 (estimated)
- Study startApr 2008
- Primary completionDec 2008
- Study completionJun 2009
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 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- U.S. Army Medical Research and Development Command
- Sponsor type
- US federal agency
- Collaborators
- GlaxoSmithKline, United States Agency for International Development (USAID), Walter Reed Army Institute of Research (WRAIR), Kenya Medical Research Institute
- Responsible party
- Sponsor
- Investigators
- Nekoye Otsyula, Principal investigator, US Army Medical Research Unit - Kenya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02458092
- Sponsor's protocol ID
- A-14620.b
- Other IDs
- WRAIR 1417
- Status last verified
- Jun 2023
- First submitted
- 27 May 2015
- Last updated
- 28 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02458092
- Acronym / sponsor ID
- A-14620.b
- Conditions
- Malaria
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- U.S. Army Medical Research and Development CommandUS federal agency
- Collaborators
- GlaxoSmithKline, United States Agency for International Development (USAID), Walter Reed Army Institute of Research (WRAIR), Kenya Medical Research Institute
- Study start
- Apr 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 29 May 2015 (estimated)
- Results
- Posted 9 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 50 µg of FMP010 antigen in 0.5 mL AS01B adjuvant | Experimental | Biological: Plasmodium falciparum Malaria Protein 010 (FMP010)50 µg of FMP010 antigen in 0.5 mL AS01B adjuvant given intramuscularly in the deltoid muscle of the non-dominant arm. |
| Rabies Vaccine Rabipur | Experimental | Biological: RabipurRabies Vaccine Rabipur given intramuscularly in the deltoid muscle of the non-dominant arm. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- • A male or non-lactating female 18 to 50 years of age (inclusive) at the time of screening
- 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.
Key exclusion criteria (28 listed)
- • Prior receipt of any investigational malaria vaccine
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 |
|---|---|---|
| Plasmodium falciparum Malaria Protein 010 (FMP010)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 | Biological | 50 µg of FMP010 antigen in 0.5 mL AS01B adjuvant |
| RabipurRabipur is a licensed rabies vaccine. | Biological | Rabies Vaccine Rabipur |
Primary outcome
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade
Time frame: After each vaccination (Day 0), follow-up visits were scheduled on Days 1, 2, 3, and 7
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
Number of Subjects With Unsolicited Adverse Events at Specified Grades
Time frame: After each vaccination (Day 0), 30 day f/u period post vaccination
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
Number of Subjects With the Occurrence of Serious Adverse Events
Time frame: After each vaccination (Day 0), follow-up visits were scheduled on Days 1, 2, 3, and 7 post vaccination
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
2 secondary outcomes
Antibody Titers Per Subject by Enzyme Linked Immunosorbent Assay in 50 µg Dose Group
Time frame: 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
Time frame: After each vaccination, blood draws performed on Days 0, 14, 28, 42, 56, 70 and 112
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Nekoye Otsyula principal investigator
US Army Medical Research Unit - Kenya
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Plasmodium falciparum Malaria Protein 010 (FMP010) and Rabipur in people with Malaria, run by U.S. Army Medical Research and Development Command.
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 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 28 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
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 9 Jun 2020). 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?
Number of Participants With Solicited Adverse Events With Each Vaccination by Grade (time frame: After each vaccination (Day 0), follow-up visits were scheduled on Days 1, 2, 3, and 7). The study lists 3 primary outcomes in all. 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 28 Jun 2023.