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AzTrials

MalariaPhase 1NCT02174978

Phase 1 Clinical Trial With Controlled Human Malaria Infection (CHMI) to Evaluate the Safety and Efficacy of the Plasmodium Falciparum Vaccine Candidate FMP012 Administered Intramuscularly With AS01B Adjuvant System in Healthy Malaria-Naïve Adults

A Phase 1 study testing FMP012 with AS01B adjuvant system in people with Malaria, run by U.S. Army Medical Research and Development Command at 1 site in United States.

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 proposed study is a Phase 1 study with controlled human malaria infection (CHMI) designed primarily to evaluate the safety of the FMP012 combined with AS01B adjuvant system. AS01B is a proprietary current good manufacturing practices (cGMP) grade adjuvant manufactured by GlaxoSmithKline (GSK) Biologicals. 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?
FMP012 with AS01B adjuvant system
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
1 siteUnited States
Study dates
Aug 2014to Oct 2015
Phase
Phase 1
Are there results?
None posted in the registry

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

  • Healthy adults (male or non-pregnant, non-lactating female) 18 to 50 years of age (inclusive) at the time of screening
  • If the subject is female,
  • Non-childbearing potential (ie, either surgically sterilized or one year post-menopausal), abstinent or using adequate contraceptive precautions (eg, intrauterine contraceptive device; oral contraceptives; diaphragm or condom in combination with contraceptive jelly, cream or foam; Norplant® or Depo-Provera®) during this study and must agree to continue such precautions until three months after challenge
  • A negative pregnancy test at the time of enrollment
  • Free of significant health problems as established by medical history, laboratory, and clinical examination before entering the study
  • Subjects must have low cardiac risk factors according to the National Health and Nutrition Examination Survey (NHANES) I criteria, medical history and family history, blood pressure measurements, and a normal or normal variant ECG
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  • Available to participate and reachable by phone for duration of study (approximately 8-14 months) and reachable by phone at the 6 month post Controlled Human Malaria Infection (CMHI) follow-up
  • No plans to travel to outside the Washington DC area between the day of challenge and either completion of treatment course (post-challenge) or, if subject remains uninfected, 28 days post-challenge
  • No plans to travel to a malaria endemic area during the course of the study
  • Written informed consent must be obtained from the subject before screening procedures are performed
  • Subjects must score at least 80% correct on a multiple-choice quiz that assesses their understanding of this study
  • If a subject is active duty military, he or she must obtain approval from his or her supervisor per Walter Reed Army Institute of Rese (WRAIR) Policy 11-45

Who cannot join

  • Any history of malaria infection
  • History of travel to P falciparum endemic areas in the 3 months prior to day of first vaccination (Vaccination Groups) or day of challenge (Infectivity Control Group)
  • Any history of receiving a malaria vaccine
  • Receipt of any licensed vaccine within 7 days prior to first vaccination (Note: subjects are encouraged to get recommended licensed preventive vaccinations during the course of the study but are requested to schedule any routine preventive vaccinations for at least 7 days before or after a scheduled FMP012/AS01B vaccination day)
  • History of receipt of malaria prophylaxis during the 2 months prior to day of first vaccination (Vaccination Groups) or day of challenge (Infectivity Control Group)
  • History of use of any antibiotics with significant antimalarial activity (examples include tetracycline, doxycycline, clindamycin, azithromycin, and sulfa drugs) during the course of the study period (period starting one month prior to challenge, Infectivity Control Group)
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  • Use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of study vaccine or planned use during the study period.
  • Any history of allergic reaction or anaphylaxis to previous vaccination (Vaccination Groups)
  • Allergy to egg protein (Vaccination Groups)
  • Pregnant (positive β-human chorionic gonadotropin test, β-HCG) or lactating female at screening or plans to become pregnant or breastfeed from the time of enrollment until three months after challenge
  • Allergy to antimalarial drugs or use of medications known to interact with chloroquine (CQ)
  • Significant (eg, systemic) hypersensitivity reactions to mosquito bites (local hypersensitivity reactions at the site of mosquito bites are not an exclusion criterion)
  • History of sickle cell disease
  • History of psoriasis or porphyria
  • History of splenectomy
  • Any confirmed or suspected immunodeficiency, including HIV infection
  • Administration of chronic (defined as more than 14 days) immunosuppressive drugs or other immune-modifying drugs within 6 months of vaccination
  • History of autoimmune disease
  • Family history of congenital or hereditary immunodeficiency
  • Acute or chronic, clinically significant, pulmonary, cardiovascular, endocrine, hepatic, or renal functional abnormality, as determined by history, physical examination, or laboratory evaluation
  • Chronic or active neurologic disease including seizure disorder and chronic migraine headaches
  • Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or any planned administration during the study period
  • Any abnormal baseline laboratory screening tests to include:
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) above normal range,
  • Creatinine above normal range,
  • Hemoglobin out of normal range,
  • Platelet count out of normal range, or
  • Total white blood cell (WBC) count out of normal range
  • Seropositive for HIV or Hepatitis C virus (HCV) or hepatitis B surface antigen (HBsAg) positive
  • Hepatomegaly, right upper quadrant abdominal pain or tenderness
  • An abnormal baseline screening ECG suggestive of cardiac disease as determined by a clinical investigator
  • Suspected or known current alcohol or drug abuse as determined from the medical history or by physical examination
  • Any other significant finding that in the opinion of the PI 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

  • Clinical Trials Center, WRAIR

    Silver Spring, Maryland, 20910

Other trials in United States

About this study

Official title: Phase 1 Clinical Trial With Controlled Human Malaria Infection (CHMI) Open-label Dose Safety, Reactogenicity, Immunogenicity, and Efficacy of the Vaccine Candidate Plasmodium Falciparum Malaria Protein (FMP012), Administered Intramuscularly With AS01B Adjuvant System in Healthy Malaria-Naïve Adults

The proposed study is a Phase 1 study with controlled human malaria infection (CHMI) designed primarily to evaluate the safety of the FMP012 combined with AS01B adjuvant system. AS01B is a proprietary current good manufacturing practices (cGMP) grade adjuvant manufactured by GlaxoSmithKline (GSK) Biologicals. It is a formulation based on liposomes mixed with the immunostimulants monophosphoryl lipid (MPL) and Quillaja saponaria (QS)-21. The immunogenicity and efficacy of this new candidate vaccine will be evaluated in addition to safety.

Conditions
Malaria
Being tested
FMP012 with AS01B adjuvant system, P falciparum Controlled Human Malaria Infection (CHMI)
Keywords
Malaria vaccine
Medical subject headings
Malaria

What participants receive

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

  • FMP012 with AS01B adjuvant systemBiological

    Also called FMP012 antigen adjuvanted with AS01B

    Candidate malaria vaccine based on the recombinant protein FMP012, which is Escherichia coli-expressed Plasmodium falciparum cell-traversal protein for ookinetes and sporozoites (PfCelTOS)

  • P falciparum Controlled Human Malaria Infection (CHMI)Other

Study groups in NCT02174978
Study groupRoleWhat they receive
Group 1: 10 µg FMP012 adjuvanted AS01BExperimentalFMP012 with AS01B adjuvant system: 10 µg FMP012 antigen reconstituted with 500 µL AS01B adjuvant to equal 0.5 mL final volume. Doses administered intramuscular at week 0, 4, 8, and 24. On week week 27, there is a P falciparum Controlled Human Malaria Infection (CHMI) challenge.
Receives: Biological: FMP012 with AS01B adjuvant system; Other: P falciparum Controlled Human Malaria Infection (CHMI)
Group 2: 30 µg FMP012 adjuvanted AS01BExperimentalFMP012 with AS01B adjuvant system: 30 µg FMP012 antigen reconstituted with 500 µL AS01B adjuvant to equal 0.5 mL final volume administered intramuscular at week 2, 6, 10, and 24. On week week 27, there is a challenge with P falciparum Controlled Human Malaria Infection (CHMI).
Receives: Biological: FMP012 with AS01B adjuvant system; Other: P falciparum Controlled Human Malaria Infection (CHMI)
Infectivity controlOtherNon-immunized infectivity control challenged with P falciparum Controlled Human Malaria Infection (CHMI)
Receives: Other: P falciparum Controlled Human Malaria Infection (CHMI)

What is being measured

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

  1. Number of solicited adverse events (AE)

    Measured: 7 days after each vaccination

  2. Number of unsolicited AEs

    Measured: 28 days after each vaccination

  3. Occurrence of serious adverse events (SAE) at any time during the study period (enrollment to final follow-up visit)

    Measured: 12 months after vaccination

Secondary outcomes (2)

  1. Anti-FMP012 antibody titers in serum

    Measured: 12 months

  2. Time to parasitemia by blood smear after the P falciparum challenge

    Measured: 12 months

Timeline

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

  1. First posted26 Jun 2014 (estimated)
  2. Study startAug 2014
  3. Primary completionJun 2015
  4. Study completionOct 2015

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02174978
Sponsor's protocol ID
S-14-02
Status last verified
Oct 2017
First submitted
11 Jun 2014
Last updated
13 Oct 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing FMP012 with AS01B adjuvant system in people with 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 12 inclusion and 33 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 13 Oct 2017. 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 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 solicited adverse events (AE) (time frame: 7 days after each vaccination). 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?

On the ClinicalTrials.gov record for NCT02174978.

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 13 Oct 2017.

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