AzTrials
AzTrials

MalariaPhase 1NCT00666380

A Study to Determine the Effects of an Investigational Malaria Vaccine Given to Adults Living in the United States and Thereafter to Adults Living in Kenya

A Phase 1 study testing Plasmodium falciparum Malaria Protein 010 (FMP010) in people with Malaria, run by U.S. Army Medical Research and Development Command at 2 sites in 2 countries.

Completed

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

Official record
Search all trials

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)
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
2 sitesin 2 countries
Study dates
Apr 2008to Jun 2009
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

  • A male or non-pregnant, 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 be capable of preventing pregnancy, have a negative pregnancy test at the time of each vaccination, and must agree to continue such precautions for two months after completion of the vaccination series.
  • If the volunteer indicates he/she is active duty military (on the DCT sign-in page and intake form), approval from their supervisor through the Division Director using the Statement of Supervisor's Approval Form must be signed and on file prior to receipt of any test product
  • Written informed consent must be obtained from the subject before screening procedures.
  • Test of Understanding
  • Prior to entry into this study, subjects must score at least 80% correct on a 10- question multiple-choice quiz that assesses their understanding of this study. If they do not score 80% on the initial quiz, the protocol information will be reviewed with them to ensure comprehension, and they will have the opportunity to retest. If a volunteer fails to correctly answer 8 of 10 questions after two attempts they will be excluded from the study.

Who cannot join

  • Prior receipt of any investigational malaria vaccine
  • Prior receipt of a vaccine containing either QS-21, MPL or AS02 or AS01
  • 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 past history of malaria
Show all 28Show fewer
  • Planned travel to malarious areas during the study period
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
  • 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 range
  • 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
  • Seropositive for HIV, Hepatitis C virus (antibodies to HCV) and/or HBsAg
  • 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
  • Inability to make follow-up visits or complete diary cards
  • 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

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

United States1 site

  • Department of Clinical Trials, WRAIR

    Silver Spring, Maryland, 20910

Other trials in United States

Kenya1 site

  • USAMRU-K/ KEMRI. Walter Reed Project

    Kombewa, Kisumu, Nyanza Province

Other trials in Kenya

About this study

Official title: Phase 1a Open-label Dose Escalation Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of the Candidate Plasmodium Falciparum Malaria Protein 010 (FMP010) Administered Intramuscularly With GSK Biologicals' Adjuvant AS01B in Healthy Malaria-Naïve Adults

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

The study begins with the US phase in which 26 volunteers aged 18 to 50 years will be enrolled to receive an investigational malaria vaccine. The vaccine is made of a malaria protein FMP010 mixed in the adjuvant AS01B. Since this vaccine has not yet been in humans, first, 5 volunteers will get a small (10 µg) dose of FMP010 in AS01B. If it is safe, then 20 volunteers will get 50 µg FMP010 in AS01B. Vaccinations are given IM in the deltoid of the non-dominant arm, every month for 3 months. After each vaccination, the subjects will follow up at clinical trials for evaluation of any adverse events. There will be blood draws to assess safety of the vaccine as well as the level of immune response generated to the vaccine.

Upon receipt of preliminary safety results, the Kenya phase begins in which 30 volunteers who are randomized to receive either 50 µg FMP010 in AS01B (20) or the rabies vaccine (10). Vaccination and is on the same schedule as in the US phase and follow-up is for 112 days.

Conditions
Malaria
Being tested
Plasmodium falciparum Malaria Protein 010 (FMP010)
Keywords
Malaria, Vaccine, MSP-1 (merozoite surface protein-1), Phase 1
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

Study groups in NCT00666380
Study groupRoleWhat they receive
10 ug of FMP010 antigen in 0.5 mL AS01B adjuvantExperimentalNot described
Receives: Biological: Plasmodium falciparum Malaria Protein 010 (FMP010)
50 ug of FMP010 antigen in 0.5 mL AS01B adjuvantExperimentalNot described
Receives: Biological: Plasmodium falciparum Malaria Protein 010 (FMP010)

What is being measured

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

  1. Number of solicited adverse events

    Occurrence and intensity of solicited symptoms on day of vaccination and Days 1-7 after each vaccination

    Measured: 7 days

  2. Number of unsolicited adverse events

    Occurrence and intensity of unsolicited symptoms over a 30-day follow-up period (day of vaccination and 29 subsequent days) after each vaccination

    Measured: 30 days

  3. Number of serious adverse events

    Measured: 1 year

Secondary outcomes (1)

  1. Percent parasite growth inhibition

    Functionality of antibodies elicited as measured by percent parasite growth inhibition in GIA against homologous (FVO) and heterologous (3D7) parasites

    Measured: Up to 112 days

Timeline

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

  1. First posted24 Apr 2008 (estimated)
  2. Study startApr 2008
  3. Primary completionDec 2008
  4. Study completionJun 2009

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
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00666380
Sponsor's protocol ID
A-14620.a
Other IDs
A-14620 (HSRRB), WRAIR 1417
Status last verified
May 2015
First submitted
22 Apr 2008
Last updated
29 May 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Bashir IM, Otsyula N, Awinda G, Spring M, Schneider P, Waitumbi JN. Comparison of PfHRP-2/pLDH ELISA, qPCR and microscopy for the detection of plasmodium events and prediction of sick visits during a malaria vaccine study. PLoS One. 2013;8(3):e56828. doi: 10.1371/journal.pone.0056828. Epub 2013 Mar 15.

    PubMed 23554856

  • Otsyula N, Angov E, Bergmann-Leitner E, Koech M, Khan F, Bennett J, Otieno L, Cummings J, Andagalu B, Tosh D, Waitumbi J, Richie N, Shi M, Miller L, Otieno W, Otieno GA, Ware L, House B, Godeaux O, Dubois MC, Ogutu B, Ballou WR, Soisson L, Diggs C, Cohen J, Polhemus M, Heppner DG Jr, Ockenhouse CF, Spring MD. Results from tandem Phase 1 studies evaluating the safety, reactogenicity and immunogenicity of the vaccine candidate antigen Plasmodium falciparum FVO merozoite surface protein-1 (MSP1(42)) administered intramuscularly with adjuvant system AS01. Malar J. 2013 Jan 23;12:29. doi: 10.1186/1475-2875-12-29.

    PubMed 23342996

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Plasmodium falciparum Malaria Protein 010 (FMP010) in people with Malaria, run by U.S. Army Medical Research and Development Command at 2 sites in 2 countries.

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 8 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 29 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, Kenya. 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 (time frame: 7 days). 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 NCT00666380, which also lists 2 linked publications.

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 29 May 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in