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Plasmodium Falciparum MalariaPhase 1NCT00317473

Phase 1 Trial of a Malaria Vaccine in Young Kenyan Children

A Phase 1 study testing FMP1/AS02A Malaria vaccine and Imovax Rabies vaccine in people with Plasmodium Falciparum Malaria, run by U.S. Army Medical Research and Development Command at 1 site in Kenya.

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

To assess the safety and reactogenicity of the FMP-1/AS02A malaria vaccine in malaria-exposed children living in western Kenya and aged 12-47 months Read more about this study

Who is it for?
Ages 12 to 47 monthsHealthy volunteers can take part
Conditions the study is for
Plasmodium Falciparum Malaria
What is being tested?
FMP1/AS02A Malaria vaccine and Imovax Rabies vaccine
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
135 participants
Where
1 siteKenya
Study dates
Jun 2003to Jul 2005
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 12 to 47 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • A healthy male or female child, 12 to 47 months of age at the time of screening.
  • Written informed consent obtained from at least one parent before study start.
  • Available to participate for the duration of the study (12 months).

Who cannot join

  • Acute disease at the time of entry into the study
  • Axillary temperature of 37.5 degrees C
  • Respiratory rate 50
  • Serum ALT 45 IU/l (i.e., > 1.5 X ULN)
  • Decreased renal function: serum creatinine levels > 92.2 mM/l (> 1.1 mg/dl).
  • Significant anemia (Hgb <8 gm/dL).
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  • Thrombocytopenia (Platelets < 100,000 per mm3)
  • Impaired immunity: (Absolute lymphocyte count [ALC] for 1 year olds < 4.0 x 103/mm3; for 2 year olds < 3.0 x 103/mm3; for 3 year olds < 2.0 103/mm3.
  • History of homozygous sickle cell disease (SS).
  • Malnutrition (Z score; Malnutrition = Weight for height < - 3 z scores)
  • Blood transfusion or use of blood-based product in previous 6 months.
  • Prior receipt of a rabies vaccine or an investigational malaria vaccine.
  • Use of any investigational drug or vaccine other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use up to 30 days after the third dose.
  • Administration of chronic (defined as more than 14 days) immunosuppressants or other immune-modifying drugs within six months of vaccination. (For cortico-steroids, this will mean prednisone, or equivalent, greater than or equal to 0.5 mg/kg/day. Inhaled and topical steroids are allowed).
  • Administration or anticipated administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine(s) with the exception of tetanus toxoid.
  • Previous vaccination with a vaccine containing MPL or QS21 (e.g., RTS,S).
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection. (No HIV testing will be undertaken as part of this study.)
  • History of allergic reactions or anaphylaxis to immunizations or to any vaccine components.
  • History of surgical splenectomy.
  • Administration of immunoglobulins or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
  • Simultaneous participation in any other clinical trial.
  • Acute or chronic cardiovascular, pulmonary, hepatic or renal condition, which in the opinion of the PI may increase the risk to the subject from participating in the study.
  • Any other condition or circumstance that in the opinion of the investigator may pose a threat to the subject.

Trial locations and contacts

1 site in 1 country.

Kenya1 site

  • Walter Reed Project Kombewa Clinic

    Kombewa, Nyanza Province

Other trials in Kenya

About this study

Official title: Double-blind,Randomized,Controlled,Dose Escalation Phase 1 Trial in 12-47 Month Old Children in Western Kenya to Evaluate the Safety and Immunogenicity of WRAIR's MSP-1(FMP1) Malaria Vaccine Adjuvanted in GSK's AS02A Versus Rabies Vaccine.

To assess the safety and reactogenicity of the FMP-1/AS02A malaria vaccine in malaria-exposed children living in western Kenya and aged 12-47 months

Read the detailed description

Study consists of 3 cohorts (12 to 23 months, 24 to 35 months, and 36 to 47 months). Within each cohort subjects were randomized in a 2:1 ration to receive one of three dose levels of FMP1/AS02A (Cohort A, 10 ug; Cohort B, 25 ug; Cohort C, 50 ug) or Imovax Rabies vaccine. Immunization was staggered among dose cohorts; subjects in Cohort B received their first immunization only after the Local Medical Monitor and Data Safety Monitoring Board reviewed Cohort A safety data for the eight-day follow-up period following their first immunization. The same procedure was followed for the immunization of Cohort C. This will be conducted in western Kenya a the Walter Reed Project Lumbewa Clinic.

Being tested
FMP1/AS02A Malaria vaccine, Imovax Rabies vaccine
Keywords
Vaccine, Phase 1, Plasmodium falciparum, Malaria, Merozoite surface protein-1, MSP-1, Falciparum malaria protein 1, FMP-1, AS02A
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.

  • FMP1/AS02A Malaria vaccineBiological

    Subjects vaccinated with FMP1/AS02 vaccine

  • Imovax Rabies vaccineBiological

    Subjects vaccinated on corresponding FMP1/AS02A vaccination days

Study groups in NCT00317473
Study groupRoleWhat they receive
FMP1/AS02A Malaria vaccine 10ugExperimentalSubject vaccinated with 10 ug of FMP1/AS02A on days 0, 29 and 57
Receives: Biological: FMP1/AS02A Malaria vaccine
FMP1/AS02A Malaria vaccine 25 ugExperimentalSubject vaccinated with 25 ug of FMP1/AS02A on days 14, 42, and 70
Receives: Biological: FMP1/AS02A Malaria vaccine
FMP1/AS02A Malaria vaccine 50 ugExperimentalSubject vaccinated with 50 ug of FMP1/AS02A on days 28, 56 and 84
Receives: Biological: FMP1/AS02A Malaria vaccine
Imovax Rabies VaccineActive comparatorSubject vaccinated with Imovax Rabies Vaccine on corresponding FMP1/AS021 vaccination days
Receives: Biological: Imovax Rabies vaccine

What is being measured

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

  1. Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination

    Occurrence of any, local, or general solicited symptoms during the 8 day follow-up period

    Measured: 40 days

  2. Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination

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

    Measured: 90 days

  3. Occurrence of Serious Adverse Events During an 8 Month Follow-up Period Following the First Dose of Study Vaccine

    Occurrence of solicited and unsolicited serious adverse events during an 8 month follow-up period following the first dose of study vaccine

    Measured: 8 months

Secondary outcomes (1)

  1. Anti-FMP1 Antibody Titer Responses

    Antibody responses to FMP1 by ELISA following immunization with the study vaccine through 364 days following the first dose of study vaccine

    Measured: 364 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 2006 (estimated)
  2. Study startJun 2003
  3. Primary completionJul 2004
  4. Study completionJul 2005

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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
135 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00317473
Sponsor's protocol ID
WRAIR 1030
Other IDs
HSRRB Log No. A-12094, KEMRI SSC No. 761, HSPC No. HS171
Status last verified
May 2017
First submitted
20 Apr 2006
Last updated
2 Oct 2017
Data monitoring committee
Yes
Individual data sharing
Yes: Kenya Medical Research Institute; WRAIR; The Path Malaria Vaccine Initiative; United States Agency for International Development; GlaxoSmith Kline

Publications

  • Pichyangkul S, Gettayacamin M, Miller RS, Lyon JA, Angov E, Tongtawe P, Ruble DL, Heppner DG Jr, Kester KE, Ballou WR, Diggs CL, Voss G, Cohen JD, Walsh DS. Pre-clinical evaluation of the malaria vaccine candidate P. falciparum MSP1(42) formulated with novel adjuvants or with alum. Vaccine. 2004 Sep 28;22(29-30):3831-40. doi: 10.1016/j.vaccine.2004.07.023.

    PubMed 15364429

  • Ockenhouse CF, Angov E, Kester KE, Diggs C, Soisson L, Cummings JF, Stewart AV, Palmer DR, Mahajan B, Krzych U, Tornieporth N, Delchambre M, Vanhandenhove M, Ofori-Anyinam O, Cohen J, Lyon JA, Heppner DG; MSP-1 Working Group. Phase I safety and immunogenicity trial of FMP1/AS02A, a Plasmodium falciparum MSP-1 asexual blood stage vaccine. Vaccine. 2006 Apr 5;24(15):3009-17. doi: 10.1016/j.vaccine.2005.11.028. Epub 2005 Nov 28.

    PubMed 16356603

  • Stoute JA, Gombe J, Withers MR, Siangla J, McKinney D, Onyango M, Cummings JF, Milman J, Tucker K, Soisson L, Stewart VA, Lyon JA, Angov E, Leach A, Cohen J, Kester KE, Ockenhouse CF, Holland CA, Diggs CL, Wittes J, Heppner DG Jr; MSP-1 Malaria Vaccine Working Group. Phase 1 randomized double-blind safety and immunogenicity trial of Plasmodium falciparum malaria merozoite surface protein FMP1 vaccine, adjuvanted with AS02A, in adults in western Kenya. Vaccine. 2007 Jan 2;25(1):176-84. doi: 10.1016/j.vaccine.2005.11.037. Epub 2005 Dec 7.

    PubMed 16388879

  • Angov E, Aufiero BM, Turgeon AM, Van Handenhove M, Ockenhouse CF, Kester KE, Walsh DS, McBride JS, Dubois MC, Cohen J, Haynes JD, Eckels KH, Heppner DG, Ballou WR, Diggs CL, Lyon JA. Development and pre-clinical analysis of a Plasmodium falciparum Merozoite Surface Protein-1(42) malaria vaccine. Mol Biochem Parasitol. 2003 May;128(2):195-204. doi: 10.1016/s0166-6851(03)00077-x.

    PubMed 12742586

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing FMP1/AS02A Malaria vaccine and Imovax Rabies vaccine in people with Plasmodium Falciparum Malaria, run by U.S. Army Medical Research and Development Command at 1 site in Kenya.

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 3 inclusion and 23 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 2 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 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?

Yes. Results are posted in the registry (first posted 2 Oct 2017). 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 Symptoms During a 8 Day Follow-up Period After Each Vaccination (time frame: 40 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 NCT00317473, which also lists 4 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 2 Oct 2017.

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