- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00317473
Phase 1 Trial of a Malaria Vaccine in Young Kenyan Children
May 4, 2017 updated by: U.S. Army Medical Research and Development Command
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
135
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Nyanza Province
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Kombewa, Nyanza Province, Kenya
- Walter Reed Project Kombewa Clinic
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 3 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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).
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: FMP1/AS02A Malaria vaccine 10ug
Subject vaccinated with 10 ug of FMP1/AS02A on days 0, 29 and 57
|
Subjects vaccinated with FMP1/AS02 vaccine
|
Experimental: FMP1/AS02A Malaria vaccine 25 ug
Subject vaccinated with 25 ug of FMP1/AS02A on days 14, 42, and 70
|
Subjects vaccinated with FMP1/AS02 vaccine
|
Experimental: FMP1/AS02A Malaria vaccine 50 ug
Subject vaccinated with 50 ug of FMP1/AS02A on days 28, 56 and 84
|
Subjects vaccinated with FMP1/AS02 vaccine
|
Active Comparator: Imovax Rabies Vaccine
Subject vaccinated with Imovax Rabies Vaccine on corresponding FMP1/AS021 vaccination days
|
Subjects vaccinated on corresponding FMP1/AS02A vaccination days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination
Time Frame: 40 days
|
Occurrence of any, local, or general solicited symptoms during the 8 day follow-up period
|
40 days
|
Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination
Time Frame: 90 days
|
Occurrence of unsolicited symptoms during a 30 day follow-up period after each vaccination (day of vaccination and the 29 subsequent days)
|
90 days
|
Occurrence of Serious Adverse Events During an 8 Month Follow-up Period Following the First Dose of Study Vaccine
Time Frame: 8 months
|
Occurrence of solicited and unsolicited serious adverse events during an 8 month follow-up period following the first dose of study vaccine
|
8 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anti-FMP1 Antibody Titer Responses
Time Frame: 364 days
|
Antibody responses to FMP1 by ELISA following immunization with the study vaccine through 364 days following the first dose of study vaccine
|
364 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Mark R. Withers, M.D., MPH, USAMRU-K
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2003
Primary Completion (Actual)
July 1, 2004
Study Completion (Actual)
July 1, 2005
Study Registration Dates
First Submitted
April 20, 2006
First Submitted That Met QC Criteria
April 20, 2006
First Posted (Estimate)
April 24, 2006
Study Record Updates
Last Update Posted (Actual)
October 2, 2017
Last Update Submitted That Met QC Criteria
May 4, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- WRAIR 1030
- HSRRB Log No. A-12094 (Other Identifier: IRB)
- KEMRI SSC No. 761 (Other Identifier: Ethics Committee)
- HSPC No. HS171 (Other Identifier)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Kenya Medical Research Institute; WRAIR; The Path Malaria Vaccine Initiative; United States Agency for International Development; GlaxoSmith Kline
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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