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Phase 1 Trial of a Malaria Vaccine in Young Kenyan Children

Information source: U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Plasmodium Falciparum Malaria

Intervention: MSP-1 (FMP-1) with AS02A vs Imovax rabies vaccine (Biological)

Phase: Phase 1

Status: Completed

Sponsored by: U.S. Army Medical Research and Materiel Command

Official(s) and/or principal investigator(s):
Mark R. Withers, M.D., MPH, Principal Investigator, Affiliation: USAMRU-K

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

Clinical Details

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.

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Primary outcome:

Occurrence of solicited symptoms during a 7 day follow-up period after each vaccination (5 visits: day of vaccination and days 1, 2, 3, and 7)

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

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

Secondary outcome: Antibody responses to MSP-1 by ELISA following immunization with the study vaccine through 364 days following the first dose of study vaccine

Eligibility

Minimum age: 12 Months. Maximum age: 47 Months. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Walter Reed Project Kombewa Clinic, Kombewa, Nyanza Province, Kenya
Additional Information

Related 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.

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. 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. Epub 2005 Dec 7.

Starting date: June 2003
Last updated: June 4, 2015

Page last updated: August 23, 2015

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