Phase 1 Trial of a Malaria Vaccine in Young Kenyan Children

NCT00317473 | Completed Phase 1 Results DMC

• 4 other identifiers: WRAIR 1030HSRRB Log No. A-12094KEMRI SSC No. 761HSPC No. HS171
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Plasmodium Falciparum Malaria

Keywords

Vaccine; Phase 1; Plasmodium falciparum; Malaria; Merozoite surface protein-1; MSP-1; Falciparum malaria protein 1; FMP-1; AS02A

Outcome Measures

Primary Outcomes (3)

• 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

  40 days

• 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)

  90 days

• 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

  8 months

Secondary Outcomes (1)

• Anti-FMP1 Antibody Titer Responses

  364 days

Study Arms (4)

FMP1/AS02A Malaria vaccine 10ug

EXPERIMENTAL

Subject vaccinated with 10 ug of FMP1/AS02A on days 0, 29 and 57

Biological: FMP1/AS02A Malaria vaccine

FMP1/AS02A Malaria vaccine 25 ug

EXPERIMENTAL

Subject vaccinated with 25 ug of FMP1/AS02A on days 14, 42, and 70

Biological: FMP1/AS02A Malaria vaccine

FMP1/AS02A Malaria vaccine 50 ug

EXPERIMENTAL

Subject vaccinated with 50 ug of FMP1/AS02A on days 28, 56 and 84

Biological: FMP1/AS02A Malaria vaccine

Imovax Rabies Vaccine

ACTIVE COMPARATOR

Subject vaccinated with Imovax Rabies Vaccine on corresponding FMP1/AS021 vaccination days

Biological: Imovax Rabies vaccine

Interventions

FMP1/AS02A Malaria vaccine BIOLOGICAL

Subjects vaccinated with FMP1/AS02 vaccine

FMP1/AS02A Malaria vaccine 10ug; FMP1/AS02A Malaria vaccine 25 ug; FMP1/AS02A Malaria vaccine 50 ug

Imovax Rabies vaccine BIOLOGICAL

Subjects vaccinated on corresponding FMP1/AS02A vaccination days

Imovax Rabies Vaccine

Eligibility Criteria

• Age: 12 Months - 47 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• U.S. Army Medical Research and Development Command: lead
• Kenya Medical Research Institute: collaborator
• Walter Reed Army Institute of Research (WRAIR): collaborator
• The PATH Malaria Vaccine Initiative (MVI): collaborator
• United States Agency for International Development (USAID): collaborator
• GlaxoSmithKline: collaborator

Study Sites (1)

Walter Reed Project Kombewa Clinic

Kombewa, Nyanza Province, Kenya

Location

Related Publications (4)

• 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.

  PMID: 15364429 BACKGROUND

• 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.

  PMID: 16356603 BACKGROUND

• 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.

  PMID: 16388879 BACKGROUND

• 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.

  PMID: 12742586 RESULT

MeSH Terms

Conditions

Malaria, Falciparum; Malaria

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Results Point of Contact

• Title: Mark A. Withers, MD PhD
• Organization: USAMRU-K

aodika@wrp-ksm.org

+254-722-449-357

Study Officials

• Mark R. Withers, M.D., MPH

  USAMRU-K

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2006
• First Posted: April 24, 2006
• Study Start: June 1, 2003
• Primary Completion: July 1, 2004
• Study Completion: July 1, 2005
• Last Updated: October 2, 2017
• Results First Posted: October 2, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will share

Locations

KE (1)