Safety Study of Candidate Malaria Vaccine FMP1/AS02A in Healthy Adults in Bandiagara, Mali

NCT00308061 | Completed Phase 1 Results FDA Drug

• 5 other identifiers: WRAIR 1029NIH DMID 02-184Univ of Maryland IRB 0303311HSRRB A-12093NIAID IRB 177
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study tested the safety of a new malaria vaccine in adults in Mali, West Africa, and measured the ability of the vaccine to stimulate antibodies directed against the malaria protein that the vaccine is based on. Forty adults were randomly assigned to get either the experimental malaria vaccine or a rabies vaccine, for comparison.

Conditions

Malaria

Keywords

Plasmodium falciparum; malaria; merozoite surface protein-1

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Solicited Adverse Events by Immunization and Type

  Number of participants with solicited adverse events by immunization and type (local, general and any) during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7.

  Days 0, 1, 2, 3, 7, 30, 31, 32, 33, 37, 60, 61, 62, 63, 67

Secondary Outcomes (1)

• Geometric Mean Titers for Anti-FMP1 Antibody

  Days 0, 14, 30, 44, 60, 74, 90, 180, 272, and 364

Study Arms (2)

FMP1/AS02A Vaccine

EXPERIMENTAL

500 uL of FMP1/AS02A is given to subject on days 0, 30+7, and 60+7 in the left deltoid muscle

Biological: FMP1/AS02A

Imovax Rabies Vaccine

ACTIVE COMPARATOR

1 mL of Imovax Rabies Vaccine is given to subject on days 0, 30+7, and 60+7 in the left deltoid muscle

Biological: Imovax Rabies Vaccine

Interventions

FMP1/AS02A BIOLOGICAL

FMP1 antigen contained 62.5 ug of lyophilized protein with 3.1 percent lactose as cryoprotectant. It's reconstituted in approx. 600 uL AS02A adjuvant manufactured by GSK. AS02A contains 50 ug MPL and 50ug QS21, 250uL of SB62 (oil/water emulsion) in phosphate buffered saline (PBS) per volume of 0.5 mL. All AS02A vials contained 0.65 to 0.75 mL of liquid.

FMP1/AS02A Vaccine

Imovax Rabies Vaccine BIOLOGICAL

Sterile, stable, freeze-dried suspension of rabies virus prepared from the strain PM-1503-3M, obtained from the Wistar Inst. in Philadelphia. Each 1 mL dose of vaccine contained 100 mg of human albumin, \<150g of neomycin sulfate, and \>2.5 IU of rabies antigen.

Imovax Rabies Vaccine

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• A male or non-pregnant female aged 18-55 years inclusive at the time of screening.
• For women, willingness not to become pregnant until 1 month after the last dose of vaccine
• Written informed screening and study consent obtained from the participant before study start.
• Available and willing to participate in follow-up for the duration of study (12 months)

You may not qualify if:

• Previous vaccination with an investigational malaria vaccine or with any rabies vaccine.
• Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use up to 30 days after the third dose.
• Chronic administration (defined as more than 14 days) of immuno-suppressants or other immune-modifying drugs within six months prior to the first vaccine dose. This will include oral steroids and inhaled steroids, but not topical steroids.
• Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before the first dose of study vaccine(s) with the exception of tetanus toxoid.
• Previous vaccination with a vaccine containing MPL and/or QS-21 such as RTS,S.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
• Any confirmed or suspected autoimmune disease
• History of allergic reactions or anaphylaxis to immunizations or to any vaccine component.
• History of serious allergic reactions to any substance, requiring hospitalization or emergent medical care
• History of allergy to tetracycline, doxycycline or neomycin
• History of splenectomy
• Serum ALT \>=35 IU/L
• Serum creatinine level \>133 micro moles per Liter (1.5 mg/dL)
• Hb \<11 g/dL for males and \<10 g/dL for females
• WBC \<3.0 x 103/mm3 or \>13.5 x 103/mm3

Sponsors & Collaborators

• U.S. Army Medical Research and Development Command: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• Walter Reed Army Institute of Research (WRAIR): collaborator
• GlaxoSmithKline: collaborator
• United States Agency for International Development (USAID): collaborator

Study Sites (1)

Bandiagara Malaria Project

Bandiagara, Mali

Location

Related Publications (3)

• 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

• 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

• Thera MA, Doumbo OK, Coulibaly D, Diallo DA, Kone AK, Guindo AB, Traore K, Dicko A, Sagara I, Sissoko MS, Baby M, Sissoko M, Diarra I, Niangaly A, Dolo A, Daou M, Diawara SI, Heppner DG, Stewart VA, Angov E, Bergmann-Leitner ES, Lanar DE, Dutta S, Soisson L, Diggs CL, Leach A, Owusu A, Dubois MC, Cohen J, Nixon JN, Gregson A, Takala SL, Lyke KE, Plowe CV. Safety and immunogenicity of an AMA-1 malaria vaccine in Malian adults: results of a phase 1 randomized controlled trial. PLoS One. 2008 Jan 23;3(1):e1465. doi: 10.1371/journal.pone.0001465.

  PMID: 18213374 DERIVED

MeSH Terms

Conditions

Malaria; Malaria, Falciparum

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Mahamadou A. Thera, MD MPH
• Organization: University of Bamako Faculty of Medicine, Mali

mthera@mrtcbko.org

223-222-1809

Study Officials

• Mahamadou A Thera, MD MPH

  University of Bamako Faculty of Medicine, Mali

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED

Study Record Dates

• First Submitted: March 24, 2006
• First Posted: March 28, 2006
• Study Start: July 1, 2003
• Primary Completion: September 1, 2004
• Study Completion: July 1, 2005
• Last Updated: July 31, 2017
• Results First Posted: July 31, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

MA (1)