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Safety and Preliminary Efficacy of the Malaria Vaccine Candidates Falciparum Merozoite Protein-1 (FMP1) and SmithKlineBeecham (SKBB) Candidate Malaria Vaccine RTS,S (MAL019)

Primary Purpose

Malaria, Falciparum

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
FMP1/AS02
RTS,S/AS02
AS02 adjuvant alone
Malaria challenge
Sponsored by
U.S. Army Medical Research and Development Command
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Malaria, Falciparum focused on measuring P. falciparum, vaccine, healthy volunteers

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy adult, 18-45
  • Available for duration of study (9 months)
  • Written informed consent prior to any study procedures

Exclusion Criteria:

  • Prior receipt of an investigational malaria vaccine or one containing MPL or QS-21
  • Use of any investigational or non-registered drug/vaccine or planned administration of vaccine not foreseen by study protocol; each issue within 30 days preceding the first dose of study vaccine
  • Administration of chronic immunosuppressants
  • Chronic use of antibiotics
  • History of malaria ever, or use of malaria chemoprophylaxis within 60 days prior to vaccination
  • Known exposure to malaria within the past 12 months or planned travel to malarious area during the study period
  • Confirmed or suspected immunosuppressive or immunodeficient condition
  • Family history of congenital or hereditary immunodeficiency
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine
  • Chronic or active neurologic disease including seizures
  • History of splenectomy
  • Seropositive for hepatitis B or hepatitis C or Human Immunodeficiency Virus (HIV), or other abnormal labs such as significant anemia, elevated creatinine
  • Hepatomegaly, or right upper quadrant abdominal pain
  • Pregnant or lactating female
  • Chronic or active drug or alcohol use
  • History of severe reactions to mosquito bites
  • Any history of anaphylaxis to vaccinations

Sites / Locations

  • WRAIR Clinical Trials Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Group A : FMP1/AS02 + RTS,S/AS02

Group B : FMP1/AS02 + RTS,S/AS02

Group C: FMP1/AS02 + AS02

Group D : RTS,S/AS02 + AS02

Control cohort

Arm Description

FMP1 malaria vaccine given with the GlaxoSmithKline (GSK) adjuvant system, number 2 (AS02) and a second experimental malaria vaccine RTS,S also given with AS02 adjuvant concomitantly as separate sites of injection on days 0, 28 and 84. Malaria challenge phase began 14-30 days after the last vaccine.

FMP1 malaria vaccine given with the adjuvant AS02 and a second experimental malaria vaccine RTS,S also given with AS02 adjuvant at one injection site and saline at the opposite site on days 0, 28 and 84. Malaria challenge phase began 14-30 days after the last vaccine.

FMP1 malaria vaccine given with the adjuvant AS02 and a second experimental malaria vaccine RTS,S also given with adjuvant AS02 adjuvant alone at one injection site and saline at the opposite site on days 0, 28 and 84. Malaria challenge phase began 14-30 days after the last vaccine.

RTS,S malaria vaccine given with the adjuvant AS02 and an adjuvant AS02 alone concomitantly at separate sites of injection on days 0, 28 and 84. Malaria challenge phase began 14-30 days after the last vaccine.

Infectivity controls (unvaccinated). Non-randomized infectivity controls were recruited specifically for the malaria challenge phase of the trial.

Outcomes

Primary Outcome Measures

Safety
Measured through adverse event collection and immunogenicity results

Secondary Outcome Measures

Full Information

First Posted
March 14, 2012
Last Updated
May 1, 2014
Sponsor
U.S. Army Medical Research and Development Command
Collaborators
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT01556945
Brief Title
Safety and Preliminary Efficacy of the Malaria Vaccine Candidates Falciparum Merozoite Protein-1 (FMP1) and SmithKlineBeecham (SKBB) Candidate Malaria Vaccine RTS,S
Acronym
MAL019
Official Title
Phase I/IIa Safety, Immunogenicity, and Preliminary Efficacy of an Administration Schedule of FMP1 and SmithKlineBeecham Biologicals' Candidate Malaria Vaccine RTS,S Each Adjuvanted With SBAS2, Given Concomitantly in Separate Injections
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
April 2001 (undefined)
Primary Completion Date
February 2002 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
U.S. Army Medical Research and Development Command
Collaborators
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to see if two new malaria vaccines called FMP1 and RTSS, combined with an adjuvant (called SBAS2) which helps stimulate the body's immune system, are safe, demonstrate an immune response through blood tests, and lastly, to see if the vaccines can prevent malaria infection. The RTS,S vaccine contains a malaria protein in combination with a portion of the commercially available hepatitis B vaccine. The FMP1 vaccine also contains a malaria protein. The adjuvant called SBAS2, is a special oil in water emulsion. Vaccinations are done at study days 0, 28 and 84, followed by a malaria challenge approximately 14 days after the 3rd vaccination.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria, Falciparum
Keywords
P. falciparum, vaccine, healthy volunteers

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A : FMP1/AS02 + RTS,S/AS02
Arm Type
Experimental
Arm Description
FMP1 malaria vaccine given with the GlaxoSmithKline (GSK) adjuvant system, number 2 (AS02) and a second experimental malaria vaccine RTS,S also given with AS02 adjuvant concomitantly as separate sites of injection on days 0, 28 and 84. Malaria challenge phase began 14-30 days after the last vaccine.
Arm Title
Group B : FMP1/AS02 + RTS,S/AS02
Arm Type
Experimental
Arm Description
FMP1 malaria vaccine given with the adjuvant AS02 and a second experimental malaria vaccine RTS,S also given with AS02 adjuvant at one injection site and saline at the opposite site on days 0, 28 and 84. Malaria challenge phase began 14-30 days after the last vaccine.
Arm Title
Group C: FMP1/AS02 + AS02
Arm Type
Experimental
Arm Description
FMP1 malaria vaccine given with the adjuvant AS02 and a second experimental malaria vaccine RTS,S also given with adjuvant AS02 adjuvant alone at one injection site and saline at the opposite site on days 0, 28 and 84. Malaria challenge phase began 14-30 days after the last vaccine.
Arm Title
Group D : RTS,S/AS02 + AS02
Arm Type
Experimental
Arm Description
RTS,S malaria vaccine given with the adjuvant AS02 and an adjuvant AS02 alone concomitantly at separate sites of injection on days 0, 28 and 84. Malaria challenge phase began 14-30 days after the last vaccine.
Arm Title
Control cohort
Arm Type
Placebo Comparator
Arm Description
Infectivity controls (unvaccinated). Non-randomized infectivity controls were recruited specifically for the malaria challenge phase of the trial.
Intervention Type
Biological
Intervention Name(s)
FMP1/AS02
Intervention Description
The vaccine antigen FMP1 consists of a recombinant histidine-tagged (His6) fusion protein expressed in E. coli. The lyophilized pellet contained per vaccine vial 62.5 μg merozoite surface protein-142 (MSP-142) with 3.1% lactose as cryoprotectant in each 3 ml monodose vial. The pellet was reconstituted with AS02.
Intervention Type
Biological
Intervention Name(s)
RTS,S/AS02
Intervention Description
The vaccine antigen RTS,S, is a recombinant subunit vaccine produced in, and purified from yeast cells. The final lyophilized pellet contained 62.5 μg RTS,S with 3.15% lactose as cryoprotectant per 3 ml monodose vial. The pellet was reconstituted in AS02 and each 0.5 ml dose contained 50 μg RTS,S.
Intervention Type
Other
Intervention Name(s)
AS02 adjuvant alone
Intervention Description
AS02 adjuvant contains 50 μg monophosphoryl lipid A (MPL) and 50 μg Quillaja saponaria 21 (QS-21), 250 μl of SB62 (oil/water emulsion) in phosphate buffered saline (PBS) per volume of 0.5 ml.
Intervention Type
Other
Intervention Name(s)
Malaria challenge
Intervention Description
Experimental challenge homologous strain of P.falciparum sporozoites. Mosquitoes infected with malaria approximately 17 to 19 days earlier and that contained sporozoites in their salivary glands. For each volunteer, five mosquitoes were allowed to feed over five minutes, after which they were dissected to confirm how many were infected, and the salivary glands scored.
Primary Outcome Measure Information:
Title
Safety
Description
Measured through adverse event collection and immunogenicity results
Time Frame
two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy adult, 18-45 Available for duration of study (9 months) Written informed consent prior to any study procedures Exclusion Criteria: Prior receipt of an investigational malaria vaccine or one containing MPL or QS-21 Use of any investigational or non-registered drug/vaccine or planned administration of vaccine not foreseen by study protocol; each issue within 30 days preceding the first dose of study vaccine Administration of chronic immunosuppressants Chronic use of antibiotics History of malaria ever, or use of malaria chemoprophylaxis within 60 days prior to vaccination Known exposure to malaria within the past 12 months or planned travel to malarious area during the study period Confirmed or suspected immunosuppressive or immunodeficient condition Family history of congenital or hereditary immunodeficiency History of allergic disease or reactions likely to be exacerbated by any component of the vaccine Chronic or active neurologic disease including seizures History of splenectomy Seropositive for hepatitis B or hepatitis C or Human Immunodeficiency Virus (HIV), or other abnormal labs such as significant anemia, elevated creatinine Hepatomegaly, or right upper quadrant abdominal pain Pregnant or lactating female Chronic or active drug or alcohol use History of severe reactions to mosquito bites Any history of anaphylaxis to vaccinations
Facility Information:
Facility Name
WRAIR Clinical Trials Center
City
Silver Spring
State/Province
Maryland
ZIP/Postal Code
20910
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Safety and Preliminary Efficacy of the Malaria Vaccine Candidates Falciparum Merozoite Protein-1 (FMP1) and SmithKlineBeecham (SKBB) Candidate Malaria Vaccine RTS,S

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