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

Malaria, Falciparum Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01556945
• Other study ID #: WRAIR #849
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 14, 2012
• Last updated: May 1, 2014
• Start date: April 2001

Study information

• Verified date: May 2014
• Source: U.S. Army Medical Research and Materiel Command
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. primary completion date: February 2002
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Malaria
• Malaria, Falciparum

Intervention

Biological:
• FMP1/AS02
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.
• RTS,S/AS02
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.

Other:
• AS02 adjuvant alone
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.
• Malaria challenge
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.

Locations

Country	Name	City	State
United States	WRAIR Clinical Trials Center	Silver Spring	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
U.S. Army Medical Research and Materiel Command	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety	Measured through adverse event collection and immunogenicity results	two years	Yes