A Study to Determine Whether 2 Investigational Malaria Vaccines Are Safe, Protective Against Malaria in Adults

NCT00385047 | Completed Phase 1

• 5 other identifiers: WRAIR 1280A-13949ETrack Protocol No. 104936MAL-045#20060900
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether 2 investigational malaria vaccines are safe as well as protective against malaria in adults living in the United States

Conditions

Malaria

Keywords

malaria; vaccine; AMA-1 (apical membrane antigen-1); efficacy

Outcome Measures

Primary Outcomes (1)

• Number of adverse events

  Up to 1 year

Secondary Outcomes (5)

• Anti-AMA-1 antibody titers during Immunization Phase

  Up to 70 days

• Anti-AMA-I antibody titers during Challenge Phase

  Up to 90 days

• Anti-AMA-I antibodies as percent parasite growth inhibition during Immunization Phase

  Up to 70 days

• Anti-AMA-I antibodies as percent parasite growth inhibition during Challenge Phase

  Up to 90 days

• Time to parasitemia development after primary challenge following administration of the FMP2.l/ASOIB and FMP2.l /AS02A

  Up to 1 Year

Study Arms (2)

Group A

EXPERIMENTAL

FMP 2.1 50 μg FMP2.1/AS01B

Biological: Group A FMP2.1/AS01B

Group B

EXPERIMENTAL

FMP 2.1 50 μg FMP2.1/AS02A

Biological: Group B FMP2.1/AS02A

Interventions

Group A FMP2.1/AS01B BIOLOGICAL

Also known as: FMP 2.1 50 μg FMP2.1/AS01B

Group A

Group B FMP2.1/AS02A BIOLOGICAL

Also known as: FMP 2.1 50 μg FMP2.1/AS02A

Group B

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• A male or non-pregnant female 18 to 50 years of age (inclusive) at the time of screening
• Written informed consent obtained from the participant before screening procedures
• Free of clinically significant health problems as established by medical history and clinical examination before entering into the study\*
• Available to participate for duration of study (approximately five months, not including screening)
• If the participant is female, she must be of non-childbearing potential, i.e., either surgically sterilized or one year post-menopausal; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions (e.g., intrauterine contraceptive device; oral contraceptives; diaphragm or condom in combination with contraceptive jelly, cream or foam; Norplant® or Depo-Provera®) during this study, have a negative pregnancy test at the time of each immunization, and must agree to continue such precautions for two months after completion of the immunization series and the malaria challenge.
• Prior to entry into this study, participants must score at least 80% correct on a short multiple-choice quiz that assesses their understanding of this study. If they do not score 80% on the initial quiz, the protocol information will be reviewed with them to ensure comprehension and they will have the opportunity to retest. Participants who fail the Comprehension Assessment for the second time will not be enrolled.

You may not qualify if:

• Prior receipt of an investigational malaria vaccine
• Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first study immunization or planned use during the study period, or receipt of investigational vaccine containing 3-D MPL and/or QS-21 at any time in the past (Have you received an experimental vaccine with a GSK adjuvant in the past?)
• Administration of chronic (defined as more than 14 days) immunosuppressants or other immune-modifying drugs within six months of immunization. (For corticosteroids, this will mean prednisone, or equivalent, greater than or equal to 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
• Chronic use of antibiotics with anti-malarial effects (e.g., tetracyclines for dermatologic patients, sulfa for recurrent urinary tract infections, etc.)
• Planned administration of a vaccine not foreseen by the study protocol 30 days prior to or after the first immunization
• History of malaria chemoprophylaxis within 60 days prior to immunization
• Any history of malaria
• Known exposure to malaria within the previous 12 months
• Planned travel to malarious areas during the study period
• Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
• History of allergic disease or reactions to any vaccine
• Chronic or active neurologic disorders including seizures, excluding a single febrile seizure as a child
• History of splenectomy
• Acute disease at the time of enrollment (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e., oral temperature \< 37.5°C/99.5°F).
• Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests

Sponsors & Collaborators

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

Study Sites (1)

Clinical Trials Center, Walter Reed Army Institute of Research

Silver Spring, Maryland, 20910, United States

Location

Related Publications (2)

• Dutta S, Lalitha PV, Ware LA, Barbosa A, Moch JK, Vassell MA, Fileta BB, Kitov S, Kolodny N, Heppner DG, Haynes JD, Lanar DE. Purification, characterization, and immunogenicity of the refolded ectodomain of the Plasmodium falciparum apical membrane antigen 1 expressed in Escherichia coli. Infect Immun. 2002 Jun;70(6):3101-10. doi: 10.1128/IAI.70.6.3101-3110.2002.

  PMID: 12011004 BACKGROUND

• Spring MD, Cummings JF, Ockenhouse CF, Dutta S, Reidler R, Angov E, Bergmann-Leitner E, Stewart VA, Bittner S, Juompan L, Kortepeter MG, Nielsen R, Krzych U, Tierney E, Ware LA, Dowler M, Hermsen CC, Sauerwein RW, de Vlas SJ, Ofori-Anyinam O, Lanar DE, Williams JL, Kester KE, Tucker K, Shi M, Malkin E, Long C, Diggs CL, Soisson L, Dubois MC, Ballou WR, Cohen J, Heppner DG Jr. Phase 1/2a study of the malaria vaccine candidate apical membrane antigen-1 (AMA-1) administered in adjuvant system AS01B or AS02A. PLoS One. 2009;4(4):e5254. doi: 10.1371/journal.pone.0005254. Epub 2009 Apr 23.

  PMID: 19390585 DERIVED

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

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

Study Officials

• Michele D. Spring, MD, M.S.P.H.

  Walter Reed Army Institute of Research (WRAIR)

  PRINCIPAL INVESTIGATOR

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
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2006
• First Posted: October 6, 2006
• Study Start: September 1, 2006
• Primary Completion: April 1, 2007
• Study Completion: September 1, 2007
• Last Updated: June 8, 2015

Record last verified: 2015-06

Locations

US (1)