NCT00513669

Brief Summary

This is a phase Ib double-blind randomized placebo controlled age-deescalating trial to assess sagety and immunogenicity of two virosome formulated anti-malaria vaccine components (PEV 301 and PEV 302) administered in combination to healthy semi-immune Tanzanian adult and children.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 8, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 9, 2007

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

March 15, 2013

Status Verified

March 1, 2013

Enrollment Period

1.2 years

First QC Date

August 8, 2007

Last Update Submit

March 14, 2013

Conditions

Falciparum Malaria

Keywords

MalariaVaccineFalciparumTrialPhase ISafetyImmunogenicity

Outcome Measures

Primary Outcomes (1)

  • Safety (incidence of local and systemic adverse events) Humoral immunity

    30 days post-injection

Secondary Outcomes (1)

  • Cell-mediated immunity

    14 days post-injection

Study Arms (2)

1 PEV301&302

EXPERIMENTAL

The vaccine includes two antigens (CSP and AMA1- derived)in combination and formulated with virosomes

Biological: PEV 301& 302 in virosomes

2 Influenza vaccine

ACTIVE COMPARATOR

Inflexal V is the comparator that includes 3 antigens from flu formulated in virosomes

Biological: Inflexal V (active comparator)

Interventions

PEV 301& 302 in virosomesBIOLOGICAL

PEV 301 50 µg plus PEV 302 10 µg formulated in virosomes and injected at day 0 and 90

1 PEV301&302
Inflexal V (active comparator)BIOLOGICAL

Inflexal V is a marketed influenza vaccine that will be given at day 0 and 90

2 Influenza vaccine

Eligibility Criteria

Age5 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Male volunteers aged between 18 and 45 years for the adult group, and children of both sexes aged 5-9 years for schoolchildren group
  • Written informed consent obtained from the volunteer (adult) or guardian/ legal representative (children). In case patient is illiterate, an impartial witness should be present during the entire consent procedure
  • Free of obvious health problems as established by medical history and clinical examination before entering the study
  • Body Mass Index between 18 and 30 for adults; MUAC less than 12 for children

You may not qualify if:

  • Use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period and safety follow-up
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose
  • Any chronic drug therapy to be continued during the study period
  • Any confirmed or suspected acquired immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection, or history of congenital or hereditary immunodeficiency
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine
  • Acute disease at the time of enrollment. Acute disease is defined as the presence of a moderate or severe illness with or without fever (defined as temperature more than 37.5°C)
  • Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests
  • Acute or chronic diabetes
  • History of chronic alcohol consumption and/or intravenous drug abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bagamoyo Research and Training Unit

Bagamoyo, Tanzania

Location

Related Publications (1)

  • Cech PG, Aebi T, Abdallah MS, Mpina M, Machunda EB, Westerfeld N, Stoffel SA, Zurbriggen R, Pluschke G, Tanner M, Daubenberger C, Genton B, Abdulla S. Virosome-formulated Plasmodium falciparum AMA-1 & CSP derived peptides as malaria vaccine: randomized phase 1b trial in semi-immune adults & children. PLoS One. 2011;6(7):e22273. doi: 10.1371/journal.pone.0022273. Epub 2011 Jul 22.

    PMID: 21799810DERIVED

Related Links

MeSH Terms

Conditions

Malaria, FalciparumMalaria

Interventions

VirosomesInflexal V

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Intervention Hierarchy (Ancestors)

Membranes, ArtificialBiomedical and Dental MaterialsDrug CarriersDosage FormsPharmaceutical PreparationsManufactured MaterialsTechnology, Industry, and AgricultureBiomimetic Materials

Study Officials

  • Blaise Genton, MD PhD

    Swiss tropical institute, Ifakara Health Research and Development Center

    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
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2007

First Posted

August 9, 2007

Study Start

January 1, 2008

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

March 15, 2013

Record last verified: 2013-03

Locations

TA(1)