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Phase Ib Trial of Two Virosome Formulated Malaria Vaccine Components (PEV 301, PEV 302) in Tanzania (PMAL03)

Primary Purpose

Falciparum Malaria

Status

Completed

Phase

Phase 1

Locations

Tanzania

Study Type

Interventional

Intervention

PEV 301& 302 in virosomes

Inflexal V (active comparator)

About this trial

This is an interventional prevention trial for Falciparum Malaria focused on measuring Malaria, Vaccine, Falciparum, Trial, Phase I, Safety, Immunogenicity

Eligibility Criteria

5 Years - 45 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Bagamoyo Research and Training Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1 PEV301&302

2 Influenza vaccine

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Cell-mediated immunity

Full Information

NCT ID

NCT00513669

First Posted

August 8, 2007

Last Updated

March 14, 2013

Sponsor

Swiss Tropical & Public Health Institute

Collaborators

Mymetics Corporation, Pevion Biotech Ltd

1. Study Identification

Unique Protocol Identification Number

NCT00513669

Brief Title

Phase Ib Trial of Two Virosome Formulated Malaria Vaccine Components (PEV 301, PEV 302) in Tanzania

Acronym

PMAL03

Official Title

A Phase Ib Double-blind Randomized Placebo Controlled Age-deescalating Trial of Two Virosome Formulated Anti-malaria Vaccine Components (PEV 301 and PEV 302) Administered in Combination to Healthy Semi-immune Tanzanian Volunteers

Study Type

Interventional

2. Study Status

Record Verification Date

March 2013

Overall Recruitment Status

Completed

Study Start Date

January 2008 (undefined)

Primary Completion Date

March 2009 (Actual)

Study Completion Date

March 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Swiss Tropical & Public Health Institute

Collaborators

Mymetics Corporation, Pevion Biotech Ltd

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

Volunteers will be screened, enrolled, injected with the vaccine or comparator and followed by the clinicians at the Bagamoyo Research and Training Unit of the the Ifakara Health Research and Development Center (BRTU-IHRDC). First, 10 adult males will be enrolled and randomized in 2 groups: Group AV (n=8) will be injected with the vaccine combination and group AP (n=2) will be vaccinated with the placebo=comparator (Inflexal V). 5 weeks later, 8 children will be enrolled first and randomized in 2 groups: Group CV (n=6) will be injected with the vaccine combination and group CP (n=2) will be vaccinated with comparator. 1 week later, the rest of the cohort (n=32) will be enrolled and randomized in 2 groups: Group CV (n=26) will be injected with the vaccine combination and group CP (n=6) will be vaccinated with comparator. Immunogenicity assessments for humoral immune response will be made at baseline (days -10 to -2), day 30 (+4), day 90 (+4) (day of 2nd vaccination), 120 (+4), 180 (+7), and 365 (+14). Cellular immune responses will be assessed before 1st vaccination (day 0), two weeks after 2nd vaccination (day 104 ±2), and one year after the 1st vaccination (day 365) Safety assessments will be made by the investigator at baseline (days -10 to -2, before the 1st immunization) and at day 1, 2, 3, 7, 14, 30 after each vaccination.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Falciparum Malaria

Keywords

Malaria, Vaccine, Falciparum, Trial, Phase I, Safety, Immunogenicity

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1 PEV301&302

Arm Type

Experimental

Arm Description

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

Arm Title

2 Influenza vaccine

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

PEV 301& 302 in virosomes

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

Inflexal V (active comparator)

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

30 days post-injection

Secondary Outcome Measure Information:

Title

Cell-mediated immunity

Time Frame

14 days post-injection

10. Eligibility

Sex

All

Minimum Age & Unit of Time

5 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Blaise Genton, MD PhD

Organizational Affiliation

Swiss tropical institute, Ifakara Health Research and Development Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Bagamoyo Research and Training Unit

City

Bagamoyo

Country

Tanzania

12. IPD Sharing Statement

Citations:

PubMed Identifier

21799810

Citation

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.

Results Reference

derived

Links:

URL

http://www.sti.ch

Description

Website of the Swiss Tropical Institute

Learn more about this trial

Phase Ib Trial of Two Virosome Formulated Malaria Vaccine Components (PEV 301, PEV 302) in Tanzania

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