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

Falciparum Malaria Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00513669
• Other study ID #: PMAL03
• Status: Completed
• Phase: Phase 1
• First received: August 8, 2007
• Last updated: March 14, 2013
• Start date: January 2008
• Est. completion date: March 2009

Study information

• Verified date: March 2013
• Source: Swiss Tropical & Public Health Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Tanzania: Tanzania Food and Drug Authority
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 5 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Male volunteers aged between 18 and 45 years for the adult group, and children of both sexes aged 5-9 years for schoolchildren group

2. 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

3. Free of obvious health problems as established by medical history and clinical examination before entering the study

4. Body Mass Index between 18 and 30 for adults; MUAC less than 12 for children

Exclusion Criteria:

1. 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

2. Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose

3. Any chronic drug therapy to be continued during the study period

4. Any confirmed or suspected acquired immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection, or history of congenital or hereditary immunodeficiency

5. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine

6. 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)

7. Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests

8. Acute or chronic diabetes

9. History of chronic alcohol consumption and/or intravenous drug abuse

Study Design

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

Related Conditions & MeSH terms

• Falciparum Malaria
• Malaria
• Malaria, Falciparum

Intervention

Biological:
• PEV 301& 302 in virosomes
PEV 301 50 µg plus PEV 302 10 µg formulated in virosomes and injected at day 0 and 90
• Inflexal V (active comparator)
Inflexal V is a marketed influenza vaccine that will be given at day 0 and 90

Locations

Country	Name	City	State
Tanzania	Bagamoyo Research and Training Unit	Bagamoyo

Sponsors (3)

Lead Sponsor	Collaborator
Swiss Tropical & Public Health Institute	Mymetics Corporation, Pevion Biotech Ltd

Country where clinical trial is conducted

Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety (incidence of local and systemic adverse events) Humoral immunity		30 days post-injection	Yes
Secondary	Cell-mediated immunity		14 days post-injection	No

External Links

•   Website of the Swiss Tropical Institute