A phase I randomised single-blinded single-centre study comparing doses of Plasmodium falciparum chimeric protein 2.9 (PfCP-2.9) recombinant vaccine adjuvanted with Montanide ISA 720 for safety and immunogenicity

Completed

• Conditions: Malaria; Infections and Infestations

• Registration Number: ISRCTN66850051
• Lead Sponsor: World Health Organization (WHO) (Switzerland)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10-01
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 52

Inclusion Criteria

Healthy adult volunteers ages 18 - 45 years.

Exclusion Criteria

1. History of malaria: persons infected with malaria or with positive markers for antibodies to malaria parasite by Indirect Fluorescent Antibody (IFA) assay
2. History of ever traveling to or residing in a malaria endemic region or malaria exposure within last two years

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Local and systemic tolerability<br>2. Reported adverse events

Secondary Outcome Measures

Name	Time	Method
1. Antibody titres by Enzyme-Linked Immuno-Sorbent Assay (ELISA)<br>2. Antibody titres by IFA Test (IFAT)<br>3. Lymphocyte stimulation indices