Phase Ib Trial of MSP3 LSP in Children in Tanzania

Summary

This study will evaluate the safety of candidate malaria vaccine MSP3 in children aged 12-24 months in Tanzania in a highland area with low malaria transmission.

Written informed consent will be sought from all guardians/parents of potentially participating children. Eligible children will be randomly allocated to receive either the the study vaccine (MSP3 for a total of 30 children)) or the control vaccine (hepatitis B for a total of 15 children). The vaccines will be given in 3 immunizations one month apart to all the study children and neither the clinical investigators nor the children's parents will be aware of which vaccine has been administered during the initial four months of the study. The study is designed to begin with a lower dose of the MSP3 vaccine (15µg of MSP3 for 15 children) and then followed by the higher dose(30µg MSP3 for 15 children). Following each immunization, children will be evaluated for a seven day solicited symptoms. Unsolicited symptoms will also be collected throughout the study duration.

The study will be overseen by an international safety monitoring committee who will follow safety matters closely as the trial progresses. The study will also be approved by the Tanzania National ethics Committee, The Tanzania Food and Drugs Authority, and the London school of hygiene and tropical medicine ethics committee. The study is planned to last 13 months for each participant.

Conditions

• Malaria

Interventions

BIOLOGICAL

MSP 3 Long Synthetic Peptide

Lyophilized MSP3 vaccine adjuvanted in Aluminium hydroxide

BIOLOGICAL

MSP3 vaccine

Lyophilized vaccine adjuvanted in Aluminium hydroxide

BIOLOGICAL

Hepatitis B vaccine

Hepatitis B vaccine adjuvanted in Aluminium hydroxide

BIOLOGICAL

MSP3 candidate vaccine

Lyophilized MSP3 adjuvanted in Aluminium hydroxide

BIOLOGICAL

Hepatitis B control vaccine

Hepatitis B vaccine adjuvanted in Aluminium Hydroxide

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine

  collaborator OTHER

• African Malaria Network Trust

  lead NETWORK

Principal Investigators

• Martha M Lemnge, MS, PhD · National Institute For Medical Research in Tanzania

• John P Lusingu, MD, PhD · National Institute for Medical Research in Tanzania

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

SINGLE_GROUP

Eligibility

Min Age

12 Months

Max Age

24 Months

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2007-10-31

Completion

2008-08-31

Countries

• Tanzania

Study Locations