Proof-of-Concept Study of MSP3-LSP Vaccine to Protect Against Malaria in Africa

Summary

Hypothesis: The MSP3-LSP/Alum vaccine, administered to children will have a protective efficacy of at least 30% (lower bound of confidence interval of 0) against malaria disease occurring during a period beginning from 14 days after the 3rd immunization until 1 year after.

The primary objective of this double-blind, randomized, controlled trial will be to assess the clinical efficacy of MSP3-LSP/AlOH vaccine when administered by subcutaneous route in children aged 12-48 months against all clinical malaria episodes occurring during a period beginning from 14 days after the 3rd immunization until 3 months after 3rd immunization, when administered according to the following schedule:- Primary administration: Three doses of administered 4 weeks apart

Secondary administration (Boost): One dose 3 months after the third dose in year 1 of the trial; and two doses, given exactly one year after the date corresponding to the third dose and the first boost given during Year 1

Case definition for an episode of malaria is a febrile illness with axillary temperature of ≥ 37.5ºC with P. falciparum parasitemia ≥ 5000 per μL

Conditions

• Malaria

Interventions

BIOLOGICAL

MSP3-LSP/AlOH

30 µg of test vaccine MSP3-LSP/AlOH, administered by subcutaneous route according to the following schedule:- Primary administration: Three doses administered at 4 weeks interval: D0, D28 (± 2 days), D56 (± 4 days) Secondary administration (Boost): Year 1: One dose 3 months after the third dose Year 2: Two doses, given exactly one year after the date corresponding to the third dose and the first boost given during Year 1

BIOLOGICAL

Verorab Vaccine

The Verorab rabies vaccine will be given as control for the primary series of the experimental vaccine. It consists of inactivated rabies virus produced in vero cells (Wistar Rabies PM/W138 1503-3M (inactivated). Manufacturer SANOFI PASTEUR SA. Presentation is 0.5 ml per dose in a pre-filled syringe.

OTHER

0.9% NaCl/Normal Saline

0.5 ml per dose; to be given as control for the secondary/booster doses of experimental vaccine

Sponsors & Collaborators

• University of Bamako

  collaborator OTHER

• Vac4All

  lead INDUSTRY

Principal Investigators

• Mahamadou Sissoko, MD · Malaria Research and Training Center Department of Epidemiology of Parasitic Diseases Faculty of Medicine, Pharmacy and Dentistry University of Bamako BP 1805, Point G Bamako, Mali, West Africa

• Pierre L Druilhe, MD · CEO, Vac4All

• Ogobara Doumbo, MD · Chief, MRTC

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

12 Months

Max Age

48 Months

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2011-05-31

Primary Completion

2011-12-31

Completion

2013-03-31

Countries

• Mali

Study Locations