Phase 2B Double Blind, Randomized, Controlled Trial to Evaluate the Safety, Immunogenicity and Protective Efficacy of MSP3-LSP Vaccine Candidate Adjuvanted in Aluminium Hydroxide (AIOH) Against Plasmodium Falciparum Clinical Malaria in Healthy Children Aged 12-48 Months in Mali (MSP3-POC)

NCT01341704 Phase 2 COMPLETED

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

Details

Lead sponsor	Vac4All
Phase	Phase 2
Status	COMPLETED
Enrolment	800
Start date	2011-05
Completion	2013-03

Conditions

• Malaria

Interventions

• MSP3-LSP/AlOH
• Verorab Vaccine
• 0.9% NaCl/Normal Saline

Primary outcomes

• Number of episodes of clinical malaria occurring during a period beginning from 14 days after the 3rd immunization until 3 months after 3rd immunization in all subjects. — 3 months
  A clinical malaria episode is defined as a febrile illness with a documented axillary temperature of

Countries

Mali