NCT00703066

A Phase I, Randomized, Controlled, Double-Blind, Single Centre Trial to Evaluate the Safety and Immunogenicity of 30 and 100 µg of GMZ2 in Gabonese Children Aged 1-5 Years

Status unknown Phase 1 Last updated 23 November 2008

What this trial tests

Phase 1 trial testing GMZ 2 vaccine (GLURP + MSP 3) in Malaria in 30 participants. Status unknown.

Timeline

1 June 2008

Primary endpoint
1 July 2009

1 August 2009

Quick facts

Lead sponsor	African Malaria Network Trust
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	quadruple
Primary purpose	prevention
Enrollment	30
Start date	1 June 2008
Primary completion	1 July 2009
Estimated completion	1 August 2009
Sites	1 location across Gabon

Drugs / interventions tested

• GMZ 2 vaccine (GLURP + MSP 3) — full drug profile →
• GMZ 2 vaccine (GLURP + MSP 3) — full drug profile →
• Rabies vaccine — full drug profile →

Conditions studied

• Malaria — all drugs for Malaria →

Sponsor

African Malaria Network Trust

Who can join

Adults 1 to 5, any sex, with Malaria. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Immediate reactogenicity.
  Time frame: within 30 minutes after each injection
• Local and systemic reactogenicity
  Time frame: 14 days following each immunization
• unsolicited Adverse events
  Time frame: up to 1 month after the 3rd vaccination
• Occurrence of serious adverse events
  Time frame: 1 year
• Biological safety
  Time frame: 1 year

Sponsor's own description

The study aims to show that the candidate malaria vaccine GMZ2 is as safe as the already publicly used vaccine against rabies. 30 Gabonese children aged 1-5 years will be enrolled and randomly allocated to receive either malaria vaccine or rabies vaccine without the investigator or the participants knowing what they received. They will receive 3 doses each at one month intervals, and will be followed up for one year to evaluate safety parameters. 30 and 100µg doses for the candidate malaria vaccine GMZ 2 will be evaluated for safety.

This is the second time that candidate malaria vaccine GMZ 2 is being tested in Africa, the first time being in Gabonese adults where the product was found to be safe.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. A randomized controlled phase Ib trial of the malaria vaccine candidate GMZ2 in African children.
   Bélard S, Issifou S, Hounkpatin AB, Schaumburg F, et al · · 2011 · cited 56× · PMID 21829466 · DOI 10.1371/journal.pone.0022525
2. Blood stage vaccines for Plasmodium falciparum: current status and the way forward.
   Ellis RD, Sagara I, Doumbo O, Wu Y. · · 2010 · cited 45× · PMID 20519960 · DOI 10.4161/hv.6.8.11446