Safety and Immunogenicity of 30 and 100 µg of GMZ2 in Gabonese Children Aged 1-5 Years

NCT00703066 | Unknown Phase 1 DMC

• 1 other identifier: GMZ2_3_08
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Malaria

Keywords

Malaria; Vaccine; GMZ2; Safety; African; immunogenicity

Outcome Measures

Primary Outcomes (5)

• Immediate reactogenicity.

  within 30 minutes after each injection

• Local and systemic reactogenicity

  14 days following each immunization

• unsolicited Adverse events

  up to 1 month after the 3rd vaccination

• Occurrence of serious adverse events

  1 year

• Biological safety

  1 year

Secondary Outcomes (2)

• Humoral immune response to GLURP and MSP 3

  1 year

• Cellular immune response

  1 year

Study Arms (3)

1

EXPERIMENTAL

three doses of 30µg GMZ2,

Biological: GMZ 2 vaccine (GLURP + MSP 3)

2

EXPERIMENTAL

3 doses of 100 µg of GMZ2

Biological: GMZ 2 vaccine (GLURP + MSP 3)

3

ACTIVE COMPARATOR

Rabies vaccine

Biological: Rabies vaccine

Interventions

GMZ 2 vaccine (GLURP + MSP 3) BIOLOGICAL

three doses of 30µg of GMZ 2 vaccine,

1

Rabies vaccine BIOLOGICAL

3 doses of Rabies vaccine

3

Eligibility Criteria

• Age: 1 Year - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children age 1-5 years inclusive at the time of screening;
• Residing in Lambaréné for the duration of the study;
• Written informed consent obtained before screening and study start, respectively;
• Available to participate in follow-up for the duration of study (13 months);
• General good health based on history and clinical examination.

You may not qualify if:

• Previous vaccination with any other malaria candidate vaccine.
• Concomitant vaccination with a investigational vaccine or a rabies vaccine;
• Use of a investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first study vaccination, or planned use up to 30 days after the third vaccination;
• Chronic administration (defined as more than 14 days) of immuno-suppressants or other immune-modifying drugs within six months prior to the first vaccination. This includes any dose level of oral steroids or inhaled steroids, but not topical steroids;
• Confirmed or suspected immunosuppressive or immuno-deficient condition, including human immunodeficiency virus (HIV) infection;
• Confirmed or suspected autoimmune disease;
• History of allergic reactions or anaphylaxis to immunizations or to any of the vaccine components, or of serious allergic reactions to any substance, requiring hospitalization or emergent medical care;
• History of splenectomy;
• Laboratory evidence of liver disease (Alanine aminotransferase \[ALT\] greater than 1.25 times the upper limit of normal (\<45 U/L) of the testing laboratory);
• Laboratory evidence of renal disease (serum creatinine greater than the upper limit of normal of the testing laboratory, or more than trace protein or blood on urine dipstick testing);
• Laboratory evidence of haematological disease (absolute leukocyte count 3.5-11/µL, absolute lymphocyte count 560-5280/µL, platelet count 120,000-400,000/µL, or haemoglobin 10.0-16.5g/dL);
• Administration of immunoglobulins and/or any blood products within the three months preceding the first study vaccination or planned administration during the study period;
• Simultaneous participation in any other interventional clinical trial;
• Acute or chronic pulmonary, cardiovascular, hepatic, renal or neurological condition, malnutrition, or any other clinical findings that in the opinion of the clinical investigator, may increase the risk of participating in the study;
• Other condition that in the opinion of the clinical investigator would jeopardize the safety or rights of a participant in the trial or would render the participant unable to comply with the protocol.

Sponsors & Collaborators

• African Malaria Network Trust: lead

Study Sites (1)

Medical Research Unit, Albert Schweitzer Hospital

Lambaréné, Gabon

Location

Related Publications (1)

• Belard S, Issifou S, Hounkpatin AB, Schaumburg F, Ngoa UA, Esen M, Fendel R, de Salazar PM, Murbeth RE, Milligan P, Imbault N, Imoukhuede EB, Theisen M, Jepsen S, Noor RA, Okech B, Kremsner PG, Mordmuller B. A randomized controlled phase Ib trial of the malaria vaccine candidate GMZ2 in African children. PLoS One. 2011;6(7):e22525. doi: 10.1371/journal.pone.0022525. Epub 2011 Jul 28.

  PMID: 21829466 DERIVED

MeSH Terms

Conditions

Malaria

Interventions

Rabies Vaccines

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Peter Kremsner, MD, PhD

  Medical research Unit, Albert Schweitzer Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: June 20, 2008
• First Posted: June 23, 2008
• Study Start: June 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: August 1, 2009
• Last Updated: November 25, 2008

Record last verified: 2008-11

Locations

GA (1)