Phase II multi-centre study to evaluate efficacy, safety, and immunogenicity of GMZ2 candidate malaria vaccine in children aged 12 to 60 months

• Register: PACTR
• Last refreshed on: 29 April 2013
• Main ID: PACTR2010060002033537
• Date of registration: 07/04/2010
• Primary sponsor: Statens Serum Intitute
• Public title: Phase II multi-centre study to evaluate efficacy, safety, and immunogenicity of GMZ2 candidate malaria vaccine in children aged 12 to 60 months
• Scientific title: A phase II, randomized, controlled, double-blind, multi-centre study to evaluate the efficacy, safety, and immunogenicity of GMZ2 candidate malaria vaccine in Gabonese, Bukinabe, Ghanaian, and Ugandan children aged 12 to 60 months
• Date of first enrolment: 2010-11-01
• Target sample size: 1849
• Recruitment status: Closed to recruitment: follow up continuing
• URL: HTTP://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?da=true&tno=PACTR2010060002033537
• Study type: interventional
• Study design: Parallel: different groups receive different interventions at same time during study,; Randomised,; Independent Statistician (LSHTM); Simple randomization using Computer software,; Sealed opaque envelopes ,

Countries of recruitment

South Africa

Contacts

• Name: Dawit Ejigu
• Affiliation: Staten Serum Institute

• Name: Thomas L Richie, MD PhD
• Affiliation: Director, Malaria Program, Navy Component

Key inclusion & exclusion criteria

Inclusion criteria: 1. Children aged 12 - 60 months inclusive at the time of the first dose
2. Healthy by medical history and physical examination
3. Signed or thumb-printed Informed Consent by guardian/parent. Where guardian/parent cannot sign, a witness will be asked to sign to indicate that the procedures were understood and consent was given.
4. Resident in the study villages during the whole clinical trial period

Exclusion criteria: 1. Symptoms, physical signs of disease that could interfere with the interpretation of the clinical trial results or compromise the health of the subjects if they were vaccinated
2. Immunosuppressive therapy (steroids, immune modulators or immune suppressors) within three (3) months prior recruitment. (for corticosteroids, this will mean prednisone, or equivalent, ? 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
3. Cannot be followed for any social, psychological or geographical reasons.
4. Use of any investigational drug or vaccine other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use up to the end of the child?s participation in this clinical trial.
5. Suspected or known hypersensitivity to any of the vaccine components or to any vaccine.
6. Acute or chronic, clinically significant hepatic or renal functional abnormality.
7. Anaemia associated with clinical signs or symptoms of decompensation or haemoglobin ` 7.0 g/dL.
8. Planned administration of a vaccine not foreseen by the trial protocol within 30 days of the first dose of vaccine. An exception, is the receipt of an EPI or licensed vaccine (measles, oral polio, Hib, meningococcal and combined diphtheria/ pertussis/ tetanus vaccines) which may be given 14 days or more before or after vaccination
9. Presence of chronic illness that, in the judgement of the investigator, would interfere with the study outcomes or pose a threat to the participant?s health.
10. Administration of immunoglobulin and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period
11. History of surgical splenectomy.
12. Severe malnutrition at screening defined as weight for age Z-score less than 3


Age minimum: 12 Month
Age maximum: 60 Month
Gender: Both

Health Condition(s) or Problem(s) studied

Malaria
null

Primary Outcome(s)

Efficacy

Secondary Outcome(s)

Efficacy on anemia and severe anemia

Efficacy on clinical malaria by other case definitions

EXPLORATORY: Assess changes in parasite population

EXPLORATORY: Effect of other infections on immune response and vaccine efficacy

EXPLORATORY: Functionality of immune responses

EXPLORATORY: Humoral and cellular responses

EXPLORATORY: Investigate evidence for waning of efficacy

safety and reactogenicity

Source(s) of Monetary Support

EDCTP