safety and immunogenicity of gsk biologicals' malaria vaccine 257049 when administered on 7 schedules to african infants

Conditions: Malaria

Summary: the aim of the malaria vaccine program of the mvi/gsk partnership is to develop an efficacious malaria vaccine that is deliverable through the existing system, the expanded program on immunization (epi) of who. this study has been designed to: * investigate the safety and immunogenicity of 7 infant immunization schedules of the experimental malaria vaccine integrated with an epi regimen. * investigate how to maximize the antibody response to the experimental malaria vaccine.


Eligibility criteria:
inclusion criteria: all subjects must satisfy the following criteria at study entry: * a male or female infant between 1 and 7 days (inclusive) of age (where day 1 is day of birth). * signed or thumb-printed informed consent obtained from the parent(s)/guardian(s) of the child. where parent(s)/guardian(s) are illiterate, the consent form will be countersigned by a witness. * subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g. return for follow-up visits) should be enrolled in the study. * born to a mother negative for hiv antibody and hepatitis b surface antigen. * subjects who are born after a normal gestation period (between 37 and 42 weeks) (gestational age will be determined by carrying out a clinical assessment on infants according to the principles set out by dubowitz (1970) in the first 5 days of life). * a minimum weight of 2.5 kg. exclusion criteria: the following criteria should be checked at the time of study entry. if any apply, the subject must not be included in the study: * acute or chronic illness determined by clinical or physical examination and laboratory screening tests including, but not limited to: * any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * a family history of congenital or hereditary immunodeficiency. * major congenital defects. * history of any neurological disorders or seizures. * laboratory screening tests out of normal ranges/limits defined per protocol. * previous vaccination with diphtheria, tetanus, pertussis (whole-cell or acellular), hemophilus influenzae type b, hepatitis b, bcg tuberculosis, measles or oral polio vaccines. * planned administration/administration of a licensed vaccine (i.e. a vaccine that is approved by one of the following authorities: fda or eu member state or who \[with respect to prequalification\]) not foreseen by the study protocol within 7 days of the first dose of study vaccine. * administration of immunoglobulins, blood transfusions or other blood products since birth to the first dose of study vaccine or planned administration during the study period. * use of a drug or vaccine that is not approved for that indication (by one of the following authorities: fda or eu member state or who \[with respect to prequalification\]) other than the study vaccine starting at birth or planned use during the study period. * chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth. * simultaneous participation in any other clinical trial. * same-sex twins (to avoid misidentification). * maternal death. * history of allergic reactions (significant ige-mediated events) or anaphylaxis to previous immunizations. * history of allergic disease or reactions likely to be exacerbated by any component of the vaccine. * children will not be enrolled if any maternal, obstetrical or neonatal event that has occurred might, in the judgment of the investigator, result in increased neonatal/infant morbidity * any other findings that the investigator feels would increase the risk of having an adverse outcome from participation in the trial.

Keywords: africa malaria vaccine schedule epi plasmodium falciparum