Safety and Immunogenicity of GSK Biologicals' Investigational Malaria Vaccine in HIV Infected Infants and Children
Condition: Malaria
MeSH terms: Malaria
Intervention: GSK Biological's Investigational Malaria Vaccine 257049; Human Diploid Cell Vaccine (HDCV) or Purified Vero Cell Rabies Vaccine (PVRV, Verorab) (Aventis Pasteur);; Purified Chick Embryo Cell Culture (PCEC) Rabies Vaccine (Rabipur or equivalent) (Novartis).
Intervention description: All infants enrolled to group A will receive 3 doses of the experimental vaccine. The vaccine will be administered intramuscularly.; To ensure consistent vaccine availability, three cell culture rabies vaccines from two manufacturers may be sourced for this trial (Aventis-Pasteur and Novartis). It will be ensured that an individual child will receive all 3 doses of cell culture rabies vaccine from the same product.
The vaccine will be administered intramuscularly; To ensure consistent vaccine availability, three cell culture rabies vaccines from two manufacturers may be sourced for this trial (Aventis-Pasteur and Novartis). It will be ensured that an individual child will receive all 3 doses of cell culture rabies vaccine from the same product.
The vaccine will be administered intramuscularly.
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 200.0
Sex: All
Minimum age: 6 Weeks
Maximum age: 17 Months
Healthy volunteers: No
Keywords: Plasmodium falciparum; schedule; HIV; malaria vaccine; EPI; Africa

Summary:

      The purpose of this study is to assess the safety and immunogenicity of the candidate malaria
      vaccine in HIV-infected infants and children
    

Eligibility criteria:

        Inclusion Criteria:

        All subjects must satisfy ALL the following criteria at study entry:

          -  A male or female infant or child between and including 6 weeks to 17 months of age, at
             the time of first vaccination.

          -  Signed or thumb-printed informed consent obtained from the parent(s)/LAR(s) of the
             infant or child. Where parents/LARs are illiterate, the consent form will be
             countersigned by a witness.

          -  Subjects who the investigator believes that their parents/LARs can and will comply
             with the requirements of the protocol should be enrolled in the study.

          -  Subjects who are known to be HIV-infected (documented positive DNA PCR), whether
             taking HIV antiretroviral treatment (ART) or not.

          -  Subjects who are born following a normal gestation period.

        Exclusion Criteria:

        The following criteria should be checked at the time of study entry. If ANY exclusion
        criterion applies, the subject must not be included in the study:

          -  Acute disease at the time of enrolment. However, the presence of an illness listed as
             Grade I or Grade II (WHO pediatric AIDS clinical staging) will not of itself
             constitute an exclusion criterion. Enrolment should be deferred if axillary
             temperature is >=37.5°C.

          -  Grade III or Grade IV abnormality on screening laboratory blood sample.

          -  Grade III or IV AIDS at the time of enrolment (WHO pediatric AIDS clinical staging).

          -  Major congenital defects.

          -  Planned administration/administration of a vaccine not foreseen by the study protocol
             prior to or within 7 days of study vaccine.

          -  Use of any investigational or non-registered product (drug or vaccine) other than the
             study vaccine 30 days preceding Dose°1 of study vaccine, or planned use during the
             study period.

          -  Previous participation in any other malaria vaccine trial.

          -  Simultaneous participation in another clinical trial including administration of
             experimental treatment.

          -  Same sex twins.

          -  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 study vaccine.

          -  Child in care.