Safety and Immunogenicity of GSK Biologicals' Investigational Malaria Vaccine in HIV Infected Infants and Children

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Malaria

Treatments: Biological: Human Diploid Cell Vaccine (HDCV) or Purified Vero Cell Rabies Vaccine (PVRV, Verorab) (Aventis Pasteur);; Biological: Purified Chick Embryo Cell Culture (PCEC) Rabies Vaccine (Rabipur or equivalent) (Novartis).; Biological: GSK Biological's Investigational Malaria Vaccine 257049

Study type: Interventional

Funder types: Industry

Identifiers

NCT01148459

112745

Details and patient eligibility

About

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

Full description

This protocol posting has been updated due to protocol Amendment 2.

Enrollment: 200 patients

Sex: All

Ages: 6 weeks to 17 months old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups

Group A

Experimental group

Description:

Infants enrolled to this group will receive 3 doses of the experimental vaccine.

Treatment:

Biological: GSK Biological's Investigational Malaria Vaccine 257049

Group B

Active Comparator group

Description:

Infants enrolled to this group will receive 3 doses of the rabies comparator vaccine.

Treatment:

Biological: Purified Chick Embryo Cell Culture (PCEC) Rabies Vaccine (Rabipur or equivalent) (Novartis).

Biological: Human Diploid Cell Vaccine (HDCV) or Purified Vero Cell Rabies Vaccine (PVRV, Verorab) (Aventis Pasteur);