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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01148459
First received: June 17, 2010
Last updated: April 6, 2017
Last verified: April 2017
  Purpose
The purpose of this study is to assess the safety and immunogenicity of the candidate malaria vaccine in HIV-infected infants and children

Condition Intervention Phase
Malaria Biological: GSK Biological's Investigational Malaria Vaccine 257049 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). Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Safety and Immunogenicity Study of GSK Biologicals' Plasmodium Falciparum Malaria Vaccine 257049 Administered to HIV Infected Infants and Children

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of subjects with serious adverse events (SAEs) [ Time Frame: During the entire study period (from 30 days before Dose 1 up to Month 14) ]
    SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.


Secondary Outcome Measures:
  • Number of subjects with any and Grade 3 solicited local symptoms [ Time Frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses ]
    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.

  • Number of subjects with any, Grade 3 and related solicited general symptoms [ Time Frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses ]
    Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 irritability/fussiness = crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as causally related to the study vaccination.

  • Number of subjects with any unsolicited adverse events (AEs) [ Time Frame: During the 30-day (Days 0-29) post-vaccination period ]
    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.

  • Number of subjects with non-malaria related SAEs [ Time Frame: During the entire study period (from 30 days before vaccine Dose 1 up to Month 14) ]
    SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

  • Anti-CS antibody titers [ Time Frame: Prior to vaccination and one month post Dose 3 ]
  • Anti-HBs antibody titers [ Time Frame: Prior to vaccination and one month post Dose 3 ]
  • Anti-CS antibody titers [ Time Frame: 12 months post Dose 3 ]
  • Anti-HBs antibody titers [ Time Frame: 12 months post Dose 3 ]
  • Occurrence of malaria disease according to specific case definitions [ Time Frame: From Day 0 to Day 420 ]
  • Asexual P. falciparum parasitemia prevalence and density [ Time Frame: 12 months post Dose 3 ]
  • HIV viral load [ Time Frame: At baseline and at one month, 6 months and 12 months post Dose 3 ]
  • Rate of positive CD4 and absolute cell counts [ Time Frame: At baseline and at one month, 6 months and 12 months post Dose 3 ]
  • WHO HIV clinical classification progression [ Time Frame: At baseline, one month, 6 months and 12 months post Dose3 ]
  • Growth parameters: weight, age/length and middle upper arm circumference for age score [ Time Frame: At Day 0 and Day 420 ]

Enrollment: 200
Study Start Date: July 30, 2010
Study Completion Date: May 24, 2013
Primary Completion Date: May 24, 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Infants enrolled to this group will receive 3 doses of the experimental vaccine.
Biological: GSK Biological's Investigational Malaria Vaccine 257049
All infants enrolled to group A will receive 3 doses of the experimental vaccine. The vaccine will be administered intramuscularly.
Active Comparator: Group B
Infants enrolled to this group will receive 3 doses of the rabies comparator vaccine.
Biological: Human Diploid Cell Vaccine (HDCV) or Purified Vero Cell Rabies Vaccine (PVRV, Verorab) (Aventis Pasteur);

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

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

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.


Detailed Description:
This protocol posting has been updated due to protocol Amendment 2.
  Eligibility

Ages Eligible for Study:   6 Weeks to 17 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01148459

Locations
Kenya
GSK Investigational Site
Kisian, Kenya
GSK Investigational Site
Kisumu, Kenya
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Study Data/Documents: Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 112745
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 112745
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 112745
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 112745
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 112745
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 112745
For additional information about this study please refer to the GSK Clinical Study Register

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01148459     History of Changes
Other Study ID Numbers: 112745
Study First Received: June 17, 2010
Last Updated: April 6, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Keywords provided by GlaxoSmithKline:
Plasmodium falciparum
schedule
HIV
malaria vaccine
EPI
Africa

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases
Vaccines
Lactitol
Immunologic Factors
Physiological Effects of Drugs
Cathartics
Gastrointestinal Agents

ClinicalTrials.gov processed this record on September 21, 2017