Last updated: 11/03/2018 00:24:38

Examine Safety and Immune Responses of GSK 257049 vaccine when administered to Infants living in a malaria-endemic region

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GSK study ID
103967
See study documents
Clinicaltrials.gov ID
NCT00197028
See results summary
EudraCT ID
2015-001538-25
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Phase I/IIb randomized, double-blind, controlled study of the safety, immunogenicity and proof-of-concept of RTS,S/AS02D, a candidate malaria vaccine in infants living in a malaria-endemic region
Trial description: GSK Biologicals is developing in partnership with the Program for Appropriate Technology in Health (PATH) Malaria Vaccine Initiative a candidate malaria vaccine for the routine immunization of infants and children living in malaria endemic areas. The vaccine would offer protection against malaria disease due to the parasite Plasmodium falciparum. The vaccine would also provide protection against infection with hepatitis B virus (HBV).
This trial is being carried out following the demonstration of efficacy of a previous version of the malaria candidate vaccine in children in Mozambique: there, the vaccine demonstrated approximately 30% efficacy against clinical episodes of malaria and approximately 58% efficacy against severe malaria disease.
In order to integrate the malaria vaccine into the Expanded Program on Immunization (EPI) regimen, in malaria-endemic regions, for this trial, a 0.5 ml dose of GSK 257049 vaccine has been developed. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Triple (Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:

Number of subjects with serious adverse events (SAEs).

Timeframe: From Month 0 to Month 6

Secondary outcomes:

Number of subjects with serious adverse events (SAEs).

Timeframe: Throughout the entire study period (from Month 0 to Month 14)

Concentrations of antibodies against hepatitis B (Anti-HB)

Timeframe: Prior to vaccination at Month 0 (PRE) and 1 month post Dose 3 of Engerix-B® or RTS,S/AS02D vaccine (Day 104).

Concentrations of anti-circumsporozoite protein (anti-CS) antibodies.

Timeframe: Prior to vaccination at Month 0 (PRE), 1 month post Dose 3 of Engerix-B® or RTS,S/AS02D vaccine (Day 104) and 3½ months post Dose 3 of Engerix-B® or RTS,S/AS02D vaccine (Day 180).

Concentrations of antibodies against anti-diphtheria (Anti-D)

Timeframe: At Day 90 (1 month post Dose 3 of TETRActHib™ vaccine)

Concentrations of antibodies against tetanus (Anti-T)

Timeframe: At Day 90 (1 month post Dose 3 of TETRActHib™ vaccine)

Concentrations of anti-Bordetella pertussis toxin antibodies (Anti-BPT).

Timeframe: At Day 90 (1 month post Dose 3 of TETRActHib™ vaccine)

Concentrations of anti-polyribosyl ribitol phosphate antibodies (Anti-PRP).

Timeframe: At Day 90 (1 month post Dose 3 of TETRActHib™ vaccine)

Time to first malaria infection

Timeframe: Over the period starting 14 days after Dose 3 of RTS,S/AS02D or Engerix-B® vaccine and extending for 12 weeks thereafter (from Month 2.5 to Month 6)

Number of subjects prevalent for Plasmodium falciparum (P. falciparum)

Timeframe: At Month 6 (3½ months post Dose 3 of RTS,S/AS02D or Engerix-B® vaccine)

Plasmodium falciparum (P. falciparum) parasite density in subjects prevalent for parasitemia

Timeframe: At Month 6 (3½ months post Dose 3 of RTS,S/AS02D or Engerix-B® vaccine)

Number of subjects with solicited local symptoms.

Timeframe: During the 7 day (Days 0-6) follow-up period after any vaccination with TETRActHib™ vaccine.

Number of subjects with solicited local symptoms.

Timeframe: During the 7 day (Days 0-6) follow-up period after any vaccination with Engerix-B® or RTS,S/AS02D vaccine.

Number of subjects with solicited general symptoms.

Timeframe: During the 7 day (Days 0-6) follow-up period after any vaccination with TETRActHib™ vaccine

Number of subjects with solicited general symptoms.

Timeframe: During the 7 day (Days 0-6) follow-up period after any vaccination with Engerix-B® or RTS,S/AS02D vaccine

Number of subjects with unsolicited Adverse Events (AEs).

Timeframe: During the 14 day (Days 0-13) follow-up period after any vaccination with of TETRActHib™ vaccine

Number of subjects with unsolicited Adverse Events (AEs).

Timeframe: During the 14 day (Days 0-13) follow-up period after vaccination with any among Doses 1 and 2 of Engerix-B® or RTS,S/AS02D vaccine.

Number of subjects with unsolicited Adverse Events (AEs).

Timeframe: During the 30 day (Days 0-29) follow-up period after vaccination with Dose 3 of Engerix-B® or RTS,S/AS02D vaccine.

Interventions:
  • Biological/vaccine: RTS,S/AS02D
  • Biological/vaccine: TETRActHib™
  • Biological/vaccine: Engerix-B®
    • Enrollment:
    214
    Primary completion date:
    2007-27-12
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Aide Pedro et al. (2010) Safety, immunogenicity and duration of protection of the RTS,S/AS02D malaria vaccine: One year follow-up of a randomized controlled phase I/IIb trial. Plos One. 5(11): e13838.
    Aponte JJ et al. (2007) Safety of the RTS,S/AS02D candidate malaria vaccine in infants living in a highly endemic area of Mozambique: a double blind randomised controlled phase I/IIb trial. Lancet 370 (9598):1543-1551.
    Medical condition
    Malaria
    Product
    SB257049
    Collaborators
    Not applicable
    Study date(s)
    August 2005 to December 2007
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    6 - 12 weeks
    Accepts healthy volunteers
    Yes
    • A male or female infant of between 6 and 12 weeks of age at the time of first vaccination.
    • Written informed consent obtained from the parent(s) or guardian(s) of the subject
    • Bacillus Calmette-Guérin tuberculosis vaccine (BCG) administration within one week of proposed administration of a study vaccine.
    • Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • A male or female infant of between 6 and 12 weeks of age at the time of first vaccination.
    • Written informed consent obtained from the parent(s) or guardian(s) of the subject
    • Free of obvious health problems as established by medical history and clinical examination before entering into the study.
    • Born to a mother who is hepatitis B surface antigen (HBsAg) negative and human immunodeficiency virus (HIV) negative.
    • Born after a normal gestation period (between 36 and 42 weeks).
    • Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
    Exclusion criteria:
    • Bacillus Calmette-Guérin tuberculosis vaccine (BCG) administration within one week of proposed administration of a study vaccine.
    • Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
    • Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
    • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth
    • Any chronic drug therapy to be continued during the study period.
    • Previous vaccination with diphtheria, tetanus, pertussis, Haemophilus influenzae type b or hepatitis B vaccines.
    • Major congenital abnormality.
    • Serious acute or chronic illness determined by clinical, physical examination and laboratory screening tests
    • Any medically diagnosed or suspected immunodeficient condition based on medical history and physical examination
    • A family history of congenital or hereditary immunodeficiency.
    • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
    • History of any neurological disorders or seizures.
    • Maternal death.
    • Hemoglobin < 80 g/L
    • Simultaneous participation in any other clinical trial.
    • Same sex twin
    • Any other findings that the investigator feels would increase the risk of having an adverse outcome from participation in the trialModerate malnutrition at screening

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Maputo, Mozambique
    Status
    Study Complete
    Contact us

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2007-27-12
    Actual study completion date
    2007-27-12

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

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