Clinical trial NCT01148459: Safety and Immunogenicity of GSK Biologicals' Investigational Malaria Vaccine in HIV Infected Infants and Children
Official title: Safety and Immunogenicity Study of GSK Biologicals' Plasmodium Falciparum Malaria Vaccine 257049 Administered to HIV Infected Infants and Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Malaria
Keywords: Plasmodium falciparum
schedule
HIV
malaria vaccine
EPI
Africa
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2010-06-22
Enrollment: 200
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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

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.

Primary outcomes:
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: During the entire study period (from 30 days before Dose 1 up to Month 14)
Secondary outcomes:
measure: Number of Subjects With Any and Grade 3 Solicited Local Symptoms
timeFrame: During the 7-day post-vaccination period following each dose and across doses: Day 1 through Day 7, Month 1 through Month 1 + 7 days (Day 37), Month 2 through Month 2 + 7 days (Day 67)
measure: Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
timeFrame: During the 7-day post-vaccination period following each dose and across doses: Day 1 through Day 7, Month 1 through Month 1 + 7 days (Day 37), Month 2 through Month 2 + 7 days (Day 67)
measure: Number of Subjects With Any Unsolicited Adverse Events (AEs)
timeFrame: During the 30-day post-vaccination period (up to Day 90)
measure: Number of Subjects With Non-malaria Related SAEs
timeFrame: During the entire study period (from 30 days before vaccine Dose 1 up to Month 14)
measure: Anti-circumsporozoite Protein of P. Falciparum (Anti-CS) Antibody Concentrations
timeFrame: Prior to vaccination (PRE) and one month post Dose 3 (Month 3)
measure: Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Titers
timeFrame: Prior to vaccination (PRE) and one month post Dose 3 (Month 3)
measure: Anti-CS Antibody Concentrations
timeFrame: 12 months post Dose 3 (Month 14)
measure: Anti-HBs Antibody Titers
timeFrame: 12 months post Dose 3 (Month 14)
measure: Number of Episodes With Clinical Malaria Disease According to Primary Case Definition
timeFrame: From Day 0 to Month 14
measure: Number of Episodes With Severe Malaria According to Primary Case Definition
timeFrame: From Day 0 to Month 14
measure: Number of Subjects Affected by Prevalent Parasitemia and Prevalent Moderate Anemia
timeFrame: 12 months post Dose 3 (Month 14)
measure: Asexual P. Falciparum Parasitemia Density
timeFrame: 12 months post Dose 3 (Month 14)
measure: Prevalent Hemoglobin Level
timeFrame: 12 months post Dose 3 (Month 14)
measure: HIV Viral Load
timeFrame: At baseline (PRE) and at one month (Month 3), 6 months (Month 8) and 12 months (Month 14) post Dose 3
measure: Percentage of CD4+ Cells
timeFrame: At baseline (PRE) and at one month (Month 3), 6 months (Month 8) and 12 months (Month 14) post Dose 3
measure: CD4+ Absolute Cell Counts
timeFrame: At baseline (PRE) and at 1 month (Month 3), 6 months (Month 8) and 12 months (Month 14) post Dose 3
measure: World Health Organization (WHO) HIV Clinical Classification Progression
timeFrame: At baseline (PRE), at study months 1 (Month 1) and 2 (Month 2) and at 1 month (Month 3), 6 months (Month 8) and 12 months (Month 14) post Dose 3
measure: Growth Parameters: Weight, Age/Length and Middle Upper Arm Circumference for Age Z-score
timeFrame: At baseline (PRE), at Month 3 and at study end (Month 14)
Other outcomes:
Locations:
city: Kisian
country: Kenya
facility: GSK Investigational Site
city: Kisumu
country: Kenya
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Otieno L, Oneko M, Otieno W, Abuodha J, Owino E, Odero C, Mendoza YG, Andagalu B, Awino N, Ivinson K, Heerwegh D, Otsyula N, Oziemkowska M, Usuf EA, Otieno A, Otieno K, Leboulleux D, Leach A, Oyieko J, Slutsker L, Lievens M, Cowden J, Lapierre D, Kariuki S, Ogutu B, Vekemans J, Hamel MJ. Safety and immunogenicity of RTS,S/AS01 malaria vaccine in infants and children with WHO stage 1 or 2 HIV disease: a randomised, double-blind, controlled trial. Lancet Infect Dis. 2016 Oct;16(10):1134-1144. doi: 10.1016/S1473-3099(16)30161-X. Epub 2016 Jul 7.