Clinical trial NCT00307021: Double-blind Study of Safety and Immunogenicity of Two Candidate Malaria Vaccines in Gabonese Children
Official title: Bridging Safety & Immunogenicity Study of GSK Biologicals' Candidate Malaria Vaccine RTS,S/AS01E (0.5 mL Dose) to RTS,S/AS02D (0.5 mL Dose) Administered IM According to a 0, 1, 2-Month Schedule in Gabonese Children Aged 18 Months to 4 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Malaria
Keywords: Parasitic Diseases
Malaria, Falciparum
Malaria
Coccidiosis
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-03-27
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: GSK Biologicals is developing a number of candidate malaria vaccines for the routine immunization of infants and children living in malaria-endemic areas. The candidate vaccines are designed to offer protection against malaria disease due to the parasite Plasmodium falciparum. Candidate vaccines containing the RTS,S antigen would also provide protection against infection with hepatitis B virus (HBV). This study will evaluate two candidate vaccines. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.


Eligibility criteria: Inclusion criteria:

* A male or female child between 18 months and 4 years of age (up to but not including 5th birthday) at the time of first vaccination.
* Written or oral, signed or thumb-printed and witnessed informed consent obtained from the parent(s)/guardian(s) of the child.
* Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g. return for follow-up visits)

Exclusion criteria:

* Acute disease at the time of enrolment.
* Serious acute or chronic illness determined by clinical or physical examination and laboratory screening tests.
* Laboratory screening tests for haemoglobin, total white cell count, platelets, ALT and creatinine out of range.
* Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine(s) with the exception of tetanus toxoid.
* Use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Administration of immunoglobulins, blood transfusions or other blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
* Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
* Previous participation in any other malaria vaccine trial.
* Simultaneous participation in any other clinical trial.
* Same sex twin.
* 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 vaccine.
* Any other findings that the investigator feels would increase the risk of having an adverse outcome from participation in the trial.

Primary outcomes:
measure: Occurrence of SAEs.
timeFrame: From the time of first vaccination until one month post Dose 3
measure: Antibody titers to the P. falciparum circumsporozoite repeat domain (anti-CS).
timeFrame: One month post Dose 3.
Secondary outcomes:
measure: Occurrence of solicited general and local reactions.
timeFrame: Over a 7-day follow-up period after each vaccination.
measure: Occurrence of unsolicited symptoms.
timeFrame: After each vaccination over a 30-day follow-up
measure: Anti-CS antibody titers.
timeFrame: Prior to vaccination, one month post Dose 2
measure: Anti-Hepatitis B surface agent (anti-HBs) antibody titers.
timeFrame: Prior to vaccination, one month post Dose 2 and one month post Dose 3.
Other outcomes:
Locations:
city: Lambaréné
country: Gabon
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Agnandji ST, Fendel R, Mestre M, Janssens M, Vekemans J, Held J, Gnansounou F, Haertle S, von Glasenapp I, Oyakhirome S, Mewono L, Moris P, Lievens M, Demoitie MA, Dubois PM, Villafana T, Jongert E, Olivier A, Cohen J, Esen M, Kremsner PG, Lell B, Mordmuller B. Induction of Plasmodium falciparum-specific CD4+ T cells and memory B cells in Gabonese children vaccinated with RTS,S/AS01(E) and RTS,S/AS02(D). PLoS One. 2011 Apr 11;6(4):e18559. doi: 10.1371/journal.pone.0018559.
citation: Lell B, Agnandji S, von Glasenapp I, Haertle S, Oyakhiromen S, Issifou S, Vekemans J, Leach A, Lievens M, Dubois MC, Demoitie MA, Carter T, Villafana T, Ballou WR, Cohen J, Kremsner PG. A randomized trial assessing the safety and immunogenicity of AS01 and AS02 adjuvanted RTS,S malaria vaccine candidates in children in Gabon. PLoS One. 2009 Oct 27;4(10):e7611. doi: 10.1371/journal.pone.0007611.