Double-blind Study of Safety and Immunogenicity of Two Candidate Malaria Vaccines in Gabonese Children

NCT00307021 | Completed Phase 2

• 1 other identifier: 105874
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Malaria

Keywords

Parasitic Diseases; Malaria, Falciparum; Malaria; Coccidiosis

Outcome Measures

Primary Outcomes (2)

• Occurrence of SAEs.

  From the time of first vaccination until one month post Dose 3

• Antibody titers to the P. falciparum circumsporozoite repeat domain (anti-CS).

  One month post Dose 3.

Secondary Outcomes (4)

• Occurrence of solicited general and local reactions.

  Over a 7-day follow-up period after each vaccination.

• Occurrence of unsolicited symptoms.

  After each vaccination over a 30-day follow-up

• Anti-CS antibody titers.

  Prior to vaccination, one month post Dose 2

• Anti-Hepatitis B surface agent (anti-HBs) antibody titers.

  Prior to vaccination, one month post Dose 2 and one month post Dose 3.

Study Arms (2)

Group A

ACTIVE COMPARATOR

Biological: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049

Group B

EXPERIMENTAL

Biological: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049

Interventions

GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049 BIOLOGICAL

3-dose intramuscular injection, 2 different formulations

Group A; Group B

Eligibility Criteria

• Age: 18 Months - 48 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Lambaréné, Gabon

Location

Related Publications (2)

• 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.

  PMID: 21494604 BACKGROUND

• 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.

  PMID: 19859560 BACKGROUND

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Malaria; Parasitic Diseases; Malaria, Falciparum; Coccidiosis

Condition Hierarchy (Ancestors)

Protozoan Infections; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2006
• First Posted: March 27, 2006
• Study Start: April 7, 2006
• Primary Completion: September 15, 2006
• Study Completion: August 22, 2007
• Last Updated: April 25, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share

Locations

GA (1)