A Study to Evaluate the Safety, Immunogenicity and Efficacy of GlaxoSmithKline (GSK) Biologicals' Candidate Malaria Vaccine RTS,S/AS02A, When Administered to Children Aged 1 to 4 Years Living in a Malaria-endemic Region of Mozambique.

NCT00197041 | Completed Phase 2

• 1 other identifier: 257049/026
• Study Type: interventional
• Target: 2,022
• Locations: 1 country
• Sites: 1

Brief Summary

Malaria is an important cause of death and serious illness among Mozambican children. Although the risk of malaria can be reduced by drugs and by impregnated bed nets, it would be helpful if children could be protected against malaria by a vaccine. GSK Biologicals is developing in partnership with Malaria Vaccine Initiative at PATH a candidate malaria vaccine RTS,S/AS02 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 and also would provide protection against infection with hepatitis B virus. Previous studies have shown the candidate malaria vaccine RTS,S/AS02 to be safe when administered in adults and children aged 1-11 years. However, to assess if this vaccine could provide protection against malaria in children, this study has been undertaken.

Conditions

Malaria

Outcome Measures

Primary Outcomes (1)

• Time to the first clinical episode of symptomatic Plasmodium falciparum malaria infection detected over the 6-month surveillance period after Dose 3 vaccination.

Secondary Outcomes (1)

• Occurrence of episodes of asymptomatic and symptomatic infections of Plasmodium falciparum malaria. Occurrence of solicited symptoms, unsolicited symptoms and SAEs.

Interventions

RTS,S/AS02A BIOLOGICAL

Eligibility Criteria

• Age: 1 Year - 4 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy male and female children, 1 to 4 years of age at the time of first vaccination (up to but not including 5th birthday).
• Written/thumbprinted and witnessed informed consent obtained from the parents or legal guardians.

You may not qualify if:

• Major congenital defects or serious chronic illness.
• History of allergic reactions to vaccination or to any component of the Hiberix™, Prevnar® or Engerix-B™ vaccines.
• Chronic administration (defined as more than 14 days) of immuno-suppressants or other immune modifying drugs within six months prior to the first vaccine dose .
• Previous vaccination with an experimental vaccine or with hepatitis B vaccine in children equal to or more than 18 months of age.
• Simultaneous participation in any other clinical trial.
• Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
• Planned administration of a vaccine not foreseen by the study protocol within 30 days before the first dose of vaccine. An exception, is the receipt of an EPI or licensed vaccine.
• Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Maputo, Mozambique

Location

Related Publications (8)

• Jairoce C, Macia D, Torres-Yaguana JP, Mayer L, Vidal M, Santano R, Hurtado-Guerrero R, Reiter K, Narum DL, Lopez-Gutierrez B, Hamerly T, Sacarlal J, Aguilar R, Dinglasan RR, Moncunill G, Izquierdo L, Dobano C. RTS,S/AS02A Malaria Vaccine-Induced IgG Responses Equally Recognize Native-Like Fucosylated and Nonfucosylated Plasmodium falciparum Circumsporozoite Proteins. J Infect Dis. 2024 Mar 14;229(3):795-799. doi: 10.1093/infdis/jiad471.

  PMID: 37889513 DERIVED

• Feng G, Kurtovic L, Agius PA, Aitken EH, Sacarlal J, Wines BD, Hogarth PM, Rogerson SJ, Fowkes FJI, Dobano C, Beeson JG. Induction, decay, and determinants of functional antibodies following vaccination with the RTS,S malaria vaccine in young children. BMC Med. 2022 Aug 25;20(1):289. doi: 10.1186/s12916-022-02466-2.

  PMID: 36002841 DERIVED

• Cheung YB, Ma X, Lam KF, Milligan P. Estimation of the primary, secondary and composite effects of malaria vaccines using data on multiple clinical malaria episodes. Vaccine. 2020 Jul 6;38(32):4964-4969. doi: 10.1016/j.vaccine.2020.05.086. Epub 2020 Jun 12.

  PMID: 32536547 DERIVED

• Campo JJ, Dobano C, Sacarlal J, Guinovart C, Mayor A, Angov E, Dutta S, Chitnis C, Macete E, Aponte JJ, Alonso PL. Impact of the RTS,S malaria vaccine candidate on naturally acquired antibody responses to multiple asexual blood stage antigens. PLoS One. 2011;6(10):e25779. doi: 10.1371/journal.pone.0025779. Epub 2011 Oct 12.

  PMID: 22022448 DERIVED

• Aide P, Dobano C, Sacarlal J, Aponte JJ, Mandomando I, Guinovart C, Bassat Q, Renom M, Puyol L, Macete E, Herreros E, Leach A, Dubois MC, Demoitie MA, Lievens M, Vekemans J, Loucq C, Ballou WR, Cohen J, Alonso PL. Four year immunogenicity of the RTS,S/AS02(A) malaria vaccine in Mozambican children during a phase IIb trial. Vaccine. 2011 Aug 11;29(35):6059-67. doi: 10.1016/j.vaccine.2011.03.041. Epub 2011 Apr 7.

  PMID: 21443960 DERIVED

• Sacarlal J, Aide P, Aponte JJ, Renom M, Leach A, Mandomando I, Lievens M, Bassat Q, Lafuente S, Macete E, Vekemans J, Guinovart C, Sigauque B, Sillman M, Milman J, Dubois MC, Demoitie MA, Thonnard J, Menendez C, Ballou WR, Cohen J, Alonso PL. Long-term safety and efficacy of the RTS,S/AS02A malaria vaccine in Mozambican children. J Infect Dis. 2009 Aug 1;200(3):329-36. doi: 10.1086/600119.

  PMID: 19569964 DERIVED

• Guinovart C, Aponte JJ, Sacarlal J, Aide P, Leach A, Bassat Q, Macete E, Dobano C, Lievens M, Loucq C, Ballou WR, Cohen J, Alonso PL. Insights into long-lasting protection induced by RTS,S/AS02A malaria vaccine: further results from a phase IIb trial in Mozambican children. PLoS One. 2009;4(4):e5165. doi: 10.1371/journal.pone.0005165. Epub 2009 Apr 14.

  PMID: 19365567 DERIVED

• Alonso PL, Sacarlal J, Aponte JJ, Leach A, Macete E, Aide P, Sigauque B, Milman J, Mandomando I, Bassat Q, Guinovart C, Espasa M, Corachan S, Lievens M, Navia MM, Dubois MC, Menendez C, Dubovsky F, Cohen J, Thompson R, Ballou WR. Duration of protection with RTS,S/AS02A malaria vaccine in prevention of Plasmodium falciparum disease in Mozambican children: single-blind extended follow-up of a randomised controlled trial. Lancet. 2005 Dec 10;366(9502):2012-8. doi: 10.1016/S0140-6736(05)67669-6.

  PMID: 16338450 DERIVED

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

Interventions

RTS,S-AS02A vaccine

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; 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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 20, 2005
• Study Start: July 1, 2003
• Primary Completion: April 1, 2005
• Study Completion: April 1, 2005
• Last Updated: September 21, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will share

Locations

MO (1)