Examine Safety and Immune Responses of GSK 257049 Vaccine When Administered to Infants Living in a Malaria-endemic Region

NCT00197028 | Completed Phase 2 Results

• 1 other identifier: 103967
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Malaria

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With Serious Adverse Events (SAEs).

  SAEs were defined as medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.

  From Month 0 to Month 6

Secondary Outcomes (17)

• Number of Subjects With Serious Adverse Events (SAEs).

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

• Concentrations of Antibodies Against Hepatitis B (Anti-HB)

  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.

  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)

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

• Concentrations of Antibodies Against Tetanus (Anti-T)

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

Study Arms (2)

RTS,S/AS02D Group

EXPERIMENTAL

Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.

Biological: RTS,S/AS02D; Biological: TETRActHib™

Engerix-B Group

ACTIVE COMPARATOR

Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.

Biological: TETRActHib™; Biological: Engerix-B®

Interventions

RTS,S/AS02D BIOLOGICAL

3-dose intramuscular injection in the thigh

RTS,S/AS02D Group

TETRActHib™ BIOLOGICAL

3-dose intramuscular injection in the thigh.

Engerix-B Group; RTS,S/AS02D Group

Engerix-B® BIOLOGICAL

3-dose intramuscular injection in the thigh.

Engerix-B Group

Eligibility Criteria

• Age: 6 Weeks - 12 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Maputo, Mozambique

Location

Related Publications (2)

• Aide P, Aponte JJ, Renom M, Nhampossa T, Sacarlal J, Mandomando I, Bassat Q, Manaca MN, Leach A, Lievens M, Vekemans J, Dubois MC, Loucq C, Ballou WR, Cohen J, Alonso PL. Safety, immunogenicity and duration of protection of the RTS,S/AS02(D) malaria vaccine: one year follow-up of a randomized controlled phase I/IIb trial. PLoS One. 2010 Nov 4;5(11):e13838. doi: 10.1371/journal.pone.0013838.

  PMID: 21079803 BACKGROUND

• Aponte JJ, Aide P, Renom M, Mandomando I, Bassat Q, Sacarlal J, Manaca MN, Lafuente S, Barbosa A, Leach A, Lievens M, Vekemans J, Sigauque B, Dubois MC, Demoitie MA, Sillman M, Savarese B, McNeil JG, Macete E, Ballou WR, Cohen J, Alonso PL. 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. 2007 Nov 3;370(9598):1543-51. doi: 10.1016/S0140-6736(07)61542-6. Epub 2007 Oct 18.

  PMID: 17949807 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

Interventions

RTS malaria vaccine; Engerix-B

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: 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: August 23, 2005
• Primary Completion: December 27, 2007
• Study Completion: December 27, 2007
• Last Updated: August 20, 2018
• Results First Posted: January 18, 2013

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share

Locations

MO (1)