Partially-blind (Observer-blind) Study of Safety and Immunogenicity of Two Malaria Vaccines in Ghanaian Children

Malaria Clinical Trial

Official title:

A Partially-blind (Observer-blind) Study to Evaluate the Safety and Immunogenicity of 3 Different Vaccination Schedules With 2 GSK Biologicals' Candidate Plasmodium Falciparum Vaccines in Children Aged 5 to 17 Months Living in Ghana

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00360230
• Other study ID #: 106367
• Status: Completed
• Phase: Phase 2
• First received: July 31, 2006
• Last updated: August 10, 2017
• Start date: August 30, 2006
• Est. completion date: May 30, 2008

Study information

• Verified date: August 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will investigate the safety and immunogenicity of 2 candidate malaria vaccines administered according to 3 different vaccination schedules in 5 to 17 months old Ghanaian children. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Description:

This study will be conducted in a partially blind fashion: it will be observer-blind as to which vaccine was administered, and open as to the vaccination schedule. One group of children on the 0, 1, 2-schedule will receive a Rabies vaccine as a control. One group on the same schedule will receive the RTS,S/AS02D experimental vaccine as an active comparator.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 540
• Est. completion date: May 30, 2008
• Est. primary completion date: August 25, 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Months to 17 Months

Eligibility

Inclusion Criteria:

• A male or female child between 5 months and 17 months of age 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.

• Proof that child has received a full 3-dose regimen of licensed Hepatitis B vaccine in infancy.

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 acceptable limits.

• Planned administration/administration of a vaccine (not in the scope of the study) within 30 days of the first dose of vaccine(s) with the exception of tetanus toxoid or scheduled Yellow fever or Measles vaccine.

• Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the first dose of the 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.

• Simultaneous participation in any other clinical trial;

• Previous participation in any other malaria vaccine trial;

• Any 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 vaccine.

• Any other findings that the investigator feels would increase the risk of having an adverse outcome from participation in the trial.

Related Conditions & MeSH terms

• Malaria

Intervention

Biological:
• GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049
2 different formulations are tested. For each formulation, 3 different dosing schedules are tested
• Rabipur
3-dose intramuscular injection.

Locations

Country	Name	City	State
Ghana	GSK Investigational Site	Kintampo
Ghana	GSK Investigational Site	Kumasi

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Ghana, 

References & Publications (2)

Ansong D, Asante KP, Vekemans J, Owusu SK, Owusu R, Brobby NA, Dosoo D, Osei-Akoto A, Osei-Kwakye K, Asafo-Adjei E, Boahen KO, Sylverken J, Adjei G, Sambian D, Apanga S, Kayan K, Janssens MH, Lievens MJ, Olivier AC, Jongert E, Dubois P, Savarese BM, Cohen J, Antwi S, Greenwood BM, Evans JA, Agbenyega T, Moris PJ, Owusu-Agyei S. T cell responses to the RTS,S/AS01(E) and RTS,S/AS02(D) malaria candidate vaccines administered according to different schedules to Ghanaian children. PLoS One. 2011 Apr 27;6(4):e18891. doi: 10.1371/journal.pone.0018891. — View Citation

Owusu-Agyei S, Ansong D, Asante K, Kwarteng Owusu S, Owusu R, Wireko Brobby NA, Dosoo D, Osei Akoto A, Osei-Kwakye K, Adjei EA, Boahen KO, Sylverken J, Adjei G, Sambian D, Apanga S, Kayan K, Vekemans J, Ofori-Anyinam O, Leach A, Lievens M, Demoitie MA, Dubois MC, Cohen J, Ballou WR, Savarese B, Chandramohan D, Gyapong JO, Milligan P, Antwi S, Agbenyega T, Greenwood B, Evans J. Randomized controlled trial of RTS,S/AS02D and RTS,S/AS01E malaria candidate vaccines given according to different schedules in Ghanaian children. PLoS One. 2009 Oct 2;4(10):e7302. doi: 10.1371/journal.pone.0007302. Erratum in: PLoS One. 2010;5(11). doi: 10.1371/annotation/23dc5ebf-15ce-4f77-9aaf-9afec78e19b5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects With Serious Adverse Events (SAEs)	Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.	From Day 0 to Month 10
Secondary	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Assessed solicited local symptoms were pain and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 swelling = swelling spreading beyond 20 millimeters (mm) of injection site.	During the 7-day (Days 0 - 6) post-vaccination period following each dose and across doses
Secondary	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Assessed solicited general symptoms were drowsiness, fever [defined as axillary temperature equal to or above (=) 37.5 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever higher than (>) 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.	During the 7-day (Days 0 - 6) post-vaccination period following each dose and across doses
Secondary	Number of Subjects With Any Unsolicited Adverse Events (AEs)	An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.	During the 30-day (Days 0 - 29) post-vaccination period following each dose and across doses
Secondary	Titers for Anti-Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS)	Titers are presented as geometric mean titers (GMTs) and expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).	At Day 0, at Month 2, at Month 7 and at Month 10
Secondary	Titers for Anti-Hepatitis B (Anti-HBs)	Titers are presented as geometric mean titers (GMTs) and expressed in milli-international units per milliliter (mIU/mL).	At Day 0 and at Month 2

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