Mosquirix (RTS,S)

Table 1.  Vaccine Efficacy Results from Clinical Trials

Reference	Population	Follow-up Duration	Study Period	Outcome	Vaccine Efficacy 95% CI) (Per-protocol)	Vaccine Efficacy (95% CI) (ITT)
Phase 1 and 2 trials
Alonso (2004)10	2022 children from Mozambique	8.5 months after 1st dose	April 2003-May 2004	First episode of fever and parasitemia >2500 parasites/μL (Cohort 1)	29.9% (11.0 to 44.8); n = 1490	30.2% (14.4 to 43.0); n = 1605
		6.5 months after 3rd dose		First episode of parasitemia >0 parasites/μL (Cohort 2)	45.0% (31.4 to 55.9); n = 367	NR
				Several episodes of fever and parasitemia >2500 parasites/μL (Cohort 1)	27.4% (6.2 to 43.8); n = 1490	NR
Alonso (2005)15	2022 children from Mozambique	18 months after 3rd dose		First or only episode of fever and parasitemia >2500 parasites/μL (Cohort 1)	35.3% (21.6 to 46.6); n = 1442	32.8% (20.1 to 43.4); n = 1605
				Several episodes of fever and parasitemia >2500 parasites/μL (Cohort 1)	29.8% (13.8 to 42.8); n = 1442	32.4% (17.6 to 44.5); n = 1605
Sacarlal (2009)16	2022 children from Mozambique	45 months after 1st dose	First or only episode of fever and parasitemia >2500 parasites/μL	30.5% (18.9 to 40.4); n = 1490	NR
				Several episodes of fever and parasitemia >2500 parasites/μL	25.6% (11.9 to 37.1); n = 1490	NR
Bejon (2008)11	894 children from Kenya/Tanzania	Mean 7.9 months	March 2007-August 2007	First or only episode of fever and parasitemia >2500 parasites/μL	53% (28 to 69); n = 809	49% (26 to 65) (unadjusted); n = 894
				Multiple episodes of fever and parasitemia >2500 parasites/μL	56% (31 to 72); n = 809	54% (31 to 69) (unadjusted); n = 894
Olotu (2011)17	894 children from Kenya/Tanzania	12 months after 3rd dose		First or only episode of fever and parasitemia >2500 parasites/μL	39% (20 to 54); n = 835	39% (20 to 53) (unadjusted); n = 894
				Multiple episodes of fever and parasitemia >2500 parasites/μL	42% (22 to 57); n = 835	44% (24 to 58); n = 894
		15 months after 3rd dose (Kenyan cohort only)		First or only episode of fever and parasitemia >2500 parasites/μL	46% (24 to 61); n = 415	37% (14 to 55); n = 447
				Multiple episodes of fever and parasitemia >2500 parasites/μL	51% (29 to 66); n = 415	44% (20 to 61); n = 44
Abdulla (2008)12	340 infants from Tanzania	6 months after 3rd dose	July 2006-February 2008	First or only episode of fever and parasitemia >500 parasites/μL	43.2% (−47.1 to 78.0); n = 297	41.8% (−32.9 to 74.6); n = 340
				Any infection (any level of parasitemia)	65.2% (20.7 to 84.7); n = 297	NR
Aponte (2007)13	214 infants from Mozambique	6 months after 3rd dose	June 2005-March 2007	First or only episode of fever and parasitemia >500 parasites/μL	65.8% (25.3 to 84.4); n = 185	NR
				Any infection (any level of parasitemia)	65.9% (42.6 to 79.8); n = 185	NR
Aide (2010)18	214 infants from Mozambique	1 year after 3rd dose		First or only episode of fever and parasitemia >500 parasites/μL	33.0% (−4.3 to 56.9); n = 177	25.9% (−9.9 to 50.0); n = 214
				Multiple episodes of fever and parasitemia >500 parasites/μL	25.9% (−15.7 to 52.6); n = 177	24.3% (−12.9 to 49.2); n = 214
Phase 3 trial
Agnandji (2011)14	6000 children aged 5–17 months from 7 African countries (total study population: 15,460)	12 months after 3rd dose	Randomization from March 2009 to January 2011	First or only episode of fever and parasitemia >5000 parasites/μL	55.8% (97.5% CI 51.3 to 59.8); n = 4296	50.4% (45.8 to 54.6); n = 6000
				First or only episode of fever and parasitemia >0 parasites/μL	54.1% (49.9 to 57.9); n = 4296	NR
				All episodes of fever and parasitemia >5000 parasites/μL	55.1% (50.5 to 59.2); n = 4296	53.9% (49.6 to 57.8); n = 600o

ITT = intention to treat; NR = not reported.

Authors and Disclosures

Kyle J Wilby BSP ACPR, PharmD
Kyle J Wilby BSP ACPR, PharmD Student, Faculty of Pharmaceutical Sciences, The University of British Columbia, Vancouver, BC, Canada

Tim TY Lau PharmD ACPR FCSHP
Tim TY Lau PharmD ACPR FCSHP, Pharmacotherapeutic Specialist in Infectious Diseases, Vancouver General Hospital, Vancouver; Clinical Associate Professor, Faculty of Pharmaceutical Sciences, and Associate Member, Division of Infectious Diseases, Faculty of Medicine, The University of British Columbia

Samuel E Gilchrist MSc (Pharm), PhD
Samuel E Gilchrist MSc (Pharm), PhD Candidate, Faculty of Pharmaceutical Sciences, The University of British Columbia

Mary HH Ensom PharmD FASHP FCCP FCSHP FCAHS
Mary HH Ensom PharmD FASHP FCCP FCSHP FCAHS, Professor and Director, Doctor of Pharmacy Program, Faculty of Pharmaceutical Sciences, and Distinguished University Scholar, The University of British Columbia; Clinical Pharmacy Specialist, Children's and Women's Health Centre of British Columbia, Vancouver

Conflict of interest
Authors reported none

Correspondence
Dr. Ensom, ensom@ubc.ca