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A combined analysis of immunogenicity, antibody kinetics and vaccine efficacy from phase 2 trials of the RTS,S malaria vaccine
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A combined analysis of immunogenicity, antibody kinetics and vaccine efficacy from phase 2 trials of the RTS,S malaria vaccine
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Journal Article
A combined analysis of immunogenicity, antibody kinetics and vaccine efficacy from phase 2 trials of the RTS,S malaria vaccine
2014
Overview
Background
The RTS,S malaria vaccine is currently undergoing phase 3 trials. High vaccine-induced antibody titres to the circumsporozoite protein (CSP) antigen have been associated with protection from infection and episodes of clinical malaria.
Methods
Using data from 5,144 participants in nine phase 2 trials, we explore predictors of vaccine immunogenicity (anti-CSP antibody titres), decay in antibody titres, and the association between antibody titres and clinical outcomes. We use empirically-observed relationships between these factors to predict vaccine efficacy in a range of scenarios.
Results
Vaccine-induced anti-CSP antibody titres were significantly associated with age (
P
= 0.04), adjuvant (
P
<0.001), pre-vaccination anti-hepatitis B surface antigen titres (
P
= 0.005) and pre-vaccination anti-CSP titres (
P
<0.001). Co-administration with other vaccines reduced anti-CSP antibody titres although not significantly (
P
= 0.095). Antibody titres showed a bi-phasic decay over time with an initial rapid decay in the first three months and a second slower decay over the next three to four years. Antibody titres were significantly associated with protection, with a titre of 51 (95% Credible Interval (CrI): 29 to 85) ELISA units/ml (EU/mL) predicted to prevent 50% of infections in children. Vaccine efficacy was predicted to decline to zero over four years in a setting with entomological inoculation rate (EIR) = 20 infectious bites per year (ibpy). Over a five-year follow-up period at an EIR = 20 ibpy, we predict RTS,S will avert 1,782 cases per 1,000 vaccinated children, 1,452 cases per 1,000 vaccinated infants, and 887 cases per 1,000 infants when co-administered with expanded programme on immunisation (EPI) vaccines. Our main study limitations include an absence of vaccine-induced cellular immune responses and short duration of follow-up in some individuals.
Conclusions
Vaccine-induced anti-CSP antibody titres and transmission intensity can explain variations in observed vaccine efficacy.
Publisher
BioMed Central,BioMed Central Ltd,Springer Nature B.V
Subject
/ Africa South of the Sahara - epidemiology
/ Age
/ Analysis
/ Antibodies, Protozoan - immunology
/ Antigens
/ Child
/ Clinical Trials, Phase II as Topic
/ Complications and side effects
/ Ethics
/ Female
/ Humans
/ Infant
/ Infants
/ Malaria
/ Malaria Vaccines - administration & dosage
/ Malaria, Falciparum - epidemiology
/ Malaria, Falciparum - prevention & control
/ Male
/ Medicine
/ Protozoan Proteins - immunology
/ Studies
/ Vaccines
