Abstract
Chikungunya virus (CHIKV) is a reemerging mosquito-borne virus that causes swift outbreaks. Major concerns are the persistent and disabling polyarthralgia in infected individuals. Here we present the results from a first-in-human trial of the candidate simian adenovirus vectored vaccine ChAdOx1 Chik, expressing the CHIKV full-length structural polyprotein (Capsid, E3, E2, 6k and E1). 24 adult healthy volunteers aged 18–50 years, were recruited in a dose escalation, open-label, nonrandomized and uncontrolled phase 1 trial (registry NCT03590392). Participants received a single intramuscular injection of ChAdOx1 Chik at one of the three preestablished dosages and were followed-up for 6 months. The primary objective was to assess safety and tolerability of ChAdOx1 Chik. The secondary objective was to assess the humoral and cellular immunogenicity. ChAdOx1 Chik was safe at all doses tested with no serious adverse reactions reported. The vast majority of solicited adverse events were mild or moderate, and self-limiting in nature. A single dose induced IgG and T-cell responses against the CHIKV structural antigens. Broadly neutralizing antibodies against the four CHIKV lineages were found in all participants and as early as 2 weeks after vaccination. In summary, ChAdOx1 Chik showed excellent safety, tolerability and 100% PRNT50 seroconversion after a single dose.
Highlights
Chikungunya virus (CHIKV) is a reemerging mosquito-borne virus that causes swift outbreaks
ChAdOx1 Chik was safe at doses up to 5 × 1010 vp with no serious adverse reactions reported
The vast majority of solicited adverse events (AEs) were mild (79/112; 70.54%, 95%confidence intervals (CI) 61.53–78.18) or moderate (27/112; 24.11%, 95% CI 17.13–32.8) and self-limiting in nature
Summary
Chikungunya virus (CHIKV) is a reemerging mosquito-borne virus that causes swift outbreaks. Since its emergence in Tanzania in 19521, and subsequent reemergence in a series of outbreaks in Kenya, the Indian Ocean (2004–2006)[2], and the Americas (2013–2017)[3], Chikungunya virus (CHIKV) has become a major international health concern, with both acute and long-term impacts on public health. Both mosquito species have dispersed to all continents, with Ae. aegypti present mainly in tropical and subtropical regions and Ae. albopictus expanding through temperate regions[5] Their rapid global expansion accounts for the possibility of an even greater burden of chikungunya fever (CHIKF) beyond tropical regions. One of the largest recorded outbreaks occurred during 2004–2007 in islands of the Indian Ocean and India[2] During this outbreak, 5202 new CHIKV cases were reported in one month, between February and
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