Immunogenicity, reactogenicity and safety of a human rotavirus vaccine (RIX4414) in Korean infants: a randomized, double-blind, placebo-controlled, phase IV study.
Rotavirus (RV) infection is the primary cause for childhood gastroenteritis worldwide. In Korea, RV infection is most common among children less than 5 years of age. This post-licensure study was conducted to further evaluate the RV vaccine (RIX4414) to provide additional local clinical data to the Korean Food and Drug Association. Healthy infants aged 6-12 weeks were enrolled to receive two doses of either RIX4414 or placebo as per 0, 1-2 month schedule. Blood samples were collected before dose-1 and one month post-dose-2 of RIX4414/placebo to assess serum anti-RV IgA antibody concentrations using ELISA. Gastroenteritis stool samples were tested for the presence of RV using ELISA. RV positive samples were subjected to further analysis for G and P typing. Among 684 infants enrolled and vaccinated, 432 infants (RIX4414=318; placebo=114) were included in the according-to-protocol cohort for immunogenicity. The anti-RV IgA antibody seroconversion rates in the RIX4414 group following one month post-dose-2 were 88.1% (95% CI: 84.0-91.4) and the corresponding geometric mean concentration in the RIX4414 group was 208.5 U/ml (95% CI: 174.2-249.5). Occurrence of solicited and unsolicited adverse events were similar in both, RIX4414 and placebo groups. None of the gastroenteritis stool samples tested positive for RV and no fatal SAEs were reported in either groups. The two-dose regimen of RIX4414 was observed to be immunogenic with a similar safety profile as compared to the placebo group, when administered to healthy Korean infants.
ChonBuk National University Hospital, Jeonju, Jeollabuk-do, South Korea.
Jung Soo
JS
Kim
Chong-Woo
CW
Bae
Kyung-Yil
KY
Lee
Moon Sung
MS
Park
Young Youn
YY
Choi
Kwang-Nam
KN
Kim
Jong Duck
JD
Kim
Won-Soon
WS
Park
Jong-Beom
JB
Sin
Ellen Ai-Rhan
EA
Kim
Sang-Geel
SG
Lee
Chun Soo
CS
Kim
Sung-Ho
SH
Cha
Young Jin
YJ
Hong
Son-Moon
SM
Shin
Gyu-Hong
GH
Shim
Kyong Min
KM
Choi
Jun Won
JW
Yang
Aixue
A
Liu
P V
PV
Suryakiran
Htay Htay
HH
Han
D000914:Antibodies, Viral / Q000276:immunology; D004311:Double-Blind Method; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D005759:Gastroenteritis / Q000276:immunology; D006801:Humans; D007070:Immunoglobulin A / Q000276:immunology; D007223:Infant; D008297:Male; D022243:Rotavirus Vaccines / Q000009:adverse effects* / Q000276:immunology* / Q000627:therapeutic use; D014613:Vaccines, Attenuated / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use
D000914:Antibodies, Viral; D007070:Immunoglobulin A; C492457:RIX4414 vaccine; D022243:Rotavirus Vaccines; D014613:Vaccines, Attenuated