Key result
Inactivated EV71 vaccination elicited a rapid immune response, with antibody titers ≥1:8 achieved in 89.19% of healthy infants (95% CI: 74.58-96.97%) 10 days after the first dose.
Why the study?
Short-term dynamic changes in neutralizing antibodies against EV71 and EV71-IgM following inactivated EV71 vaccination were unknown.
Does the inactivated EV71 vaccine induce a rapid neutralizing antibody response in healthy infants aged 6-35 months?
RCT (n=120)
Open-label
1:1:1
Does the inactivated EV71 vaccine induce a rapid neutralizing antibody response in healthy infants aged 6-35 months?
The EV71 vaccine induces a rapid neutralizing antibody response within 10 days, supporting its potential use for contingency vaccination during outbreaks.
Answers are grounded in this paper and cite their sources.
Supports contingency vaccination during EV71 outbreaks; extends RCT evidence for rapid infant immunogenicity.
BACKGROUND: Short-term dynamic changes in neutralizing antibodies against EV71 and EV71-IgM after inactivated EV71 vaccine injection are unknown. METHODS: This study was designed as a randomized, open-label study and was registered at ClinicalTrials.gov (NCT03278132). In total, 120 healthy infants aged 6-35 months were randomized 1:1:1 to provide a second blood sample on day 10, day 20, or day 30 after the first vaccine dose, respectively. RESULTS: According to the per-protocol set, a rapid immune response against EV71 was observed 10 days after the first EV71 vaccine dose, with antibody titers ≥1:8 in 89.19% of participants (95% CI: 74.58-96.97%) on day 10, in 80.65% (95% CI: 62.53-92.55%) on day 20, in 66.67% (95% CI: 49.03-81.44%) on day 30, and in 100% (95% CI: 96.52%-.) on day 60. Based on an ELISA, the percentages of participants positive for EV71-IgM on day 0 and day 60 were 1.71% (2 out of 117) and 82.86% (87 out of 105), respectively. CONCLUSIONS: The EV71 vaccine could be used for contingency vaccination to further control EV71-associated disease outbreaks. Caution should be taken in using the EV71-IgM test for rapid EV71 infection diagnosis after EV71 vaccine administration. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov NCT03278132.
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Wang et al. (2020) conducted an RCT in Healthy infants (n=120). Inactivated EV71 vaccine was evaluated on Antibody titers ≥1:8 on day 10 (95% CI 74.58-96.97). Inactivated EV71 vaccination elicited a rapid immune response, with antibody titers ≥1:8 achieved in 89.19% of healthy infants (95% CI: 74.58-96.97%) 10 days after the first dose.
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