Immunogenicity and safety of LBVH0101, a new Haemophilus influenzae type b tetanus toxoid conjugate vaccine, compared with Hiberix?in Korean infants and children: A randomized trial

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• 作者：Kyung-Hyo Kim^a ; Yun-Kyung Kim^b ; Nam Hee Kim^c ; Sung Hee Chang^d ; Jina Lee^e ; Eun Ae Park^a ; Su Eun Park^f ; Byung Wook Eun^g ; Hyunju Lee^a ; Hoan Jong Lee^h ; ^{hoanlee@snu.ac.kr}
• 关键词：Haemophilus influenzae type b ; Conjugate vaccine ; Safety ; Immunogenicity ; Clinical trial ; Phase III
• 刊名：Vaccine
• 出版年：2012
• 出版时间：27 February, 2012
• 年：2012
• 卷：30
• 期：10
• 页码：1886-1894
• 全文大小：456 K

文摘

Background

The World Health Organization (WHO) recommends that all countries adopt Haemophilus influenzae type b (Hib) vaccine into routine child immunization programs to protect children from the significant burden of life-threatening pneumonia and meningitis.

Methods

In this blind, comparative, randomized, phase-III Korean multicenter study, we assessed immunogenicity and safety following primary vaccination of a new H. influenzae type b tetanus toxoid conjugate vaccine, LBVH0101 (LG Life Sciences, Ltd., Seoul, Korea) compared with Hiberix?(GSK, Rixensart, Belgium) in Korean children at 2, 4 and 6 months of age followed by a booster vaccination at 12-15 months. Serum anti-PRP IgG concentration and bactericidal activity were determined. Local/systemic symptoms were assessed after vaccination. Serious adverse events were recorded throughout the study.

Results

A total of 185 infants were included in immunogenicity evaluations. After the second and third doses of LBVH0101, 90.32 % and 100 % of infants achieved an antibody level ? ¦Ìg/mL, respectively, compared with 78.26 % and 96.74 % of those who received Hiberix? After the second vaccination, the geometric mean concentration (GMC) of LBVH0101 recipients was 7.34 ¦Ìg/mL and was higher than that of Hiberix?recipients (3.55 ¦Ìg/mL). After the third vaccination, the GMCs were 14.59 ¦Ìg/mL and 12.15 ¦Ìg/mL in the LBVH0101 and Hiberix?recipients, respectively. The booster dose produced higher antibody concentrations: 30.25 ¦Ìg/mL and 71.64 ¦Ìg/mL for LBVH0101 and Hiberix?recipients, respectively. Bactericidal capacity and antibody potency of anti-PRP IgG induced by LBVH0101 was 35.05 and 116.27 after the second and third vaccinations, respectively, compared with 53.76 and 79.64 for Hiberix? Anti-PRP IgG seroprotection rate and GMC were similar post-primary immunization between the groups; both showed functional maturation and similar booster responses. LBVH0101 had comparable safety results as the control vaccine, Hiberix? as most of the solicited adverse events and unsolicited adverse events upon LBVH0101 administration were mild in severity. No serious vaccination-related adverse reactions were observed.

Conclusions

LBVH0101 showed a good immunogenicity and safety profile in infants and children. The two-dose infant-priming schedule with a booster dose may suffice for Hib immunization in Korean infants (Clinical trial registration numbers: and ).