Immunogenicity and safety of a pediatric dose of a virosomal hepatitis A vaccine in healthy children in India Results from a phase IV, open, randomized, controlled, multicenter, non-inferiority study

被引:8
作者
Jain, Hemat [1 ,2 ]
Kumavat, Vandana [3 ]
Singh, Tejinder [4 ]
Versteilen, Amanda [5 ]
Sarnecki, Michal [6 ]
机构
[1] MGM Med Coll, Indore, Madhya Pradesh, India
[2] Chacha Nehru Bal Chikitsalay, Indore, Madhya Pradesh, India
[3] Rajiv Gandhi Med Coll, Kalwa, Thane, India
[4] Christian Med Coll & Hosp, Ludhiana, Punjab, India
[5] Crucell Holland BV, Leiden, Netherlands
[6] Crucell Switzerland AG, Bern, Switzerland
关键词
pediatric; HAV vaccine; virosomes; immunogenicity; safety; India; INACTIVATED VIROSOME; IMMUNIZATION; TOLERABILITY; PREVENTION; ANTIBODIES;
D O I
10.4161/hv.28631
中图分类号
Q81 [生物工程学(生物技术)]; Q93 [微生物学];
学科分类号
071005 ; 0836 ; 090102 ; 100705 ;
摘要
As India is transitioning from high to intermediate hepatitis A endemicity, the need for hepatitis A vaccination programs increases. This study investigated the immunogenicity and safety of a virosomal hepatitis A vaccine (HAVpur Junior) compared with an aluminum-adsorbed hepatitis A vaccine (Havrix 720 Junior) in Indian children. Healthy children aged 18-47 months, stratified by age, were randomized to either HAVpur Junior or Havrix 720 Junior. The first dose of vaccine was administered on Day 1 and the second (booster) dose 6 months later. Antibodies against hepatitis A virus (HAV) were measured using a microparticle enzyme immunoassay. The primary objective assessed non-inferiority of HAVpur Junior to Havrix 720 Junior in terms of seroprotection rates (>= 10 mIU/mL anti-HAHAV antibodies) at 1 month after the first vaccination. Non-inferiority was demonstrated if the lower limit of the 90% confidence interval of the group difference was greater than -10%. Local and systemic adverse events were recorded. The seroprotection rate at 1 month was 95.9% in the HAVpur Junior group and 96.6% in the Havrix 720 Junior group. As the lower limit of the 90% confidence interval of the group difference was greater than -10% (-4.7), non-inferiority of HAVpur Junior to Havrix 720 Junior was established. The overall incidence of adverse events (solicited and unsolicited) after each vaccination was similar in both groups. In conclusion, the aluminum-free virosomal vaccine HAVpur Junior induced a similar immune response to Havrix 720 Junior in healthy Indian children aged 18 to 47 months. Both vaccines were well tolerated. The study shows that the low-dose virosomal HAV vaccine is consistently efficacious and well tolerated in children of all age groups and is suitable for inclusion into Indian childhood vaccination schedules.
引用
收藏
页码:2089 / 2097
页数:9
相关论文
共 26 条
  • [1] Immunogenicity and tolerability of a paediatric presentation of a virosomal hepatitis A vaccine in Chilean children aged 1-16 years
    Abarca, Katia
    Ibanez, Isabel
    de la Fuente, Pablo
    Cerda, Leonardo
    Bergeret, Jorge
    Froesner, Gert
    Ibarra, Humberto
    [J]. VACCINE, 2011, 29 (48) : 8855 - 8862
  • [2] Immunogenicity and protectivity of a new liposomal hepatitis A vaccine
    Ambrosch, F
    Wiedermann, G
    Jonas, S
    Althaus, B
    Finkel, B
    Gluck, R
    Herzog, C
    [J]. VACCINE, 1997, 15 (11) : 1209 - 1213
  • [3] [Anonymous], 2012, Wkly Epidemiol Rec, V87
  • [4] Interchangeability and tolerability of a virosomal and an aluminum-adsorbed hepatitis A vaccine
    Bovier, PA
    Farinelli, T
    Loutan, L
    [J]. VACCINE, 2005, 23 (19) : 2424 - 2429
  • [5] Long-term immunogenicity of an inactivated virosome hepatitis A vaccine
    Bovier, PA
    Bock, J
    Loutan, L
    Farinelli, T
    Glueck, R
    Herzog, C
    [J]. JOURNAL OF MEDICAL VIROLOGY, 2002, 68 (04) : 489 - 493
  • [6] Tolerance and immunogenicity of the simultaneous administration of virosome hepatitis A and yellow fever vaccines
    Bovier, PA
    Althaus, B
    Glueck, R
    Chippaux, A
    Loutan, L
    [J]. JOURNAL OF TRAVEL MEDICINE, 1999, 6 (04) : 228 - 233
  • [7] Epaxal®: a virosomal vaccine to prevent hepatitis A infection
    Bovier, Patrick A.
    [J]. EXPERT REVIEW OF VACCINES, 2008, 7 (08) : 1141 - 1150
  • [8] Clarke Paul D, 2006, Travel Med Infect Dis, V4, P313, DOI 10.1016/j.tmaid.2006.01.001
  • [9] Hepatitis A vaccine recommendations
    不详
    [J]. PEDIATRICS, 2007, 120 (01) : 189 - 199
  • [10] Concomitant administration of a virosome-adjuvanted hepatitis A vaccine with routine childhood vaccines at age twelve to fifteen months: A randomized controlled trial
    Dagan, Ron
    Amir, Jacob
    Livni, Gilat
    Greenberg, David
    Abu-Abed, Jaber
    Guy, Lior
    Ashkenazi, Shai
    Froesner, Gert
    Tewald, Friedemann
    Hoffmann, Dieter
    Ibanez, Ruben
    Herzog, Christian
    [J]. PEDIATRIC INFECTIOUS DISEASE JOURNAL, 2007, 26 (09) : 787 - 793