PMID- 10770746
OWN - NLM
STAT- MEDLINE
DCOM- 20000518
LR  - 20210526
IS  - 0066-4804 (Print)
IS  - 1098-6596 (Electronic)
IS  - 0066-4804 (Linking)
VI  - 44
IP  - 5
DP  - 2000 May
TI  - Comparison of immunogenicity and safety of a virosome influenza vaccine with 
      those of a subunit influenza vaccine in pediatric patients with cystic fibrosis.
PG  - 1163-7
AB  - The objective of this study was to compare the immunogenicity and safety of a 
      single-dose regimen and a two-dose regimen of a trivalent virosome influenza 
      vaccine (Inflexal Berna V) with those of a trivalent subunit influenza vaccine 
      (Influvac) in children and adolescents with cystic fibrosis (CF). In an open, 
      randomized, multicenter study with parallel groups, 11 young children with CF (1 
      to 6 years old) and 53 older children and adolescents with CF (>6 years old) were 
      randomly assigned to one of the following immunization regimens: virosome vaccine 
      at 0.5 ml on study day 0 or 0.25 ml on days 0 and 28 or a standard regimen of 
      subunit vaccine, i. e., 0.5 ml on day 0 for older children and 0.25 ml on days 0 
      and 28 for younger children. Safety assessments, i.e., recording of systemic and 
      local adverse events (AEs) and vital signs, were made for a 5-day observation 
      period after each immunization. Hemagglutination inhibition (HI) titers were 
      determined at baseline and 4 weeks after the single-dose and the two-dose 
      immunizations, respectively. Immunogenicity was assessed according to the 
      criteria of the European Agency for the Evaluation of Medicinal Products (EMEA). 
      Both vaccines induced comparable HI antibody titers. Seroconversion (> or =4-fold 
      rise in HI antibody titers, reaching a titer of > or =1:40) was achieved in 41 to 
      100% of the participants. Seroprotection (HI titer, > or =1:40) and a >2.5-fold 
      increase in geometric mean titers were achieved in 100% of the participants. 
      Thus, all three EMEA requirements for influenza vaccine efficacy were met by all 
      treatment groups and for both vaccines. The virosome vaccine, when administered 
      as a single dose, seemed to induce superior immunogenicity compared with the 
      standard pediatric two-dose regimen. Totals of 42 and 57% of vaccinees receiving 
      virosome and subunit vaccines, respectively, reported at least one local AE 
      (predominantly pain). Totals of 84 and 71% of subjects receiving virosome and 
      subunit vaccines, respectively, complained in response to questions of at least 
      one systemic AE (mainly cough, fatigue, coryza, or headache). The majority of 
      events were mild or moderate and lasted 1 or 2 days only. No obvious relationship 
      was found between AE reporting rate and vaccine formulation, age group, or dose 
      regimen. The relatively high AE reporting rate seemed to be partly related to the 
      symptomatology of the underlying CF disease. In summary, the virosome and subunit 
      vaccines induced in both age groups and against all three influenza strains an 
      efficient immune response and were well tolerated by the children and adolescents 
      with CF.
FAU - Schaad, U B
AU  - Schaad UB
AD  - University Children's Hospital Basel, Berne, Switzerland. urs-b.schaad@unibas.ch
FAU - Buhlmann, U
AU  - Buhlmann U
FAU - Burger, R
AU  - Burger R
FAU - Ruedeberg, A
AU  - Ruedeberg A
FAU - Wilder-Smith, A
AU  - Wilder-Smith A
FAU - Rutishauser, M
AU  - Rutishauser M
FAU - Sennhauser, F
AU  - Sennhauser F
FAU - Herzog, C
AU  - Herzog C
FAU - Zellmeyer, M
AU  - Zellmeyer M
FAU - Gluck, R
AU  - Gluck R
LA  - eng
PT  - Clinical Trial
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Antimicrob Agents Chemother
JT  - Antimicrobial agents and chemotherapy
JID - 0315061
RN  - 0 (Influenza Vaccines)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Child
MH  - Child, Preschool
MH  - Cystic Fibrosis/*immunology/virology
MH  - Female
MH  - Humans
MH  - Immunity
MH  - Infant
MH  - Influenza Vaccines/administration & dosage/*adverse effects/*immunology
MH  - Influenza, Human/immunology/prevention & control
MH  - Male
PMC - PMC89839
EDAT- 2000/04/19 09:00
MHDA- 2000/05/20 09:00
PMCR- 2000/05/01
CRDT- 2000/04/19 09:00
PHST- 2000/04/19 09:00 [pubmed]
PHST- 2000/05/20 09:00 [medline]
PHST- 2000/04/19 09:00 [entrez]
PHST- 2000/05/01 00:00 [pmc-release]
AID - 0815 [pii]
AID - 10.1128/AAC.44.5.1163-1167.2000 [doi]
PST - ppublish
SO  - Antimicrob Agents Chemother. 2000 May;44(5):1163-7. doi: 
      10.1128/AAC.44.5.1163-1167.2000.