PMID- 11833825
OWN - NLM
STAT- MEDLINE
DCOM- 20020710
LR  - 20190922
IS  - 0149-2918 (Print)
IS  - 0149-2918 (Linking)
VI  - 24
IP  - 1
DP  - 2002 Jan
TI  - An open-label comparison of the immunogenicity and tolerability of intranasal and 
      intramuscular formulations of virosomal influenza vaccine in healthy adults.
PG  - 100-11
AB  - BACKGROUND: Many intramuscular inactivated influenza vaccines achieve suboptimal 
      results in the prevention of respiratory disease and influenza complications. 
      This has led to the current interest in developing effective oral or intranasal 
      preparations. OBJECTIVE: This study compared the immunogenicity and tolerability 
      of intranasal and intramuscular formulations of virosomal subunit influenza 
      vaccine in healthy adults. It also assessed the immunogenicity and tolerability 
      of 3 different production lots of the intranasal vaccine containing Escherichia 
      coli heat-labile toxin adjuvant. METHODS: This was a multicenter, Phase I, 
      randomized, open-label pilot study in which the primary end point was 
      immunogenicity (hemagglutination-inhibition [HI] antibody assay on days 1 and 
      29). The secondary end point was the frequency of adverse events (AEs). Subjects 
      were assigned to 4 vaccination groups: groups AI, AII, and AIII received 
      intranasal influenza vaccine from batches that differed in the hemagglutinin and 
      neuraminidase strains used, and group B received intramuscular virosomal subunit 
      vaccine. Assessments of health status, hematology, biochemistry, body 
      temperature, heart rate, blood pressure, and incidence of AEs were made on days 
      1, 8, and 29, and serology was assessed on days 1 and 29. RESULTS: The study 
      enrolled 88 subjects. All 3 production lots of intranasal vaccine induced an 
      immune response to most of the viral strains administered (A/Singapore, A/Texas, 
      A/Wuhan, B/Beijing), with no notable immunogenic differences between lots. After 
      intranasal vaccination, geometric mean titers (GMT) increased 2.7-fold against 
      A/Singapore (group AI); 1.8- and 3.1-fold against A/Texas (groups AII and AIII, 
      respectively); 1.9- to 2.4-fold against A/Wuhan; and 1.5- to 1.7-fold against 
      B/Beijing. After intramuscular vaccination. GMT increased 11.3-, 6.3-, and 
      2.7-fold against A/Texas, A/Wuhan, and B/Beijing, respectively. Seroprotection 
      (HI antibody titers > or = 1:40 in > 70% of those vaccinated) was achieved 
      against all strains in the group that received intramuscular vaccination, against 
      A/Wuhan in all groups that received intranasal vaccination, and against A/Texas 
      in group AII. Both vaccine formulations were well tolerated. Intranasal 
      vaccination was associated with a low incidence ( < 20%) of nasal AEs. 
      CONCLUSIONS: Both the intranasal and intramuscular vaccinations elicited a 
      systemic immune response and were well tolerated. The different batches of 
      intranasal vaccine showed a similar immunogenic profile. Intranasal 
      administration may be preferred to intramuscular administration by some patients.
FAU - de, BernardidiValserraM
AU  - de B
AD  - Istituto di Farmacologia II, Facolta di Medicina e Chirurgia, Universita degli 
      Studi di Pavia, Italy.
FAU - Zanasi, Alessandro
AU  - Zanasi A
FAU - Ragusa, Salvatore
AU  - Ragusa S
FAU - Gluck, Reinhard
AU  - Gluck R
FAU - Herzog, Christian
AU  - Herzog C
LA  - eng
PT  - Clinical Trial
PT  - Clinical Trial, Phase I
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Clin Ther
JT  - Clinical therapeutics
JID - 7706726
RN  - 0 (Antibodies, Viral)
RN  - 0 (Influenza Vaccines)
SB  - IM
MH  - Administration, Intranasal
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antibodies, Viral/analysis
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Influenza A virus/immunology
MH  - Influenza B virus/immunology
MH  - Influenza Vaccines/administration & dosage/*adverse effects/*immunology
MH  - Injections, Intramuscular
MH  - Male
MH  - Middle Aged
MH  - Pilot Projects
EDAT- 2002/02/09 10:00
MHDA- 2002/07/12 10:01
CRDT- 2002/02/09 10:00
PHST- 2002/02/09 10:00 [pubmed]
PHST- 2002/07/12 10:01 [medline]
PHST- 2002/02/09 10:00 [entrez]
AID - S0149-2918(02)85008-1 [pii]
AID - 10.1016/s0149-2918(02)85008-1 [doi]
PST - ppublish
SO  - Clin Ther. 2002 Jan;24(1):100-11. doi: 10.1016/s0149-2918(02)85008-1.