HERZOG C, DURRER P, LANG A, MOSER R, SPYR C, GLUECK U, GLUECK R; Interscience Conference on Antimicrobial Agents and Chemotherapy.
Abstr Intersci Conf Antimicrob Agents Chemother Intersci Conf Antimicrob Agents Chemother. 2000 Sep 17-20; 40: 251.
Swiss Serum and Vaccine Inst. Berne, Berne, Switzerland
Objectives: To compare humoral and mucosal immune responses of HLT-adjuvanted and non-adjuvanted intranasal (i.n.) with an intramuscular (i.m.) formulation of inactivated, virosome-formulated subunit influenza vaccines in healthy young adults.METHODS: 87 adults (18-60y) were randomised to receive i.n. on day 1 and 8 spray doses of 200micro-l containing >/=7.5microg haemagglutinin (HA) from each of the 1998/99 WHO recommended influenza strains adjuvanted with 1microg HLT (Gr. A: 24f, 10m, 37.4y), without HLT (Gr. B: 20f, 7m, 34.5y) or a single i.m. dose (>/= 15microg HA per strain) of influenza vaccine (Gr. C: 14f, 12m, 34.6y). Tolerability was assessed for a 4-day period. In serum haemagglutination inhibition (HI) antibody titers and anti-HLT IgG were measured on days 1 and 29. In nasal fluid anti-HA sIgA and anti-HLT sIgA were tested on day 1, 4, 11 and 29. Full blood was assessed on day 1 and 11 for antibody secreting cells (ASC) and for cell mediated immunity (lymphocyte proliferation/phenotyping).RESULTS: The vaccine was found to be safe, with nasal and systemic adverse events (AE) being mainly mild, lasting 1-2 days only. No serious AE was noted. Only for groups A and C the European (EMEA, London) HI immunogenicity criteria for influenza vaccines were achieved, i.e. seroconversion rate of >40% and/or seroprotection rate of >70% and/or >2.5-fold rise in GMT for each influenza strain. All three vaccines showed strong ASC responses. In nasal fluid a sustained anti-HA sIgA response was found in group A only (2.5-2.8-fold GMT rise), compared to Groups B and C (1.7-1.8 and 1.2-1.4-fold). An anti-HLT response was only found in the serum in group A.CONCLUSIONS: The inactivated, virosome-formulated, HLT-adjuvanted i.n. influenza vaccine was found to be safe and immunogenic, eliciting at the nasal mucosa level an influenza-specific immune response far superior to the one after non-adjuvanted i.n. or i.m. vaccine.KEYWORDS: Influenza vaccine; Intranasal
Publication Types:
Keywords:
- Adult
- Bacterial Toxins
- Enterotoxins
- Escherichia coli Proteins
- Hemagglutination Inhibition Tests
- Humans
- Immunoglobulin A, Secretory
- Influenza Vaccines
- London
- Nasal Mucosa
- Vaccines
- Vaccines, Inactivated
- Virosomes
- enterotoxin LT
Other ID:
UI: 102249064
From Meeting Abstracts