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A double-blind trial of a new inactivated, trivalent, intra-nasal anti-influenza vaccine in general practice: relationship between immunogenicity and respiratory morbidity over the winter of 1997-98.
J Clin Virol 2001; 20(3):155-61JC

Abstract

BACKGROUND

Influenza is responsible for considerable morbidity not only among older people but in younger age groups as well. However, most large-scale anti-influenza vaccination campaigns are still aimed principally at the elderly using injectable vaccines. Until now there has been much less emphasis on targeting younger populations or using intra-nasal vaccines in mass anti-influenza immunisation programmes.

OBJECTIVES

To assess the immunogenicity of a new inactivated intra-nasal anti-influenza vaccine and to measure its effect on respiratory morbidity in a volunteer general practice population.

STUDY DESIGN

A prospective, double-blind, placebo-controlled trial using the new vaccine was carried out over the winter of 1997-98 on 274 healthy patients aged 12-60 from three Israeli general practices, 182 in the vaccine group and 92 in the placebo group. Following vaccination the changes in the antigen levels and episodes of respiratory illness in the vaccine and placebo groups were measured.

RESULTS

Protective antibody levels occurred after a single dose of vaccine [influenza H1N1, 41% immune pre-vaccination to 73% post-vaccination; influenza H3N2, 35-66%; influenza B, 27-64%]. Between January and March 1998, when influenza activity was at a peak in Israel, the average number of respiratory illness events in the vaccine group [14 events/100 subjects per month] was significantly less than in the placebo group [22 events/100 subjects per month]; similarly, the average number of respiratory illness days in the vaccine group over the same period [69 days/100 subjects per month] was significantly less than in the placebo group [117 days/100 subjects per month].

CONCLUSIONS

The new vaccine possessed significant immunogenicity and was associated with a significant reduction in respiratory morbidity among a group of healthy older children and adults. Since intra-nasal vaccines are simpler to administer and more acceptable to the public than injections the vaccine's potential for use in routine anti-influenza vaccination campaigns seems promising, especially if its beneficial effects are also reproducible in more medically vulnerable populations.

Authors+Show Affiliations

Division of Family Medicine, The Hebrew University-Hadassah Medical School, Jerusalem 91120, Israel.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

11166665

Citation

Kiderman, A, et al. "A Double-blind Trial of a New Inactivated, Trivalent, Intra-nasal Anti-influenza Vaccine in General Practice: Relationship Between Immunogenicity and Respiratory Morbidity Over the Winter of 1997-98." Journal of Clinical Virology : the Official Publication of the Pan American Society for Clinical Virology, vol. 20, no. 3, 2001, pp. 155-61.
Kiderman A, Furst A, Stewart B, et al. A double-blind trial of a new inactivated, trivalent, intra-nasal anti-influenza vaccine in general practice: relationship between immunogenicity and respiratory morbidity over the winter of 1997-98. J Clin Virol. 2001;20(3):155-61.
Kiderman, A., Furst, A., Stewart, B., Greenbaum, E., Morag, A., & Zakay-Rones, Z. (2001). A double-blind trial of a new inactivated, trivalent, intra-nasal anti-influenza vaccine in general practice: relationship between immunogenicity and respiratory morbidity over the winter of 1997-98. Journal of Clinical Virology : the Official Publication of the Pan American Society for Clinical Virology, 20(3), pp. 155-61.
Kiderman A, et al. A Double-blind Trial of a New Inactivated, Trivalent, Intra-nasal Anti-influenza Vaccine in General Practice: Relationship Between Immunogenicity and Respiratory Morbidity Over the Winter of 1997-98. J Clin Virol. 2001;20(3):155-61. PubMed PMID: 11166665.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A double-blind trial of a new inactivated, trivalent, intra-nasal anti-influenza vaccine in general practice: relationship between immunogenicity and respiratory morbidity over the winter of 1997-98. AU - Kiderman,A, AU - Furst,A, AU - Stewart,B, AU - Greenbaum,E, AU - Morag,A, AU - Zakay-Rones,Z, PY - 2001/2/13/pubmed PY - 2001/5/18/medline PY - 2001/2/13/entrez SP - 155 EP - 61 JF - Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology JO - J. Clin. Virol. VL - 20 IS - 3 N2 - BACKGROUND: Influenza is responsible for considerable morbidity not only among older people but in younger age groups as well. However, most large-scale anti-influenza vaccination campaigns are still aimed principally at the elderly using injectable vaccines. Until now there has been much less emphasis on targeting younger populations or using intra-nasal vaccines in mass anti-influenza immunisation programmes. OBJECTIVES: To assess the immunogenicity of a new inactivated intra-nasal anti-influenza vaccine and to measure its effect on respiratory morbidity in a volunteer general practice population. STUDY DESIGN: A prospective, double-blind, placebo-controlled trial using the new vaccine was carried out over the winter of 1997-98 on 274 healthy patients aged 12-60 from three Israeli general practices, 182 in the vaccine group and 92 in the placebo group. Following vaccination the changes in the antigen levels and episodes of respiratory illness in the vaccine and placebo groups were measured. RESULTS: Protective antibody levels occurred after a single dose of vaccine [influenza H1N1, 41% immune pre-vaccination to 73% post-vaccination; influenza H3N2, 35-66%; influenza B, 27-64%]. Between January and March 1998, when influenza activity was at a peak in Israel, the average number of respiratory illness events in the vaccine group [14 events/100 subjects per month] was significantly less than in the placebo group [22 events/100 subjects per month]; similarly, the average number of respiratory illness days in the vaccine group over the same period [69 days/100 subjects per month] was significantly less than in the placebo group [117 days/100 subjects per month]. CONCLUSIONS: The new vaccine possessed significant immunogenicity and was associated with a significant reduction in respiratory morbidity among a group of healthy older children and adults. Since intra-nasal vaccines are simpler to administer and more acceptable to the public than injections the vaccine's potential for use in routine anti-influenza vaccination campaigns seems promising, especially if its beneficial effects are also reproducible in more medically vulnerable populations. SN - 1386-6532 UR - https://www.unboundmedicine.com/medline/citation/11166665/A_double_blind_trial_of_a_new_inactivated_trivalent_intra_nasal_anti_influenza_vaccine_in_general_practice:_relationship_between_immunogenicity_and_respiratory_morbidity_over_the_winter_of_1997_98_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1386-6532(00)00175-X DB - PRIME DP - Unbound Medicine ER -