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A phase II, randomised clinical trial to demonstrate the non-inferiority of low-dose MF59-adjuvanted pre-pandemic A/H5N1 influenza vaccine in adult and elderly subjects.
J Prev Med Hyg. 2012 Sep; 53(3):136-42.JP

Abstract

BACKGROUND

Effective planning and preparedness against a possible future A/H5N1 influenza pandemic is a major global challenge. Because dose sparing strategies are required to meet the global demand for vaccine, efforts have focused on the development of adjuvanted vaccine formulations of relatively lower antigen content.

AIM

This study aimed to demonstrate the non-inferiority of a low-antigen-dose (3.75 μ) [DOSAGE ERROR CORRECTED] A/H5N1 pre-pandemic vaccine compared with a licensed, higher-dose (7.5 mg) formulation in adult and elderly subjects. Immunogenicity was assessed according to European and U.S. licensure criteria.

METHODS

A total of 722 subjects were randomized in equal numbers to receive either the licensed or low-dose formulation. All subjects received two vaccine doses administered three weeks apart. Immunogenicity was assessed three weeks after the administration of each vaccine dose by hemagglutination inhibition (HI), single radial haemolysis (SRH) and microneutralization assays (MN). Local and systemic reactions were assessed over a seven day period post-vaccination. Adverse events were recorded throughout.

RESULTS

The low-dose vaccine was demonstrated to be non-inferior to the licensed formulation in terms of antibody titres against the vaccine strain. All three European licensure criteria were met by adult subjects in response to the low-dose vaccine; two criteria were met by the elderly age group. Cross-reactive antibodies were detected against the heterologous A/H5N1 antigen strains A/Indonesia/05/05 and A/turkeyTurkey/01/05. Both vaccines were generally well tolerated by both age groups.

CONCLUSION

These data demonstrate that a low antigen dose in combination with MF59 adjuvant is adequate for the routine pre-pandemic immunization of adult and elderly subjects.

Authors+Show Affiliations

Provincial Children's Specialized Hospital, Krakow, Poland.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase II
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

23362618

Citation

Czajka, H, et al. "A Phase II, Randomised Clinical Trial to Demonstrate the Non-inferiority of Low-dose MF59-adjuvanted Pre-pandemic A/H5N1 Influenza Vaccine in Adult and Elderly Subjects." Journal of Preventive Medicine and Hygiene, vol. 53, no. 3, 2012, pp. 136-42.
Czajka H, Unal S, Ulusoy S, et al. A phase II, randomised clinical trial to demonstrate the non-inferiority of low-dose MF59-adjuvanted pre-pandemic A/H5N1 influenza vaccine in adult and elderly subjects. J Prev Med Hyg. 2012;53(3):136-42.
Czajka, H., Unal, S., Ulusoy, S., Usluer, G., Strus, A., Sennaroglu, E., Guzik, J., Topeli Iskit, A., Dargiewicz, A., Musial, D., Caylan, R., Dziduch, J., Eskioglu, E., Hasiec, B., Cwinarowiczliwa, E., Belli, R., Abdel-Messih, I. A., Beygo, J., & Fragapane, E. (2012). A phase II, randomised clinical trial to demonstrate the non-inferiority of low-dose MF59-adjuvanted pre-pandemic A/H5N1 influenza vaccine in adult and elderly subjects. Journal of Preventive Medicine and Hygiene, 53(3), 136-42.
Czajka H, et al. A Phase II, Randomised Clinical Trial to Demonstrate the Non-inferiority of Low-dose MF59-adjuvanted Pre-pandemic A/H5N1 Influenza Vaccine in Adult and Elderly Subjects. J Prev Med Hyg. 2012;53(3):136-42. PubMed PMID: 23362618.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A phase II, randomised clinical trial to demonstrate the non-inferiority of low-dose MF59-adjuvanted pre-pandemic A/H5N1 influenza vaccine in adult and elderly subjects. AU - Czajka,H, AU - Unal,S, AU - Ulusoy,S, AU - Usluer,G, AU - Strus,A, AU - Sennaroglu,E, AU - Guzik,J, AU - Topeli Iskit,A, AU - Dargiewicz,A, AU - Musial,D, AU - Caylan,R, AU - Dziduch,J, AU - Eskioglu,E, AU - Hasiec,B, AU - Cwinarowiczliwa,E, AU - Belli,R, AU - Abdel-Messih,I A, AU - Beygo,J, AU - Fragapane,E, PY - 2013/2/1/entrez PY - 2013/2/1/pubmed PY - 2013/3/2/medline SP - 136 EP - 42 JF - Journal of preventive medicine and hygiene JO - J Prev Med Hyg VL - 53 IS - 3 N2 - BACKGROUND: Effective planning and preparedness against a possible future A/H5N1 influenza pandemic is a major global challenge. Because dose sparing strategies are required to meet the global demand for vaccine, efforts have focused on the development of adjuvanted vaccine formulations of relatively lower antigen content. AIM: This study aimed to demonstrate the non-inferiority of a low-antigen-dose (3.75 μ) [DOSAGE ERROR CORRECTED] A/H5N1 pre-pandemic vaccine compared with a licensed, higher-dose (7.5 mg) formulation in adult and elderly subjects. Immunogenicity was assessed according to European and U.S. licensure criteria. METHODS: A total of 722 subjects were randomized in equal numbers to receive either the licensed or low-dose formulation. All subjects received two vaccine doses administered three weeks apart. Immunogenicity was assessed three weeks after the administration of each vaccine dose by hemagglutination inhibition (HI), single radial haemolysis (SRH) and microneutralization assays (MN). Local and systemic reactions were assessed over a seven day period post-vaccination. Adverse events were recorded throughout. RESULTS: The low-dose vaccine was demonstrated to be non-inferior to the licensed formulation in terms of antibody titres against the vaccine strain. All three European licensure criteria were met by adult subjects in response to the low-dose vaccine; two criteria were met by the elderly age group. Cross-reactive antibodies were detected against the heterologous A/H5N1 antigen strains A/Indonesia/05/05 and A/turkeyTurkey/01/05. Both vaccines were generally well tolerated by both age groups. CONCLUSION: These data demonstrate that a low antigen dose in combination with MF59 adjuvant is adequate for the routine pre-pandemic immunization of adult and elderly subjects. SN - 1121-2233 UR - https://www.unboundmedicine.com/medline/citation/23362618/A_phase_II_randomised_clinical_trial_to_demonstrate_the_non_inferiority_of_low_dose_MF59_adjuvanted_pre_pandemic_A/H5N1_influenza_vaccine_in_adult_and_elderly_subjects_ L2 - https://ClinicalTrials.gov/search/term=23362618 [PUBMED-IDS] DB - PRIME DP - Unbound Medicine ER -