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Cell culture (Vero cell) derived whole-virus non-adjuvanted H5N1 influenza vaccine induces long-lasting cross-reactive memory immune response: homologous or heterologous booster response following two dose or single dose priming.
Vaccine. 2012 Sep 21; 30(43):6127-35.V

Abstract

BACKGROUND

Influenza pandemic preparedness involves priming of the population with pre-pandemic vaccines. Such vaccines should be well tolerated and induce a long-lasting immunological memory that can effectively be boosted with a single dose of pandemic vaccine once available. The presented studies assessed different prime-boost regimens with a Vero cell-derived whole virus non-adjuvanted H5N1 vaccine.

METHODS

In one study, 281 healthy adult (18-59 years) and 280 elderly (≥ 60 years) subjects received two vaccinations, 21 days apart, with Vero cell-derived whole virus non-adjuvanted H5N1 vaccine (7.5 μg HA Antigen A/Vietnam/1203/2004) followed by a 6, 12-15, or 24 month booster (7.5 or 3.75μg A/Indonesia/05/2005 or A/Vietnam/1203/2004). In the other study, 230 healthy adults (18-59 years) received single dose priming (7.5 μg A/Vietnam/1203/2004) followed by a 12 month booster (7.5 or 3.75 μg A/Indonesia/05/2005). Antibody responses were assessed by microneutralization (MN) and single radial hemolysis (SRH) assay. Vaccine safety was assessed throughout.

RESULTS

Two dose priming was equally immunogenic in adults and the elderly: >72% of subjects in each population achieved MN titers ≥ 1:20 after the second vaccination. Booster vaccinations at 6, 12-15, and 24 months induced substantial antibody increases to both strains: after a 7.5 μg A/Indonesia/05/2005 booster, 93-95% of adults and 72-84% of the elderly achieved MN titers ≥ 1:20 against this strain. Homologous and heterologous booster responses were higher in the 7.5μg dose group than in the 3.75 μg dose group. Booster responses following single dose priming were similar; a 7.5 μg booster dose induced homologous MN titers ≥ 1:20 in 93% of subjects.

CONCLUSIONS

A Vero cell derived whole virus non-adjuvanted H5N1 influenza vaccine is well tolerated and induces long-lasting cross-clade immunological memory that can be effectively boosted 1-2 years after two dose or single dose priming, supporting its suitability for pre-pandemic vaccination.

Authors+Show Affiliations

Vaccine R&D, Baxter BioScience, Vienna, Austria.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 available

Pub Type(s)

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

Language

eng

PubMed ID

22884662

Citation

van der Velden, Maikel V W., et al. "Cell Culture (Vero Cell) Derived Whole-virus Non-adjuvanted H5N1 Influenza Vaccine Induces Long-lasting Cross-reactive Memory Immune Response: Homologous or Heterologous Booster Response Following Two Dose or Single Dose Priming." Vaccine, vol. 30, no. 43, 2012, pp. 6127-35.
van der Velden MV, Aichinger G, Pöllabauer EM, et al. Cell culture (Vero cell) derived whole-virus non-adjuvanted H5N1 influenza vaccine induces long-lasting cross-reactive memory immune response: homologous or heterologous booster response following two dose or single dose priming. Vaccine. 2012;30(43):6127-35.
van der Velden, M. V., Aichinger, G., Pöllabauer, E. M., Löw-Baselli, A., Fritsch, S., Benamara, K., Kistner, O., Müller, M., Zeitlinger, M., Kollaritsch, H., Vesikari, T., Ehrlich, H. J., & Barrett, P. N. (2012). Cell culture (Vero cell) derived whole-virus non-adjuvanted H5N1 influenza vaccine induces long-lasting cross-reactive memory immune response: homologous or heterologous booster response following two dose or single dose priming. Vaccine, 30(43), 6127-35. https://doi.org/10.1016/j.vaccine.2012.07.077
van der Velden MV, et al. Cell Culture (Vero Cell) Derived Whole-virus Non-adjuvanted H5N1 Influenza Vaccine Induces Long-lasting Cross-reactive Memory Immune Response: Homologous or Heterologous Booster Response Following Two Dose or Single Dose Priming. Vaccine. 2012 Sep 21;30(43):6127-35. PubMed PMID: 22884662.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Cell culture (Vero cell) derived whole-virus non-adjuvanted H5N1 influenza vaccine induces long-lasting cross-reactive memory immune response: homologous or heterologous booster response following two dose or single dose priming. AU - van der Velden,Maikel V W, AU - Aichinger,Gerald, AU - Pöllabauer,Eva Maria, AU - Löw-Baselli,Alexandra, AU - Fritsch,Sandor, AU - Benamara,Karima, AU - Kistner,Otfried, AU - Müller,Markus, AU - Zeitlinger,Markus, AU - Kollaritsch,Herwig, AU - Vesikari,Timo, AU - Ehrlich,Hartmut J, AU - Barrett,P Noel, Y1 - 2012/08/08/ PY - 2012/04/23/received PY - 2012/07/10/revised PY - 2012/07/27/accepted PY - 2012/8/14/entrez PY - 2012/8/14/pubmed PY - 2013/1/11/medline SP - 6127 EP - 35 JF - Vaccine JO - Vaccine VL - 30 IS - 43 N2 - BACKGROUND: Influenza pandemic preparedness involves priming of the population with pre-pandemic vaccines. Such vaccines should be well tolerated and induce a long-lasting immunological memory that can effectively be boosted with a single dose of pandemic vaccine once available. The presented studies assessed different prime-boost regimens with a Vero cell-derived whole virus non-adjuvanted H5N1 vaccine. METHODS: In one study, 281 healthy adult (18-59 years) and 280 elderly (≥ 60 years) subjects received two vaccinations, 21 days apart, with Vero cell-derived whole virus non-adjuvanted H5N1 vaccine (7.5 μg HA Antigen A/Vietnam/1203/2004) followed by a 6, 12-15, or 24 month booster (7.5 or 3.75μg A/Indonesia/05/2005 or A/Vietnam/1203/2004). In the other study, 230 healthy adults (18-59 years) received single dose priming (7.5 μg A/Vietnam/1203/2004) followed by a 12 month booster (7.5 or 3.75 μg A/Indonesia/05/2005). Antibody responses were assessed by microneutralization (MN) and single radial hemolysis (SRH) assay. Vaccine safety was assessed throughout. RESULTS: Two dose priming was equally immunogenic in adults and the elderly: >72% of subjects in each population achieved MN titers ≥ 1:20 after the second vaccination. Booster vaccinations at 6, 12-15, and 24 months induced substantial antibody increases to both strains: after a 7.5 μg A/Indonesia/05/2005 booster, 93-95% of adults and 72-84% of the elderly achieved MN titers ≥ 1:20 against this strain. Homologous and heterologous booster responses were higher in the 7.5μg dose group than in the 3.75 μg dose group. Booster responses following single dose priming were similar; a 7.5 μg booster dose induced homologous MN titers ≥ 1:20 in 93% of subjects. CONCLUSIONS: A Vero cell derived whole virus non-adjuvanted H5N1 influenza vaccine is well tolerated and induces long-lasting cross-clade immunological memory that can be effectively boosted 1-2 years after two dose or single dose priming, supporting its suitability for pre-pandemic vaccination. SN - 1873-2518 UR - https://www.unboundmedicine.com/medline/citation/22884662/Cell_culture__Vero_cell__derived_whole_virus_non_adjuvanted_H5N1_influenza_vaccine_induces_long_lasting_cross_reactive_memory_immune_response:_homologous_or_heterologous_booster_response_following_two_dose_or_single_dose_priming_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0264-410X(12)01112-7 DB - PRIME DP - Unbound Medicine ER -