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Clinical development of a Vero cell culture-derived seasonal influenza vaccine.
Vaccine. 2012 Jun 19; 30(29):4377-86.V

Abstract

BACKGROUND

Cell culture technologies have the potential to improve the robustness and flexibility of influenza vaccine supply and to substantially shorten manufacturing timelines. We investigated the safety, immunogenicity and efficacy of a Vero cell culture-derived seasonal influenza vaccine and utilized these studies to establish a serological correlate of vaccine protection.

METHODS

Two multicenter, randomized, double-blind phase III trials were undertaken in the US during the 2008-2009 Northern hemisphere influenza season, in young (18-49 years) and older (50-64 years and ≥ 65 years) adult subjects. 7250 young adults were randomized 1:1 to receive either Vero-derived vaccine or placebo. 3210 older adult subjects were randomized 8:1 to receive either Vero-derived vaccine or a licensed egg-derived vaccine. Serum hemagglutination inhibition antibody titers were assessed 21 days post-vaccination. Vaccine efficacy in preventing cell culture-confirmed influenza infection was determined for the young adult population. Local and systemic adverse events were recorded in both studies.

RESULTS

The Vero-derived vaccine was safe and well tolerated in both young and older adults. All US and European immunological licensing thresholds were comfortably met in both populations. Vaccine efficacy in young adults was 79% against A/H1N1 viruses antigenically matching the corresponding vaccine strain and 78.5% for all antigenically matched influenza viruses. A hemagglutination inhibition antibody titer of ≥ 1:15 provided a reliable correlate of protection for the Vero-derived influenza vaccine, with no additional benefit at titers >1:30. Bridging of the correlate of protection established in the young adult population to the older adult immunogenicity data demonstrated the likely effectiveness of the Vero-derived vaccine in the older adult population.

CONCLUSIONS

A Vero cell culture-derived seasonal influenza vaccine is safe, immunogenic and protects against infection with influenza virus. The novel vaccine technology has the potential to make a substantial contribution to improving influenza vaccine supply.

CLINICAL TRIAL REGISTRATION

The studies are registered with ClinicalTrials.gov, numbers NCT00566345 and NCT00782431.

Authors+Show Affiliations

Global R&D, Baxter BioScience, IZD Tower, Wagramerstraβe 17-19, A-1220 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 available

Pub Type(s)

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

Language

eng

PubMed ID

22172502

Citation

Ehrlich, Hartmut J., et al. "Clinical Development of a Vero Cell Culture-derived Seasonal Influenza Vaccine." Vaccine, vol. 30, no. 29, 2012, pp. 4377-86.
Ehrlich HJ, Berezuk G, Fritsch S, et al. Clinical development of a Vero cell culture-derived seasonal influenza vaccine. Vaccine. 2012;30(29):4377-86.
Ehrlich, H. J., Berezuk, G., Fritsch, S., Aichinger, G., Singer, J., Portsmouth, D., Hart, M. K., El-Amin, W., Kistner, O., & Barrett, P. N. (2012). Clinical development of a Vero cell culture-derived seasonal influenza vaccine. Vaccine, 30(29), 4377-86. https://doi.org/10.1016/j.vaccine.2011.11.114
Ehrlich HJ, et al. Clinical Development of a Vero Cell Culture-derived Seasonal Influenza Vaccine. Vaccine. 2012 Jun 19;30(29):4377-86. PubMed PMID: 22172502.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Clinical development of a Vero cell culture-derived seasonal influenza vaccine. AU - Ehrlich,Hartmut J, AU - Berezuk,Gregory, AU - Fritsch,Sandor, AU - Aichinger,Gerald, AU - Singer,Julia, AU - Portsmouth,Daniel, AU - Hart,Mary Kate, AU - El-Amin,Wael, AU - Kistner,Otfried, AU - Barrett,P Noel, Y1 - 2011/12/13/ PY - 2011/06/30/received PY - 2011/11/21/revised PY - 2011/11/30/accepted PY - 2011/12/17/entrez PY - 2011/12/17/pubmed PY - 2012/10/17/medline SP - 4377 EP - 86 JF - Vaccine JO - Vaccine VL - 30 IS - 29 N2 - BACKGROUND: Cell culture technologies have the potential to improve the robustness and flexibility of influenza vaccine supply and to substantially shorten manufacturing timelines. We investigated the safety, immunogenicity and efficacy of a Vero cell culture-derived seasonal influenza vaccine and utilized these studies to establish a serological correlate of vaccine protection. METHODS: Two multicenter, randomized, double-blind phase III trials were undertaken in the US during the 2008-2009 Northern hemisphere influenza season, in young (18-49 years) and older (50-64 years and ≥ 65 years) adult subjects. 7250 young adults were randomized 1:1 to receive either Vero-derived vaccine or placebo. 3210 older adult subjects were randomized 8:1 to receive either Vero-derived vaccine or a licensed egg-derived vaccine. Serum hemagglutination inhibition antibody titers were assessed 21 days post-vaccination. Vaccine efficacy in preventing cell culture-confirmed influenza infection was determined for the young adult population. Local and systemic adverse events were recorded in both studies. RESULTS: The Vero-derived vaccine was safe and well tolerated in both young and older adults. All US and European immunological licensing thresholds were comfortably met in both populations. Vaccine efficacy in young adults was 79% against A/H1N1 viruses antigenically matching the corresponding vaccine strain and 78.5% for all antigenically matched influenza viruses. A hemagglutination inhibition antibody titer of ≥ 1:15 provided a reliable correlate of protection for the Vero-derived influenza vaccine, with no additional benefit at titers >1:30. Bridging of the correlate of protection established in the young adult population to the older adult immunogenicity data demonstrated the likely effectiveness of the Vero-derived vaccine in the older adult population. CONCLUSIONS: A Vero cell culture-derived seasonal influenza vaccine is safe, immunogenic and protects against infection with influenza virus. The novel vaccine technology has the potential to make a substantial contribution to improving influenza vaccine supply. CLINICAL TRIAL REGISTRATION: The studies are registered with ClinicalTrials.gov, numbers NCT00566345 and NCT00782431. SN - 1873-2518 UR - https://www.unboundmedicine.com/medline/citation/22172502/Clinical_development_of_a_Vero_cell_culture_derived_seasonal_influenza_vaccine_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0264-410X(11)01910-4 DB - PRIME DP - Unbound Medicine ER -