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A randomized clinical trial to identify the optimal antigen and MF59(®) adjuvant dose of a monovalent A/H1N1 pandemic influenza vaccine in healthy adult and elderly subjects.
Vaccine. 2012 May 14; 30(23):3470-7.V

Abstract

BACKGROUND

Vaccines against pandemic A/H1N1 influenza are required to protect the entire population. This dose range study aimed to identify priming antigen and adjuvant doses resulting in optimal levels of antibody-mediated protection after primary and one-year booster immunizations.

METHODS

This randomised trial enrolled 410 healthy adult (18-60 years) and 251 healthy elderly (>60 years) participants. Subjects received vaccine containing either 3.75 μg or 7.5 μg antigen, adjuvanted with half the standard dose, or a standard dose of MF59(®) (Novartis Vaccines) adjuvant, respectively. An additional adult cohort received non-adjuvanted vaccine containing 15 μg antigen. Two doses of investigational vaccine were administered three weeks apart, followed by a single booster dose of adjuvanted seasonal influenza vaccine one year after priming. Immunogenicity was assessed by haemagglutination inhibition and microneutralization assays pre- and post-immunization, the safety profile of each vaccine was also evaluated.

RESULTS

All of the vaccine formulations investigated were highly immunogenic and well tolerated in both adult and elderly subjects. The 7.5 μg formulation induced the highest antibody titres after primary and booster immunizations, and resulted in better long-term antibody persistence, in both age groups. Assessment according to European licensure criteria for influenza vaccines concluded that single adjuvanted priming doses containing 3.75 μg and 7.5 μg antigen were optimal for the adult and elderly populations, respectively.

CONCLUSIONS

These data demonstrate that one priming dose of MF59-adjuvanted A/H1N1 vaccine provided healthy adult (3.75 μg or 7.5 μg formulations) and healthy elderly (7.5 μg formulation) individuals with adequate levels of seroprotection. Booster administration after two priming doses of either vaccine formulation resulted in the rapid development of seroprotective antibody titres.

TRIAL REGISTRATION

www.clinicaltrials.gov (NCT00971906).

Authors+Show Affiliations

Division of Communicable Diseases, Institute for Social and Preventive Medicine, University of Zurich, 8001 Zurich, Switzerland. christoph.hatz@unibas.chNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

22446638

Citation

Hatz, Christoph, et al. "A Randomized Clinical Trial to Identify the Optimal Antigen and MF59(®) Adjuvant Dose of a Monovalent A/H1N1 Pandemic Influenza Vaccine in Healthy Adult and Elderly Subjects." Vaccine, vol. 30, no. 23, 2012, pp. 3470-7.
Hatz C, von Sonnenburg F, Casula D, et al. A randomized clinical trial to identify the optimal antigen and MF59(®) adjuvant dose of a monovalent A/H1N1 pandemic influenza vaccine in healthy adult and elderly subjects. Vaccine. 2012;30(23):3470-7.
Hatz, C., von Sonnenburg, F., Casula, D., Lattanzi, M., & Leroux-Roels, G. (2012). A randomized clinical trial to identify the optimal antigen and MF59(®) adjuvant dose of a monovalent A/H1N1 pandemic influenza vaccine in healthy adult and elderly subjects. Vaccine, 30(23), 3470-7. https://doi.org/10.1016/j.vaccine.2012.03.017
Hatz C, et al. A Randomized Clinical Trial to Identify the Optimal Antigen and MF59(®) Adjuvant Dose of a Monovalent A/H1N1 Pandemic Influenza Vaccine in Healthy Adult and Elderly Subjects. Vaccine. 2012 May 14;30(23):3470-7. PubMed PMID: 22446638.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A randomized clinical trial to identify the optimal antigen and MF59(®) adjuvant dose of a monovalent A/H1N1 pandemic influenza vaccine in healthy adult and elderly subjects. AU - Hatz,Christoph, AU - von Sonnenburg,Frank, AU - Casula,Daniela, AU - Lattanzi,Maria, AU - Leroux-Roels,Geert, Y1 - 2012/03/22/ PY - 2011/11/01/received PY - 2012/03/05/revised PY - 2012/03/08/accepted PY - 2012/3/27/entrez PY - 2012/3/27/pubmed PY - 2012/8/9/medline SP - 3470 EP - 7 JF - Vaccine JO - Vaccine VL - 30 IS - 23 N2 - BACKGROUND: Vaccines against pandemic A/H1N1 influenza are required to protect the entire population. This dose range study aimed to identify priming antigen and adjuvant doses resulting in optimal levels of antibody-mediated protection after primary and one-year booster immunizations. METHODS: This randomised trial enrolled 410 healthy adult (18-60 years) and 251 healthy elderly (>60 years) participants. Subjects received vaccine containing either 3.75 μg or 7.5 μg antigen, adjuvanted with half the standard dose, or a standard dose of MF59(®) (Novartis Vaccines) adjuvant, respectively. An additional adult cohort received non-adjuvanted vaccine containing 15 μg antigen. Two doses of investigational vaccine were administered three weeks apart, followed by a single booster dose of adjuvanted seasonal influenza vaccine one year after priming. Immunogenicity was assessed by haemagglutination inhibition and microneutralization assays pre- and post-immunization, the safety profile of each vaccine was also evaluated. RESULTS: All of the vaccine formulations investigated were highly immunogenic and well tolerated in both adult and elderly subjects. The 7.5 μg formulation induced the highest antibody titres after primary and booster immunizations, and resulted in better long-term antibody persistence, in both age groups. Assessment according to European licensure criteria for influenza vaccines concluded that single adjuvanted priming doses containing 3.75 μg and 7.5 μg antigen were optimal for the adult and elderly populations, respectively. CONCLUSIONS: These data demonstrate that one priming dose of MF59-adjuvanted A/H1N1 vaccine provided healthy adult (3.75 μg or 7.5 μg formulations) and healthy elderly (7.5 μg formulation) individuals with adequate levels of seroprotection. Booster administration after two priming doses of either vaccine formulation resulted in the rapid development of seroprotective antibody titres. TRIAL REGISTRATION: www.clinicaltrials.gov (NCT00971906). SN - 1873-2518 UR - https://www.unboundmedicine.com/medline/citation/22446638/A_randomized_clinical_trial_to_identify_the_optimal_antigen_and_MF59_®__adjuvant_dose_of_a_monovalent_A/H1N1_pandemic_influenza_vaccine_in_healthy_adult_and_elderly_subjects_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0264-410X(12)00380-5 DB - PRIME DP - Unbound Medicine ER -