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A phase II, open-label, multicentre study to evaluate the immunogenicity and safety of an adjuvanted prepandemic (H5N1) influenza vaccine in healthy Japanese adults.
BMC Infect Dis. 2010 Nov 25; 10:338.BI

Abstract

BACKGROUND

Promising clinical data and significant antigen-sparing have been demonstrated for a pandemic H5N1 influenza split-virion vaccine adjuvanted with AS03A, an α-tocopherol-containing oil-in-water emulsion-based Adjuvant System. Although studies using this formulation have been reported, there have been no data for Japanese populations. This study therefore aimed to assess the immunogenicity and tolerability of a prepandemic (H5N1) influenza vaccine adjuvanted with AS03A in Japanese adults.

METHODS

This open-label, single-group study was conducted at two centres in Japan in healthy Japanese males and females aged 20-64 years (n = 100). Subjects received two doses of vaccine, containing 3.75 μg haemagglutinin of the A/Indonesia/5/2005-like IBCDC-RG2 Clade 2.1 (H5N1) strain adjuvanted with AS03A, 21 days apart. The primary endpoint evaluated the humoral immune response in terms of H5N1 haemagglutination inhibition (HI) antibody titres against the vaccine strain (Clade 2.1) 21 days after the second dose. Ninety five percent confidence intervals for geometric mean titres, seroprotection, seroconversion and seropositivity rates were calculated. Secondary and exploratory endpoints included the assessment of the humoral response in terms of neutralising antibody titres, the response against additional H5N1 strains (Clade 1 and Clade 2.2), as well as the evaluation of safety and reactogenicity.

RESULTS

Robust immune responses were elicited after two doses of the prepandemic influenza vaccine adjuvanted with AS03A. Overall, vaccine HI seroconversion rates and seroprotection rates were 91% 21 days after the second vaccination. This fulfilled all regulatory acceptance criteria for the vaccine-homologous HI antibody level. A substantial cross-reactive humoral immune response was also observed against the virus strains A/turkey/Turkey/1/2005 (Clade 2.2) and A/Vietnam/1194/2004 (Clade 1) after the second vaccine administration. A marked post-vaccination response in terms of neutralising antibody titres was demonstrated and persistence of the immune response was observed 6 months after the first dose. The vaccine was generally well tolerated and there were no serious adverse events reported.

CONCLUSIONS

The H5N1 candidate vaccine adjuvanted with AS03A elicited a strong and persistent immune response against the vaccine strain A/Indonesia/5/2005 in Japanese adults. Vaccination with this formulation demonstrated a clinically acceptable reactogenicity profile and did not raise any safety concerns in this population.

TRIAL REGISTRATION

Clinicaltrials.gov NCT00742885.

Authors+Show Affiliations

National Hospital Organization Tokyo National Hospital, 3-1-1, Takeoka, Kiyose-city, Tokyo 204-8585, Japan. hnagai-in@tokyo-hosp.jpNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase II
Journal Article
Multicenter Study

Language

eng

PubMed ID

21108818

Citation

Nagai, Hideaki, et al. "A Phase II, Open-label, Multicentre Study to Evaluate the Immunogenicity and Safety of an Adjuvanted Prepandemic (H5N1) Influenza Vaccine in Healthy Japanese Adults." BMC Infectious Diseases, vol. 10, 2010, p. 338.
Nagai H, Ikematsu H, Tenjinbaru K, et al. A phase II, open-label, multicentre study to evaluate the immunogenicity and safety of an adjuvanted prepandemic (H5N1) influenza vaccine in healthy Japanese adults. BMC Infect Dis. 2010;10:338.
Nagai, H., Ikematsu, H., Tenjinbaru, K., Maeda, A., Dramé, M., & Roman, F. P. (2010). A phase II, open-label, multicentre study to evaluate the immunogenicity and safety of an adjuvanted prepandemic (H5N1) influenza vaccine in healthy Japanese adults. BMC Infectious Diseases, 10, 338. https://doi.org/10.1186/1471-2334-10-338
Nagai H, et al. A Phase II, Open-label, Multicentre Study to Evaluate the Immunogenicity and Safety of an Adjuvanted Prepandemic (H5N1) Influenza Vaccine in Healthy Japanese Adults. BMC Infect Dis. 2010 Nov 25;10:338. PubMed PMID: 21108818.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A phase II, open-label, multicentre study to evaluate the immunogenicity and safety of an adjuvanted prepandemic (H5N1) influenza vaccine in healthy Japanese adults. AU - Nagai,Hideaki, AU - Ikematsu,Hideyuki, AU - Tenjinbaru,Kazuyoshi, AU - Maeda,Atsushi, AU - Dramé,Mamadou, AU - Roman,François P, Y1 - 2010/11/25/ PY - 2010/06/22/received PY - 2010/11/25/accepted PY - 2010/11/27/entrez PY - 2010/11/27/pubmed PY - 2011/4/19/medline SP - 338 EP - 338 JF - BMC infectious diseases JO - BMC Infect Dis VL - 10 N2 - BACKGROUND: Promising clinical data and significant antigen-sparing have been demonstrated for a pandemic H5N1 influenza split-virion vaccine adjuvanted with AS03A, an α-tocopherol-containing oil-in-water emulsion-based Adjuvant System. Although studies using this formulation have been reported, there have been no data for Japanese populations. This study therefore aimed to assess the immunogenicity and tolerability of a prepandemic (H5N1) influenza vaccine adjuvanted with AS03A in Japanese adults. METHODS: This open-label, single-group study was conducted at two centres in Japan in healthy Japanese males and females aged 20-64 years (n = 100). Subjects received two doses of vaccine, containing 3.75 μg haemagglutinin of the A/Indonesia/5/2005-like IBCDC-RG2 Clade 2.1 (H5N1) strain adjuvanted with AS03A, 21 days apart. The primary endpoint evaluated the humoral immune response in terms of H5N1 haemagglutination inhibition (HI) antibody titres against the vaccine strain (Clade 2.1) 21 days after the second dose. Ninety five percent confidence intervals for geometric mean titres, seroprotection, seroconversion and seropositivity rates were calculated. Secondary and exploratory endpoints included the assessment of the humoral response in terms of neutralising antibody titres, the response against additional H5N1 strains (Clade 1 and Clade 2.2), as well as the evaluation of safety and reactogenicity. RESULTS: Robust immune responses were elicited after two doses of the prepandemic influenza vaccine adjuvanted with AS03A. Overall, vaccine HI seroconversion rates and seroprotection rates were 91% 21 days after the second vaccination. This fulfilled all regulatory acceptance criteria for the vaccine-homologous HI antibody level. A substantial cross-reactive humoral immune response was also observed against the virus strains A/turkey/Turkey/1/2005 (Clade 2.2) and A/Vietnam/1194/2004 (Clade 1) after the second vaccine administration. A marked post-vaccination response in terms of neutralising antibody titres was demonstrated and persistence of the immune response was observed 6 months after the first dose. The vaccine was generally well tolerated and there were no serious adverse events reported. CONCLUSIONS: The H5N1 candidate vaccine adjuvanted with AS03A elicited a strong and persistent immune response against the vaccine strain A/Indonesia/5/2005 in Japanese adults. Vaccination with this formulation demonstrated a clinically acceptable reactogenicity profile and did not raise any safety concerns in this population. TRIAL REGISTRATION: Clinicaltrials.gov NCT00742885. SN - 1471-2334 UR - https://www.unboundmedicine.com/medline/citation/21108818/A_phase_II_open_label_multicentre_study_to_evaluate_the_immunogenicity_and_safety_of_an_adjuvanted_prepandemic__H5N1__influenza_vaccine_in_healthy_Japanese_adults_ L2 - https://bmcinfectdis.biomedcentral.com/articles/10.1186/1471-2334-10-338 DB - PRIME DP - Unbound Medicine ER -