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Immunogenicity and safety of an AS03-adjuvanted H7N1 vaccine in adults 65years of age and older: A phase II, observer-blind, randomized, controlled trial.
Vaccine. 2017 04 04; 35(15):1865-1872.V

Abstract

BACKGROUND

H7 influenza strains can cause severe and often fatal human infections, especially in the elderly. This phase II, observer-blind, randomized trial (www.ClinicalTrials.gov: NCT01949090) assessed the immunogenicity and safety of a novel AS03-adjuvanted H7N1 vaccine that may serve as a model H7-subtype vaccine.

METHODS

360 adults ≥65years of age in stable health received either 1 of 4 adjuvanted A/mallard/Netherlands/12/2000 split virion vaccine formulations (3.75μg or 7.5μg hemagglutinin adjuvanted with either AS03A or AS03B) or saline placebo, given as a 2-dose series. Immunogenicity was assessed using hemagglutination-inhibition (HI) and microneutralization (MN) assays for the per-protocol cohort, comprising 332 participants at 21days post-each dose, 332 at month 6, and 309 at month 12 (HI assay only). Safety was assessed up to month 12 for all participants who had received ≥1 dose (360 participants).

RESULTS

For H7N1 HI antibody assessment at day 42 (21days post-dose 2), seroprotection rates (SPR) in the vaccinated groups were 69.6%-88.7%, seroconversion rates (SCR) 69.6%-88.5%, mean geometric increase (MGI) 11.0-18.9, and HI geometric mean titers (GMTs) 55.0-104.8. These parameters declined by month 6 and month 12. Microneutralization GMTs were 46.2-74.7 in the vaccinated groups at day 42, while vaccine response rate (VRR; proportion with ≥4-fold increase in MN titer) was 46.4%-81.5%. For the cross-reactive H7N9 strain, at day 42, HI GMT were 64.3-201.3, SPR 78.6%-96.3%, SCR 79.3%-96.3%, and MGI 14.1-37.7; MN GMTs were 44.0-85.6, and VRR 46.4-85.2%. The most frequent solicited symptom was injection site pain (41.7%-65.0% of vaccine recipients). In total, 40 participants reported 67 serious adverse events; none were considered causally related to vaccination.

CONCLUSIONS

In adults aged ≥65years, the adjuvanted H7N1 vaccine was immunogenic after 2 doses, and had an acceptable safety profile. www.ClinicalTrials.gov: NCT01949090.

Authors+Show Affiliations

GSK, 2301 Renaissance Blvd, RN0220, King of Prussia, PA 19406, USA. Electronic address: Anu.2.Madan@gsk.com.Colchester Research Group, 68 Robie Street, Truro, Nova Scotia B2N 1L2, Canada.Medicor Research Inc, 202-1280 Lasalle Blvd, Sudbury P3A 1Y8, Canada.Broward Research Group, 7261 Sheridan Street, Suite 210, Hollywood 33024, USA.Manna Research, 2291 Kipling Avenue Suite 117B, Toronto, Ontario M9W 4L6, Canada. Electronic address: azhar.toma@mannaresearch.com.GSK, Avenue Fleming, 1300 Wavre, Belgium. Electronic address: damien.j.friel@gsk.com.GSK, No. 5, Embassy, Bangalore 560052, India.GSK, 2301 Renaissance Blvd, RN0220, King of Prussia, PA 19406, USA. Electronic address: ping.li4@pfizer.com.GSK, 2301 Renaissance Blvd, RN0220, King of Prussia, PA 19406, USA. Electronic address: bruce.2.innis@gsk.com.GSK, 2301 Renaissance Blvd, RN0220, King of Prussia, PA 19406, USA.

Pub Type(s)

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

Language

eng

PubMed ID

28302407

Citation

Madan, Anuradha, et al. "Immunogenicity and Safety of an AS03-adjuvanted H7N1 Vaccine in Adults 65years of Age and Older: a Phase II, Observer-blind, Randomized, Controlled Trial." Vaccine, vol. 35, no. 15, 2017, pp. 1865-1872.
Madan A, Ferguson M, Rheault P, et al. Immunogenicity and safety of an AS03-adjuvanted H7N1 vaccine in adults 65years of age and older: A phase II, observer-blind, randomized, controlled trial. Vaccine. 2017;35(15):1865-1872.
Madan, A., Ferguson, M., Rheault, P., Seiden, D., Toma, A., Friel, D., Soni, J., Li, P., Innis, B. L., & Schuind, A. (2017). Immunogenicity and safety of an AS03-adjuvanted H7N1 vaccine in adults 65years of age and older: A phase II, observer-blind, randomized, controlled trial. Vaccine, 35(15), 1865-1872. https://doi.org/10.1016/j.vaccine.2017.02.057
Madan A, et al. Immunogenicity and Safety of an AS03-adjuvanted H7N1 Vaccine in Adults 65years of Age and Older: a Phase II, Observer-blind, Randomized, Controlled Trial. Vaccine. 2017 04 4;35(15):1865-1872. PubMed PMID: 28302407.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Immunogenicity and safety of an AS03-adjuvanted H7N1 vaccine in adults 65years of age and older: A phase II, observer-blind, randomized, controlled trial. AU - Madan,Anuradha, AU - Ferguson,Murdo, AU - Rheault,Paul, AU - Seiden,David, AU - Toma,Azhar, AU - Friel,Damien, AU - Soni,Jyoti, AU - Li,Ping, AU - Innis,Bruce L, AU - Schuind,Anne, Y1 - 2017/03/13/ PY - 2016/10/21/received PY - 2017/02/23/revised PY - 2017/02/24/accepted PY - 2017/3/18/pubmed PY - 2017/12/15/medline PY - 2017/3/18/entrez KW - AS03 adjuvant KW - Elderly population KW - H7 influenza vaccine KW - H7N1 KW - H7N9 KW - Pandemic flu SP - 1865 EP - 1872 JF - Vaccine JO - Vaccine VL - 35 IS - 15 N2 - BACKGROUND: H7 influenza strains can cause severe and often fatal human infections, especially in the elderly. This phase II, observer-blind, randomized trial (www.ClinicalTrials.gov: NCT01949090) assessed the immunogenicity and safety of a novel AS03-adjuvanted H7N1 vaccine that may serve as a model H7-subtype vaccine. METHODS: 360 adults ≥65years of age in stable health received either 1 of 4 adjuvanted A/mallard/Netherlands/12/2000 split virion vaccine formulations (3.75μg or 7.5μg hemagglutinin adjuvanted with either AS03A or AS03B) or saline placebo, given as a 2-dose series. Immunogenicity was assessed using hemagglutination-inhibition (HI) and microneutralization (MN) assays for the per-protocol cohort, comprising 332 participants at 21days post-each dose, 332 at month 6, and 309 at month 12 (HI assay only). Safety was assessed up to month 12 for all participants who had received ≥1 dose (360 participants). RESULTS: For H7N1 HI antibody assessment at day 42 (21days post-dose 2), seroprotection rates (SPR) in the vaccinated groups were 69.6%-88.7%, seroconversion rates (SCR) 69.6%-88.5%, mean geometric increase (MGI) 11.0-18.9, and HI geometric mean titers (GMTs) 55.0-104.8. These parameters declined by month 6 and month 12. Microneutralization GMTs were 46.2-74.7 in the vaccinated groups at day 42, while vaccine response rate (VRR; proportion with ≥4-fold increase in MN titer) was 46.4%-81.5%. For the cross-reactive H7N9 strain, at day 42, HI GMT were 64.3-201.3, SPR 78.6%-96.3%, SCR 79.3%-96.3%, and MGI 14.1-37.7; MN GMTs were 44.0-85.6, and VRR 46.4-85.2%. The most frequent solicited symptom was injection site pain (41.7%-65.0% of vaccine recipients). In total, 40 participants reported 67 serious adverse events; none were considered causally related to vaccination. CONCLUSIONS: In adults aged ≥65years, the adjuvanted H7N1 vaccine was immunogenic after 2 doses, and had an acceptable safety profile. www.ClinicalTrials.gov: NCT01949090. SN - 1873-2518 UR - https://www.unboundmedicine.com/medline/citation/28302407/Immunogenicity_and_safety_of_an_AS03_adjuvanted_H7N1_vaccine_in_adults_65years_of_age_and_older:_A_phase_II_observer_blind_randomized_controlled_trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0264-410X(17)30270-0 DB - PRIME DP - Unbound Medicine ER -