Evaluation of Influenza A/H3N2 Vaccine in Patients With Rheumatologic Diseases

NCT03540823 | Completed Phase 4

• 1 other identifier: H3N2VaccineReumatoHC
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Studies in the literature have shown reduced effectiveness of influenza A (H3N2) virus vaccine (20-40%) when compared to A (H1N1) and influenza B. This reduction in efficacy may partly result of the need to propagate A (H3N2) virus into egg components for the preparation of the vaccine. Other factors that may also contribute to the reduction of efficacy against A (H3N2) viruses include the high level of genetic diversity and the rate of rapid evolution of this particular virus subtype and the modification of the immune response to the vaccine secondary of prior infection or vaccination. Vaccine efficacy studies are required to verify the immunogenicity of the H3N2 influenza vaccine in immunosuppressed patients with rheumatologic disease. In addition, it is relevant to evaluate the safety of the vaccine in this population as well as the possibility of reactivation of the rheumatologic disease itself. The objectives of this study are to evaluate the immunogenicity of the H3N2 component of the inactivated and fragmented influenza vaccine in patients with two systemic autoimmune rheumatic diseases (Systemic Lupus Erythematosus - Adult and Juvenile, Primary Sjögren's Syndrome).

Conditions

Systemic Lupus; Sjogren's Syndrome

Outcome Measures

Primary Outcomes (1)

• Number of participants with seroprotection and seroconversion after Influenza vaccine

  Immunogenicity (seroprotection and seroconversion) of the H3N2 component of the inactivated and fragmented influenza vaccine (A / Michigan / 45/2015 (H1N1) pdm09-like virus, A / Singapore / INFIMH-16-0019 / 2016 (H3N2) -like virus; B / Phuket / 3073/2013-like virus) will be evaluated by haemagglutination inhibition (HI) assay

  30 days

Secondary Outcomes (1)

• Number of participants with vaccine-related adverse events as assessed by CTCAE v4.0

  30 days

Study Arms (2)

Patients with rheumatic diseases

EXPERIMENTAL

Patients with diagnosis of adult and juvenile systemic lupus erythematosus (SLE and JSLE) and Sjogren syndrome (SSp)

Biological: Inactivated and fragmented influenza vaccine (A / Michigan / 45/2015 (H1N1) pdm09-like virus, A / Singapore / INFIMH-16-0019 / 2016 (H3N2) -like virus; B / Phuket / 3073/2013-like virus)

Healthy controls

OTHER

Healthy children and adults

Biological: Inactivated and fragmented influenza vaccine (A / Michigan / 45/2015 (H1N1) pdm09-like virus, A / Singapore / INFIMH-16-0019 / 2016 (H3N2) -like virus; B / Phuket / 3073/2013-like virus)

Interventions

Inactivated and fragmented influenza vaccine (A / Michigan / 45/2015 (H1N1) pdm09-like virus, A / Singapore / INFIMH-16-0019 / 2016 (H3N2) -like virus; B / Phuket / 3073/2013-like virus) BIOLOGICAL

Single dose of Inactivated and fragmented influenza vaccine (A / Michigan / 45/2015 (H1N1) pdm09-like virus, A / Singapore / INFIMH-16-0019 / 2016 (H3N2) -like virus; B / Phuket / 3073/2013-like virus)

Healthy controls; Patients with rheumatic diseases

Eligibility Criteria

• Age: 9 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult and juvenile systemic lupus erythematosus (SLE) and juvenile SLE patients according to the ACR classification criteria aged ≥ 18 years for adults and aged ≥ 9 and \<18 years for the juvenile group
• Patients with primary Sjögren's Syndrome (SSp) (classification criteria of the European Study Group on Diagnostic Criteria for Sjögren's Syndrome) aged ≥ 18 years

You may not qualify if:

• History of anaphylactic response to vaccine components or egg allergy
• Moderate or severe acute febrile illness
• Guillain-Barré syndrome, decompensated heart failure (class III or IV), demyelinating disease.
• History of live virus vaccine up to 4 weeks before, virus vaccine inactivated up to 2 weeks prior, influenza vaccine up to 6 months prior to study.
• History of having received blood products up to 6 months prior to the study.
• Individuals who do not agree to participate in the study and / or whose parents do not agree to participate in the study.
• Inpatients
• Patients with severe conditions requiring hospitalization

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Rheumatology Division of Hospital das Clínicas da Faculdade de Medicina da Universidade de Sao Paulo

São Paulo, 05403-000, Brazil

Location

Related Publications (12)

• Silva CA, Aikawa NE, Bonfa E. Vaccinations in juvenile chronic inflammatory diseases: an update. Nat Rev Rheumatol. 2013 Sep;9(9):532-43. doi: 10.1038/nrrheum.2013.95. Epub 2013 Jul 2.

  PMID: 23820860 BACKGROUND

• Pasoto SG, Ribeiro AC, Bonfa E. Update on infections and vaccinations in systemic lupus erythematosus and Sjogren's syndrome. Curr Opin Rheumatol. 2014 Sep;26(5):528-37. doi: 10.1097/BOR.0000000000000084.

  PMID: 25022358 BACKGROUND

• Kuruma KA, Borba EF, Lopes MH, de Carvalho JF, Bonfa E. Safety and efficacy of hepatitis B vaccine in systemic lupus erythematosus. Lupus. 2007;16(5):350-4. doi: 10.1177/0961203307078225.

  PMID: 17576737 BACKGROUND

• Aikawa NE, Franca IL, Ribeiro AC, Sallum AM, Bonfa E, Silva CA. Short and long-term immunogenicity and safety following the 23-valent polysaccharide pneumococcal vaccine in juvenile idiopathic arthritis patients under conventional DMARDs with or without anti-TNF therapy. Vaccine. 2015 Jan 29;33(5):604-9. doi: 10.1016/j.vaccine.2014.12.030. Epub 2014 Dec 29.

  PMID: 25554240 BACKGROUND

• Saad CG, Borba EF, Aikawa NE, Silva CA, Pereira RM, Calich AL, Moraes JC, Ribeiro AC, Viana VS, Pasoto SG, Carvalho JF, Franca IL, Guedes LK, Shinjo SK, Sampaio-Barros PD, Caleiro MT, Goncalves CR, Fuller R, Levy-Neto M, Timenetsky Mdo C, Precioso AR, Bonfa E. Immunogenicity and safety of the 2009 non-adjuvanted influenza A/H1N1 vaccine in a large cohort of autoimmune rheumatic diseases. Ann Rheum Dis. 2011 Jun;70(6):1068-73. doi: 10.1136/ard.2011.150250.

  PMID: 21540203 BACKGROUND

• Aikawa NE, Campos LM, Silva CA, Carvalho JF, Saad CG, Trudes G, Duarte A, Miraglia JL, Timenetsky Mdo C, Viana VS, Franca IL, Bonfa E, Pereira RM. Glucocorticoid: major factor for reduced immunogenicity of 2009 influenza A (H1N1) vaccine in patients with juvenile autoimmune rheumatic disease. J Rheumatol. 2012 Jan;39(1):167-73. doi: 10.3899/jrheum.110721. Epub 2011 Nov 15.

  PMID: 22089462 BACKGROUND

• Borba EF, Saad CG, Pasoto SG, Calich AL, Aikawa NE, Ribeiro AC, Moraes JC, Leon EP, Costa LP, Guedes LK, Silva CA, Goncalves CR, Fuller R, Oliveira SA, Ishida MA, Precioso AR, Bonfa E. Influenza A/H1N1 vaccination of patients with SLE: can antimalarial drugs restore diminished response under immunosuppressive therapy? Rheumatology (Oxford). 2012 Jun;51(6):1061-9. doi: 10.1093/rheumatology/ker427. Epub 2012 Jan 31.

  PMID: 22298793 BACKGROUND

• Korsun N, Angelova S, Trifonova I, Tzotcheva I, Mileva S, Voleva S, Georgieva I, Perenovska P. Predominance of influenza A(H3N2) viruses during the 2016/2017 season in Bulgaria. J Med Microbiol. 2018 Feb;67(2):228-239. doi: 10.1099/jmm.0.000668. Epub 2018 Jan 3.

  PMID: 29297852 RESULT

• Chiu SS, Kwan MYW, Feng S, Wong JSC, Leung CW, Chan ELY, Chan KH, Ng TK, To WK, Cowling BJ, Peiris JSM. Influenza Vaccine Effectiveness Against Influenza A(H3N2) Hospitalizations in Children in Hong Kong in a Prolonged Season, 2016/2017. J Infect Dis. 2018 Apr 11;217(9):1365-1371. doi: 10.1093/infdis/jiy027.

  PMID: 29346614 RESULT

• Skowronski DM, Chambers C, De Serres G, Dickinson JA, Winter AL, Hickman R, Chan T, Jassem AN, Drews SJ, Charest H, Gubbay JB, Bastien N, Li Y, Krajden M. Early season co-circulation of influenza A(H3N2) and B(Yamagata): interim estimates of 2017/18 vaccine effectiveness, Canada, January 2018. Euro Surveill. 2018 Feb;23(5):18-00035. doi: 10.2807/1560-7917.ES.2018.23.5.18-00035.

  PMID: 29409570 RESULT

• Aikawa NE, Borba EF, Balbi VA, Sallum AME, Buscatti IM, Campos LMA, Kozu KT, Garcia CC, Capao ASV, de Proenca ACT, Leon EP, da Silva Duarte AJ, Lopes MH, Silva CA, Bonfa E. Safety and immunogenicity of influenza A(H3N2) component vaccine in juvenile systemic lupus erythematosus. Adv Rheumatol. 2023 Nov 28;63(1):55. doi: 10.1186/s42358-023-00339-7.

  PMID: 38017564 DERIVED

• Claudino Formiga FF, Silva CA, Pedrosa TDN, Aikawa NE, Pasoto SG, Garcia CC, Capao ASV, Martins VAO, Proenca ACT, Fuller R, Yuki EFN, Vendramini MBG, Rosario DCD, Brandao LMKR, Sartori AMC, Antonangelo L, Bonfa E, Borba EF. Influenza A/Singapore (H3N2) component vaccine in systemic lupus erythematosus: A distinct pattern of immunogenicity. Lupus. 2021 Oct;30(12):1915-1922. doi: 10.1177/09612033211040371. Epub 2021 Aug 28.

  PMID: 34459317 DERIVED

MeSH Terms

Conditions

Sjogren's Syndrome

Condition Hierarchy (Ancestors)

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Eduardo Borba, MD, PhD

  Rheumatology Division of Hospital das Clínicas da Faculdade de Medicina da Universidade de Sao Paulo São Paulo, Sao Paulo Brazil

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2018
• First Posted: May 30, 2018
• Study Start: April 23, 2018
• Primary Completion: June 23, 2018
• Study Completion: August 23, 2018
• Last Updated: April 26, 2019

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)