Uma avaliação pragmática da eficácia da vacina contra influenza no DoD (PAIVED)
A total of 18,000 eligible subjects (or 6,000 subject distributed evenly between the 3 study arms) will be enrolled. Eligible subjects will be randomized in 1:1:1 (cell-culture-based vaccine, the recombinant vaccine, or the egg-based vaccine) over four influenza seasons (2018-2019, 2019-2020, 2020-2021, and 2021-2022).
Visão geral do estudo
Status
Descrição detalhada
This four-year, pragmatic, prospective study will compare the effectiveness of licensed egg-based inactivated influenza vaccines to the effectiveness of two other types of licensed vaccines, the cell-culture based inactivated influenza vaccine and the recombinant influenza vaccine, in the prevention of laboratory-confirmed influenza infection in active duty members, military retirees, and other DoD beneficiaries. Military treatment facilities (MTFs) in the United States will participate in this protocol. Enrollment will be restricted to adults (≥18 years and older) who are preparing to receive seasonal influenza vaccination at participating DoD sites. Subjects will be randomized to receive one of the three licensed influenza vaccines types for evaluation of effectiveness. There is no exclusion for pregnancy, as none of these licensed products are contraindicated in pregnant women.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 4
Contactos e Locais
Locais de estudo
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California
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San Diego, California, Estados Unidos, 34800
- Naval Medical Center San Diego
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Maryland
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Annapolis, Maryland, Estados Unidos, 21402
- United States Naval Academy
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Bethesda, Maryland, Estados Unidos, 20814
- Walter Reed National Military Medical Center
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Bethesda, Maryland, Estados Unidos, 20307
- USU
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North Carolina
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Fort Bragg, North Carolina, Estados Unidos, 28310
- Womack Army Medical Center
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Texas
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Fort Sam Houston, Texas, Estados Unidos, 78234
- Brooke Army Medical Center
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San Antonio, Texas, Estados Unidos, 78243
- Lackland Airforce Base
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Virginia
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Portsmouth, Virginia, Estados Unidos, 23704
- Naval Medical Center Portsmouth
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Washington
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Tacoma, Washington, Estados Unidos, 98431
- Madigan Army Medical Center
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Eligible for care in Department of Defense medical facilities (Defense Enrollment Eligibility Reporting System eligible)
- ≥18 years of age.
- At a participating Military Treatment Facility site for the purpose of receiving a seasonal (2018-2019, 2019-2020,2020-2021, 2021-2022) influenza vaccination.
- Able to speak English and able to provide informed consent
- Able to receive and respond to texts and/or emails, or a military recruit
Exclusion Criteria:
- Adults intending to receive or who have received the current seasons FluMist Vaccine (LAIV)
- Adults who have already received a flu vaccine within the current season
- Individual who cannot receive a flu vaccine or standard dosing due to another medical condition
- Allergic to gentamicin, polymyxin and/or neomycin
- Individuals who fail to meet the inclusion criteria
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: Egg based influenza vaccines
Quadrivalent egg-based vaccines, which contain an inactivated form of the virus. Vaccines will be given to the participant in accordance with standard clinical practices for those in the US military. All egg-based vaccines are FDA licensed for use in the United States. |
Participants will be randomly allocated to one of three vaccine types in accordance with standard clinical practices for those in the US military. All vaccines are FDA licensed for use in the United States. |
|
Comparador Ativo: Recombinant influenza vaccines
FluBlok, recombinant HA influenza vaccine. Vaccines will be given to the participant in accordance with standard clinical practices for those in the US military. Flublok Quadrivalent is a quadrivalent recombinant influenza vaccine that has been licensed by the FDA for use in the United States. |
Participants will be randomly allocated to one of three vaccine types in accordance with standard clinical practices for those in the US military. All vaccines are FDA licensed for use in the United States. |
|
Comparador Ativo: Cell-culture based influenza vaccines
Flucelvax, Madin-Darby canine kidney (MDCK)-cell-culture based inactivated influenza vaccine. Vaccines will be given to the participant in accordance with standard clinical practices for those in the US military. Flucelvax quadrivalent, the only cell-based flu vaccine FDA licensed for use in the United States. |
Participants will be randomly allocated to one of three vaccine types in accordance with standard clinical practices for those in the US military. All vaccines are FDA licensed for use in the United States. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Number of Participants With Laboratory Confirmed Influenza
Prazo: Onset > 13 days after vaccination up to 1 year
|
Laboratory-confirmed influenza as ascertained by a sensitive and specific assay. |
Onset > 13 days after vaccination up to 1 year
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Hemagglutination Inhibition (HI) Titer Responses to Influenza Vaccine Strains.
Prazo: Baseline to 21-35 days post vaccine
|
Strain-specific seroconversion rate determined by reference hemagglutination inhibition assay. |
Baseline to 21-35 days post vaccine
|
|
Pseudovirion Neutralization (PVN) Responses to Influenza Vaccine.
Prazo: Baseline to 21-35 days post vaccine
|
Neutralizing antibody responses (4-fold rise) to HA-psuedoviruses corresponding to vaccine-matched viruses, recently circulating influenza virus, and emerging influenza strain. |
Baseline to 21-35 days post vaccine
|
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Anti-Neuraminidase (Anti-NA) Titer Responses to Influenza Vaccine.
Prazo: Baseline to 21-35 days post vaccine
|
Anti-Neuraminidase (Anti-NA) titer responses determined by enzyme linked immuno-assay. |
Baseline to 21-35 days post vaccine
|
|
Number of Participants With Influenza-Like Illness
Prazo: Onset > 13 days after vaccination up to 1 year
|
Rate of protocol defined influenza-like illness ascertained by participant response to active surveillance. |
Onset > 13 days after vaccination up to 1 year
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Number of Participants With SARS-CoV-2 and Influenza Co-Infection
Prazo: Onset > 13 days after influenza vaccination up until one year
|
Laboratory-confirmed SARS CoV2, and SARS CoV2 plus influenza co-infection, as ascertained by nasal swab PCR. |
Onset > 13 days after influenza vaccination up until one year
|
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Symptom Severity of SARS CoV2
Prazo: onset >13 days after Influenza vaccination up to 1 year
|
Symptom severity scores were reported by participants using FLU-PRO Plus (Influenza Patient Reported Outcomes), a standardized instrument developed to measure the intensity and frequency of viral respiratory tract symptoms. FluPRO Plus symptom scores range from 0 ("not at all") to 4 ("very much"), with higher scores indicating greater severity. |
onset >13 days after Influenza vaccination up to 1 year
|
Colaboradores e Investigadores
Colaboradores
Investigadores
- Investigador principal: Timothy Burgess, MD, Uniformed Services University of the Health Sciences
- Diretor de estudo: Rhonda Colombo, MD, Infectious Diseases Clinical Research Program
Publicações e links úteis
Publicações Gerais
- Sanchez JL, Cooper MJ, Myers CA, Cummings JF, Vest KG, Russell KL, Sanchez JL, Hiser MJ, Gaydos CA. Respiratory Infections in the U.S. Military: Recent Experience and Control. Clin Microbiol Rev. 2015 Jul;28(3):743-800. doi: 10.1128/CMR.00039-14.
- Flannery B, Chung JR, Belongia EA, McLean HQ, Gaglani M, Murthy K, Zimmerman RK, Nowalk MP, Jackson ML, Jackson LA, Monto AS, Martin ET, Foust A, Sessions W, Berman L, Barnes JR, Spencer S, Fry AM. Interim Estimates of 2017-18 Seasonal Influenza Vaccine Effectiveness - United States, February 2018. MMWR Morb Mortal Wkly Rep. 2018 Feb 16;67(6):180-185. doi: 10.15585/mmwr.mm6706a2.
- Zost SJ, Parkhouse K, Gumina ME, Kim K, Diaz Perez S, Wilson PC, Treanor JJ, Sant AJ, Cobey S, Hensley SE. Contemporary H3N2 influenza viruses have a glycosylation site that alters binding of antibodies elicited by egg-adapted vaccine strains. Proc Natl Acad Sci U S A. 2017 Nov 21;114(47):12578-12583. doi: 10.1073/pnas.1712377114. Epub 2017 Nov 6.
- Wu NC, Zost SJ, Thompson AJ, Oyen D, Nycholat CM, McBride R, Paulson JC, Hensley SE, Wilson IA. A structural explanation for the low effectiveness of the seasonal influenza H3N2 vaccine. PLoS Pathog. 2017 Oct 23;13(10):e1006682. doi: 10.1371/journal.ppat.1006682. eCollection 2017 Oct.
- Skowronski DM, Janjua NZ, De Serres G, Sabaiduc S, Eshaghi A, Dickinson JA, Fonseca K, Winter AL, Gubbay JB, Krajden M, Petric M, Charest H, Bastien N, Kwindt TL, Mahmud SM, Van Caeseele P, Li Y. Low 2012-13 influenza vaccine effectiveness associated with mutation in the egg-adapted H3N2 vaccine strain not antigenic drift in circulating viruses. PLoS One. 2014 Mar 25;9(3):e92153. doi: 10.1371/journal.pone.0092153. eCollection 2014.
- Cobey S, Gouma S, Parkhouse K, Chambers BS, Ertl HC, Schmader KE, Halpin RA, Lin X, Stockwell TB, Das SR, Landon E, Tesic V, Youngster I, Pinsky BA, Wentworth DE, Hensley SE, Grad YH. Poor Immunogenicity, Not Vaccine Strain Egg Adaptation, May Explain the Low H3N2 Influenza Vaccine Effectiveness in 2012-2013. Clin Infect Dis. 2018 Jul 18;67(3):327-333. doi: 10.1093/cid/ciy097.
- Wang W, Butler EN, Veguilla V, Vassell R, Thomas JT, Moos M Jr, Ye Z, Hancock K, Weiss CD. Establishment of retroviral pseudotypes with influenza hemagglutinins from H1, H3, and H5 subtypes for sensitive and specific detection of neutralizing antibodies. J Virol Methods. 2008 Nov;153(2):111-9. doi: 10.1016/j.jviromet.2008.07.015. Epub 2008 Sep 4.
- Wang W, Xie H, Ye Z, Vassell R, Weiss CD. Characterization of lentiviral pseudotypes with influenza H5N1 hemagglutinin and their performance in neutralization assays. J Virol Methods. 2010 May;165(2):305-10. doi: 10.1016/j.jviromet.2010.02.009. Epub 2010 Feb 11.
- Colombo RE, Richard SA, Schmidt K, Schofield C, Ganesan A, Campbell W, Hrncir D, Lalani T, Mende K, Markelz AE, Berjohn CM, Housel L, Becher D, Zell ER, Ewing D, Sundaram AK, Modi JR, Saperstein A, Tilley DH Jr, Williams A, McClenathan B, Collins L, Spooner C, Seshadri S, Fries A, Maves RC, Powers Iii JH, O'Connell RJ, Pollett SD, Simons MP, Coles CL, Burgess TH; PAIVED Study Group. Randomized Pragmatic Trial of the Comparative Effectiveness of Chicken Egg-Based Inactivated, Mammalian Cell Culture-Based Inactivated, and Recombinant Protein Quadrivalent Seasonal Influenza Vaccines in United States Military Health System Beneficiaries. Clin Infect Dis. 2025 Dec 24;81(5):e454-e463. doi: 10.1093/cid/ciaf503.
- Kautz M, Schmidt K, Richard SA, Colombo RE, Epsi NJ, Ganesan A, Maves RC, Mende K, Schofield C, Montgomery JR, Pollett S, Larson DT, Fries AC, Burgess TH, Lalani T. Participant self-collected versus research coordinator-collected nasal swabs for respiratory viral surveillance following influenza-like illness. Front Public Health. 2026 Aug 19;14:1846269. doi: 10.3389/fpubh.2026.1846269. eCollection 2026.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- IDCRP-120
- AAI1201200007000 (Número de outro subsídio/financiamento: NIAID)
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