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Immune Responses Induced by Different Licensed Influenza Vaccines

Immune Response Induced by Different Manufacturers of Influenza Vaccines

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00902278
Enrollment
193
Registered
2009-05-15
Start date
2008-10-31
Completion date
2016-04-30
Last updated
2017-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immune Response

Keywords

influenzavirus A, influenzavirus B, human influenza, T lymphocytes, influenza vaccines

Brief summary

The goal of this research is to find out how the body's immune system responds to different manufacturer's flu vaccines.

Detailed description

There are currently five licensed inactivated influenza vaccines approved for use in the United States by the Food and Drug Administration.Current influenza virus vaccines consist of 3 components: the HA protein from an H1N1 virus, an H3N2 and an influenza B virus.Influenza vaccines are evaluated and approved by the FDA on the basis of HA and NA content. However, different manufacturing processes are involved in the preparation of these commercial vaccines and evidence suggests that each of these vaccines contain similar patterns of HA protein but different patterns of influenza influenza internal proteins such as NP and M1. The presence of these additional internal proteins of influenza virus which are targets of T cell responses suggest not only the potential for additional protection derived from influenza vaccines other than antibody mediated protection but also differential levels of T cell mediated protection between different manufacturers of commercial influenza vaccines.Each subject will have four blood samples taken- prevaccination and at Days 7, 14,30 and 3-5 months post vaccination. These samples will be tested for T and B cell responses and the results compared between different manufacturers.

Interventions

BIOLOGICALFlulaval

one 0.5-mL dose via intramuscular injection

BIOLOGICALFluvirin

one 0.5-mL dose via intramuscular injection

BIOLOGICALFluzone

one 0.5-mL dose via intramuscular injection

BIOLOGICALFluarix

one 0.5-mL dose via intramuscular injection

BIOLOGICALAfluria

one 0.5-mL dose via intramuscular injection

Sponsors

University of Massachusetts, Worcester
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Adults (18-50 years of age) * Willing to donate a blood sample multiple times * Willing to sign informed consent and HIPAA

Exclusion criteria

* Known systemic hypersensitivity reactions to egg proteins (eggs or egg products), to chicken proteins * Known hypersensitivity to neomycin, thimerosol (mercury derivative), neomycin, or polymyxin * Previous life threatening reaction to influenza vaccine * Individuals with altered immunocompetence state from medical condition ( HIV, cancer) or through immunosuppressive therapy(irradiation,corticosteroids, antimetabolites, alkylating agents, cytotoxic agents) * Occurrence of neurological syndrome within six weeks of previous influenza immunization * Active neurological disorder characterized by changing neurological disorder * Pregnancy * Acute febrile illness * History of anemia or bleeding disorders

Design outcomes

Primary

MeasureTime frameDescription
T Cell Responses Following ImmunizationPrevaccination and approximately 7 days,14 days ,1month and up to 3-5 months post vaccinationComparison of mean peak fold increases in ELISPOT H1N1, H3N2, and B responses between different vaccine groups

Secondary

MeasureTime frameDescription
Antibody Responses Following ImmunizationPrevaccination and approximately 1 month post vaccinationGeometric mean fold rise in antibody titer between day 0 ( baseline) and approximately 1 month post vaccination within each vaccine group

Countries

United States

Participant flow

Recruitment details

We recruited healthy adults subjects during the 2008-2009, 2009-2010, 2010-2011, and 2011-2012 influenza seasons in a clinical research setting.

Participants by arm

ArmCount
Flulaval
Flulaval: one 0.5-mL dose via intramuscular injection
54
Fluvirin
Fluvirin: one 0.5-mL dose via intramuscular injection
36
Fluzone
Fluzone: one 0.5-mL dose via intramuscular injection
54
Fluarix
Fluarix: one 0.5-mL dose via intramuscular injection
12
Afluria
Afluria: one 0.5-mL dose via intramuscular injection
37
Total193

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003FG004
Overall StudyLost to Follow-up32301
Overall StudyPhysician Decision10201

Baseline characteristics

CharacteristicFlulavalFluvirinFluzoneFluarixAfluriaTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
54 Participants36 Participants54 Participants12 Participants37 Participants193 Participants
Region of Enrollment
United States
54 participants36 participants54 participants12 participants37 participants193 participants
Sex: Female, Male
Female
41 Participants32 Participants37 Participants6 Participants25 Participants141 Participants
Sex: Female, Male
Male
13 Participants4 Participants17 Participants6 Participants12 Participants52 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
deaths
Total, all-cause mortality
0 / 520 / 340 / 530 / 110 / 36
other
Total, other adverse events
30 / 5224 / 3432 / 536 / 1125 / 36
serious
Total, serious adverse events
0 / 520 / 340 / 530 / 110 / 36

Outcome results

Primary

T Cell Responses Following Immunization

Comparison of mean peak fold increases in ELISPOT H1N1, H3N2, and B responses between different vaccine groups

Time frame: Prevaccination and approximately 7 days,14 days ,1month and up to 3-5 months post vaccination

Population: Data was collected only for participants from the 2008-2009 influenza season. Data was not collected for Flulaval group.Only participants with evaluable data were included in the analysis.

ArmMeasureGroupValue (MEAN)Dispersion
FluvirinT Cell Responses Following ImmunizationH1N1 virus1.5 fold changeStandard Deviation 0.55
FluvirinT Cell Responses Following ImmunizationB virus1.5 fold changeStandard Deviation 0.61
FluvirinT Cell Responses Following ImmunizationH3N2 virus2.4 fold changeStandard Deviation 1.28
FluzoneT Cell Responses Following ImmunizationH1N1 virus1.7 fold changeStandard Deviation 0.84
FluzoneT Cell Responses Following ImmunizationB virus1.6 fold changeStandard Deviation 0.59
FluzoneT Cell Responses Following ImmunizationH3N2 virus2.1 fold changeStandard Deviation 1.34
FluarixT Cell Responses Following ImmunizationH3N2 virus2.7 fold changeStandard Deviation 1.23
FluarixT Cell Responses Following ImmunizationH1N1 virus1.9 fold changeStandard Deviation 0.56
FluarixT Cell Responses Following ImmunizationB virus1.6 fold changeStandard Deviation 0.59
AfluriaT Cell Responses Following ImmunizationH1N1 virus1.6 fold changeStandard Deviation 0.71
AfluriaT Cell Responses Following ImmunizationB virus1.4 fold changeStandard Deviation 0.61
AfluriaT Cell Responses Following ImmunizationH3N2 virus1.7 fold changeStandard Deviation 0.6
Secondary

Antibody Responses Following Immunization

Geometric mean fold rise in antibody titer between day 0 ( baseline) and approximately 1 month post vaccination within each vaccine group

Time frame: Prevaccination and approximately 1 month post vaccination

Population: Data was collected only for participants from the 2008-2009 influenza season. Data was not collected for the flulaval group. Only participants with evaluable data were included in this analysis.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
FluvirinAntibody Responses Following ImmunizationB3.4 fold change
FluvirinAntibody Responses Following ImmunizationH3N27.6 fold change
FluvirinAntibody Responses Following ImmunizationH1N17.32 fold change
FluzoneAntibody Responses Following ImmunizationB9.3 fold change
FluzoneAntibody Responses Following ImmunizationH1N17.02 fold change
FluzoneAntibody Responses Following ImmunizationH3N27.2 fold change
FluarixAntibody Responses Following ImmunizationH1N15.71 fold change
FluarixAntibody Responses Following ImmunizationB9.6 fold change
FluarixAntibody Responses Following ImmunizationH3N24.9 fold change
AfluriaAntibody Responses Following ImmunizationH3N25.6 fold change
AfluriaAntibody Responses Following ImmunizationB4.0 fold change
AfluriaAntibody Responses Following ImmunizationH1N15.26 fold change

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026