NCT03163342

Immune Response Following Seasonal Influenza Vaccination

Completed Phase 4 Results posted Last updated 26 April 2019

What this trial tests

Phase 4 trial testing Licensed seasonal influenza vaccine in Influenza in 20 participants. Completed in 15 June 2018.

Timeline

8 May 2017

Primary endpoint
21 November 2017

15 June 2018

Quick facts

Lead sponsor	Altimmune, Inc.
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	20
Start date	8 May 2017
Primary completion	21 November 2017
Estimated completion	15 June 2018
Sites	1 location across United States

Drugs / interventions tested

• Licensed seasonal influenza vaccine — full drug profile →

Conditions studied

• Influenza — all drugs for Influenza →

Sponsor

Altimmune, Inc. — full company profile →

Who can join

Adults 18 to 50, any sex, with Influenza. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

HAI Antibody Immune Response to Matched Influenza Strain H1N1 A/California/04/2009 Strain Primary · Day 29 after vaccine

To evaluate antibody response against matched influenza strain H1N1 A/California/04/2009 strain as measured by hemagglutination inhibition (HAI) following administration of a seasonal influenza vaccine.

Group	Value	95% CI
FluZone	293.4	186.7 – 461.3

Antibody Response to Divergent Influenza Strains Secondary · Day 29 after vaccine

l) antibody responses to divergent influenza strains as measured by hemagglutination inhibition (HAI) following administration of a seasonal influenza vaccine

A/Brisbane/59/2007 (H1 strain)

Group	Value	95% CI
FluZone	12.3	6.9 – 21.8

A/New Jersey/76 (H1 strain)

Group	Value	95% CI
FluZone	37.3	22.5 – 61.9

A/Saint-Petersburg/61/2015 (H1 strain)

Group	Value	95% CI
FluZone	40.7	21.8 – 76.1

A/Vietnam/1203/2004XPR8 (H5 strain)

Group	Value	95% CI
FluZone	9.3	6.0 – 14.6

Cellular Immune Response Secondary · Day 8 after vaccine

To evaluate cellular immune responses to influenza as measured by PBMC ELISpot following administration of seasonal influenza vaccine

Group	Value	95% CI
FluZone	37.1	14.3 – 96.2

Mucosal Influenza Antibody Response Secondary · Day 29 after vaccine

To evaluate mucosal influenza antibody responses as measured by IgA ELISA following administration of seasonal influenza vaccine

Group	Value	95% CI
FluZone	1.8	1.2 – 2.7

Sponsor's own description

This is an open-label, single administration dose study in adult healthy male and female subjects. After qualifying for the study, subjects will receive a single intramuscular injection of the FDA approved 2016-2017 quadrivalent influenza vaccine.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Safety and Immunogenicity of a Novel Intranasal Influenza Vaccine (NasoVAX): A Phase 2 Randomized, Controlled Trial.
   Tasker S, Wight O'Rourke A, Suyundikov A, Jackson Booth PG, et al · · 2021 · cited 19× · PMID 33807649 · DOI 10.3390/vaccines9030224