Trial Outcomes & Findings for Nasal and Systemic Immune Responses to Nasal Influenza Vaccine (NCT NCT04110366)

Results Overview

Vaccine virus shedding in nasosorption samples collected between 1-7 days post-vaccination and quantified using multiplex qPCR assay measures in the LAIV vaccine recipient cohort.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

48 participants

Primary outcome timeframe

1-7 days post vaccination

Results posted on

2021-12-06

Participant Flow

No significant events occur after participant enrollment but prior to assignment to a study arm. Participants were not randomised for assignment to LAIV or Mucosal immune stability arms, but were assigned based on their having responded to different enrollment advertisements.

Participant milestones

Participant milestones
Measure	Live Attenuated Influenza Vaccine Participants receiving live attenuated influenza vaccine (LAIV) were initially screened per the study protocol to ensure that inclusion and exclusion criteria were complete. Participants were then invited to the vaccination arm of the study, where n=40 participants received LAIV and completed 5 study visits each over the course of 28 days.	Mucosal Immune Stability Cohort Vehicle control nasal challenge recipients n=8
Overall Study STARTED	40	8
Overall Study COMPLETED	40	8
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Nasal and Systemic Immune Responses to Nasal Influenza Vaccine

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Live Attenuated Influenza Vaccine n=40 Participants Participants receiving live attenuated influenza vaccine (LAIV) were initially screened per the study protocol to ensure that inclusion and exclusion criteria were complete. Participants were then invited to the vaccination arm of the study, where n=40 participants received LAIV and completed 5 study visits each over the course of 28 days.	Mucosal Immune Stability Cohort n=8 Participants In the placebo/vehicle challenge 'Mucosal immune stability' arm, a further n=8 participants attended for a single visit at which repeat nasal samples were collected to match the LAIV arm.	Total n=48 Participants Total of all reporting groups
Age, Continuous	22 years n=5 Participants	23 years n=7 Participants	22 years n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	5 Participants n=7 Participants	35 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	3 Participants n=7 Participants	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	40 Participants n=5 Participants	8 Participants n=7 Participants	48 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1-7 days post vaccination

Population: All participants

Vaccine virus shedding in nasosorption samples collected between 1-7 days post-vaccination and quantified using multiplex qPCR assay measures in the LAIV vaccine recipient cohort.

Outcome measures

Outcome measures
Measure	Live Attenuated Influenza Vaccine n=40 Participants Participants receiving live attenuated influenza vaccine (LAIV) were initially screened per the study protocol to ensure that inclusion and exclusion criteria were complete. Participants were then invited to the vaccination arm of the study, where n=40 participants received LAIV and completed 5 study visits each over the course of 28 days. n=31 participants (78%) shed at least one vaccine virus, measured by qPCR, on at least one study timepoint.	Mucosal Immune Stability Cohort Stability of cytokine levels measured in nasosorption samples collected from participants for the 8 hour duration of this arm. Cytokines measured by multiplex immunoassays.
Number of Participants Shedding Each Vaccine Virus Measured by qPCR of Nasosorption Samples	31 participants	—

SECONDARY outcome

Timeframe: 28 days post vaccination

Vaccine specific antibody (IgG and IgA) titres in serum and/or respiratory secretions (nasosorption and nasal wash) measured using endpoint titre and arbitrary unit level immunoassay measurements of samples collected from the n=40 LAIV vaccine recipient arm.

Outcome measures

Outcome measures
Measure	Live Attenuated Influenza Vaccine n=40 Participants Participants receiving live attenuated influenza vaccine (LAIV) were initially screened per the study protocol to ensure that inclusion and exclusion criteria were complete. Participants were then invited to the vaccination arm of the study, where n=40 participants received LAIV and completed 5 study visits each over the course of 28 days. n=31 participants (78%) shed at least one vaccine virus, measured by qPCR, on at least one study timepoint.	Mucosal Immune Stability Cohort Stability of cytokine levels measured in nasosorption samples collected from participants for the 8 hour duration of this arm. Cytokines measured by multiplex immunoassays.
Number of Participants With >2-fold Rise in Mucosal and/or Serum Antibody Titre Against Each Vaccine Virus Haemagglutinin Antigens	28 Participants	—

Adverse Events

Live Attenuated Influenza Vaccine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Mucosal Immune Stability Cohort

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Ryan Thwaites

Imperial College London

Phone: (0044) 0203 3125730

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place