A Study of Intranasal Live Attenuated Influenza Vaccine Immunogenicity and Associations With the Nasopharyngeal Microbiome Among Children in the Gambia

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02972957
• Date of registration: 17/11/2016
• Prospective Registration: Yes
• Primary sponsor: London School of Hygiene and Tropical Medicine
• Public title: A Study of Intranasal Live Attenuated Influenza Vaccine Immunogenicity and Associations With the Nasopharyngeal Microbiome Among Children in the Gambia NASIMMUNE
• Scientific title: A Study of Intranasal Live Attenuated Influenza Vaccine Immunogenicity and Associations With the Nasopharyngeal Microbiome Among Children in the Gambia - The NASIMMUNE Study
• Date of first enrolment: January 30, 2017
• Target sample size: 364
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02972957
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Single (Outcomes Assessor).
• Phase: Phase 4

Countries of recruitment

Gambia

Key inclusion & exclusion criteria

Inclusion Criteria:

- • Healthy male or female child at least 24 months of age and less than 60 months of
age at the time of study entry.

- Resident in the study area and with no plans to travel outside the study area
during the period of subject participation.

- Informed consent for the study participation obtained from a parent (or guardian
only if neither parent is alive or if guardianship has been legally transferred
(see section 11.2).

- Willingness and capacity to comply with the study protocol as judged by a member
of the clinical trial team.

Exclusion Criteria:

- • Serious, active, medical condition, including but not limited to:

- chronic disease of any body system

- severe protein-energy malnutrition (weight-for-height Z-score of less than -3)

- known genetic disorders, such as Down's syndrome or other cytogenetic disorder

- Active wheezing

- History of documented hypersensitivity to eggs or other components of the
vaccine (including gelatin, sorbitol, lactalbumin and chicken protein), or
with life-threatening reactions to previous influenza vaccinations.

- History of documented hypersensitivity to macrolide antibiotics

- History of Guillain-Barré syndrome.

- Receipt of aspirin therapy or aspirin-containing therapy within the two
weeks before planned study vaccination.

- Any suspected or confirmed congenital or acquired state of immune deficiency
including but not limited to primary immunodeficiencies including thymus
disorders, HIV/AIDS, hematological or lymphoid malignancies (blood tests
will not be routinely undertaken with this regard as part of the study).

- Any current immunosuppressive/immunomodulatory treatment or receipt of any
such treatment within the six months preceding trial enrolment (for
corticosteroids this is defined as a dose of prednisolone (or equivalent) of
greater than 2mg/kg/day for one week or 1mg/kg/day for one month. The use of
topical corticosteroids is not an exclusion criterion.

- The use of inhaled corticosteroids within the last one month.

- Receipt of an influenza vaccine within the past 12 months.

- Has any condition determined by investigator as likely to interfere with
evaluation of the vaccine or be a significant potential health risk to the
child or make it unlikely that the child would complete the study.

- Any significant signs or symptoms of an acute illness or infection
including:

- an axillary temperature of 38.0°C or above or documented fever of 38°C or above
in the preceding 14 days.

- Any acute respiratory infection within 14 days of enrollment visit. If the reason
for ineligibility is likely to be temporary (e.g. a fever of 38°C or above or
acute respiratory infection) and either will or may resolve before the infant
reaches 60 months, they will not be recorded as a screening failure but instead
will be re-screened within an appropriate future time-window (e.g. at least 14
days after the last documented fever of 38°C or above or resolution of
respiratory illness) and a decision made regarding eligibility at that point.



Age minimum: 24 Months
Age maximum: 59 Months
Gender: All

Health Condition(s) or Problem(s) studied

Influenza

Intervention(s)

Biological: Nasovac-S

Drug: Azithromycin

Primary Outcome(s)

fold increase in oral fluid influenza-specific/total IgG ratio [Time Frame: Day 0 - Day 21]

nasal IgA response [Time Frame: 21 days post LAIV]

fold increase in oral fluid influenza-specific/total IgA ratio [Time Frame: day 0 - Day 21]

Secondary Outcome(s)

Changes in the relative abundance of different operational taxanomic units (OTUs) of nasopharyngeal microbiota [Time Frame: day 7 and day 21 compared to day 0 in each participant]

gene expression changes in nasal and systemic samples [Time Frame: 2 days after LAIV]

density of S. Pneumoniae [Time Frame: day 7 and day 21 after LAIV compared to day 0]

Secondary ID(s)

SCC 1502

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Edinburgh

National Institute for Public Health and the Environment (RIVM)

Public Health England

University of Oxford