Evaluation of the Effects of Age, Prior Exposure, and Previous Vaccination on the B Cell Response to Inactivated Influenza Vaccine in Healthy Adults and Children
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Influenza
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Enrollment
- 152
- Locations
- 2
- Primary Endpoint
- Magnitude of the Serum Antibody Response by Hemagglutination-inhibition (HAI)
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
The study will be designed as a prospective surveillance of the immune response to seasonal influenza vaccination in 240 healthy children and adults ages 9 and over. Study duration will be 5 years, with a participant duration of 6 months. Subjects will receive a quadrivalent inactivated influenza vaccine, at a dose of not less than 15 ug of hemagglutinin (HA), by intramuscular injection in open label fashion on day 0. Blood draws will occur at baseline, day 7, 28 and 90. The primary objective of this study is to evaluate the relationship between first influenza A virus exposure (inferred by age), vaccine history, and baseline serum antibody response to seasonal influenza vaccine in healthy adults and children.
Detailed Description
The study will be designed as a prospective surveillance of the immune response to seasonal influenza vaccination in 240 healthy children and adults ages 9 and over. Study duration will be 5 years, with a participant duration of 6 months. Subjects will receive a quadrivalent inactivated influenza vaccine, at a dose of not less than 15 ug of hemagglutinin (HA), by intramuscular injection in open label fashion on day 0. Blood draws will occur at baseline, day 7, 28 and 90. The primary hypothesis being tested in this study is that there will be differences in the specificity and magnitude of the HA-specific B cell response depending on the age, previous vaccine history and baseline B cell reactivity. The primary objective of this study is to evaluate the relationship between first influenza A virus exposure (inferred by age), vaccine history, and baseline serum antibody response to seasonal influenza vaccine in healthy adults and children. The secondary objective is to evaluate factors related to failure of vaccine to provide protection against symptomatic influenza and the immune response to infection in vaccinated individuals by prospective surveillance of the vaccine cohort.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Aged equal to or greater than 9 years of age and weigh at least 50 pounds
- •The subject must be in good health, as determined by: medical history; and targeted physical examination, when necessary, based on medical history. Stable medical or psychiatric condition is defined as: no recent increase in prescription medication, dose, or frequency of medication in the last 3 months and health outcomes of the specific disease are considered to be within acceptable limits in the last 6 months
- •The subject is able to understand and comply with the planned study procedures, including being available for all study visits
- •The subject/parent has provided informed consent/assent prior to any study procedures
- •Subjects who have not received seasonal flu vaccine for the current year
Exclusion Criteria
- •Subject report of known hypersensitivity to allergy to components of the study vaccine or other components of the study vaccine
- •Subject report of known latex allergy
- •Subject report of a history of severe reactions following previous immunization with licensed or unlicensed influenza virus vaccines
- •Subject report of a history of Guillain-Barre syndrome within 6 weeks of receipt of a previous influenza vaccine
- •The subject is a female of childbearing potential who is currently pregnant or breastfeeding or intends to become pregnant during the study period between enrollment and 90 days following receipt of vaccine. Pregnancy will be determined by subject interview. Pregnancy testing is not done in this study since there is no increased risk in pregnancy
- •The subject is immunosuppressed as a result of an underlying illness or treatment with immunosuppressive or cytotoxic drugs, or use of anticancer chemotherapy or radiation therapy within the preceding 36 months
- •The subject has an active neoplastic disease (excluding non-melanoma skin cancer or prostate cancer that is stable in the absence of therapy) or a history of any hematological malignancy. For this criterion, "active" is defined as having received treatment within the past 5 years
- •Have taken high-dose inhaled corticosteroids within 30 days prior to study vaccination. High-dose defined as per age as using inhaled high dose per reference chart https://www.nhlbi.nih.gov/health-pro/guidelines/current/asthma-guidelines/quick-reference-html#estimated-comparative-daily-doses
- •The subject received immunoglobulin or another blood product within the 3 months prior to enrollment in this study
- •The subject has received an inactivated vaccine within the 2 weeks or a live vaccine within the 4 weeks prior to enrollment in this study or plans to receive another vaccine within the next 28 days after vaccination
Outcomes
Primary Outcomes
Magnitude of the Serum Antibody Response by Hemagglutination-inhibition (HAI)
Time Frame: Through Day 28
A/Hong Kong/4801/2014 (H3N2) day 28 Season 2017-2018
Magnitude of the Serum Antibody Response by Microneutralization (MN)
Time Frame: Day 28
A/Hong Kong/4801/2014 (H3N2) Day 28 MN Season 2017-2018
Serum Antibody Response by Hemagglutination-inhibition (HAI)
Time Frame: Day 90
A/Hong Kong/4801/2014 (H3N2) Day 90 Season 2017-2018
Serum Antibody Response by Microneutralization (MN)
Time Frame: Day 90
A/Hong Kong/4801/2014 (H3N2) Day 90 MN Season 2017-2018
Specificity of the Serum Antibody Response by Hemagglutination-inhibition (HAI)
Time Frame: Day 28
A/H1N1/Michigan/45/2015 pdm09 Day 28 Season 2017-2018
Specificity of the Serum Antibody Response by Microneutralization (MN)
Time Frame: Day 28
A/H1N1/Michigan/45/2015 pdm09 Day 28 Season 2017-18
Secondary Outcomes
- Age at Time of First Influenza A Exposure(Baseline)
- Baseline B Cell Reactivity(Baseline)
- Vaccine History (Number and Percentage of Participants to Receive Vaccine)(Baseline)