Influenza Clinical Trial
Official title:
Evaluation of the Safety and Cellular and Humoral Immune Response to Primary and Secondary Immunization With Subvirion H5N1 Vaccines Representing Different Clades
The purpose of the study is to evaluate safety and compare how the body reacts to 2 different strengths of the Clade (specific type of H5N1 virus) 2 H5N1 flu vaccine when given as a single vaccination with a high dose (90 mcg) or low dose (15 mcg) to volunteers who have received at least 2 doses of the Clade 1 H5N1 vaccine, in a previous National Institute of Health study or who have never received a H5N1 vaccine (naïve). Previously vaccinated subjects (in studies 04-0063, 05-0090, 05-0127) will receive either 15 or 90 mcg of H5N1 vaccine. Multiply boosted volunteers who participated study 05-0043 and received Clade 1 and 3 vaccines, will receive the same dose (15mcg). Vaccine naïve subjects will receive 2 doses of vaccine (15 or 90 mcg) separated by 28 days. Blood samples will be collected. 115 volunteers age 18-64 may participate in study related procedures for approximately 7 months.
In response to the steadily increasing number of reports of human infection with avian influenza A (H5N1) viruses, there is now a world-wide effort to develop and test potential candidate vaccines for this and other avian viruses with pandemic potential. The study will be conducted as a laboratory blinded assessment of the humoral and cellular immune response to A/Indonesia/5/05 vaccine in three populations: healthy adults who have previously received a clade 1 H5 vaccine in a Division of Microbiology and Infectious Diseases (DMID)-sponsored study; healthy adult recipients of prime-boost regimens representing two clades; and healthy adults with no previous H5 vaccination and who are not at risk for H5 exposures. Primed subjects are randomized to receive a single dose of either 15 mcg or 90 mcg of A/Indonesia/5/05 vaccine. Multiply boosted subjects are those who participated in study 05-0043, and have previously received both A/HK/97 (Clade 3) and A/VN/04 (Clade 1) vaccines. Because only a small number of such subjects are available, they will not be randomized but will all receive the same dose of vaccine. Unprimed subjects are randomized to receive 2 doses of 15 mcg or 90 mcg of A/Indonesia/5/05 vaccine separated by 28 days. In all groups, sera and peripheral blood mononuclear cells (PBMC) are obtained prior to and on days 3, 7, 14, and 28 after each dose. Primed and multiply boosted subjects also have sera and PBMC obtained on day 56. All groups will make a final study visit at 6 months following the last dose of vaccine (day 180 for primed and boosted subjects and day 208 for unprimed subjects). Approximately 115 subjects between the ages of 18 and 64 will participate in this study. The primary objective is to determine the safety of administration of the A/Indonesia/05 subvirion vaccine when administered to healthy, primed or unprimed adults. The secondary objective is to: determine the effects of priming with a clade 1 vaccine on antibody responses to revaccination with a clade 2 vaccine. The tertiary objectives are to determine the effects of priming on the repertoire and phenotypes of B and T cells generated in response to vaccination; to evaluate whether pre-existing immunity to seasonal influenza viruses impacts the specificity and magnitude of the cluster of differentiation marker (CD)4 T cell response to H5 vaccination and to describe the kinetics of the cellualr immune response to subvirion H5N1 vaccinatin in primed and unprimed individuals. The primary endpoint is reactogenicity, adverse event (AE) and serious adverse event (SAE) information, solicited in-clinic and via memory aids. The secondary endpoints are: levels of HAI antibody recognizing A/Indonesia/05 (Clade 2), A/Vietnam/04 (Clade 1) and representative Clade 2 subclade viruses, and levels of neutralizing antibody assessed by neutralization tests using the rgA/Indonesia/5/05 virus prior to and Days 3, 7, 14, and 28 after each vaccination. This study is linked to DMID protocols 04-063, 05-0090, 05-0043 and 05-0127. ;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05523089 -
The Effectiveness of CD388 to Prevent Flu in an Influenza Challenge Model in Healthy Adults
|
Phase 2 | |
Completed |
NCT05009251 -
Using Explainable AI Risk Predictions to Nudge Influenza Vaccine Uptake
|
N/A | |
Completed |
NCT03282240 -
Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Participants ≥65 Years in the US
|
Phase 3 | |
Completed |
NCT00971425 -
Evaluation of the Immune Response and the Safety of a Pandemic Influenza Candidate Vaccine (H1N1)
|
Phase 3 | |
Completed |
NCT00968526 -
Study to Evaluate Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) in Adults
|
Phase 3 | |
Completed |
NCT00968539 -
Study to Evaluate the Immunogenicity & Safety of an Investigational Influenza Vaccine (H1N1) in Adults
|
Phase 3 | |
Completed |
NCT05525494 -
Patient Portal Flu Vaccine Reminders (5)
|
N/A | |
Completed |
NCT04074928 -
Safety and Immunogenicity Study of QIVc in Healthy Pediatric Subjects
|
Phase 3 | |
Completed |
NCT04695717 -
This Study Was Conducted to Evaluate the Safety and Immunogenicity of IVACFLU-S Produced in Children From 6 Months to Under 18 Years Old and the Elderly Over 60 Years Old in Vietnam
|
Phase 3 | |
Completed |
NCT05012163 -
Lottery Incentive Nudges to Increase Influenza Vaccinations
|
N/A | |
Completed |
NCT03888989 -
Response to Influenza Vaccine During Pregnancy
|
Phase 1 | |
Completed |
NCT04109222 -
Collection of Serum Samples From Children and Older Adults Receiving the 2019-2020 Formulations of Fluzone® Quadrivalent and Fluzone® High-Dose Influenza Vaccines, Respectively
|
Phase 4 | |
Completed |
NCT02587221 -
Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an MF59-Adjuvanted Quadrivalent Influenza Vaccine Compared to Non-influenza Vaccine Comparator in Adults ≥ 65 Years of Age
|
Phase 3 | |
Completed |
NCT03453801 -
The Role of CD4+ Memory Phenotype, Memory, and Effector T Cells in Vaccination and Infection
|
Phase 1 | |
Completed |
NCT01440387 -
A Study of Immunogenicity and Safety of GSK Biologicals' Influenza Vaccine FLU-Q-QIV in Adults Aged 18 Years and Older
|
Phase 3 | |
Terminated |
NCT01195779 -
Trial to Evaluate Safety and Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2584786A in Healthy Children
|
Phase 2 | |
Completed |
NCT03321968 -
Lot-to-lot Consistency of a Plant-Derived Quadrivalent Virus-Like Particles Influenza Vaccine in Healthy Adults
|
Phase 3 | |
Completed |
NCT00972517 -
Study to Evaluate the Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) in Children
|
Phase 3 | |
Completed |
NCT04570904 -
Broadening Our Understanding of Early Versus Late Influenza Vaccine Effectiveness
|
||
Recruiting |
NCT03331991 -
Prevention of Influenza and Other Wintertime Respiratory Viruses Among Healthcare Professionals in Israel
|
N/A |