RSV-F Vaccine and Influenza Vaccine Co-Administration Study in the Elderly
A Phase I Randomized, Observer-Blinded, Dose-Ranging Study to Evaluate the Immunogenicity and Safety of an RSV-F Protein Nanoparticle Vaccine, With or Without Aluminum Adjuvant, and Co-administered With a Licensed Inactivated Influenza Vaccine, in Healthy Subjects ≥ 60 Years of Age.
1 other identifier
interventional
220
1 country
4
Brief Summary
Up to 220 eligible subjects will be enrolled into one of five treatment groups. It is anticipated that some of the randomized study subjects may not complete the study; subjects who withdraw or are discontinued, will not be replaced. Randomization will be stratified by age (60 to \<75 years and ≥ 75 years) in order to distribute the proportion of such persons in each age group equally across treatment groups. Treatments will comprise a single IM dose of a placebo or RSV-F protein nanoparticle vaccine on Day 0, with concurrent IM immunization with a licensed inactivated influenza vaccine. A rescue dose of the licensed TIV will be provided to subjects in all groups except the placebo group on Day 28, the placebo group will receive saline. For each subject, study follow-up will span approximately one year from the first immunization (on Day 0) for all subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Oct 2012
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 15, 2012
CompletedFirst Posted
Study publicly available on registry
October 17, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2014
CompletedMarch 5, 2014
March 1, 2014
9 months
October 15, 2012
March 4, 2014
Conditions
Outcome Measures
Primary Outcomes (2)
Assessment of Safety
Number (and percentage) of subjects with solicited local and systemic Adverse Events over the seven days post injection; all adverse events, solicited and unsolicited over 56 days post-first injection. Significant New Medical Conditions, Medically Attended Events and Serious Adverse Events will be collected for one year.
Day 0 to Day 364
Immunogenicity as assessed by serum IgG antibody titers for the F-Protein antigen
Immunogenicity will be measured using derived / calculated endpoints based on: * Geometric mean titer (GMT) * Geometric mean ratio (GMR) * Seroconversion rate (SCR) * Seroresponse rate (SRR)
Day 0 to Day 364
Secondary Outcomes (1)
Immunogenicity as assessed by serum HAI titers specific for the influenza antigens contained in the seasonal vaccine.
Day 0 to Day 56
Study Arms (5)
Group A
EXPERIMENTALLow dose RSV-F Vaccine with Adjuvant (Day 0); Seasonal TIV (Day 0 \& Day 28)
Group B
EXPERIMENTALLow dose RSV-F Vaccine without Adjuvant (Day 0); Seasonal TIV (Day 0 \& Day 28)
Group C
EXPERIMENTALHigh dose RSV-F Vaccine with Adjuvant (Day 0); Seasonal TIV (Day 0 \& Day 28)
Group D
EXPERIMENTALHigh dose RSV-F Vaccine without Adjuvant (Day 0); Seasonal TIV (Day 0 \& Day 28)
Group E
PLACEBO COMPARATORPlacebo (Day 0 \& Day 28); Seasonal TIV (Day 28)
Interventions
0.5mL IM injections
0.5mL IM injections
0.5mL IM injections
0.5mL IM injections
Eligibility Criteria
You may qualify if:
- Adult males and females, ≥ 60 years of age, without symptomatic cardiopulmonary disease. Note that subjects who have any functional limitation or symptoms related to cardiac and/or pulmonary disease (including asthma or other episodic symptoms), or who receive ongoing therapy to control symptoms or functional limitation, are not eligible. The following are examples of subjects who may bear cardio-pulmonary diagnoses but who would remain eligible:
- Subjects on stable (no change in ≥ 2 months) therapy for findings (e.g., hypertension or hyperlipidemia) that are not associated with current symptoms or disability.
- Subjects who receive intermittent prophylaxis for risks associated with asymptomatic findings (e.g., antibiotic prophylaxis prior to dental procedures in a subject with asymptomatic mitral valve prolapse).
- Other clinically insignificant findings, not deemed to be associated with increased risk due to respiratory viral infections as determined by the Investigator.
- Free of other illnesses which are believed to increase the risk of influenza or influenza related complications including: diabetes mellitus, congenital or acquired blood dyscrasias, renal or hepatic dysfunction, and morbid obesity.
- Willing and able to give informed consent prior to study enrollment.
- Able to comply with study requirements.
You may not qualify if:
- Participation in research involving investigational product (drug / biologic / device) within 45 days before planned date of first vaccination and/or planned participation at any time during the study.
- History of a serious reaction to any prior vaccination or known allergy to constituents of licensed TIV (e.g., egg proteins).
- History of Guillain-Barré Syndrome within 6 weeks following a previous influenza vaccine.
- Receipt of any influenza vaccine within the preceding 3 months.
- Receipt of any vaccine in the 4 weeks preceding the study vaccination and planned receipt of a licensed vaccine any time prior to Day 56.
- Receipt of an RSV vaccine at any time.
- Any known or suspected immunosuppressive condition, acquired or congenital, as determined by medical history and/or physical examination.
- Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the study vaccine or during the study.
- Acute disease at the time of enrollment (defined as the presence of a moderate or severe illness with or without fever, or an oral temperature \>38.0°C on the planned day of vaccine administration).
- Known disturbance of coagulation.
- Suspicion or recent history (within one year of planned vaccination) of alcohol or other substance abuse.
- Any condition that in the opinion of the Investigator would pose a health risk to the subject if enrolled or could interfere with evaluation of the vaccine or interpretation of study results (including neurologic or psychiatric conditions deemed likely to impair the quality of safety reporting).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novavaxlead
Study Sites (4)
Genova Clinical Research
Tucson, Arizona, 85704, United States
Accelovance
Melbourne, Florida, 32935, United States
Research Across America
Dallas, Texas, 75234, United States
Jean Brown Research
Salt Lake City, Utah, 84124, United States
Related Publications (1)
Fries L, Shinde V, Stoddard JJ, Thomas DN, Kpamegan E, Lu H, Smith G, Hickman SP, Piedra P, Glenn GM. Immunogenicity and safety of a respiratory syncytial virus fusion protein (RSV F) nanoparticle vaccine in older adults. Immun Ageing. 2017 Apr 12;14:8. doi: 10.1186/s12979-017-0090-7. eCollection 2017.
PMID: 28413427DERIVED
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
D. Nigel Thomas, Ph.D.
Novavax, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 15, 2012
First Posted
October 17, 2012
Study Start
October 1, 2012
Primary Completion
July 1, 2013
Study Completion
March 1, 2014
Last Updated
March 5, 2014
Record last verified: 2014-03