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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03026348




Registration number
NCT03026348
Ethics application status
Date submitted
17/01/2017
Date registered
20/01/2017
Date last updated
6/12/2021

Titles & IDs
Public title
Safety and Immunogenicity Study to Evaluate Single- or Two-Dose Regimens Of RSV F Vaccine With and Without Aluminum Phosphate or Matrix-M1™ Adjuvants In Clinically-Stable Older Adults
Scientific title
Safety and Immunogenicity Study to Evaluate Single- or Two-Dose Regimens Of RSV F Vaccine With and Without Aluminum Phosphate or Matrix-M1™ Adjuvants In Clinically-Stable Older Adults
Secondary ID [1] 0 0
RSV-E-205
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory Syncytial Viruses 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Active comparator: Treatment Group A - Day 0 RSV F Vaccine 135µg/0.5mL Day 21 Phosphate Buffer

Active comparator: Treatment Group B - Day 0 Treatment / Formulation 1 Day 21 Phosphate Buffer

Active comparator: Treatment Group C - Day 0 Treatment / Formulation 1 Day 21 Treatment / Formulation 1

Active comparator: Treatment Group D - Day 0 Treatment / Formulation 2 Day 21 Phosphate Buffer

Active comparator: Treatment Group E - Day 0 Treatment / Formulation 2 Day 21 Treatment / Formulation 2

Active comparator: Treatment Group F - Day 0 Treatment / Formulation 3 Day 21 Phosphate Buffer

Active comparator: Treatment Group G - Day 0 Treatment / Formulation 3 Day 21 Treatment / Formulation 3

Active comparator: Treatment Group H - Day 0 Treatment / Formulation 4 Day 21 Phosphate Buffer

Active comparator: Treatment Group J - Day 0 Treatment / Formulation 4 Day 21 Treatment / Formulation 4

Active comparator: Treatment Group K - Day 0 Treatment / Formulation 5 Day 21 Phosphate Buffer

Active comparator: Treatment Group L - Day 0 Treatment / Formulation 5 Day 21 Treatment / Formulation 5

Placebo comparator: Treatment Group M - Day 0 Phosphate Buffer Day 21 Phosphate Buffer
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Neutralizing antibody titers to at least one RSV/A strain
Timepoint [1] 0 0
Day 0, 21, 28
Primary outcome [2] 0 0
Subjects with solicited local and systemic AEs occurring within the 7-day period following dosings on Day 0 and Day 21 and all adverse events, solicited and unsolicited, occurring within the 56-day period of Day 0.
Timepoint [2] 0 0
Day 0 - Day 6, Day 21 - Day 27; Day 0 - Day 56
Secondary outcome [1] 0 0
Serum concentrations of antibodies competitive with palivizumab (i.e., PCA) for binding to the RSV F protein.
Timepoint [1] 0 0
Day 0, 21, 28, 56, 119, 385
Secondary outcome [2] 0 0
Serum IgG antibody concentrations as ELISA units (EUs) specific for the F protein antigen.
Timepoint [2] 0 0
Day 0, 21, 28, 56, 119, 385
Secondary outcome [3] 0 0
Counts of IFN-? spot forming units following in vitro stimulation of Day 0, Day 7, and Day 28 PBMC isolates with RSV F peptides.
Timepoint [3] 0 0
Day 0, 7, 28
Secondary outcome [4] 0 0
Counts and proportions of Day 0, Day 7, and Day 28 peripheral blood T cells positive by intracellular staining for IL-2, IFN-?, or TNF-a production (alone or any combination thereof) following in vitro stimulation with RSV F peptides.
Timepoint [4] 0 0
Day 0, 7, 28

Eligibility
Key inclusion criteria
1. Males and females 60 through 80 years of age who are ambulatory and live in the community or in an assisted-living facility that provides minimal assistance, such that the subject is primarily responsible for self-care and activities of daily living. Subjects may have one or more chronic medical diagnoses, but should be clinically stable as assessed by:

* Absence of changes in medical therapy within one month due to treatment failure or toxicity (dose adjustments of ongoing therapies for optimal effect, or replacements within a class of drugs due to convenience or cost, will be deemed acceptable),
* Absence of medical events qualifying as SAEs within one month of the planned vaccination on Day 0, and
* Absence of known, current, and life-limiting diagnoses which, in the opinion of the investigator, render survival to completion of the protocol unlikely.
2. Willing and able (on both a physical and cognitive basis) to give informed consent prior to study enrollment. To complete the consent process, all qualifying subjects will correctly answer at least 4 out of 5 questions of the informed consent form (ICF) comprehension assessment in no more than 2 attempts.
3. Able to comply with study requirements. As the protocol procedures involve telephone contacts for safety ascertainment, eligible subjects must have a reliable access to a telephone.
Minimum age
60 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Received any prior RSV vaccine.
2. Participation in research involving any additional investigational product (drug / biologic / device) within 45 days before planned date of first vaccination.
3. History of a serious reaction to any prior vaccination or a history of Guillain-Barré syndrome (GBS) within 6 weeks of any prior influenza immunization.
4. Receipt of inactivated influenza vaccine within 14 days prior to the Day 0 dose of test article or any other vaccine within the 4 weeks prior to the Day 0 dose of test article.
5. Any known or suspected immunosuppressive condition, acquired or congenital, as determined by history and/or physical examination.
6. Chronic administration (defined as more than 14 continuous days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of the study vaccine. An immunosuppressant dose of glucocorticoid will be defined as a systemic dose = 10 mg of prednisone per day or equivalent. The use of topical, inhaled, and nasal glucocorticoids will be permitted.
7. Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the study vaccine or during the study.
8. 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).
9. Known disturbance of coagulation. Potential subjects receiving aspirin, clopidogrel, prasugrel, dipyridamole, dabigatran, apixaban, rivaroxaban, or warfarin under good control for cardiovascular prophylaxis or prophylaxis of thromboembolic disease or stroke in the setting of atrial fibrillation will NOT be excluded.
10. Suspicion or recent history (within one year of planned vaccination) of alcohol or other substance abuse.
11. 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, cognitive, or psychiatric conditions deemed likely to impair the quality of study compliance or safety reporting).

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
18/05/2018
Sample size
Target
Accrual to date
Final
300
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Research Site AU004 - Sydney
Recruitment hospital [2] 0 0
Research Site AU005 - Herston
Recruitment hospital [3] 0 0
Research Site AU002 - Adelaide
Recruitment hospital [4] 0 0
Research Site AU006 - Prahran
Recruitment hospital [5] 0 0
Resarch Site AU001 - Nedlands
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment postcode(s) [2] 0 0
4006 - Herston
Recruitment postcode(s) [3] 0 0
50000 - Adelaide
Recruitment postcode(s) [4] 0 0
3181 - Prahran
Recruitment postcode(s) [5] 0 0
6009 - Nedlands

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novavax
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a randomized, observer-blind, trial in clinically-stable older adults. Up to 300 eligible older adults 60 through 80 years of age will be enrolled at a 1:1 ratio into multiple dose/formulation treatment arms. Safety and immunogenicity data through Day 56 will be used to select a vaccine candidate to potentially evaluate in a Part 2 study. Proportions of subjects in various strata will not be pre-specified and the goal will be to achieve an approximately equal distribution of subjects with these characteristics across the treatment groups. Serology measures consistent with the study outcomes will be reported.
Trial website
https://clinicaltrials.gov/study/NCT03026348
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Development
Address 0 0
Novavax
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03026348