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RSV F Vaccine with Aluminum Adjuvant

Phase 2

Respiratory Syncytial Viruses | Monoclonal antibody | Infectious Disease |Novavax, Inc.|Last Updated: Dec 6, 2021

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment300

FDA Designations

No designations recorded

Clinical trial landscape

RSV F Vaccine with Aluminum Adjuvant · 1 trial · 1 indication

Phase 2 1
NCT03026348Safety 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 AdultsRespiratory Syncytial Viruses
COMPLETED300 Analytics
PHASE2COMPLETED
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
Respiratory Syncytial Viruses
NCT03026348300
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Study Endpoints

Primary Endpoints

Neutralizing antibody titers to at least one RSV/A strain
Day 0, 21, 28
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.
Day 0 - Day 6, Day 21 - Day 27; Day 0 - Day 56

Secondary Endpoints

Serum concentrations of antibodies competitive with palivizumab (i.e., PCA) for binding to the RSV F protein.
Day 0, 21, 28, 56, 119, 385
Serum IgG antibody concentrations as ELISA units (EUs) specific for the F protein antigen.
Day 0, 21, 28, 56, 119, 385
Counts of IFN-γ spot forming units following in vitro stimulation of Day 0, Day 7, and Day 28 PBMC isolates with RSV F peptides.
Day 0, 7, 28
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Treatment Group AACTIVE_COMPARATORDay 0 RSV F Vaccine 135µg/0.5mL Day 21 Phosphate Buffer
Treatment Group BACTIVE_COMPARATORDay 0 Treatment / Formulation 1 Day 21 Phosphate Buffer
Treatment Group CACTIVE_COMPARATORDay 0 Treatment / Formulation 1 Day 21 Treatment / Formulation 1
Treatment Group DACTIVE_COMPARATORDay 0 Treatment / Formulation 2 Day 21 Phosphate Buffer
Treatment Group EACTIVE_COMPARATORDay 0 Treatment / Formulation 2 Day 21 Treatment / Formulation 2
Treatment Group FACTIVE_COMPARATORDay 0 Treatment / Formulation 3 Day 21 Phosphate Buffer
Treatment Group GACTIVE_COMPARATORDay 0 Treatment / Formulation 3 Day 21 Treatment / Formulation 3
Treatment Group HACTIVE_COMPARATORDay 0 Treatment / Formulation 4 Day 21 Phosphate Buffer
Treatment Group JACTIVE_COMPARATORDay 0 Treatment / Formulation 4 Day 21 Treatment / Formulation 4
Treatment Group KACTIVE_COMPARATORDay 0 Treatment / Formulation 5 Day 21 Phosphate Buffer
Treatment Group LACTIVE_COMPARATORDay 0 Treatment / Formulation 5 Day 21 Treatment / Formulation 5
Treatment Group MPLACEBO_COMPARATORDay 0 Phosphate Buffer Day 21 Phosphate Buffer

Interventions

NameTypeDescription
RSV F Vaccine with Aluminum Phosphate AdjuvantBIOLOGICAL -
RSV F VaccineBIOLOGICAL -
Matrix-M1 AdjuvantBIOLOGICAL -
Phosphate BufferOTHER -
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Eligibility Criteria

Age Range60 Years to 80 Years
SexALL
Healthy VolunteersYes
Study Sites5

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 ...

Countries:Australia
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Frequently asked questions about RSV F Vaccine with Aluminum Adjuvant

What is RSV F Vaccine with Aluminum Adjuvant used for?

RSV F Vaccine with Aluminum Adjuvant is an investigational vaccine being studied for the prevention of Respiratory Syncytial Virus (RSV) infections. It is being evaluated in clinical trials for use in pregnant women to protect infants via maternal immunization, as well as in older adults and young children.

Who makes RSV F Vaccine with Aluminum Adjuvant?

RSV F Vaccine with Aluminum Adjuvant is being developed by Novavax, Inc., a biotechnology company traded on the NASDAQ under the ticker symbol NVAX. The vaccine is currently in clinical development and has not yet been approved by regulatory authorities.

What phase is RSV F Vaccine with Aluminum Adjuvant in?

RSV F Vaccine with Aluminum Adjuvant has completed clinical trials in Phase 1, Phase 2, and Phase 3. The most advanced completed study was a Phase 3 trial evaluating maternal immunization to protect infants from RSV. The vaccine remains investigational and is not yet approved.

What clinical trials has RSV F Vaccine with Aluminum Adjuvant been in?

RSV F Vaccine with Aluminum Adjuvant has been studied in four completed clinical trials. These include NCT02247726, a Phase 2 maternal immunization study in pregnant women; NCT02296463, a Phase 1 dose-ranging study in toddlers; NCT02624947, a Phase 3 maternal immunization efficacy trial; and NCT03026348, a Phase 2 study in older adults.

Is RSV F Vaccine with Aluminum Adjuvant the same as other RSV vaccines?

RSV F Vaccine with Aluminum Adjuvant is a specific vaccine formulation developed by Novavax that includes the RSV F protein combined with an aluminum adjuvant. It is distinct from other RSV vaccine candidates that may use different antigens or adjuvant systems, such as Matrix-M1.