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RSV F vaccine with adjuvant
RSV F vaccine with adjuvant is a Recombinant protein vaccine Biologic drug developed by Novavax. It is currently in Phase 3 development for Prevention of respiratory syncytial virus (RSV) disease in older adults (≥60 years), Prevention of RSV disease in infants (via maternal immunization).
This vaccine stimulates the immune system to produce antibodies and cellular immunity against the respiratory syncytial virus (RSV) F protein, preventing RSV infection.
This vaccine stimulates the immune system to produce antibodies and cellular immunity against the respiratory syncytial virus (RSV) F protein, preventing RSV infection. Used for Prevention of respiratory syncytial virus (RSV) disease in older adults (≥60 years), Prevention of RSV disease in infants (via maternal immunization).
At a glance
| Generic name | RSV F vaccine with adjuvant |
|---|---|
| Sponsor | Novavax |
| Drug class | Recombinant protein vaccine |
| Target | RSV F protein (fusion protein) |
| Modality | Biologic |
| Therapeutic area | Immunology / Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
The vaccine contains the RSV fusion (F) protein, a key surface antigen that the virus uses to enter host cells. When administered with an adjuvant to enhance immune response, it trains the immune system to recognize and neutralize RSV before infection occurs. This approach aims to prevent RSV disease across age groups, particularly in older adults and infants.
Approved indications
- Prevention of respiratory syncytial virus (RSV) disease in older adults (≥60 years)
- Prevention of RSV disease in infants (via maternal immunization)
Common side effects
- Injection site pain
- Injection site erythema
- Myalgia
- Fatigue
- Headache
Key clinical trials
- A Study to Determine the Safety and Efficacy of the RSV F Vaccine to Protect Infants Via Maternal Immunization (PHASE3)
- RSV F Vaccine Maternal Immunization Study in Healthy Third-trimester Pregnant Women. (PHASE2)
- 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 (PHASE2)
- Dose, Safety, Tolerability and Immunogenicity of a Stabilized Prefusion RSV F Subunit Protein Vaccine, VRC-RSVRGP084-00-VP (DS-Cav1), Alone or With Alum Adjuvant, in Healthy Adults (PHASE1)
- A Study to Evaluate the Safety and Reactogenicity of DPX-RSV(A), a Respiratory Syncytial Virus Vaccine (PHASE1)
- A Study to Evaluate the Safety and Ability of the Vaccine to Induce Antibodies Against the Respiratory Syncytial Virus in Healthy Adults (PHASE1)
- RSV F Dose-Ranging Study in Women (PHASE2)
- A Phase I Randomized, Observer-Blinded, Dose-Ranging Study in Healthy Subjects 24 to <72 Months of Age (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- RSV F vaccine with adjuvant CI brief — competitive landscape report
- RSV F vaccine with adjuvant updates RSS · CI watch RSS
- Novavax portfolio CI
Frequently asked questions about RSV F vaccine with adjuvant
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Related
- Drug class: All Recombinant protein vaccine drugs
- Target: All drugs targeting RSV F protein (fusion protein)
- Manufacturer: Novavax — full pipeline
- Therapeutic area: All drugs in Immunology / Infectious Disease
- Indication: Drugs for Prevention of respiratory syncytial virus (RSV) disease in older adults (≥60 years)
- Indication: Drugs for Prevention of RSV disease in infants (via maternal immunization)
- Compare: RSV F vaccine with adjuvant vs similar drugs
- Pricing: RSV F vaccine with adjuvant cost, discount & access