Advances and Challenges in RSV Vaccine Development: Pathways

toward Global Protection

Haoxiang Wang

Guangxi University of Chinese Medicine, Nanning, Guangxi Zhuang Autonomous Region, China

Keywords: RSV Vaccine, Prefusion F Protein, Immunogenicity.

Abstract: Respiratory syncytial virus (RSV) is the leading cause of acute lower respiratory tract infection in infants

and young children worldwide. Recent breakthroughs in molecular biology and vaccine technology have

shifted prevention efforts from antivirals to targeted immunization, including protein and nucleic acid–

based platforms. Currently approved recombinant protein vaccines—Abrysvo (for pregnant women) and

Arexvy (for older adults)—demonstrate strong safety and efficacy profiles. However, developing

vaccines for neonates remains challenging due to their immature immune systems and variable responses.

This review summarizes the evolution of RSV vaccine design, underlying immunological mechanisms,

and results from pivotal clinical trials. We highlight ongoing strategies to overcome neonatal

immunogenicity hurdles and outline future directions for creating safe, broad-spectrum RSV vaccines

suitable for all age groups.

1 INTRODUCTION

RSV is a single-negative-strand RNA virus that

causes respiratory infections and is mainly

transmitted through droplets. The infection rate is

higher in the elderly, infants and young children, and

people with weakened immunity. RSV can easily

cause infectious bronchiolitis in infants and young

children, and in severe cases, it can lead to death

(Esther Redondo et al., 2024). In older adults, RSV

infection can lead to heart failure, stroke, and even

acute kidney disease (Schmoele-Thoma et al., 2022).

Viruses enter the human body mainly through

glycoproteins on their membranes (especially G

proteins) to recognize receptors on the host cell

membrane (Schmoele-Thoma et al., 2022) and bind

to F proteins to promote the fusion of viruses and cell

membranes. Recently, it has been found that the

integrin on the cell surface (integrin αvβ1) may also

be an important medium for RSV to enter host cells

(Zheng et al., 2022). RSV infection triggers elevated

levels of cytokines such as IL-6 and IL-8, leading to

neutrophil and eosinophil infiltration, which can lead

to bronchiolitis. At the same time, the Th2 immune

response induced by RSV infection may lead to

asthma symptoms in infants and young children

(Makrinioti et al., 2022; Van Royen et al., 2022). At

present, the treatment of RSV infection mainly relies

on monoclonal antibody (such as palivizumab) to

target the viral F protein for prophylaxis, especially in

neonates (Hammitt et al., 2022), but this therapy has

limited effect on specific populations (such as

neonates and immunocompromised patients), and the

protection period is short (half-life about 20 days),

which cannot provide lifelong immunity (Drysdale et

al., 2023). In addition, there is a lack of effective

monoclonal antibody therapy for older adults,

especially in the setting of immune failure and the

presence of chronic inflammatory underlying

diseases such as COPD, chronic bronchitis, and

cardiovascular disease (Falsey et al., 2022). There

may also be some potential adverse effects, such as

mild allergic reactions to the vaccine in infants

(Terstappen et al., 2024). The immune escape

mechanism of RSV virus itself, such as the non-

structural protein NS2 inhibits the interferon pathway

by blocking STAT2 phosphorylation (Jo et al., 2021),

and the secretory G protein of RSV hinders the

recognition of neutralizing antibodies, which brings

difficulties to clinical treatment (Bukreyev et al.,

2008).

Vaccines against RSV are mainly divided into

inactivated vaccines, attenuated vaccines,

recombinant protein vaccines, and mRNA vaccines.

Live attenuated vaccines attenuate RSV strains

through genetic engineering (e.g., reduce the

expression of their antigens) to mimic the natural

infection process, thereby inducing mucosal

324

Wang, H.

Advances and Challenges in RSV Vaccine Development: Pathways toward Global Protection.

DOI: 10.5220/0014487800004933

Paper published under CC license (CC BY-NC-ND 4.0)

In Proceedings of the 1st International Conference on Biomedical Engineering and Food Science (BEFS 2025), pages 324-329

ISBN: 978-989-758-789-4

immunity; Viral vector vaccines use vectors such as

adenoviruses that are not pathogenic and self-

encoding to express antigens on RSV by presenting

RSV antigen genes, thereby inducing T cells to

produce immune responses. Recombinant vaccines

(also known as recombinant protein vaccines) are

vaccines based on pre-F, a pre-stabilized

conformation of the RSV fusion protein (F protein),

which can induce the production of neutralizing

antibodies. The mRNA vaccine is the delivery of the

mRNA encoding the RSV F protein through lipid

nanoparticles to induce collective expression of

antigens and elicit an immune response (Topalidou et

al., 2023). However, compared with live attenuated

vaccines, protein subunit vaccines usually require

adjuvants to enhance immunogenicity (e.g.,

Pfizer/GSK), and at the same time, the storage

requirements for mRNA vaccines are high, and long-

term storage data have yet to be accumulated. For

example, Moderna's vaccine not only did not protect

infants and young children in the III clinical trial, but

worsened respiratory symptoms (Mahase, 2024). In

addition, the effectiveness of different vaccines in

different age groups varies significantly, for example,

the elderly and children are more suitable for live

attenuated vaccines, less virulent vaccines such as

mRNA vaccines, and for high-risk infants (preterm

birth, heart and lung disease, etc.), monoclonal

antibodies are required for passive immunization

strategies to directly provide specific antibodies. In

2019, global RSV-associated hospitalizations

occurred mainly in low- and middle-income

countries, while vaccine coverage remained

concentrated in high-income areas. This highlights

the disparate challenges faced by RSV vaccination

globally (Li et al., 2022). Despite this, the research

and development of RSV vaccines and monoclonal

antibodies is still very promising. This review

discusses the current status of RSV vaccine

development, analyze the main challenges, and look

forward to future vaccine technologies, so as to

provide new ideas for the prevention and control of

RSV.

2 RSV INACTIVATED

VACCINES

2.1 FI-RSV Vaccines

The formalin‑inactivated RSV (FI‑RSV) vaccine

employs a traditional inactivation approach, wherein

formalin treatment renders the virus noninfectious

while preserving its fusion (F) protein to elicit

immune responses and serve as the principal target of

neutralizing antibodies. Although the FI-RSV

vaccine has shown some immunogenicity in animal

experiments, it has not only failed to respond to the

expected immune response in clinical trials, but has

instead led to serious side effects, mainly manifested

as enhanced respiratory disease (ERD), which mainly

occurs in the middle and lower respiratory tract,

accompanied by clinical symptoms such as fever,

bronchial and lung inflammation, and even leads to

death in children. The failure mechanism of this

method is mainly due to the recognition of the

neutralizing antibody epitope of RSV only on the pre-

F conformation and not on the post-F (Magro et al.,

2012; Ngwuta et al., 2015), and the post-F

conformation may induce non-neutralizing antibodies

and Th2 immunotype responses.

2.2 RI-RSV Vaccine

The γ‑irradiated RSV (RI‑RSV) vaccine inactivates

the virus via gamma irradiation, employing a

development strategy analogous to that of the

formalin‑inactivated FI‑RSV vaccine. In animal

trials, RI-RSV vaccines have induced similar levels

of neutralizing antibodies to FI-RSV vaccines. RI-

RSV vaccine has shown certain advantages in

enhancing immunogenicity and focusing on vaccine

heterogeneity protection, but it also produces side

effects, such as weight loss and lung inflammation,

which may be related to RI-RSV vaccine-induced

conversion from pre-F to post-F (Chen et al., 2023).

Therefore, the design of inactivated vaccines should

focus more on antigen design specificity and take into

ac-count population differences. As structural

insights into the RSV F protein deepen—particularly

evidence demonstrating that the pre‑F conformation

presents superior neutralizing epitopes—vaccine

development has increasingly focused on optimizing

the balance between immunogenic potency and

targeted immunoreactivity.

3 LIVE ATTENUATED RSV

VACCINE

Live attenuated vaccines mainly weaken the

virulence of the virus through gene editing or physical

and chemical methods, simulating the natural

infection process, so that its replication in the host is

limited and does not cause host disease, while

retaining its immunogenicity. The immune

Advances and Challenges in RSV Vaccine Development: Pathways toward Global Protection

325

mechanism is mainly through mucosal immunity to

produce secretory IgA and local T cell responses. For

example, CodaVax-RSVTM reduces viral virulence

through codon optimization, while activating secreted

IgA antibodies in the mucosa to form a local immune

barrier and block early viral colonization. Deletion of

NS1/NS2 virulence-related genes can reduce

pathogenicity by reducing the ability of the virus to

inhibit the production of interferon by the host,

effectively detect immunogenicity during clinical

treatment, and elicit a massive memory-immune

response to RSV (Karron et al., 2024). Similarly,

partial deletion of the G protein domain has been

shown in animal models to reduce viral toxicity while

preserving immunogenicity (Roe et al., 2022). The

targeted design of the F antigen is to generate

disulfide bonds through the DS-Cav1 mutation,

which stabilizes the pre-F conformation that can

produce highly effective neutralizing antibodies.

CodaVx-RSVTM vaccine demonstrated a favorable

safety profile in healthy adults during Phase I clinical

trials, eliciting both mucosal IgA and systemic

neutralizing antibodies; however, its safety and

immunogenicity in neonates remain to be established.

4 RECOMBINANT RSV

VACCINES

The RSV recombinant vaccine is a non‑replicating

formulations that express target antigens and require

adjuvants to elicit robust immune responses. The

sources of immune response elicited by using the

virus's own information are mainly divided into

recombinant protein vaccines, recombinant vector

vaccines and DNA vaccines (Giese, 2015). In the

development of RSV proteins, G membrane proteins

are prone to mutations, so the breakthrough is mainly

aimed at the relatively conserved F protein on the

RSV membrane, which is responsible for helping the

virus enter and fuse cells, and its conformational pre-

F has more neutralizing antibody epitopes (such as

site Ø, site V) than another conformational post-F, but

because its pre-F is naturally unstable and easily

spontaneously transformed into post-F, stabilizing the

pre-F protein conformation is the core challenge of

vaccine development(McLellan et al., 2013). Genetic

engineering plays an important role here, as GSK's

Arexvy (pre-F) vaccine has demonstrated its

effectiveness in clinical trials – up to 80% in older

adults by stabilizing pre-F by stabilizing the pre-F

mutation with a DS-CAV1 mutation and increasing

the disulfide bond to improve protection. The

adenovirus vector AdC68 was used to express three

different gene mutations (DS-CAV1, SC-TM, DS2),

and then the neutralizing antibody titer and

immunogenicity size were determined, and the results

showed that DS2 showed better immunogenicity

(Yang et al., 2024). Pregnant women receiving the

pre-F vaccine during pregnancy are effective in

preventing neonatal RSV-related respiratory illness,

but in people aged ≥ 60 years, the immune efficacy

(vaccine efficacy) of the two doses before and after

vaccination within one year at the RSVAPREF3 time

of vaccination is about the same (Ison et al., 2024). In

2024, Clover Biosciences Inc. developed an

unadjuvanted bivalent RSV Pre-F-trimer vaccine,

SCB-1019, induced two neutralizing antibodies

(RSV-A and RSV-B) in animal trials, with antibody

titers comparable to Arexvy within one month,

yielding approximately 1.5-fold more specific

antibodies than SCB-10191, and local adverse events

(16.7% ) significantly lower than Arexty (76.7%).

5 mRNA RSV VACCINES

mRNA vaccines do not require cell culture or risk

integration into the host genome, with lower risk and

higher antigenicity because they do not integrate

nucleic acids into the host genome. LVRNA007 is a

lipid nanoparticle mRNA vaccine encoding a

DS‑Cav1–stabilized prefusion (pre‑F) RSV F protein.

In animal experiments, LVRNA007 showed a long-

lasting cellular and humoral immune response,

effectively fighting RSV while avoiding vaccine-

enhanced disease (VED) (Li et al., 2025). The

production of mRNA-1345 is introduced to optimize

structural biology, exposing pre-F neutralizing

antibody epitope, using pseudouridine instead of

natural uridine to reduce the immunogenicity of

mRNA and prolong its half-life in the human body

(Bansal, 2023). Packaging mRNA into nanoparticles

prevents enzyme degradation and improves delivery

efficiency. Finally, modification and purification are

made, and the lipid components in the nanoparticles

act as adjuvant ingredients to enhance the immune

response. At the same time, in clinical trials, the

vaccine has a protective effect of up to 80% on RSV-

A and RSV-B subtypes, and its neutralizing antibody

titers are significantly higher than those of traditional

protein vaccines. No vaccine-enhanced diseases are

seen. The possible side effects are local injection

reactions and temporary fatigue (Wilson et al., 2023).

A team from Xiamen University designed a new type

of truncated pre-F protein to make a vaccine as an

immunogen. By removing inefficient neutralizing

BEFS 2025 - International Conference on Biomedical Engineering and Food Science

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antibody epitopes and enhancing high-efficiency

neutralizing antibody epitopes, the vaccine antibody

response generated by the delivery of lipid

nanoparticles can effectively target the two subtypes

of RSV A and B. Moreover, no vaccine-enhanced

disease (VED) was found (Lin et al., 2025).

6 CHALLENGES FOR RSV

VACCINES

6.1 Immune Evasion

RSV infection is characterized by dysregulation of

type I interferon (IFN) signaling. Nonstructural

proteins on the RSV membrane (such as NS1 and

NS2 proteins) will hinder the host's natural immune

response. For example, the key molecule MAVS

(mitochondrial antiviral signaling protein) on the

outer mitochondrial membrane is a key molecular

platform of the antiviral RLR pathway. The specific

recognition effect of RSV's NS1 protein on the

protein TUFM on the mitochondria will initiate the

mitochondrial autophagy mechanism, thereby

affecting the host's immune signaling (Cheng et al.,

2023). At the same time, N protein can isolate the

antiviral protein, the immune-stimulating protein, in

the inclusion body, and then negatively regulate the

innate immune-related proteins (Cheng et al., 2023).

In addition, the Post-F conformation of RSV exposed

inefficient binding antibody epitopes (siteI and site

III), inducing nonprotective antibodies and at risk of

inflammation, which is more common in clinical

trials of advanced vaccines (inactivated and partially

attenuated vaccines). When the human body is

infected with RSV normally, due to the instability of

pre-F, it will turn into a relatively stable post-F

conformation, thereby escaping the pre-F-specific

antibodies produced by the host, resulting in immune

failure (Venkatesan, 2023). To overcome this

challenge, the key to vaccine design is how to

stabilize the pre-F conformation and prevent it from

transitioning to post-F. According to the recombinant

protein vaccines prepared by RSV viruses for proteins

(F and G proteins) that are closely involved in the host

response, although they can activate immune

responses as antigenic components, they require

adjuvants to enhance their immunogenicity in most

cases. New research direction - RSV nano-lipid

particle mRNA vaccine, which uses viral mRNA to

generate antigen proteins in host cells and activate

immune responses while lipid nanoparticles help

stabilize antigens and enhance immunogenicity.

6.2 Vaccine Efficacy and Adverse

Events across Age Groups

Infants and young children benefit most from

recombinant protein vaccines due to their lower

reactogenicity. For example, in the Abrysvo clinical

trial, after pregnant women received the maternal

vaccine, the antibodies were passed to the infant

through the placenta, and the vaccine protective

efficacy reached 81.8%. Although no serious adverse

events were reported, potential effects of maternally

derived antibodies on infant immune development

warrant monitoring. Palivizumab, an RSV

monoclonal antibody, prevents RSV infection by

inducing passive immunity, but is ineffective for RSV

treatment. In clinical experiments, severe respiratory-

related infections were observed in the RSV mRNA-

1345 vaccine produced by Moderna. This may be

related to the infancy of the immune system of infants

and young children, which leads to the inability to

make timely immune responses. Elderly and high-risk

populations (such as those with low immunity)

performed well in the second-generation vaccine,

Pfizer's Abrysvo RSV-preF bivalent recombinant

protein vaccination trial (Alfano et al., 2024; Havers

et al., 2023; Surie et al., 2024). The two vaccines

Abrysvo and Arexvy can have similar side effects on

the body after vaccination, including fatigue, muscle

headaches, headaches, and pain at the vaccination

site. But these effects are temporary and transitional

(Andreoni et al., 2024). RSV infection prevention is

mainly aimed at newborns, especially babies within

one year of birth. The current strategy is composed of

multiple steps: first, the maternal antibodies that

deliver anti-RSV are delivered to the baby; then,

within 3 months of the baby, monoclonal antibodies

are injected to produce passive immunity, and then

natural infection is simulated by vaccinating vector

vaccines or attenuated vaccines to test whether an

effective immune response is generated (Zheng et al.,

2022). High-risk groups also have corresponding

vaccine response strategies (E. Redondo et al., 2024).

7 CONCLUSION

After the failure of clinical trials of the first-

generation RSV vaccine, the development of RSV

vaccines has focused more on the role of vaccines in

the human body, especially for special groups such as

newborns, the elderly, and those with

immunodeficiency.

Advances and Challenges in RSV Vaccine Development: Pathways toward Global Protection

327

With the maturity of modern biotechnology, the

direction of vaccine research and development has

gradually shifted to artificially manipulating viral

antigens, such as enhancing the immunogenicity of

vaccines through lipid nanoparticles as adjuvants

while ensuring their safety. These innovations have

successfully transitioned to recombinant vaccines,

and have prompted mRNA vaccines and monoclonal

antibody vaccines to show great potential in

immunogenicity and safety. However, RSV vaccines

still face some challenges, including the limited

vaccine supply, price issues, public inadequate

awareness of the RSV virus, and differences in the

effects and side effects of different vaccines on

different age groups. The effectiveness of vaccines,

especially in neonatal and immunity-lowering

populations, still needs further verification, and long-

term tracking of the immune response and side effects

of vaccinated people is the key to vaccine research.

With the in-depth understanding of the RSV immune

escape mechanism and the continuous innovation of

vaccine technology, RSV vaccines are expected to be

widely used worldwide in the future, thereby

effectively controlling the spread and harm of RSV

infection.

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