RSV Vaccine for Respiratory Syncytial Virus

Recruiting at 35 trial locations

Overseen By Pfizer CT.gov Call Center

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Pfizer

Disqualifiers: BMI over 40, Severe allergies, Pregnancy issues, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 week

550 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What data supports the effectiveness of the RSVpreF treatment for Respiratory Syncytial Virus?

Research shows that the RSVpreF vaccine, which targets the RSV virus, has demonstrated strong immune responses in adults and promising results in younger adults, suggesting it could be effective in preventing RSV infections. ^{1 2 3 4 5}

Is the RSVpreF vaccine generally safe for humans?

The RSVpreF vaccine has been tested in various groups, including older adults, adults aged 18-50, and pregnant women, and has shown an acceptable safety profile in these studies. ^{3 6 7 8 9}

How is the RSVpreF vaccine different from other RSV treatments?

The RSVpreF vaccine is unique because it targets the prefusion F protein of the RSV virus, which is a key part of the virus's structure before it fuses with human cells. This vaccine is designed to enhance immune responses, especially in older adults, and is approved for use in pregnant individuals to protect infants, making it distinct from other treatments that do not focus on this specific protein or population. ^{2 3 4 7 10}

What is the purpose of this trial?

This study aims to check how safe and well-tolerated a second dose of RSVpreF is when given during later pregnancies, and to see how long the immunity lasts from a single dose given during a previous pregnancy by examining the blood of nonpregnant participants who had the vaccine before.

Research Team

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Eligibility Criteria

This trial is for pregnant women aged 18 to 49, between 24 and 36 weeks along with a single baby and no known risks for complications. They must have received the RSVpreF or Abrysvo vaccine in a past pregnancy, had an ultrasound at 18+ weeks showing no major fetal issues, be deemed suitable by a doctor, consent to their baby's participation, and agree to study conditions.

Inclusion Criteria

Able to sign a consent form agreeing to follow the rules and requirements of the study

Had the RSVpreF or Abrysvo vaccine during a previous pregnancy

Had an ultrasound scan at 18 weeks or later during their current pregnancy with no major fetal problems detected

Exclusion Criteria

History of a severe bad reaction to a vaccine or a serious allergic reaction (like anaphylaxis) to any ingredient in the study vaccine or a similar vaccine

Current pregnancy problems or issues at the time of giving consent

Previous pregnancy issues or problems at the time of giving consent

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Pregnant participants receive a second dose of RSVpreF or placebo, and non-pregnant participants have blood samples taken

1 week

1 visit (in-person)

Follow-up

Infants are monitored for safety and antibody levels for six months after birth

6 months

Multiple visits (in-person)

Long-term follow-up

Non-pregnant participants' immune response persistence is evaluated over time

Long-term

Treatment Details

Interventions

• RSVpreF

Trial Overview The study tests the safety and effectiveness of administering a second dose of RSVpreF during subsequent pregnancies. It also measures how long immunity lasts from one dose given in a previous pregnancy by analyzing blood samples from nonpregnant participants who were previously vaccinated.

Participant Groups

Group I: RSVpreF Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Findings from Research

The investigational bivalent prefusion F vaccine (RSVpreF) was well tolerated in healthy adults aged 18-85, with mostly mild to moderate side effects, indicating a favorable safety profile.

RSVpreF elicited strong immune responses in older adults, significantly increasing serum-neutralizing antibodies against RSV, suggesting it could effectively protect this vulnerable population from RSV disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase 1/2 Randomized Study of the Immunogenicity, Safety, and Tolerability of a Respiratory Syncytial Virus Prefusion F Vaccine in Adults With Concomitant Inactivated Influenza Vaccine. Falsey, AR., Walsh, EE., Scott, DA., et al.[2022]

The bivalent RSVpreF vaccine was found to be safe and well-tolerated in a study of 618 adults aged 18-49, with mostly mild or moderate local and systemic reactions and no serious adverse events reported within 12 months post-vaccination.

The vaccine induced strong virus-neutralizing responses, with antibody levels significantly higher than those needed for protection in high-risk infants, suggesting its potential effectiveness for maternal immunization against RSV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Phase 1/2 Study of a Respiratory Syncytial Virus Prefusion F Vaccine. Walsh, EE., Falsey, AR., Scott, DA., et al.[2022]

The Ad26.RSV.preF vaccine, tested in a phase 1/2a study with 352 adults aged 60 and older, was found to be well tolerated, showing similar side effects across different regimens.

Combining Ad26.RSV.preF with RSV preF protein significantly enhanced humoral immune responses while maintaining cellular responses, suggesting this combination could be more effective in generating immunity against RSV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, Immunogenicity, and Regimen Selection of Ad26.RSV.preF-based Vaccine Combinations: A Randomized, Double-blind, Placebo-Controlled, Phase 1/2a Study. Comeaux, CA., Bart, S., Bastian, AR., et al.[2023]

The Ad26.RSV.preF vaccine candidate showed good safety and immunogenicity in a study involving 12 adults and 36 RSV-seropositive children, with no serious adverse events reported and only mild to moderate reactions observed.

The vaccine significantly increased RSV neutralization titers in children and resulted in fewer RSV infections compared to the placebo group, indicating its potential effectiveness in preventing RSV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase 1/2a Safety and Immunogenicity of an Adenovirus 26 Vector Respiratory Syncytial Virus (RSV) Vaccine Encoding Prefusion F in Adults 18-50 Years and RSV-Seropositive Children 12-24 Months. Stuart, ASV., Virta, M., Williams, K., et al.[2023]

The RSVpreF vaccine candidate was found to be safe and well-tolerated in older adults (ages 65-85), eliciting strong and lasting immune responses against the respiratory syncytial virus, regardless of the formulation used.

Adding the adjuvant CpG/Al(OH)3 did not enhance the immune response compared to the standard aluminum hydroxide adjuvant, and most side effects were mild, indicating that the vaccine is a promising option for protecting older adults from RSV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Phase 1/2 Study of a Respiratory Syncytial Virus Prefusion F Vaccine With and Without Adjuvant in Healthy Older Adults. Baber, J., Arya, M., Moodley, Y., et al.[2023]

In a phase 2b trial involving 406 pregnant women, the RSVpreF vaccine demonstrated effective neutralizing antibody responses against RSV, with significant transplacental transfer to infants, indicating potential protection for newborns.

The vaccine was generally safe, with most side effects being mild to moderate, and the incidence of adverse events in both mothers and infants was similar to those in the placebo group, suggesting no major safety concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prefusion F Protein-Based Respiratory Syncytial Virus Immunization in Pregnancy. Simões, EAF., Center, KJ., Tita, ATN., et al.[2022]

The RSVPreF3 vaccine candidate was found to be safe for use in 213 healthy pregnant women, with no significant adverse events related to the vaccine or placebo reported during the study.

The vaccine effectively increased RSV-specific neutralizing antibody levels in mothers and successfully transferred these antibodies to newborns, indicating strong immunogenicity and potential protection for infants against RSV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Immunogenicity of an Investigational Respiratory Syncytial Virus Vaccine (RSVPreF3) in Mothers and Their Infants: A Phase 2 Randomized Trial. Bebia, Z., Reyes, O., Jeanfreau, R., et al.[2023]

Pfizer's bivalent RSV vaccine, RSVpreF, has been approved in the USA for use in pregnant individuals to protect infants from respiratory syncytial virus (RSV) illness, as well as for individuals aged 60 and older to prevent lower respiratory tract disease caused by RSV.

The vaccine has also received approval in the EU for both indications and is currently under review for regulatory approval in Canada and Japan, highlighting its potential global impact in preventing RSV-related illnesses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Respiratory Syncytial Virus Prefusion F Subunit Vaccine: First Approval of a Maternal Vaccine to Protect Infants. Syed, YY.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Phase 1/2 Randomized Study of the Immunogenicity, Safety, and Tolerability of a Respiratory Syncytial Virus Prefusion F Vaccine in Adults With Concomitant Inactivated Influenza Vaccine. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

A Randomized Phase 1/2 Study of a Respiratory Syncytial Virus Prefusion F Vaccine. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of a Bivalent RSV Prefusion F Vaccine in Older Adults. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Safety, Immunogenicity, and Regimen Selection of Ad26.RSV.preF-based Vaccine Combinations: A Randomized, Double-blind, Placebo-Controlled, Phase 1/2a Study. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Sequential annual administration of purified fusion protein vaccine against respiratory syncytial virus in children with cystic fibrosis. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Phase 1/2a Safety and Immunogenicity of an Adenovirus 26 Vector Respiratory Syncytial Virus (RSV) Vaccine Encoding Prefusion F in Adults 18-50 Years and RSV-Seropositive Children 12-24 Months. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

A Phase 1/2 Study of a Respiratory Syncytial Virus Prefusion F Vaccine With and Without Adjuvant in Healthy Older Adults. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Prefusion F Protein-Based Respiratory Syncytial Virus Immunization in Pregnancy. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Safety and Immunogenicity of an Investigational Respiratory Syncytial Virus Vaccine (RSVPreF3) in Mothers and Their Infants: A Phase 2 Randomized Trial. [2023]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Respiratory Syncytial Virus Prefusion F Subunit Vaccine: First Approval of a Maternal Vaccine to Protect Infants. [2023]