Today, we will be looking into the latest research and clinical trials focused on respiratory syncytial virus (RSV) immunization in adults.
The following list has been carefully curated by evaluating the ongoing Phase 3 trials for RSV vaccinations, specifically targeting adults in the United States. Please note that the dates provided are approximate and subject to change. This compilation primarily features studies that have released updates within the past 12 months and have results.
This series aims to offer a glimpse into upcoming innovations in the field and how the outcomes of these studies could potentially influence clinical guidelines related to the topic.
Without further ado, let’s explore the RSV Immunization Clinical Trials!
Quick View Table of RSV Immunization Clinical Trials
RSV Immunization Clinical Trials With Results:
A Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus Given to Adults 50-59 Years of Age, Including Adults at Increased Risk of Respiratory Syncytial Virus Lower Respiratory Tract Disease, Compared to Older Adults 60 Years of Age and Above
- Sponsor: GlaxoSmithKline
- The aim of this study is to demonstrate the non-inferiority (NI) of the immune response and evaluate safety of RSVPreF3 older adults (OA) investigational vaccine in adults 50-59 years of age (YOA), including those who are at increased risk (AIR) of respiratory syncytial virus (RSV)-lower respiratory tract disease (LRTD), versus adults >=60 YOA
- Interventions: BIOLOGICAL: RSVPreF3 OA investigational vaccine, DRUG: Placebo
- Primary Outcomes Measures: RSV-A Neutralization Titers Expressed as Group Geometric Mean Titer (GMT) in Healthy Participants Compared to OA-RSV Group, Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay. The corresponding antibody titers were expressed in Estimated Dilution 60 (ED60) and were measured on blood samples collected from vaccinated subjects. The ANCOVA model used to calculate the adjusted GMTs for RSV-A neutralizing antibodies included the baseline value as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included Adult HA_RSV and OA_RSV groups in the model as fixed effect, as specified in Statistical Analysis Plan., At 1 month after the RSVPreF3 OA vaccine administration (Day 31)|RSV-A Neutralization Titers Expressed as Group Seroresponse Rate (SRR) Difference in Healthy Participants Compared to OA-RSV Group, The SRR is defined as the proportion of participants having a fold increase in neutralization titers (1 month post-study intervention administration over pre-study intervention administration) greater than or equal to 4 (>=4)., At 1 month after the RSVPreF3 OA investigational vaccine administration (Day 31) compared to baseline (Day 1)|RSV-B Neutralization Titers Expressed as Group GMT in Healthy Participants Compared to OA-RSV Group, Serological assays for the determination of antibodies against RSV-B were performed by neutralization assay. The corresponding antibody titers were expressed in ED60. The ANCOVA model used to calculate the adjusted GMTs for RSV-B neutralizing antibodies included the baseline value as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included Adult HA_RSV and OA_RSV groups in the model as fixed effect, as specified in Statistical Analysis Plan., At 1 month after the RSVPreF3 OA vaccine administration (Day 31)|RSV-B Neutralization Titers Expressed as Group SRR in Healthy Participants Compared to OA-RSV Group, The SRR is defined as the proportion of participants having a fold increase in neutralization titers (1 month post-study intervention administration over pre-study intervention administration) >=4., At 1 month after the RSVPreF3 OA vaccine administration (Day 31) compared to baseline (Day 1)|RSV-A Neutralization Titers Expressed as Group GMT Titer in Participants at Increased Risk of RSV-LRTD (Adults-AIR-RSV Group) Compared to OA-RSV Group, Serological assays for the determination of antibodies against RSV-A are performed by neutralization assay. The corresponding antibody titers were expressed in ED60. The ANCOVA model used to calculate the adjusted GMTs for RSV-A neutralizing antibodies included the baseline value as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included Adult AIR_RSV and OA_RSV groups in the model as fixed effect, as specified in Statistical Analysis Plan., At 1 month after the RSVPreF3 OA investigational vaccine administration (Day 31)|RSV-A Neutralization Titers Expressed as Group SRR in Participants at Increased Risk of RSV-LRTD (Adults-AIR-RSV Group) Compared to OA-RSV Group, The SRR is defined as the proportion of participants having a fold increase in neutralization titers (1 month post-study intervention administration over pre-study intervention administration) >=4., At 1 month after the RSVPreF3 OA vaccine administration (Day 31) compared to baseline (Day 1)|RSV-B Neutralization Titers Expressed as Group GMT in Participants at Increased Risk of RSV-LRTD (Adults-AIR-RSV Group) Compared to OA-RSV Group, Serological assays for the determination of antibodies against RSV-B are performed by neutralization assay. The corresponding antibody titers were expressed in ED60. The ANCOVA model used to calculate the adjusted GMTs for RSV-B neutralizing antibodies included the baseline value as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included Adult AIR_RSV and OA_RSV groups in the model as fixed effect, as specified in Statistical Analysis Plan., At 1 month after the RSVPreF3 OA vaccine administration (Day 31)|RSV-B Neutralization Titers Expressed as Group SRR in Participants at Increased Risk of RSV-LRTD (Adults-AIR-RSV Group) Compared to OA-RSV Group, The SRR is defined as the proportion of participants having a fold increase in neutralization titers (1 month post-study intervention administration over pre-study intervention administration) >=4., At 1 month after the RSVPreF3 OA investigational vaccine administration (Day 31) compared to baseline (Day 1)
A Study of an Ad26.RSV.PreF-based Regimen at the End of Shelf-life in Adults Aged 60 to 75 Years
- Sponsor: Janssen Vaccines & Prevention B.V.
- The purpose of this study is to demonstrate non-inferiority in terms of humoral immune responses of Ad26.RSV.preF-based study vaccine lots representative of different aged vaccine in comparison to a non-aged Ad26.RSV.preF-based study vaccine lot.
- Interventions: BIOLOGICAL: Ad26.RSV.PreF-based Vaccine
- Primary Outcomes Measures: Geometric Mean Titers (GMTs) of Prefusion F-protein (preF) Antibodies as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) 14 Days Post Vaccination, GMTs of pre-F antibodies as assessed by ELISA at 14 days post administration of Ad26/protein preF RSV vaccine were reported., 14 days post vaccination on Day 1 (Day 15)
A Study Evaluating the Immunogenicity of Different Clinical Trial Materials of Ad26.RSV.preF- Based Vaccine in Adults Aged 60 – 75 Years Old
- Sponsor: Janssen Vaccines & Prevention B.V.
- The purpose of this study is to demonstrate non-inferiority in terms of humoral immune responses induced by vaccination with one dose of the Phase 3 clinical trial material (CTM) compared with one dose of the Phase 2b CTM.
- Interventions: BIOLOGICAL: Ad26.RSV.preF-based vaccine
- Primary Outcomes Measures: Geometric Mean Titers (GMTs) of Prefusion F-protein (preF) Antibodies as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) 14 Days Post Vaccination, GMTs of pre-F antibodies as assessed by ELISA at 14 days post administration of Ad26/protein preF RSV based vaccine were reported., 14 days post vaccination on Day 1 (Day 15)
A Study of an Ad26.RSV. preF-based Vaccine in Adults Aged 18 to 59 Years, Including Adults at High Risk for Severe RSV Infection
- Sponsor: Janssen Vaccines & Prevention B.V.
- The purpose of the study is to investigate the safety and immunogenicity of the Ad26.RSV.preF based vaccine in adults 18 to 59 years of age who are healthy or at risk for severe Respiratory Syncytial Virus (RSV) disease, compared to adults 65 years and above. to TNFi, or for whom TNFi is contraindicated.
- Interventions: BIOLOGICAL: Ad26.RSV.preF-based Vaccin, OTHER: Placebo
- Primary Outcomes Measures: Cohorts 1 and 2: Number of Participants With Solicited Local Adverse Events (AEs), Number of participants with solicited local AEs at 7 days post-vaccination in Cohorts 1 and 2 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs were predefined local events (at the injection site: erythema, pain/tenderness and swelling) that were by definition considered as related to the study vaccine and collected within 7 days after vaccination., 7 days after vaccination on Day 1 (Day 8)|Cohorts 1 and 2: Number of Participants With Solicited Systemic AEs, Number of participants with solicited systemic AEs at 7 days post-vaccination in Cohorts 1 and 2 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited systemic AEs including pyrexia, headache, fatigue, myalgia and nausea were collected within 7 days after vaccination., 7 days after vaccination on Day 1 (Day 8)|Cohorts 1 and 2: Number of Participants With Unsolicited AEs, Number of participants with unsolicited AEs post-vaccination in Cohorts 1 and 2 were reported. An AE was defined as any untoward medical occurrence in a participant participating in a clinical study that did not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were defined as all AEs for which the participant was not specifically questioned in the participant diary., 28 days after vaccination on Day 1 (Day 29)|Cohorts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), Number of participants with SAEs post-vaccination were reported. An AE was defined as any untoward medical event that occurred in a participant administered an investigational product, and it did not necessarily indicated only events with clear causal relationship with the relevant investigational product. SAE was defined as any AE that resulted in: death, persistent or significant disability/incapacity, required inpatient hospitalization or prolongation of existing hospitalization, was life-threatening experience, was a congenital anomaly/birth defect and would jeopardize participant and/or required medical or surgical intervention to prevent one of the outcomes listed above., 6 months after vaccination on Day 1 (Day 183)|Cohorts 1, 2, and 3: Number of Participants With Adverse Events of Special Interest (AESI), Number of participants with AESI post-vaccination were reported. AESIs were significant AEs that were judged to be of special interest because of clinical importance, known or suspected class effects, or based on nonclinical signals. Thrombosis with thrombocytopenia syndrome (TTS) was considered as an AESI., 6 months after vaccination on Day 1 (Day 183)|Cohorts 1 (Group 1), 2 (Group 3), and 3 (Group 5): Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers, RSV A2 strain neutralizing antibody titers of the vaccine-induced immune response was assessed through virus neutralization assay and were expressed as 50% inhibitory concentration (IC50) units., 14 days after vaccination on Day 1 (Day 15)|Cohorts 1 (Group 1), 2 (Group 3), and 3 (Group 5): Percentage of Participants With Seroresponse as Assessed by Virus Neutralizing Assay (VNA-A2), Percentage of participants with seroresponse as assessed by VNA-A2 strain were reported. Seroresponse was defined as a 4-fold increase from baseline in Day 15 VNA A2 antibody titers., 14 days after vaccination on Day 1 (Day 15)
A Phase III Study to Assess the Lot-to-lot Consistency of GSK’s Investigational RSV Maternal Vaccine and the Immune Response and Safety of RSV Maternal Vaccine When Given Alone or Co-administered With GSK’s Influenza D-QIV Vaccine in Healthy Non-pregnant Women
- Sponsor: GlaxoSmithKline
- The purpose of this study is to evaluate the clinical lot-to-lot consistency of the respiratory syncytial virus (RSV) maternal (RSV MAT) vaccine administered to healthy non-pregnant women 18-49 years of age (YOA). In addition, this study will evaluate immunogenicity, safety and reactogenicity from co-administration of RSV MAT vaccine and GSK’s quadrivalent seasonal influenza (Flu D-QIV) vaccine.
- Interventions: COMBINATION_PRODUCT: RSVPreF3(120 μg), COMBINATION_PRODUCT: Flu Quadrivalent influenza vaccine (15 μg HA), COMBINATION_PRODUCT: Placebo
- Primary Outcomes Measures: Percentage of Participants Reporting Solicited Administration Site Events in RSV Pooled Group, RSV+Flu Pooled Group and Flu+Placebo Group, Assessed solicited administration site events include pain, erythema and swelling. This objective analyzed the safety and reactogenicity of RSV MAT vaccine when given alone (pooled lots) or co-administered with Flu D-QIV. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV and RSV+Flu groups and Flu+Placebo Group, since minimal differences were expected between participants who received different RSV lots of the vaccine., From Day 1 to Day 7 (including Day 7)|Percentage of Participants Reporting Solicited Systemic Events in RSV Pooled Group, RSV+Flu Pooled Group and Flu+Placebo Group, Assessed solicited systemic events include fatigue, headache, gastrointestinal (GI) symptoms (nausea, vomiting, diarrhea, abdominal pain) and fever. The preferred location for measuring temperature was the oral cavity. Fever was defined as temperature equal to or above (≥) 38.0 °C/ 100.4 °F. This objective analyzed the safety and reactogenicity of RSV MAT vaccine when given alone (pooled lots) or co-administered with Flu D-QIV. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV and RSV+Flu groups and Flu+Placebo Group, since minimal differences were expected between participants who received different RSV lots of the vaccine., From Day 1 to Day 7 (including Day 7)|Percentage of Participants Reporting Unsolicited Adverse Events (AEs) in RSV Pooled Group, RSV+Flu Pooled Group and Flu+Placebo Group, An unsolicited AE is any AE reported in addition to those solicited during the clinical study. Also, any ‘solicited’ symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited adverse event. This objective analyzed the safety and reactogenicity of RSV MAT vaccine when given alone (pooled lots) or co-administered with Flu D-QIV. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV and RSV+Flu groups and Flu+Placebo Group, since minimal differences were expected between participants who received different RSV lots of the vaccine., From Day 1 to Day 30 (including Day 30)|Percentage of Participants Reporting Serious Adverse Events (SAEs) in RSV Pooled Group, RSV+Flu Pooled Group and Flu+Placebo Group, An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant or results i+F2n abnormal pregnancy outcomes. This objective analyzed the safety and reactogenicity of RSV MAT vaccine when given alone (pooled lots) or co-administered with Flu D-QIV. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV and RSV+Flu groups and Flu+Placebo Group, since minimal differences were expected between participants who received different RSV lots of the vaccine., From Day 1 to Day 30 (including Day 30)|Percentage of Participants Reporting SAEs in RSV Pooled Group, RSV+Flu Pooled Group and Flu+Placebo Group, An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant or results in abnormal pregnancy outcomes.This objective analyzed the safety and reactogenicity of RSV MAT vaccine when given alone (pooled lots) or co-administered with Flu D-QIV. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV and RSV+Flu groups and Flu+Placebo Group, since minimal differences were expected between participants who received different RSV lots of the vaccine., From first vaccination up to study end (Day 1 to Day 181)|RSV MAT Immunoglobulin G (IgG) Enzyme-Linked Immunosorbent Assay (ELISA) Concentrations for Participants in RSV lot1, RSV lot2 and RSV lot3 Groups at Day 31, Serological assays for the determination of IgG antibodies against RSV MAT were performed by ELISA. RSV MAT IgG concentrations were expressed as geometric mean concentrations (GMCs), in ELISA units per milliliter (EU/mL). As pre-specified in protocol, data reported in this outcome measure was presented only for individual RSV lot groups (RSV lot1, RSV lot2, RSV lot3), as the purpose was to analyze RSV MAT IgG ELISA concentrations, in order to demonstrate the lot-to-lot consistency of the vaccine lots., At Day 31|Flu D-QIV Haemagglutinin Inhibition (HI) Antibody Titers Against 3 Influenza Strains for Participants in Flu+Placebo Group and RSV+Flu Pooled Group at Day 31, Flu D-QIV HI antibody titers against 3 influenza strains (A/Tasmania/503/2020 (H3N2) IVR-221; B/Washington/02/2019; B/Phuket/3073/2013) were expressed as geometric mean titers (GMTs), as assessed by HI assay. This objective analyzed the humoral immune response to the Flu D-QIV vaccine when given alone and co-administered with RSV MAT vaccine in terms of antibody titers against 3 influenza strains. As pre-specified in protocol, data reported in this outcome measure was presented for the pooled RSV+Flu Group and Flu+Placebo Group, since minimal differences were expected between participants who received different RSV lots of the vaccine., At Day 31
A Study on the Safety and Immune Response to an Unadjuvanted RSV Maternal Vaccine, in High-Risk Pregnant Women Aged 15 to 49 Years and Infants Born to the Vaccinated Mothers
- Sponsor: GlaxoSmithKline
- “The purpose of this study was to evaluate the safety, reactogenicity and immune response of a single intramuscular dose of the respiratory syncytial virus (RSV) maternal vaccine compared to placebo, when administered in the second or third trimester of pregnancy in women, 15 to 49 years of age (YOA), with high risk pregnancies and in the infants born to the vaccinated mothers.
- Following a recommendation from the Independent Data Monitoring Committee of NCT04605159 (RSV MAT 009), GSK made the decision to stop enrolment and vaccination in the study. Ongoing study participants at that time continued to be monitored as part of the study.”
- Interventions: BIOLOGICAL: RSV MAT, DRUG: Placebo
- Primary Outcomes Measures: “Percentage of Maternal Participants Reporting Any Solicited Administration Site Events, Assessed solicited administration site events included erythema, pain and swelling. Any pain = occurrence of the symptom regardless of intensity grade. Any erythema and swelling = symptom reported with a surface diameter greater than or equal to 20 millimeters., From Day 1 to Day 7 included|Percentage of Maternal Participants Reporting Any Solicited Systemic Events, Assessed solicited systemic events included abdominal pain, diarrhea, fatigue, headache, nausea, fever [temperature equal to or above (>=) 38 degrees Celsius ( °C)/100.4 degrees Fahrenheit ( °F), regardless of the location of measurement] and vomiting. Any = occurrence of the adverse event regardless of intensity grade or relation to study vaccination., From Day 1 to Day 7 included|Percentage of Maternal Participants Reporting Any Unsolicited Adverse Events (AEs), An unsolicited AE was defined as any AE reported in addition to those solicited during the clinical study. Also, any ‘solicited’ symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited AE. Any = occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination., From Day 1 to Day 30 included|Percentage of Maternal Participants Reporting Any Serious Adverse Events (SAEs) From Day 1 up to 42 Days Post-delivery, An SAE was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study participant or resulted in abnormal pregnancy outcomes or in other situations that were considered serious per medical or scientific judgment. Any = occurrence of any SAE regardless of intensity grade or relation to vaccination., From Day 1 up to 42 days post-delivery, an average of 2 months|Number of Maternal Participants Reporting (S)AEs Leading to Study Withdrawal From Day 1 up to 42 Days Post-delivery, A participant was considered to have withdrawn from the study if no new study procedure had been performed or no new information had been collected for her since the date of withdrawal/last contact. (S)AEs leading to study withdrawal were (S)AEs identified by the investigator to cause participant withdrawal until the resolution of the event. These participant withdrawals were considered different from participant withdrawals for other reasons., From Day 1 up to 42 days post-delivery, an average of 2 months|Percentage of Maternal Participants Reporting Medically Attended Adverse Events (MAEs) From Day 1 up to 42 Days Post-delivery, An MAE was defined as an unsolicited AE for which the participant received medical attention such as hospitalization, or an emergency room visit, or visit to/by a health care provider., From Day 1 up to 42 days post-delivery, an average of 2 months|Percentage of Live Births With no Congenital Anomalies, Live Births With Minor Congenital Anomaly(Ies) and Live Births With at Least 1 Major Congenital Anomaly, The percentage of live births with no congenital anomalies, live births with minor congenital anomaly(ies) only and live births with at least 1 major congenital anomaly is reported., From Day 1 up to 42 days post-delivery, an average of 2 months|Percentage of Maternal Participants Reporting Pregnancy-related Adverse Events of Special Interest (AESIs) From Day 1 up to 42 Days Post-delivery, Pregnancy-related AESIs included preterm labor, provider-initiated preterm birth, premature preterm rupture of membranes, pre-eclampsia, pre-eclampsia with severe features including eclampsia, gestational hypertension and fetal growth restriction., From Day 1 up to 42 days post-delivery, an average of 2 months|Percentage of Maternal Participants Reporting Worsening of Pre-existing Medical Conditions and/or Obstetric Complications From Day 1 up to 42 Days Post-delivery, Worsening of pre-existing medical condition and/or obstetric complication was considered by the investigator, using clinical judgment and the following criteria:
- Change in medication and/or medication dose.
- Medically attended event in relation to pre-existing condition and/or obstetric complication that are outside the routine management of the condition/complication. * SAE and/or hospitalization in relation to pre-existing condition and/or obstetric complication., From Day 1 up to 42 days post-delivery, an average of 2 months|Percentage of Infant Participants Reporting Neonatal/Infant AESIs From Birth up to 42 Days Post-birth, Neonatal/infant AESIs included low birth weight (below [\<] 2500 grams), very low birth weight (\<1500 grams), extremely low birth weight (\<1000 grams), preterm birth (\<37 weeks of gestational age), small for gestational age (weight below 10th percentile for gestational age), congenital anomalies with internal structural defects and neonatal death in a preterm live birth (gestational age equal to or above \[\>=] 28 and \<37 weeks)., From birth up to 42 days post-birth, an average of 2 months|Percentage of Infant Participants Reporting Any SAEs From Birth up to 42 Days Post-birth, An SAE was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect or resulted in other situations that were considered serious per medical or scientific judgment. Any = occurrence of any SAE regardless of intensity grade or relation to vaccination., From birth up to 42 days post-birth, an average of 2 months|Number of Infant Participants Reporting (S)AEs Leading to Study Withdrawal From Birth up to 42 Days Post-birth, A participant was considered to have withdrawn from the study if no new study procedure had been performed or no new information had been collected for her since the date of withdrawal/last contact. (S)AEs leading to study withdrawal were (S)AEs identified by the investigator to cause participant withdrawal until the resolution of the event. These participant withdrawals were considered different from participant withdrawals for other reasons., From birth up to 42 days post-birth, an average of 2 months|Percentage of Infant Participants Reporting MAEs From Birth up to 42 Days Post-birth, An MAE was defined as an unsolicited AE for which the participants received medical attention such as hospitalization, or an emergency room visit, or visit to/by a health care provider., From birth up to 42 days post-birth, an average of 2 months|Percentage of Infant Participants Reporting Any SAEs From Birth up to 180 Days Post-birth, An SAE was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect or resulted in other situations that were considered serious per medical or scientific judgment. Any = occurrence of any SAE regardless of intensity grade or relation to vaccination., From birth up to 180 days post-birth|Number of Infant Participants Reporting (S)AEs Leading to Study Withdrawal From Birth up to 180 Days Post-birth, A participant was considered to have withdrawn from the study if no new study procedure had been performed or no new information had been collected for her since the date of withdrawal/last contact. (S)AEs leading to study withdrawal were (S)AEs identified by the investigator to cause participant withdrawal until the resolution of the event. These participant withdrawals were considered different from participant withdrawals for other reasons., From birth up to 180 days post-birth|Percentage of Infant Participants Reporting MAEs From Birth up to 180 Days Post-birth, An MAE was defined as an unsolicited AE for which the participants received medical attention such as hospitalization, or an emergency room visit, or visit to/by a health care provider., From birth up to 180 days post-birth|Percentage of Infant Participants Reporting Any SAEs From Birth up to 365 Days Post-birth, An SAE was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect or resulted in other situations that were considered serious per medical or scientific judgment. Any = occurrence of any SAE regardless of intensity grade or relation to vaccination., From birth up to 365 days post-birth|Number of Infant Participants Reporting (S)AEs Leading to Study Withdrawal From Birth up to 365 Days Post-birth, A participant was considered to have withdrawn from the study if no new study procedure had been performed or no new information had been collected for her since the date of withdrawal/last contact. (S)AEs leading to study withdrawal were (S)AEs identified by the investigator to cause participant withdrawal until the resolution of the event. These participant withdrawals were considered different from participant withdrawals for other reasons., From birth up to 365 days post-birth|Percentage of Infant Participants Reporting MAEs From Birth up to 365 Days Post-birth, An MAE was defined as an unsolicited AE for which the participants received medical attention such as hospitalization, or an emergency room visit, or visit to/by a health care provider., From birth up to 365 days post-birth|RSV MAT Immunoglobulin G (IgG)-Specific Antibody Concentrations for Maternal Participants at Pre-dosing (Day 1), RSV MAT IgG-specific antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs) in ELISA units per milliliter (ELU/mL)., At pre-dosing (Day 1)|RSV MAT IgG-specific Antibody Concentrations for Maternal Participants at Delivery, RSV MAT IgG-specific antibody concentrations were determined by ELISA and expressed as GMCs in ELU/mL., At delivery|RSV-A Neutralizing Titers for Maternal Participants at Pre-dosing (Day 1), RSV-A neutralizing titers were determined by neutralization assay and expressed as geometric mean titers (GMTs)., At pre-dosing (Day 1)|RSV-A Neutralizing Titers for Maternal Participants at Delivery, RSV-A neutralizing titers were determined by neutralization assay and expressed as GMTs., At delivery|Geometric Mean Ratio (GMR) Between Cord Blood and Maternal RSV MAT IgG-specific Antibody Concentrations, The placental transfer ratio of IgG-specific antibody concentration was determined from cord blood (or infant blood sample collected within 72 hours after birth [if no cord blood could be obtained]) over that of the blood sample from mother at delivery (if no blood sample was collected during delivery)., At delivery (for maternal participants) or within 72 hours after birth (for infant participants)|RSV MAT IgG-specific Antibody Concentrations for Infant Participants at Delivery or Within 72 Hours After Birth, RSV MAT IgG-specific antibody concentrations were determined by ELISA and expressed as GMCs in ELU/mL. The antibody concentrations were measured on the cord blood sample collected at delivery, or on a blood sample collected from the infant within 72 hours after birth (if no cord blood sample could be obtained)., At delivery or within 72 hours after birth|RSV-A Neutralizing Titers for Infant Participants at Delivery or Within 72 Hours After Birth, RSV-A neutralizing titers were determined by neutralization assay and expressed as GMTs. The titers were measured on the cord blood sample collected at delivery, or on a blood sample collected from the infant within 72 hours after birth (if no cord blood sample could be obtained)., At delivery or within 72 hours after birth”
A Study of an Adenovirus Serotype 26 Pre-fusion Conformation-stabilized F Protein (Ad26. RSV. preF) Based Respiratory Syncytial Virus (RSV) Vaccine in the Prevention of Lower Respiratory Tract Disease in Adults Aged 60 Years and Older (EVERGREEN)
- Sponsor: Janssen Vaccines & Prevention B.V.
- The study will enroll up to 27,200 participants in order to demonstrate the efficacy of the active Ad26.RSV.preF-based study vaccine in the prevention of Reverse Transcription Polymerase Chain Reaction (RT-PCR) confirmed Respiratory Syncytial Virus (RSV)-mediated Lower Respiratory Tract Disease (LRTD) when compared to placebo in adults aged 60 years and above.
- Interventions: BIOLOGICAL: Adenovirus serotype 26 (Ad26)-based respiratory syncytial virus (RSV). preF|BIOLOGICAL: Placebo
- Primary Outcomes Measures:Number of Participants With First Occurrence of Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)-Confirmed Respiratory Syncytial Virus (RSV) Mediated Lower Respiratory Tract Disease (LRTD), Number of participants with first occurrence of RT-PCR-confirmed RSV mediated LRTD according to protocol defined criteria were reported. A participant was considered to have RT-PCR-confirmed RSV-mediated LRTD if the following criteria were met: new onset or worsening from baseline of 3 or more of the symptoms as captured on the respiratory infection intensity and impact questionnaire (RiiQ, version 2) at the same assessment time point: cough, short of breath, coughing up phlegm (sputum), and wheezing and confirmation of RSV by RT-PCR in one or more of the nasal swabs, or in the sputum sample. RiiQ symptom scale was a 13-item questionnaire rated on a 4-point scale. Each symptom was rated on a scale of 0 to 3 where 0=None, 1=Mild, 2=Moderate, and 3=Severe. Higher scores indicated greater severity. The total LRTD symptom score was calculated as the mean of the 4 lower respiratory scores (cough, short of breath, coughing up phlegm \[sputum\] and wheezing)., From Baseline (Day 1) up to 12 months
Efficacy Study of GSK’s Investigational Respiratory Syncytial Virus (RSV) Vaccine in Adults Aged 60 Years and Above
- Sponsor: GlaxoSmithKline
- This study will evaluate the efficacy of the RSVPreF3 OA investigational vaccine in preventing Lower Respiratory Tract Disease (LRTD) caused by RSV in adults ≥60 years of age following a single dose of the RSVPreF3 OA vaccine and following annual revaccination doses in Northern Hemisphere (NH) and in Southern Hemisphere (SH). This study will also assess if the vaccine is safe and induces an immune response.
- Interventions: BIOLOGICAL: Placebo, BIOLOGICAL: RSVPreF3 OA vaccine
- Primary Outcomes Measures: Number of Participants With First Episode of RT-PCR Confirmed RSV A and/or B Associated Lower Respiratory Tract Disease (LRTD) During the First Season Following a Single Dose of the RSVPreF3 OA Vaccine, First episode of Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated LRTD during the first season was assessed. The case definition for RSV-confirmed LRTD is as follows: Presence of at least one RSV-positive swab detected by RT-PCR., From Day 15 post-vaccination up to end of season 1 in the Northern Hemisphere (NH) [assessed approximately 6.7 months per participant]
Immunogenicity, Safety, Reactogenicity and Persistence of an Investigational Respiratory Syncytial Virus (RSV) Vaccine in Adults Aged 60 Years and Above
- Sponsor: GlaxoSmithKline
- The purpose of this study is to assess the safety, reactogenicity, immunogenicity and long-term persistence of immune response up to 3 years following a single dose vaccination of GSK’s investigational vaccine RSVPreF3 OA, in adults aged 60 years and above. The study will also evaluate the immunogenicity, safety and reactogenicity of additional vaccine doses given according to different revaccination schedules.
- Interventions: BIOLOGICAL: RSVPreF3 OA investigational vaccine
- Primary Outcomes Measures: Humoral Immune Response in Terms of Respiratory Syncytial Virus (RSV)-A Neutralizing Antibody Geometric Mean Titers (GMTs) at Day 1, RSV-A neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60)., At Day 1|Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Day 31, RSV-A neutralizing antibodies were given as GMTs and expressed as ED60., At Day 31|Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Month 6, RSV-A neutralizing antibodies were given as GMTs and expressed as ED60., At Month 6|Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Month 12, RSV-A neutralizing antibodies were given as GMTs and expressed as ED60., At Month 12|Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Day 1, RSV-B neutralizing antibodies measured as GMTs and expressed as ED60., At Day 1|Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Day 31, RSV-B neutralizing antibodies measured as GMTs and expressed as ED60., At Day 31|Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Month 6, RSV-B neutralizing antibodies measured as GMTs and expressed as ED60., At Month 6|Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Month 12, RSV-B neutralizing antibodies measured as GMTs and expressed as ED60., At Month 12
Potential Guideline That May Be Affected Includes:
- Recommended Adult Immunization Schedule: United States, 2024
- Centers for Disease Control and Prevention (CDC)
- Published: January 12, 2024
- Vaccination of Adults with Cancer
- American Society of Clinical Oncology
- Published: March 17, 2024
This is it – a list of Phase 3 Clinical Trials for RSV Immunization as of July 2024. Stay tuned, for our next Guidelines+ Trials Rundown. Sign up for alerts and stay informed on the latest published guidelines and articles.
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