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VAC18193RSV3001_PLS_22Feb2024

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VAC18193RSV3001_PLS_22Feb2024_Zulu(South Africa)

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.

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

Respiratory Syncytial Viruses

Respiratory Syncytial Virus

Respiratory Syncytial Viruses Prevention

Respiratory Syncytial Virus Prevention

Respiratory Syncytial Virus Infection Prevention

Respiratory Syncytial Virus Infections

Lower Respiratory Tract Disease

Lung Conditions

Heart and lung conditions

Placebo

Adenovirus serotype 26 (Ad26)-based respiratory syncytial virus (RSV). preF

A Randomized, Double-blind, Placebo-controlled Phase 3 Efficacy Study of an Ad26.RSV.preF-based Vaccine in the Prevention of Lower Respiratory Tract Disease Caused by RSV in Adults Aged 60 Years and Older

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).

A participant was considered to have RT-PCR-confirmed RSV-mediated ARI if the following protocol defined criteria were met: ARI episode initiated by the participant and confirmed by the site with symptoms consistent with an ARI (new symptoms or worsening from baseline of at least one of the symptoms as captured on the RiiQ): sore throat, nasal congestion, cough, short of breath, coughing up phlegm (sputum), 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-items 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 ARI symptom score was calculated as the mean of the 4 lower respiratory scores (cough, short of breath, coughing up phlegm [sputum] and wheezing).

Number of participants with first occurrence of any RT-PCR-confirmed RSV mediated LRTD during the second year 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 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-items 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).

A participant was considered to have RT-PCR-confirmed RSV-mediated ARI according to protocol defined criteria were reported. A participant was considered to have RT-PCR-confirmed RSV-mediated ARI if the following criteria were met: ARI episode initiated by the participant and confirmed by the site with symptoms consistent with an ARI (new symptoms or worsening from baseline of at least one of the symptoms as captured on the RiiQ): sore throat, nasal congestion, cough, short of breath, coughing up phlegm (sputum), 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-items 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 ARI symptom score was calculated as the mean of the 4 lower respiratory scores (cough, short of breath, coughing up phlegm [sputum] and wheezing).

A participant was considered to have clinically relevant disease with specific parameters associated with an RT-PCR-confirmed RSV-mediated ARI if the following criteria were met: the participant had an RT-PCR-confirmed RSV-mediated ARI: ARI episode initiated by the participant and confirmed by the site with symptoms consistent with an ARI (new symptoms or worsening from baseline of at least one of the symptoms as captured on the RiiQ): sore throat, nasal congestion, cough, short of breath, coughing up phlegm (sputum), wheezing and confirmation of RSV by RT-PCR in one or more of the nasal swabs, or in the sputum sample; any of the following associated with ARI: hospitalization, emergency department visit, per clinical judgement of complications, decreased oxygen saturation, tachypnea, need of supplemental oxygen, hypotension, pulmonary function test and arterial blood gas result.

Number of participants with SAEs were reported. An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. An SAE is any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.

Number of participants with potential AESIs 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. AESIs were embolic and thrombotic events, hematopoietic thrombocytopenia, and cerebral hemorrhage.

Number of participants with solicited local AEs 7 days post vaccination were reported. An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Solicited local AEs were precisely defined events that participants were specifically asked about and which were noted by participants in the diary. Solicited local AEs included erythema, swelling, and pain/tenderness at the study vaccine injection site, were used to assess the reactogenicity of the study vaccine and were pre-defined local (injection site). All solicited AEs at the injection site (local) were considered related to the study vaccine administration.

Number of participants with solicited systemic AEs 7 days post vaccination were reported. An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Solicited systemic AEs included fatigue, headache, myalgia, nausea, pyrexia, for which participants were specifically questioned and which were noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).

Number of participants with unsolicited AEs 28 days post vaccination were reported. An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Unsolicited adverse events included all adverse events for which the participant was not specifically questioned in the subject diary.

RSV A2 strain neutralizing antibody titers of the vaccine-induced immune response was assessed through virus neutralization assay.

GMTs of preF antibodies IgG at 14 days after the administration of Ad26.RSV.preF-based vaccine as assessed by ELISA were reported.

T-cell IFN gamma responses to RSV F protein specific peptides at 14 days after vaccination as measured by ELISpot assay were reported. RSV F specific T-cell IFN gamma ELISpot responses were measured as counts of spot forming cells per million peripheral blood mononuclear cells (SFC/10^6 PBMCs).

RiiQ symptom scale was a 13-items questionnaire rated on a 4-point scale. The respiratory symptoms included 2 upper respiratory tract infection (URTI) symptoms (nasal congestion and sore throat), 4 lower respiratory tract infection (LRTI) symptoms (cough, wheezing, short of breath, and coughing up phlegm/sputum) and 7 systemic symptoms (headache, feeling feverish, neck pain, body aches and pain, fatigue/tiredness, interrupted sleep, and loss of appetite). 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. RiiQ total Symptom score was the mean of all scores (based on 13 symptoms). The AUC of the change from baseline for the RiiQ total symptom score and the RiiQ lower respiratory symptom score during the ARI was calculated.

All participants in the active group will receive a single dose intramuscular (IM) injection of study vaccine on Day 1.

All participants in the placebo group will receive a single IM injection of matching placebo on Day 1.

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.

Central Research Associates, Inc.

Synexus Clinical Research US, Inc

Achieve Clinical Research, LLC

Optimal Research

Coastal Clinical Research, Inc

Hope Research Institute

Central Phoenix Medical Clinic

Medpharmics, LLC

Clinical Research Consortium Arizona

Baptist Health Center for Clinical Research

Rancho Paseo Medical Group

Hope clinical Research LLC

eStudySite

Velocity Clinical Research, San Diego

Paradigm Clinical Research Centers, Inc.

Encompass Clinical Research

Tekton Research Inc.

JEM Research, LLC

Clinical Research of South Florida, an AMR Company

Prestige Clinical Research Center, Inc.

Avail Clinical Research, LLC

Velocity Clinical Research, Inc.

AMR Fort Myers Clinical Physiology Associates, an AMR company

Velocity Clinical Research, Hallandale Beach

Westside Center for Clinical Research

Jacksonville Center For Clinical Research

Altus Research, Inc

Accel Research Sites

Compass Research LLC

Suncoast Research Group

New Horizon Research Center

Suncoast Research Associates, LLC

Clinical Site Partners, LLC

Harmony Clinical Research Inc

Healthcare Clinical Data Inc.

Clinical NeuroScience Solutions, Inc

Headlands Research Orlando

Progressive Medical Research

Sandhill Research

DBC Research

Palm Beach Research Center

Atlanta Center for Medical Research

Meridian Clinical Research, LLC

Clinical Research Atlanta

Advanced Clinical Research

Christie Clinic

Medisphere Medical Research Center, Llc

The South Bend Clinic Center for Research

Buynak Clinical Research

The Iowa Clinic, P.C.

Heartland Research Associates, LLC

Johnson County Clin-Trials

Heartland Clinical Research

Central Kentucky Research Associates, Inc.

University of Louisville

Centex Studies, Inc.

Clinical Trials of America

Tulane University School of Medicine

AMR New Orleans, Formerly New Orleans Center for Clinical Research - New Orleans, an AMR company

Central Maine Medical Center

Centennial Medical Group

MedPharmics - Biloxi

Jefferson City Medical Group Family

The Center for Pharmaceutical Research (CPR)

Sundance Clinical Research

Mercury Street Medical Group, PLLC

Meridian Clinical Research - Omaha

Clinical Research Consortium, an AMR company

CHEAR Center, LLC

Regional Clinical Research, Inc.

Harlem Hospital Center

Finger Lakes Clinical Research

Richmond Behavioral Associates

Percentage of participants with protocol defined RT-PCR confirmed RSV mediated LRTD will be reported.

Percentage of participants with RT-PCR confirmed RSV-mediated ARI will be reported.

Percentage of participants with RT-PCR confirmed RSV-mediated LRTD during the second year will be reported.

Percentage of participants with RT-PCR confirmed RSV-mediated ARI during the second year will be reported.

Percentage of participants with predefined clinically relevant disease associated with RT-PCR confirmed RSV mediated ARI over the whole study will be reported.

An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

Percentage of participants with AESIs will be reported. Confirmed thrombosis with thrombocytopenia syndrome (TTS) is considered to be an AESI in this study.

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 are pre-defined local (at the injection site) AEs for which participants will be specifically questioned and which will be noted by participants in their ediary for 7 days post vaccination (day of vaccination and the subsequent 7 days). Solicited local AEs are: injection site pain/tenderness, erythema and swelling at the vaccination site.

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. Participants will be instructed on how to note signs and symptoms in the electronic diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic events will include fatigue, headache, nausea, and myalgia.

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. Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant eDiary.

Analysis of neutralizing antibodies to the RSV A strain will be reported.

Antibodies binding to RSV F protein in pre-fusion and/or post-fusion form will be assessed by ELISA.

RSV F-specific cellular immune responses elicited by the different vaccine regimens.

RiiQ is a 4-point scale and it can be scored as a mean of all scores (total symptom scale score) or 2 subscales scores that is respiratory symptoms and systemic symptoms. Respiratory symptoms subscale score is the mean of 6 symptoms, that is, 2 upper respiratory tract infection (URTI) symptoms (nasal congestion and sore throat) and 4 lower respiratory tract infection (LRTI) symptoms (cough, wheezing, shortness of breath, and coughing up phlegm/sputum) whereas systemic symptom subscale score is the mean of 7 systemic symptoms (headache, feeling feverish, neck pain, body aches and pain, fatigue/tiredness, interrupted sleep, and loss of appetite). Each symptom is rated on the scale of 0 to 3 where 0=None, 1=Mild, 2=Moderate, and 3=Severe. Higher scores indicating greater severity.
The area under the curve during the ARI episode is determined.

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

Trials at a glance

Trials at a glance

Plain Language Summary