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Trial record 1 of 1 for:    NCT05842967
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A Study to Assess the Safety, Tolerability, and Immunogenicity of RSVpreF in Adults at High Risk of Severe RSV Disease (MONET)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05842967
Recruitment Status : Completed
First Posted : May 6, 2023
Last Update Posted : April 9, 2024
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:

The purpose of this study is to learn about the safety and immunogenicity of a study vaccine (called RSVpreF) in several adult groups. Respiratory Syncytial Virus (RSV) is a common type of virus (germ) that can cause severe illness, where medical help is needed. RSV can lead to airway diseases in all ages. Vaccines help your body make antibodies which help fight against diseases. This is called an immune response. This study will measure how much antibody participants make after receiving RSVpreF (immunogenicity).

The study consists of 2 groups (Substudy A and Substudy B).

Substudy A is seeking approximately 675 participants who are:

  • Between 18 and 60 years of age.
  • Considered having a high likelihood of severe RSV disease due to certain long-term medical conditions. Such medical conditions do not include immunocompromising conditions.

Participants will need to come to the study clinic at least 2 times. At the first clinic visit, participants will receive 1 shot of RSVpreF or placebo in the arm by chance. A placebo looks like the study vaccine but contains no active ingredients. At each clinic visit, a blood sample will be taken. A third (final) visit can be either completed in clinic or via telephone contact. This study is about 6 months long for each participant.

Substudy B is seeking approximately 200 participants who are:

  • At least 18 years of age. About half of the participants will be at least 60 years of age.
  • Considered having a weakened immune system (immunocompromised). Participants will need to come to the study clinic at least 3 times. All participants will receive a shot of RSVpreF at the first study clinic visit. The second study clinic visit will be 1 month later. All participants will receive a second shot of the study vaccine at this second study clinic visit. Blood samples will be taken at the 3 study clinic visits. A fourth (final) visit can be either completed in clinic or via telephone contact. This study is about 7 months long for each participant.

Condition or disease Intervention/treatment Phase
RESPIRATORY SYNCYTIAL VIRUS (RSV) Biological: RSVpreF Other: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 886 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Substudy A: Phase 3, multicenter, randomized, double-blinded, placebo-controlled study that will assess the safety, tolerability, and immunogenicity of Pfizer's RSVpreF in adults 18 to <60 years of age considered to be at high risk of RSV disease due to certain chronic medical conditions. Approximately 675 participants ≥18 to <60 years of age considered at high risk of RSV disease due to certain chronic medical conditions, excluding immunocompromising conditions, will be randomized to receive a single 120-µg dose of RSVpreF or placebo in a 2:1 ratio.

Substudy B: Phase 3, single-arm, open-label, multicenter study that will assess the safety, tolerability, and immunogenicity of Pfizer's RSVpreF in immunocompromised adults. Approximately 200 immunocompromised adults ≥18 years of age will receive 2 120-µg doses of RSVpreF with an interval of 1 month. Approximately 100 participants will be ≥60 years of age and approximately 100 participants will be ≥18 to 60 years of age.

Masking: Triple (Participant, Care Provider, Investigator)
Masking Description:

Substudy A is double blind therefore all parties (participant, site staff and sponsor) will be blinded to study intervention.

Substudy B is open-label therefore no blinding requirements are in place since all participants will receive RSVpreF.

Primary Purpose: Prevention
Official Title: A PHASE 3 PROTOCOL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF RESPIRATORY SYNCYTIAL VIRUS (RSV) PREFUSION F SUBUNIT VACCINE IN ADULTS AT HIGH RISK OF SEVERE RSV DISEASE
Actual Study Start Date : May 11, 2023
Actual Primary Completion Date : March 18, 2024
Actual Study Completion Date : March 18, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Viral Infections

Arm Intervention/treatment
Experimental: Substudy A - RSVpreF
Participants will receive a single 120-µg dose of RSVpreF at Visit 1
Biological: RSVpreF
120-µg

Placebo Comparator: Substudy A - Placebo
Participants will receive placebo at Visit 1
Other: Placebo
Placebo

Experimental: Substudy B - RSVpreF
Participants will receive 120-µg doses of RSVpreF at Visit 1 and Visit 2 (open label, single arm only)
Biological: RSVpreF
120-µg




Primary Outcome Measures :
  1. Substudy A: Primary Safety - The proportion of participants reporting local reactions [ Time Frame: Within 7 days following study administration intervention ]
    Local reactions included pain at injection site, redness and swelling recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm and graded as mild: >2.0 to 5.0 cm, moderate: > 5.0 to 10.0 cm and severe: >10 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfere with daily activity and severe: prevented daily activity

  2. Substudy A: Primary Safety - The proportion of participants reporting systemic reactions [ Time Frame: Within 7 days following study administration intervention ]
    Systemic reactions: fever, fatigue/tiredness, headache, nausea, muscle pain, joint pain, vomiting, diarrhea and any systemic event recorded by participants in an e-diary. Fever: greater than equal to (>=) 38.0 degrees (deg) Celsius (C), mild (>=38.0 to 38.4 deg C), moderate (>38.4 to 38.9 deg C), severe (>38.9 to 40.0 deg C), and grade 4 (>40.0 deg C). Fatigue, headache, nausea, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24 hours(h), moderate: >2 times in 24h and severe: requires intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h.

  3. Substudy A: Primary Safety - The proportion of participants reporting adverse events [ Time Frame: Through 1 month following study administration intervention ]
    An adverse event was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. Adverse events included both serious and non-serious adverse events.

  4. Substudy A: Primary Safety - The proportion of participants reporting newly diagnosed chronic medical conditions [ Time Frame: Throughout the study duration (an average of 6 months) ]
    A newly diagnosed chronic medical conditions is defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects (eg, asthma).

  5. Substudy A: Primary Safety - The proportion of participants reporting serious adverse events [ Time Frame: Throughout the study duration (an average of 6 months) ]
    Serious adverse event was an adverse event 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.

  6. Substudy A: Primary Immunogenicity - GMT ratio, estimated by the ratio of the geometric mean titers for RSV A and RSV B serum NTs with RSVpreF in Study C3671023 participants to that in Study C3671013 adults ≥60 years of age. [ Time Frame: 1 month after vaccination ]
    RSV A and RSV B neutralizing titers, expressed as geometric mean titers. geometric mean titers (GMT) ratio of the geometric mean titers for RSV A and RSV B serum neutralizing titers with RSVpreF in Study C3671023 participants to that in Study C3671013 adults ≥60 years of age.

  7. Substudy A: Primary Immunogenicity - Difference in seroresponse rate of RSV A and RSV B serum neutralizing titers at 1 month after vaccination with RSVpreF between participants in Study C3671023 and in Study C3671013 [ Time Frame: 1 month after vaccination ]
    Seroresponse is defined as a postvaccination neutralizing titer ≥4 times the lower limit of quantitation if baseline titer is below the lower limit of quantitation; or a ≥4-fold rise from baseline if the baseline titer is above the lower limit of quantitation

  8. Substudy B: Primary Safety - The proportion of participants reporting local reactions [ Time Frame: Within 7 days following study administration intervention ]
    Local reactions included pain at injection site, redness and swelling recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm and graded as mild: >2.0 to 5.0 cm, moderate: > 5.0 to 10.0 cm and severe: >10 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfere with daily activity and severe: prevented daily activity

  9. Substudy B: Primary Safety - The proportion of participants reporting systemic reactions [ Time Frame: Within 7 days following study administration intervention ]
    Systemic reactions: fever, fatigue/tiredness, headache, nausea, muscle pain, joint pain, vomiting, diarrhea and any systemic event recorded by participants in an e-diary. Fever: greater than equal to (>=) 38.0 degrees (deg) Celsius (C), mild (>=38.0 to 38.4 deg C), moderate (>38.4 to 38.9 deg C), severe (>38.9 to 40.0 deg C), and grade 4 (>40.0 deg C). Fatigue, headache, nausea, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24 hours(h), moderate: >2 times in 24h and severe: requires intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h.

  10. Substudy B: Primary Safety - The proportion of participants reporting adverse events [ Time Frame: Through 1 month following the last dose of study intervention administration ]
    An adverse event was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. Adverse events included both serious and non-serious adverse events.

  11. Substudy B: Primary Safety - The proportion of participants reporting newly diagnosed chronic medical donditions [ Time Frame: Throughout the study duration (an average of 7 months) ]
    A newly diagnosed chronic medical condition is defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects (eg, asthma).

  12. Substudy B: Primary Safety - The proportion of participants reporting serious adverse events [ Time Frame: Throughout the study duration (an average of 7 months) ]
    Serious adverse events was an adverse events 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.

  13. Substudy B: Primary Immunogenicity - Geometric mean titers of neutralizing titers for RSV A and RSV B [ Time Frame: At each blood sampling visit (Day 1, 1-month after vaccination 1, 1-month after vaccination 2) ]
    RSV A and RSV B neutralizing titers, expressed as geometric mean titers. The neutralizing titers were calculated as the interpolated reciprocal of the serum dilution resulting in 50% reduction in the number of viral focus forming units when compared to the control without test serum

  14. Substudy B: Primary Immunogenicity - Geometric mean fold rise of neutralizing titers for RSV A and RSV B [ Time Frame: From before vaccination to each postvaccination blood sampling visit (Day 1, 1-month after vaccination 1, 1-month after vaccination 2) ]
    RSV A and RSV B neutralizing titers, expressed as geometric mean fold rise. The neutralizing titers were calculated as the interpolated reciprocal of the serum dilution resulting in 50% reduction in the number of viral focus forming units when compared to the control without test serum


Secondary Outcome Measures :
  1. Substudy A: Secondary Immunogenicity - Geometric mean titers of neutralizing titers for RSV A and RSV B [ Time Frame: At each blood sampling visit (Day 1 and 1-month after vaccination) ]
    RSV A and RSV B neutralizing titers, expressed as geometric mean titers. The neutralizing titers were calculated as the interpolated reciprocal of the serum dilution resulting in 50% reduction in the number of viral focus forming units when compared to the control without test serum

  2. Substudy A: Secondary Immunogenicity - Geometric mean fold rise of neutralizing titers for RSV A and RSV B [ Time Frame: From before vaccination to the postvaccination blood sampling visit (Day 1 and 1-month after vaccination) ]
    RSV A and RSV B neutralizing titers, expressed as geometric mean fold rise. The neutralizing titers were calculated as the interpolated reciprocal of the serum dilution resulting in 50% reduction in the number of viral focus forming units when compared to the control without test serum



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Substudy A Inclusion Criteria:

  1. Capable of giving signed informed consent as described per protocol.
  2. Participants ≥18 to <60 years of age at study enrollment.
  3. Life expectancy ≥12 months (365 days) in the opinion of the investigator at enrollment.
  4. Participants who are willing and able to comply with all scheduled visits, vaccination plan, lifestyle considerations, and other study procedures.
  5. Participants who are considered at high risk of RSV disease by virtue of the following:

    • Adults with chronic pulmonary (including asthma), cardiovascular (excluding isolated hypertension), renal, hepatic, neurologic, hematologic, or metabolic disorders (including diabetes mellitus).

Chronic medical conditions for this substudy are defined as:

- Duration greater than 6 months.

  • Stable disease not requiring a significant change in therapy in the previous 6 weeks or hospitalization for worsening disease within 12 weeks before receipt of study intervention.
  • Requires regular medical follow-up or ongoing medication or hospitalization in the previous year.

    • Additional groups at high risk include:

  • Residents of nursing homes and other long-term care facilities.

Substudy A Exclusion Criteria:

  1. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
  2. History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s) or any related vaccine.
  3. Participants who do not have adequate deltoid muscle mass to allow intramuscular vaccination, in the opinion of the investigator.
  4. Serious chronic disorder, including metastatic malignancy, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that, in the investigator's opinion, excludes the participant from participating in the study.
  5. Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
  6. Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.

    Note: Specific criteria for participants with known stable infection with HIV can be found in protocol.

  7. Individuals who receive chronic systemic treatment with immunosuppressive therapy, including cytotoxic agents, immunosuppressive monoclonal antibodies, systemic corticosteroids*, eg, for cancer or an autoimmune disease, or radiotherapy, from 60 days before study intervention administration or planned receipt throughout the study.

    *Applies to systemic corticosteroids administered for ≥14 days at a dose of ≥20 mg/day of prednisone or equivalent (eg, for cancer or an autoimmune disease). Systemic corticosteroids administered at a dose of <20 mg/day of prednisone or equivalent are permitted. Inhaled/nebulized, intra-articular, intrabursal, or topical (skin, eyes, or ears) corticosteroids are permitted.

  8. Receipt of blood/plasma products or immunoglobulin within 60 days before study intervention administration or planned receipt of these medications prior to the final blood draw.

    Note: Monoclonal antibodies with targeted mechanisms of action used in the management of chronic illnesses (eg, migraine headaches, osteoporosis) are permitted, provided they do not meet exclusion criterion 7.

  9. Previous vaccination with any licensed or investigational RSV vaccine or planned receipt during study participation.
  10. Participation in other studies involving an investigational product within 28 days prior to consent and/or through and including the 6-month follow-up visit.
  11. Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.

Substudy B Inclusion Criteria

  1. Capable of giving signed informed consent as described per protocol.
  2. Participants ≥18 years of age at study enrollment.
  3. Life expectancy ≥12 months (365 days) in the opinion of the investigator at enrollment.
  4. Participants who are willing and able to comply with all scheduled visits, vaccination plan, lifestyle considerations, and other study procedures.
  5. Participants who are immunocompromised by virtue of the following:

    •Having known advanced NSCLC with at least 1 of the following:

    • Has received initial or maintenance chemotherapy at least 2 weeks (14 days) before enrollment (or is treatment-naïve), and is not expected to receive chemotherapy within at least 2 weeks (14 days) after dose administration of initial vaccination or second vaccination; and/or
    • Is receiving checkpoint inhibitor treatment (PD-1/PD-L1 inhibitor, CTLA-4 inhibitor) and has undergone at least 1 treatment cycle prior to enrollment; or
    • Is receiving targeted drug therapy (EGFR, ALK, ROS1, BRAF, RET, MET, NTRK inhibitors) and has undergone at least 1 treatment cycle prior to enrollment.

    OR - Is currently undergoing maintenance hemodialysis treatment secondary to end-stage renal disease . OR - Is on active immunomodulator therapy (eg, TNFα inhibitor, tofacitinib, or MTX) for an autoimmune inflammatory disorder (eg, inflammatory arthritis, such as rheumatoid arthritis, psoriatic arthritis, and juvenile idiopathic arthritis, or inflammatory bowel disease, such as ulcerative colitis or Crohn's disease) at a stable*dose.

    *Stable dose is defined as receiving the same dose for at least 3 months (84 days) with no changes in the 28 days prior to enrollment. See protocol for details on stable dose for MTX.

    OR - Is receiving an SOT (kidney, liver, lung, or heart) at least 3 months (84 days) prior to enrollment (Visit 201) and with no acute rejection episodes within 2 months (60 days) prior to enrollment (Visit 201).

    Substudy B Exclusion Criteria:

1.Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.

2.History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s) or any related vaccine.

3.Participants with a history of transplant rejection, or PTLD, or participants who have had treatment for these conditions within 3 months (84 days) prior to study enrollment.

4.Participants who do not have adequate deltoid muscle mass to allow intramuscular vaccination, in the opinion of the investigator.

5.Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.

Note: Specific criteria for participants with known stable infection with HIV can be found in protocol.

6.Receipt of investigational or approved monoclonal antibodies against RSV within 6 months before study intervention administration.

7.Receipt of blood/plasma products or immunoglobulin (IVIG, SCIG) within 60 days before study intervention administration or planned receipt of these medications prior to the final blood draw.

Note: Please see the inclusion criteria in the protocol regarding criteria for targeted immunoglobulin therapies for underlying medical conditions.

Note: Monoclonal antibodies with targeted mechanisms of action used in the management of chronic illnesses (eg, migraine headaches, osteoporosis) are permitted.

8.Previous vaccination with any licensed or investigational RSV vaccine or planned receipt during study participation.

9.Participation in other studies involving an investigational product within 28 days prior to consent and/or through and including the 6-month follow-up visit.

10.Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05842967


Locations
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Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT05842967    
Other Study ID Numbers: C3671023
First Posted: May 6, 2023    Key Record Dates
Last Update Posted: April 9, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pfizer:
RESPIRATORY SYNCYTIAL VIRUS (RSV)
ADULTS AT HIGH RISK
IMMUNOCOMPROMISED ADULTS