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A Study to Evaluate the Safety and Immunogenicity of an Adjuvanted RSV Vaccine in Healthy Older Adults

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: NCT03572062
Recruitment Status : Terminated (Suspended pending amendment)
First Posted : June 28, 2018
Last Update Posted : April 29, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:

The study will evaluate the safety, tolerability, and immunogenicity of up to 7 different RSV vaccine candidates, some with adjuvant, when administered concomitantly with seasonal inactivated influenza vaccine (SIIV) and may evaluate a second dose of RSV vaccine administered12 months after the initial dose.

In addition the study will evaluate a 2-dose regimen administered 2 months apart to 62 subjects.


Condition or disease Intervention/treatment Phase
Respiratory Tract Infection Biological: Formulation A Biological: Formulation B Biological: Formulation C Biological: Placebo Phase 2

Detailed Description:

The study will evaluate the safety, tolerability, and immunogenicity of up to 7 different RSV vaccine candidates, some with adjuvant, when administered concomitantly with SIIV. Healthy male and female subjects between 65 to 85 years of age will be enrolled. Subjects will receive 2 intramuscular injections to assess the concomitant administration of SIIV when given to subjects receiving one of the 3 RSV vaccine dose-level candidates formulated with or without an adjuvant.

If interim support implementation of revaccination, invited, consenting subjects will be revaccinated with the same dose and formulation of the RSV vaccine or placebo received at Visit 1, concomitantly with SIIV. The safety, tolerability, and immunogenicity of the second dose will be evaluated through 12 months after revaccination.

62 subjects will be randomized 1:1 to receive a dose of high dose adjuvanted RSV vaccine or placebo followed by a second dose 2 months later. Safety, tolerability, and immunogenicity will be evaluated. The subjects will be enrolled before the influenza season. There will be no concomitant SIIV administration.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 304 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Observer blind
Primary Purpose: Prevention
Official Title: A PHASE 1/2, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND,DOSE-FINDING, FIRST-IN-HUMAN STUDY TO DESCRIBE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF AN ADJUVANTED RESPIRATORY SYNCYTIAL VIRUS (RSV) VACCINE IN HEALTHY OLDER ADULTS
Actual Study Start Date : June 5, 2018
Actual Primary Completion Date : June 23, 2020
Actual Study Completion Date : August 19, 2020

Arm Intervention/treatment
Experimental: Arm 1
Low dose formulation A and SIIV
Biological: Formulation A
RSV vaccine

Experimental: Arm 2
Low dose formulation B and SIIV
Biological: Formulation B
Adjuvanted RSV vaccine

Experimental: Arm 3
Mid dose formulation A and SIIV
Biological: Formulation A
RSV vaccine

Experimental: Arm 4
Mid dose formulation B and SIIV
Biological: Formulation B
Adjuvanted RSV vaccine

Experimental: Arm 5
High dose formulation A and SIIV
Biological: Formulation A
RSV vaccine

Experimental: Arm 6
High dose formulation B and SIIV
Biological: Formulation B
Adjuvanted RSV vaccine

Experimental: Arm 7
High dose formulation C and SIIV
Biological: Formulation C
RSV vaccine

Placebo Comparator: Arm 8
Placebo and SIIV
Biological: Placebo
Placebo

Experimental: M0M2 Arm 1
High dose formulation B
Biological: Formulation B
Adjuvanted RSV vaccine

Placebo Comparator: M0M2 Arm 2
Placebo
Biological: Placebo
Placebo




Primary Outcome Measures :
  1. Percentage of subjects reporting local reactions and systemic events from day of vaccination 1 until Day 14 [ Time Frame: From day of vaccination until Day 14 ]
    Describe local reactions and systemic events after 1 dose of investigational product

  2. Percentage of subjects reporting Adverse Events (AEs) within 1 month after vaccination [ Time Frame: Within 1 month after vaccination ]
    Describe adverse events (AEs) after vaccination

  3. Percentage of subjects with at least 1 medically attended adverse event (MAE) or serious adverse events (SAE) within 30 days after vaccination, or during the follow-up phase [ Time Frame: Up to 12 months ]
    Describe medically attended (MAEs) and serious adverse events (SAEs)


Secondary Outcome Measures :
  1. RSV A- and RSV B-neutralizing antibody titers [ Time Frame: RSV A- and RSV B-neutralizing antibody titers measured at baseline and 1 month after vaccination. ]
    Immune responses measured by RSV A- and RSV B-neutralizing antibody titers at specified timepoints.

  2. Hemagglutination inhibition assay (HAI) titers [ Time Frame: At baseline and 1 month after vaccination ]
    Immune responses as measured by hemagglutination inhibition assay (HAI) titers at specified timepoints.



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:   65 Years to 85 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Evidence of a personally signed and dated informed consent document (ICD) indicating that the subject has been informed of all pertinent aspects of the study.
  2. Healthy adults who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study.
  3. Willing and able to comply with scheduled visits, vaccination plan, laboratory tests, and other study procedures.
  4. Male and nonchildbearing-potential female adults aged 65 to 85 years at the time of enrollment (signing of the ICD).
  5. Subjects must have received the primary vaccination (RSV vaccine or placebo) at Visit 1 and have signed and dated the ICD for participating in the revaccination stage (applies to Primary Study Cohort - Stage 2 subjects).

Exclusion Criteria:

  1. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.
  2. Participation in other studies involving investigational product within 28 days prior to study entry and/or during study participation.
  3. Known infection with HIV, hepatitis C virus (HCV), or hepatitis B virus (HBV).
  4. Previous vaccination with any licensed or investigational RSV vaccine before enrollment into the study, or planned receipt throughout the study of nonstudy RSV vaccine.
  5. Vaccination with any influenza vaccine within 6 months (182 days) before investigational product administration (applies to Primary Study Cohort - Stages 1 and 2).
  6. History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the investigational product(s), including natural rubber latex. In addition, a history of severe allergic reaction (eg, anaphylaxis) to any substance, including documented allergy to egg proteins (egg or egg products) or chicken proteins.
  7. Subjects with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
  8. Subjects who receive treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt throughout the study. If systemic corticosteroids have been administered short term (<14 days) for treatment of an acute illness, subjects should not be enrolled into the study until corticosteroid therapy has been discontinued for at least 28 days before investigational product administration.Inhaled/nebulized, intra-articular, intrabursal, or topical (epidural, skin or eyes) corticosteroids are permitted.
  9. Subject with a history of autoimmune disease or an active autoimmune disease requiring therapeutic intervention including but not limited to: systemic or cutaneous lupus erythematosus, autoimmune arthritis/rheumatoid arthritis, Guillain-Barré syndrome,multiple sclerosis, Sjögren syndrome, idiopathic thrombocytopenic purpura, autoimmune glomerulonephritis, autoimmune thyroiditis, giant cell arteritis (temporal arteritis), psoriasis, and insulin-dependent diabetes mellitus (type 1).
  10. Receipt of blood/plasma products or immunoglobulin, from 60 days before investigational product administration or planned receipt throughout the study.
  11. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
  12. Female subjects of childbearing potential or who are pregnant or breastfeeding; fertile male subjects who are unwilling to use a highly effective method of contraception for at least 28 days after the last dose of investigational product.
  13. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
  14. Planned donation of blood volumes of approximately 470 mL within 12 weeks after Vaccination 1 (applies to subjects having additional blood drawn for cellular assays).

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): NCT03572062


Locations
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United States, Florida
Qps Mra, Llc
South Miami, Florida, United States, 33143
United States, Illinois
Optimal Research, LLC
Peoria, Illinois, United States, 61614
United States, Nebraska
Synexus Clinical Research US
Fremont, Nebraska, United States, 68025
Quality Clinical Research, Inc.
Omaha, Nebraska, United States, 68114
Australia, New South Wales
Australian Clinical Research Network
Maroubra, New South Wales, Australia, 2035
AIM Centre (Hunter Diabetes Centre)
Merewether, New South Wales, Australia, 2291
Holdsworth House Medical Practice
Sydney, New South Wales, Australia, 2010
Westmead Hospital (Infectious Diseases and Microbiology)
Westmead, New South Wales, Australia, 2145
Australia, Queensland
Data Health Australia Pty Limited (Trading as AusTrials)
Taringa, Queensland, Australia, 4068
Australia, Victoria
Eastern Health
Box Hill, Victoria, Australia, 3128
Emeritus Research Pty. Ltd.
Camberwell, Victoria, Australia, 3124
Monash Medical Centre
Clayton, Victoria, Australia, 3168
Barwon Health
Geelong, Victoria, Australia, 3220
Doctors of Ivanhoe
Ivanhoe, Victoria, Australia, 3079
Australia, Western Australia
Institute for Respiratory Health
Nedlands, Western Australia, Australia, 6009
TrialsWest
Spearwood, Western Australia, Australia, 6163
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: NCT03572062    
Other Study ID Numbers: C3671002
RSV ADJUVANT ( Other Identifier: Alias Study Number )
First Posted: June 28, 2018    Key Record Dates
Last Update Posted: April 29, 2021
Last Verified: April 2021
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 tract infection, RSV, Adjuvant, vaccine
Additional relevant MeSH terms:
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Respiratory Tract Infections
Infection
Respiratory Tract Diseases