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

NCT03572062 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: C3671002RSV ADJUVANT
• Study Type: interventional
• Target: 317
• Locations: 2 countries
• Sites: 16

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.

Conditions

Respiratory Tract Infection

Keywords

Respiratory tract infection, RSV, Adjuvant, vaccine

Outcome Measures

Primary Outcomes (4)

• Primary Cohort: Percentage of Participants With Local Reactions Within 14 Days After Vaccination 1

  Local reactions included redness, swelling, and pain at the injection site (left arm) recorded by participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units (range: 1 to 20, and greater than \[\>\] 21). 1 measuring device unit = 0.5 centimeter (cm) and graded as: mild (2.5 to 5.0 cm), moderate (greater than \[\>\] 5.0 to 10.0 cm), and severe (\>10 cm). Pain at injection site was graded as: mild (did not interfere with activity), moderate (interferes with activity) and severe (prevented daily activity).

  Within 14 days after Vaccination 1

• Primary Cohort: Percentage of Participants With Systemic Events Within 14 Days After Vaccination 1

  Systemic events included fever, fatigue/tiredness, headache, vomiting, nausea, diarrhea, muscle pain and joint pain recorded by participants in an e-diary. Fever was graded as: mild (38.0 to 38.4 degrees \[deg\] Celsius \[C\]), moderate (38.5 to 38.9 deg C), severe (39 deg C to 40.0 deg C) and grade 4 (\>40.0 deg C). Fatigue, headache, nausea, muscle 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 (1-2 times in 24 hours \[h\]), moderate (\>2 times in 24h) and severe (required intravenous hydration). Diarrhea was graded as: mild (2-3 loose stools in 24h), moderate (4-5 loose stools in 24h) and severe (6 or more loose stools in 24h).

  Within 14 days after Vaccination 1

• Primary Cohort: Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination 1

  An AE is any untoward medical occurrence in a study participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. AEs included both serious and non-serious adverse events.

  Within 1 month after Vaccination 1

• Primary Cohort: Percentage of Participants With Medically Attended Adverse Events (MAEs) and Serious Adverse Events (SAEs) Through 12 Months After Vaccination 1

  An MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. A SAE is any untoward medical occurrence at any dose: results in death; is life-threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); results in congenital anomaly/birth defect.

  Up to 12 months after Vaccination 1

Secondary Outcomes (2)

• Primary Cohort: Geometric Mean Titers (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Respiratory Syncytial Virus Subgroup B (RSV B) Neutralizing Antibodies Before and 1 Month After Vaccination 1

  Before vaccination and 1 Month after Vaccination 1

• Primary Cohort: Hemagglutination Inhibition Assay (HAI) and Neutralizing Antibody Geometric Mean Titers for All Strains Following the Seasonal Inactivated Influenza Vaccine (SIIV) Before and 1 Month After Vaccination 1

  Before vaccination and 1 Month after Vaccination 1

Study Arms (10)

Arm 1

EXPERIMENTAL

Low dose formulation A and SIIV

Biological: Formulation A

Arm 2

EXPERIMENTAL

Low dose formulation B and SIIV

Biological: Formulation B

Arm 3

EXPERIMENTAL

Mid dose formulation A and SIIV

Biological: Formulation A

Arm 4

EXPERIMENTAL

Mid dose formulation B and SIIV

Biological: Formulation B

Arm 5

EXPERIMENTAL

High dose formulation A and SIIV

Biological: Formulation A

Arm 6

EXPERIMENTAL

High dose formulation B and SIIV

Biological: Formulation B

Arm 7

EXPERIMENTAL

High dose formulation C and SIIV

Biological: Formulation C

Arm 8

PLACEBO COMPARATOR

Placebo and SIIV

Biological: Placebo

M0M2 Arm 1

EXPERIMENTAL

High dose formulation B

Biological: Formulation B

M0M2 Arm 2

PLACEBO COMPARATOR

Placebo

Biological: Placebo

Interventions

Formulation A BIOLOGICAL

RSV vaccine

Arm 1; Arm 3; Arm 5

Formulation B BIOLOGICAL

Adjuvanted RSV vaccine

Arm 2; Arm 4; Arm 6; M0M2 Arm 1

Formulation C BIOLOGICAL

RSV vaccine

Arm 7

Placebo BIOLOGICAL

Placebo

Arm 8; M0M2 Arm 2

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.
• Willing and able to comply with scheduled visits, vaccination plan, laboratory tests, and other study procedures.
• Male and nonchildbearing-potential female adults aged 65 to 85 years at the time of enrollment (signing of the ICD).
• 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).

You may not qualify if:

• 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.
• Participation in other studies involving investigational product within 28 days prior to study entry and/or during study participation.
• Known infection with HIV, hepatitis C virus (HCV), or hepatitis B virus (HBV).
• Previous vaccination with any licensed or investigational RSV vaccine before enrollment into the study, or planned receipt throughout the study of nonstudy RSV vaccine.
• Vaccination with any influenza vaccine within 6 months (182 days) before investigational product administration (applies to Primary Study Cohort - Stages 1 and 2).
• 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.
• Subjects with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
• 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.
• 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).
• Receipt of blood/plasma products or immunoglobulin, from 60 days before investigational product administration or planned receipt throughout the study.
• Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
• 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.
• 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.
• 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).

Sponsors & Collaborators

• Pfizer: lead

Study Sites (16)

Qps Mra, Llc

South Miami, Florida, 33143, United States

Location

Optimal Research, LLC

Peoria, Illinois, 61614, United States

Location

Synexus Clinical Research US

Fremont, Nebraska, 68025, United States

Location

Quality Clinical Research, Inc.

Omaha, Nebraska, 68114, United States

Location

Australian Clinical Research Network

Maroubra, New South Wales, 2035, Australia

Location

AIM Centre (Hunter Diabetes Centre)

Merewether, New South Wales, 2291, Australia

Location

Holdsworth House Medical Practice

Sydney, New South Wales, 2010, Australia

Location

Westmead Hospital (Infectious Diseases and Microbiology)

Westmead, New South Wales, 2145, Australia

Location

Data Health Australia Pty Limited (Trading as AusTrials)

Taringa, Queensland, 4068, Australia

Location

Eastern Health

Box Hill, Victoria, 3128, Australia

Location

Emeritus Research Pty. Ltd.

Camberwell, Victoria, 3124, Australia

Location

Monash Medical Centre

Clayton, Victoria, 3168, Australia

Location

Barwon Health

Geelong, Victoria, 3220, Australia

Location

Doctors of Ivanhoe

Ivanhoe, Victoria, 3079, Australia

Location

Institute for Respiratory Health

Nedlands, Western Australia, 6009, Australia

Location

TrialsWest

Spearwood, Western Australia, 6163, Australia

Location

Related Publications (1)

• Baber J, Arya M, Moodley Y, Jaques A, Jiang Q, Swanson KA, Cooper D, Maddur MS, Loschko J, Gurtman A, Jansen KU, Gruber WC, Dormitzer PR, Schmoele-Thoma B. A Phase 1/2 Study of a Respiratory Syncytial Virus Prefusion F Vaccine With and Without Adjuvant in Healthy Older Adults. J Infect Dis. 2022 Dec 13;226(12):2054-2063. doi: 10.1093/infdis/jiac189.

  PMID: 35543281 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Limitations and Caveats

Study follow up of the Month-0, Month-2 cohort was terminated early due to sponsor decision, with all participants followed up through 6 months after Vaccination 2.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Observer blind
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel

Study Record Dates

• First Submitted: June 1, 2018
• First Posted: June 28, 2018
• Study Start: June 5, 2018
• Primary Completion: June 23, 2020
• Study Completion: August 19, 2020
• Last Updated: August 26, 2021
• Results First Posted: August 26, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share

Locations

US (4); AU (12)