Clinical trial NCT04071158: A STUDY OF A RSV VACCINE WHEN GIVEN TOGETHER WITH TDAP IN HEALTHY NONPREGNANT WOMEN AGED BETWEEN 18 TO 49 YEARS
Official title: A PHASE 2b, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A RESPIRATORY SYNCYTIAL VIRUS (RSV) VACCINE WHEN ADMINISTERED CONCOMITANTLY WITH TETANUS, DIPHTHERIA, AND ACELLULAR PERTUSSIS VACCINE (TDAP) IN HEALTHY NONPREGNANT WOMEN 18 THROUGH 49 YEARS OF AGE
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Respiratory Tract Infection
Keywords: Respiratory tract infection
Respiratory Syncytial Virus
RSV
Tdap
Tetanus
Diphtheria
Acellular Pertussis
Vaccine
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2019-08-28
Enrollment: 713
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This phase 2b study will evaluate safety, tolerability, and immunogenicity of an RSV vaccine when given together with Tdap in approximately 710 healthy nonpregnant women 18 through 49 years of age. This study will evaluate non-inferiority of RSV vaccine when given with Tdap and vice-versa.

Detailed description: This Phase 2b study will evaluate safety, tolerability, and immunogenicity of an RSV vaccine when given together with Tdap in approximately 710 healthy nonpregnant women 18 through 49 years of age.

The participants will be equally split into 5 treatment groups: One of a possible two dose levels of RSV vaccine (the higher dose level will be formulated with an aluminum hydroxide adjuvant) with either the Tdap or Placebo, or a Tdap and placebo combination.

This study will evaluate non-inferiority of the Tdap when co-administered with RSV vaccine candidate and vice-versa by measuring participants' immune response through appropriate antibody and component levels 1 month after vaccination.

Eligibility criteria: Inclusion Criteria:

* Healthy women ≥18 and ≤49 years of age who are of childbearing potential or not of childbearing potential. (Healthy participants with preexisting stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrollment, can be included.)
* Willing and able to comply with all scheduled visits, treatment plan, lifestyle considerations, and other study procedures.
* Expected to be available for the duration of the study and can be contacted by telephone during study participation.
* Body mass index (BMI) of \<40 kg/m2 at the time of the consent.
* Capable of giving signed informed consent as which includes compliance with the requirements and restrictions listed within.

Exclusion Criteria:

* 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 participant inappropriate for entry into this study.
* Known infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV).
* History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the vaccines being administered in the study.
* History of latex allergy.
* Immunocompromised participants with known or suspected immunodeficiency, as determined by history, laboratory tests, and/or physical examination.
* Any contraindication to Tdap (including encephalopathies).
* 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's syndrome, idiopathic thrombocytopenia purpura, glomerulonephritis, autoimmune thyroiditis, giant cell arteritis (temporal arteritis), psoriasis, and insulin dependent diabetes mellitus (type 1).
* Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
* Women who are pregnant or breastfeeding.
* Previous vaccination with any licensed or investigational RSV vaccine, or planned receipt of nonstudy RSV vaccine throughout the study.
* 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, participants 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 (skin or eyes) corticosteroids are permitted.
* Receipt of blood/plasma products or immunoglobulin within 60 days before investigational product administration or planned receipt throughout the study.
* Current alcohol abuse, marijuana abuse, or illicit drug use.
* Vaccination within 5 years with DTaP or tetanus and diphtheria toxoids adsorbed (Td) vaccine before investigational product administration.
* 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 Pfizer employees, including their family members, directly involved in the conduct of the study.
* Current febrile illness (oral temperature ≥38.0C \[≥100.4F\]) or other acute illness within 48 hours before investigational product administration.
* Receipt of any inactivated vaccine within 14 days and any live vaccine within 28 days before or anticipated receipt of any vaccine within the 14 days after investigational product administration.
* Receipt of short-term (\<14 days) systemic corticosteroids. Investigational product administration should be delayed until systemic corticosteroid use has been discontinued for at least 28 days. Inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids do not require temporary delay of investigational product administration.

Primary outcomes:
measure: Percentage of Participants Achieving Anti-Tetanus Toxoid (TTd) Antibody Concentrations of Greater Than or Equal to (>=) 0.1 International Units Per Milliliter (IU/mL) at 1 Month After Vaccination
timeFrame: 1 month after vaccination
measure: Percentage of Participants Achieving Anti-Diphtheria Toxoid (DTd) Antibody Concentrations of >= 0.1 IU/mL at 1 Month After Vaccination
timeFrame: 1 month after vaccination
measure: Geometric Mean Concentration (GMC) and Geometric Mean Ratio (GMR) of Anti-Pertussis Antibodies 1 Month After Vaccination
timeFrame: 1 month after vaccination
measure: Geometric Mean Titer (GMT) and Geometric Mean Ratio (GMR) of Respiratory Syncytial Virus Subgroup A (RSV A) Neutralizing Antibodies 1 Month After Vaccination Using 2.0 Fold Margin
timeFrame: 1 month after vaccination
measure: Geometric Mean Titer (GMT) and Geometric Mean Ratio (GMR) of Respiratory Syncytial Virus Subgroup B (RSV B) Neutralizing Antibodies 1 Month After Vaccination Using 2.0 Fold Margin
timeFrame: 1 month after vaccination
measure: Percentage of Participants With Prespecified Local Reactions Within 7 Days After Vaccination
timeFrame: Within 7 days after vaccination
measure: Percentage of Participants With Prespecified Systemic Reactions Within 7 Days After Vaccination
timeFrame: Within 7 days after vaccination
measure: Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination
timeFrame: Within 1 month after vaccination (up to 35 days)
measure: Percentage of Participants With Medically Attended Adverse Events (MAE) and Serious Adverse Events (SAE)
timeFrame: Within 1 month after vaccination (up to 35 days)
Secondary outcomes:
measure: Geometric Mean Titer (GMT) and Geometric Mean Ratio (GMR) of Respiratory Syncytial Virus Subgroup A (RSV A) Neutralizing Antibodies 1 Month After Vaccination Using 1.5 Fold Margin
timeFrame: 1 month after vaccination
measure: Geometric Mean Titer (GMT) and Geometric Mean Ratio (GMR) of Respiratory Syncytial Virus Subgroup B (RSV B) Neutralizing Antibodies 1 Month After Vaccination Using 1.5 Fold Margin
timeFrame: 1 month after vaccination
Other outcomes:
measure: Percentage of Participants Achieving Anti-TTd Antibody Concentrations of >= 0.1 IU/mL Before Vaccination
timeFrame: Before vaccination on Day 1
measure: Percentage of Participants Achieving Anti- DTd Antibody Concentrations of >= 0.1 IU/mL Before Vaccination
timeFrame: Before vaccination on Day 1
measure: Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) Neutralizing Antibodies Before Vaccination
timeFrame: Before vaccination on Day 1
measure: Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup B (RSV B) Neutralizing Antibodies Before Vaccination
timeFrame: Before vaccination on Day 1
Locations:
city: Stockbridge
country: United States
facility: Clinical Research Atlanta
state: Georgia
city: Honolulu
country: United States
facility: East-West Medical Research Institute
state: Hawaii
city: Wichita
country: United States
facility: Alliance for multispecialty research
state: Kansas
city: Saint Louis
country: United States
facility: Sundance Clinical Research
state: Missouri
city: Omaha
country: United States
facility: Meridian Clinical Research
state: Nebraska
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Warwick
country: United States
facility: Omega Medical Research
state: Rhode Island
city: Dakota Dunes
country: United States
facility: Meridian Clinical Research, LLC
state: South Dakota
city: Austin
country: United States
facility: Benchmark Research
state: Texas
city: Fort Worth
country: United States
facility: Ventavia Research Group
state: Texas
city: Houston
country: United States
facility: Texas Center for Drug Development
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc.
state: Texas
city: Tomball
country: United States
facility: Martin Diagnostic Clinic
state: Texas
city: Salt Lake City
country: United States
facility: J. Lewis Research, Inc. / Foothill Family Clinic
state: Utah
city: Salt Lake City
country: United States
facility: J. Lewis Research, Inc. / Foothill Family Clinic South
state: Utah
city: South Jordan
country: United States
facility: J. Lewis Research, Inc / Jordan River Family Medicine
state: Utah
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Peterson JT, Zareba AM, Fitz-Patrick D, Essink BJ, Scott DA, Swanson KA, Chelani D, Radley D, Cooper D, Jansen KU, Dormitzer PR, Gruber WC, Gurtman A. Safety and Immunogenicity of a Respiratory Syncytial Virus Prefusion F Vaccine When Coadministered With a Tetanus, Diphtheria, and Acellular Pertussis Vaccine. J Infect Dis. 2022 Jun 15;225(12):2077-2086. doi: 10.1093/infdis/jiab505.