Clinical trial NCT04032093: A PHASE 2B PLACEBO-CONTROLLED, RANDOMIZED STUDY OF A RESPIRATORY SYNCYTIAL VIRUS (RSV) VACCINE IN PREGNANT WOMEN
Official title: A PHASE 2B, RANDOMIZED, PLACEBO-CONTROLLED, OBSERVER-BLINDED TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A RESPIRATORY SYNCYTIAL VIRUS (RSV) VACCINE IN PREGNANT WOMEN 18 THROUGH 49 YEARS OF AGE AND THEIR INFANTS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Respiratory Tract Infection
Keywords: Respiratory tract infection
Respiratory Syncytial Virus
RSV
Vaccine
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2019-07-25
Enrollment: 1153
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 the safety, tolerability, and immunogenicity of an RSV vaccine in pregnant participants who receive either one of 2 dose levels of the vaccine, formulated with or without aluminum hydroxide, or placebo, and investigate safety and characteristics of antibodies in their infants.

Detailed description: This Phase 2b, multicenter, randomized, placebo-controlled study will evaluate the safety, tolerability, and immunogenicity of a respiratory syncytial virus stabilized prefusion F subunit vaccine (RSV vaccine) in pregnant participants who receive either one of 2 dose levels of the vaccine, formulated with or without aluminum hydroxide, or placebo, as well as assess safety and characteristics of transplacentally transferred antibodies in their infants.

Eligibility criteria: Inclusion Criteria - Maternal participants:

* Healthy women 18 to 49 years of age between 24 and 36 weeks of gestation on the day of planned vaccination, with an uncomplicated pregnancy, who are at no known increased risk for complications, and whose fetus has no significant abnormalities observed on ultrasound.
* Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
* Receiving prenatal standard of care.
* Had an ultrasound performed at \>=18 weeks of pregnancy.
* Had a negative urinalysis for protein and glucose at the screening visit. Trace protein in the urine is acceptable if the blood pressure is also normal.
* Determined by medical history, physical examination, screening laboratory assessment, and clinical judgment to be appropriate for inclusion in the study.
* Documented negative human immunodeficiency virus antibody, hepatitis B virus surface antigen, hepatitis C virus antibody, and syphilis tests at the screening visit.
* Body mass index of \</=40 kg/m2 at the time of the screening visit.
* Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent document and in this protocol.
* Expected to be available for the duration of the study and willing to give informed consent for her infant to participate in the study.

Inclusion Criteria - Infant Participants:

* Evidence of a signed and dated ICD signed by the parent(s).
* Parent(s) willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria - Maternal Participants:

* Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
* History of severe adverse reaction associated with a vaccine and/or severe allergic reaction to any component of the investigational product or any related vaccine.
* History of latex allergy.
* History of any severe allergic reaction.
* Participants with known or suspected immunodeficiency.
* Current pregnancy resulting from in vitro fertilization or other assisted reproductive technology.
* A prior history of or known current pregnancy complications or abnormalities that will increase the risk associated with the participant's participation in and completion of the study.
* Major illness of the mother or conditions of the fetus that, in the investigator's judgment, will substantially increase the risk associated with the participant's participation in, and completion of, the study or could preclude the evaluation of the participant's response.
* Participant 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's syndrome, idiopathic thrombocytopenia purpura, glomerulonephritis, autoimmune thyroiditis, giant cell arteritis (temporal arteritis), psoriasis, and insulin-dependent diabetes mellitus (type 1).
* 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.
* Participation in other studies involving investigational drug(s) within 28 days prior to study entry and/or during study participation.
* Participants who receive treatment with immunosuppressive therapy including cytotoxic agents or systemic corticosteroids (such as for cancer or an autoimmune disease), or planned receipt of such treatment or agents during study participation. 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 30 days before investigational product administration. Inhaled/nebulized, intra articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted.
* Current alcohol abuse or illicit drug use.
* Receipt of blood or plasma products or immunoglobulin, from 60 days before investigational product administration, or planned receipt through delivery, with 1 exception, Rho(D) immune globulin (eg, RhoGAM), which can be given at any time.
* Previous vaccination with any licensed or investigational RSV vaccine or planned receipt during study participation.
* Laboratory test results at the screening visit outside the normal reference value for pregnant women according to their trimester in pregnancy.
* Participants who are breastfeeding at the time of the screening visit.

Exclusion Criteria - Infant Participants:

• Infant who is a direct descendant (eg, child or grandchild) of the study personnel.

Primary outcomes:
measure: Percentage of Maternal Participants With Prespecified Local Reactions by Maximum Severity Within 7 Days After Vaccination
timeFrame: Within 7 days after vaccination
measure: Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination
timeFrame: Within 7 days after vaccination
measure: Percentage of Maternal Participants With Adverse Events (AEs) Within 1 Month After Vaccination
timeFrame: Within 1 month after vaccination
measure: Percentage of Maternal Participants With Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAEs) and Obstetric Complications
timeFrame: From day of vaccination (Day 1) up to 12 months post-delivery
measure: Percentage of Infant Participants With Specific Birth Complications
timeFrame: At birth
measure: Percentage of Infant Participants With Any AE Within 1 Month of Age
timeFrame: Within 1 month after birth
measure: Percentage of Infant Participants With MAEs and SAEs Within 12 Months of Age
timeFrame: Within 12 months after birth
measure: Percentage of Infant Participants With AEs of Special Interest of at Least Moderate Severity Within 12 Months of Age: Congenital Anomalies and Developmental Delay
timeFrame: Within 12 months after birth
Secondary outcomes:
measure: Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Maternal Participants
timeFrame: Before vaccination, 2 weeks and 1 month after vaccination and at delivery
measure: Geometric Mean Fold Rise (GMFR) for Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibody Titers in Maternal Participants
timeFrame: 2 weeks and 1 month after vaccination, at delivery
measure: Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Infant Participants
timeFrame: At birth and at 1, 2, 4, 6 months after birth
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Children's of Alabama
state: Alabama
city: Birmingham
country: United States
facility: UAB Women & Infants Center - UAB Medicine
state: Alabama
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Cullman
country: United States
facility: Cullman Clinical Research, Inc
state: Alabama
city: Cullman
country: United States
facility: Cullman Primary Care, PC
state: Alabama
city: Cullman
country: United States
facility: Cullman Regional
state: Alabama
city: Glendale
country: United States
facility: Arrowhead Hospital
state: Arizona
city: Goodyear
country: United States
facility: Abrazo West Campus Hospital
state: Arizona
city: Phoenix
country: United States
facility: St. Joseph Hospital
state: Arizona
city: Phoenix
country: United States
facility: MedPharmics, LLC
state: Arizona
city: Tucson
country: United States
facility: Mesquite Pediatrics
state: Arizona
city: Tucson
country: United States
facility: Watching Over Mothers and Babies
state: Arizona
city: Bellflower
country: United States
facility: Join Clinical Trials
state: California
city: Chowchilla
country: United States
facility: Chowchilla Hospital Clinic
state: California
city: Huntington Park
country: United States
facility: Join Clinical Trials
state: California
city: Huntington Park
country: United States
facility: Matrix Clinical Research
state: California
city: Los Angeles
country: United States
facility: Join Clinical Trials
state: California
city: Los Angeles
country: United States
facility: East Los Angeles Doctors Hospital
state: California
city: Los Angeles
country: United States
facility: White Memorial Medical Center
state: California
city: Los Angeles
country: United States
facility: Join Clinical Trials
state: California
city: Los Angeles
country: United States
facility: Matrix Clinical Research
state: California
city: Madera
country: United States
facility: Affiliated Physician Practice
state: California
city: Madera
country: United States
facility: Charles E. Ugwu-Oju, MD, FACOG
state: California
city: Madera
country: United States
facility: Madera Community Hospital
state: California
city: Madera
country: United States
facility: Madera Family Medical Group
state: California
city: Monterey Park
country: United States
facility: Monterey Park Hospital
state: California
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: Aurora
country: United States
facility: University of Colorado Anschutz Inpatient Pavilion 2
state: Colorado
city: Aurora
country: United States
facility: University of Colorado AO1
state: Colorado
city: Aurora
country: United States
facility: University of Colorado Hospital Inpatient Pavilion
state: Colorado
city: Aurora
country: United States
facility: University of Colorado Hospital Outpatient Pavilion
state: Colorado
city: Aurora
country: United States
facility: University of Colorado Leprino Building
state: Colorado
city: Aurora
country: United States
facility: University of Colorado Research II Building
state: Colorado
city: Atlanta
country: United States
facility: Emory Children's Center
state: Georgia
city: Blackfoot
country: United States
facility: Bingham Memorial Hospital
state: Idaho
city: Blackfoot
country: United States
facility: Elite Clinical Trials LLLP
state: Idaho
city: Blackfoot
country: United States
facility: Grove Creek Medical Center
state: Idaho
city: Idaho Falls
country: United States
facility: Clinical Research Prime
state: Idaho
city: Idaho Falls
country: United States
facility: Eastern Idaho Regional Medical Center
state: Idaho
city: Idaho Falls
country: United States
facility: Family First Medical Center
state: Idaho
city: Idaho Falls
country: United States
facility: Mountain View Hospital
state: Idaho
city: Idaho Falls
country: United States
facility: Snake River Research, PLLC
state: Idaho
city: Idaho Falls
country: United States
facility: The Pediatric Center
state: Idaho
city: Nampa
country: United States
facility: Saltzer Medical Group
state: Idaho
city: Nampa
country: United States
facility: ASR, LLC
state: Idaho
city: Nampa
country: United States
facility: Saltzer Medical Group
state: Idaho
city: Pocatello
country: United States
facility: Pocatello Women's Health Clinic
state: Idaho
city: Pocatello
country: United States
facility: Portneuf Medical Center
state: Idaho
city: Rigby
country: United States
facility: The Pediatric Center
state: Idaho
city: Ankeny
country: United States
facility: The Iowa Clinic
state: Iowa
city: West Des Moines
country: United States
facility: Methodist West Hospital
state: Iowa
city: West Des Moines
country: United States
facility: The Iowa Clinic
state: Iowa
city: El Dorado
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Kansas
city: Hutchinson
country: United States
facility: Hutchinson Clinic, P.A.
state: Kansas
city: Hutchinson
country: United States
facility: Hutchinson Regional Medical Center
state: Kansas
city: Alexandria
country: United States
facility: Cambridge Medical Trials
state: Louisiana
city: Metairie
country: United States
facility: MedPharmics, LLC
state: Louisiana
city: Blaine
country: United States
facility: Allina Health Blaine Clinic
state: Minnesota
city: Coon Rapids
country: United States
facility: Allina Health Coon Rapids Clinic
state: Minnesota
city: Coon Rapids
country: United States
facility: Allina Health Mercy Women's Clinic
state: Minnesota
city: Coon Rapids
country: United States
facility: Mercy Hospital (Allina Health)
state: Minnesota
city: Coon Rapids
country: United States
facility: The Mother Baby Center at Mercy with Children's (Allina Health)
state: Minnesota
city: Fridley
country: United States
facility: Allina Health Fridley Clinic
state: Minnesota
city: Minneapolis
country: United States
facility: Infectious Disease Research
state: Minnesota
city: Minneapolis
country: United States
facility: Abbott Northwestern Hospital (Allina Health)
state: Minnesota
city: Bay Saint Louis
country: United States
facility: Oshsner Medical Center - Hancock
state: Mississippi
city: Biloxi
country: United States
facility: Merit Health Biloxi
state: Mississippi
city: Gulfport
country: United States
facility: Gulfport Memorial Hospital
state: Mississippi
city: Gulfport
country: United States
facility: Gulfport OB-GYN
state: Mississippi
city: Gulfport
country: United States
facility: MedPharmics, LLC
state: Mississippi
city: Gulfport
country: United States
facility: Singing River Health System
state: Mississippi
city: Chesterfield
country: United States
facility: St Lukes Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Baer Pediatrics
state: Missouri
city: Saint Louis
country: United States
facility: KDB Enterprises
state: Missouri
city: Saint Louis
country: United States
facility: Mercy Hospital St. Louis
state: Missouri
city: Saint Louis
country: United States
facility: Sundance Clinical Research, LLC
state: Missouri
city: Great Falls
country: United States
facility: Boeson Research
state: Montana
city: Missoula
country: United States
facility: Boeson Research
state: Montana
city: Lincoln
country: United States
facility: Bryan Health
state: Nebraska
city: Lincoln
country: United States
facility: Bryan Women's Care Physicians
state: Nebraska
city: Lincoln
country: United States
facility: Midwest Childrens Health Research Institute
state: Nebraska
city: Norfolk
country: United States
facility: Meridian Clinical Research, LLC
state: Nebraska
city: Albuquerque
country: United States
facility: MedPharmics
state: New Mexico
city: Hempstead
country: United States
facility: Winthrop Women's Wellness
state: New York
city: Johnson City
country: United States
facility: Sante Comprehensive Women's Healthcare
state: New York
city: Mineola
country: United States
facility: NYU Winthrop Hospital, Research Pharmacy
state: New York
city: Mineola
country: United States
facility: NYU Winthrop Hospital
state: New York
city: Mineola
country: United States
facility: NYU Winthrop Pediatric Infectious Diseases
state: New York
city: Mineola
country: United States
facility: Women's Contemporary Care Associates
state: New York
city: Rochester
country: United States
facility: University of Rochester Obstetrics and Gynecology
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Durham
country: United States
facility: Duke Children's Primary Care - Roxboro Street
state: North Carolina
city: Durham
country: United States
facility: Duke Regional Hospital
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Durham
country: United States
facility: Duke University Hospital
state: North Carolina
city: Dayton
country: United States
facility: Sugarcamp Family Practice
state: Ohio
city: Dayton
country: United States
facility: Needmore Medical Center
state: Ohio
city: Dayton
country: United States
facility: Kettering Medical Center
state: Ohio
city: Englewood
country: United States
facility: HWC Women's Center Research
state: Ohio
city: Summerville
country: United States
facility: Lowcountry Womens Specialists
state: South Carolina
city: Summerville
country: United States
facility: Summerville Medical Center
state: South Carolina
city: Summerville
country: United States
facility: Coastal Pediatric Research
state: South Carolina
city: Beaumont
country: United States
facility: Center for Women''s Health and Birthcare
state: Texas
city: Beaumont
country: United States
facility: CHRISTUS St. Elizabeth Hospital
state: Texas
city: Beaumont
country: United States
facility: Gadolin Research, LLC
state: Texas
city: Beaumont
country: United States
facility: Pediatric Clinic of Dr. Alvin H. Prause
state: Texas
city: Bedford
country: United States
facility: Texas Health Harris Methodist Hurst-Euless-Bedford Hospital
state: Texas
city: Burleson
country: United States
facility: Texas Health Huguley Hospital South
state: Texas
city: Fort Worth
country: United States
facility: 8th Avenue Obstetrics and Gynecology
state: Texas
city: Fort Worth
country: United States
facility: Baylor Scott & White of Fort Worth
state: Texas
city: Fort Worth
country: United States
facility: Texas Health Harris Methodist Hospital FTW
state: Texas
city: Fort Worth
country: United States
facility: Ventavia Research Group, LLC
state: Texas
city: Fort Worth
country: United States
facility: Texas Health Harris Methodist Hospital Southwest
state: Texas
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
city: Georgetown
country: United States
facility: Chisholm Trail Pediatrics
state: Texas
city: Georgetown
country: United States
facility: FMC Science, LLC
state: Texas
city: Georgetown
country: United States
facility: Georgetown OBGYN
state: Texas
city: Georgetown
country: United States
facility: St. David's Georgetown Hospital
state: Texas
city: Grapevine
country: United States
facility: Baylor Scott & White of Grapevine (Hospital)
state: Texas
city: Houston
country: United States
facility: Dr Van Tran Family Practice
state: Texas
city: Houston
country: United States
facility: HG Pediatrics
state: Texas
city: Houston
country: United States
facility: Memorial Herman Greater Heights Hospital
state: Texas
city: Houston
country: United States
facility: Ventavia Research Group, LLC
state: Texas
city: Houston
country: United States
facility: Texas Center for Drug Development, Inc.
state: Texas
city: Houston
country: United States
facility: Biopharma Informatic, LLC
state: Texas
city: Lampasas
country: United States
facility: AdventHealth Family Medicine Rural Health Clinic, Inc.
state: Texas
city: Lampasas
country: United States
facility: FMC Science
state: Texas
city: Longview
country: United States
facility: DCOL Center For Clinical Research
state: Texas
city: Longview
country: United States
facility: Diagnostic Clinic of Longview
state: Texas
city: Longview
country: United States
facility: Longview Regional Medical Center
state: Texas
city: McAllen
country: United States
facility: Dr. Ruben Aleman and Associates
state: Texas
city: Pharr
country: United States
facility: Exygon Clinical Research
state: Texas
city: Plano
country: United States
facility: Texas Health Presbyterian Hospital
state: Texas
city: Plano
country: United States
facility: Ventavia Research Group LLC
state: Texas
city: Round Rock
country: United States
facility: Ascension Seton Williamson
state: Texas
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Salt Lake City
country: United States
facility: JBR Clinical Research
state: Utah
city: Salt Lake City
country: United States
facility: Old Farm Obstetrics & Gynecology, LLC
state: Utah
city: Salt Lake City
country: United States
facility: St. Marks Hospital
state: Utah
city: Richmond
country: United States
facility: Clinical Research Partners, LLC
state: Virginia
city: Richmond
country: United States
facility: Johnston Willis Hospital
state: Virginia
city: Huntington
country: United States
facility: Cabell Huntington Hospital
state: West Virginia
city: Huntington
country: United States
facility: Marshall Health dba University Pediatrics
state: West Virginia
city: Huntington
country: United States
facility: Marshall Health Department of Obstetrics and Gynecology
state: West Virginia
city: Huntington
country: United States
facility: Translational Genomic Research Institute
state: West Virginia
city: San Miguel de Tucuman
country: Argentina
facility: Clinica Mayo De U.M.C.B. S.R.L.
state: Tucuman
city: San Miguel de Tucuman
country: Argentina
facility: Instituto de Maternidad y Ginecologia, Nuestra Senora de Las Mercedes
state: Tucuman
city: Santiago
country: Chile
facility: Hospital Clinico Universidad de Chile
state: Region Metropolitana
city: Santiago
country: Chile
facility: Hospital Padre Hurtado
state: Region Metropolitana
city: Osorno
country: Chile
facility: Hospital Base San Jose de Osorno
state: Región DE LOS Lagos
city: Santiago
country: Chile
facility: Clinica Universidad de los Andes
state: Región Metropolitana
city: Santiago
country: Chile
facility: Instituto de Investigaciones Materno Infantil (IDIMI)
state: Región Metropolitana
city: Santiago
country: Chile
facility: Hospital San Jose
state: Región Metropolitana
city: Santiago
country: Chile
facility: Grupo Estudios Clinicos Infectologia Respiratoria, Facultad de Medicina Universidad de Chile
state: Región Metropolitana
city: Santiago
country: Chile
facility: Centro Internacional de Estudios Clinicos - CIEC
state: Región Metropolitana
city: Santiago
country: Chile
facility: Hospital San Borja Arriaran
state: RM
city: Christchurch
country: New Zealand
facility: Christchurch Clinical Studies Trust Ltd
city: Christchurch
country: New Zealand
facility: Christchurch Hospital (Canterbury District Health Board)
city: Soweto
country: South Africa
facility: Respiratory and Meningeal Pathogens Research Unit (RMPRU)
state: Gauteng
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Simoes EAF, Center KJ, Tita ATN, Swanson KA, Radley D, Houghton J, McGrory SB, Gomme E, Anderson M, Roberts JP, Scott DA, Jansen KU, Gruber WC, Dormitzer PR, Gurtman AC. Prefusion F Protein-Based Respiratory Syncytial Virus Immunization in Pregnancy. N Engl J Med. 2022 Apr 28;386(17):1615-1626. doi: 10.1056/NEJMoa2106062.