Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of A Multivalent Group B Streptococcus Vaccine In Healthy Nonpregnant Women And Pregnant Women And Their Infants

Group B Streptococcus Infections Clinical Trial

Official title:

A PHASE 1/2, RANDOMIZED, PLACEBO-CONTROLLED, OBSERVER-BLINDED TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A MULTIVALENT GROUP B STREPTOCOCCUS VACCINE IN HEALTHY NONPREGNANT WOMEN AND PREGNANT WOMEN 18 TO 40 YEARS OF AGE AND THEIR INFANTS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03765073
• Other study ID #: C1091002
• Secondary ID: 2020-005074-96
• Status: Completed
• Phase: Phase 2
• Start date: January 14, 2019
• Est. completion date: March 4, 2024

Study information

• Verified date: March 2024
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Phase 1/2, randomized, placebo-controlled, observer-blinded study will evaluate the safety, tolerability and immunogenicity of the investigational multivalent group B streptococcus vaccine administered at one dose level (various formulations) in healthy nonpregnant women (various formulations at one dose level), and then in healthy pregnant women (various formulations at three dose levels), and finally in healthy pregnant women at a selected dose level/formulation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1214
• Est. completion date: March 4, 2024
• Est. primary completion date: March 4, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 0 Years to 40 Years

Eligibility

Inclusion Criteria Stage 1 Nonpregnant Women:

• Healthy nonpregnant females 18 to 40 years of age at enrollment who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study.

• Negative urine pregnancy test at Visit 1 (prior to vaccination).

• Documented negative HIV, hepatitis C virus (HCV), and acute or chronic hepatitis B virus (HBV) infection at screening.

Inclusion Criteria Stage 1 Booster Vaccination:

• Participant must have received investigational product at Visit 1.

• Healthy nonpregnant female determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for booster vaccination and received investigational product at Visit 1.

• Negative urine pregnancy test at Visit 6 (prior to vaccination).

• Documented negative HIV, hepatitis C virus (HCV), and acute or chronic hepatitis B virus (HBV) infection at screening.

Inclusion Criteria Stage 2 and 3 Maternal Participants:

• Healthy females >=18 and <=40 years of age who are >=27 0/7 (Stage 2) or >=24 0/7 (Stage 3) to <=35 6/7 weeks' gestation on the day of planned vaccination, with an uncomplicated, singleton pregnancy, and at no increased risk for complications and no significant fetal abnormalities observed on ultrasound performed at any time prior to study entry and/or at the screening visit.

• Documented negative HIV antibody, HBV surface antigen, HCV antibody, and syphilis tests at screening.

Inclusion Criteria Stage 2 and 3 Infant Participants:

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

Exclusion Criteria Stage 1 Nonpregnant Women:

• Other 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.

• History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the investigational product or any diphtheria toxoid-containing or CRM197 containing vaccine.

• History of microbiologically proven invasive disease caused by GBS (S agalactiae).

• Previous vaccination with any licensed or investigational GBS vaccine (other than GBS6 received as a primary vaccination at Visit 1), or planned receipt during the participant's participation in the study (through the last blood draw).

Exclusion criteria Stage 2 and 3 Maternal Participants:

• Other 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.

• History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the investigational product or any diphtheria toxoid-containing or CRM197 containing vaccine.

• History of microbiologically proven invasive disease caused by GBS (S agalactiae).

• Previous vaccination with any licensed or investigational group B streptococcus vaccine, or planned receipt during the participant's participation in the study (through the last blood draw).

• Prepregnancy body mass index (BMI) of =40 kg/m2. If prepregnancy BMI is not available, the BMI at the time of the first obstetric visit during the current pregnancy may be used.

• A prior history of or current pregnancy complications or abnormalities that will increase the risk associated with the participant's participation.

• 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.

Exclusion criteria Stage 2 and 3 Infant Participants:

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

Related Conditions & MeSH terms

• Group B Streptococcus Infections
• Streptococcal Infections

Intervention

Biological:
• Multivalent Group B streptococcus vaccine
Various formulations at three dose levels
• Placebo
Saline control

Locations

Country	Name	City	State
South Africa	Empilweni Services and Research Unit (ESRU)	Coronationville	Johannesburg
South Africa	Wits Reproductive Health and HIV Institute	Johannesburg	Gauteng
South Africa	Khayelitsha Hospital	Khayelitsha	Western CAPE
South Africa	Michael Mapongwana Community Health Centre	Khayelitsha	Western CAPE
South Africa	Charlotte Maxeke Johannesburg Academic Hospital	Parktown	Johannesburg
South Africa	FAMCRU	Parow Valley	Western CAPE
South Africa	Respiratory and Meningeal Pathogens Research Unit (RMPRU)	Soweto	Gauteng
United Kingdom	St George's University Hospitals NHS Foundation Trust	London	Tooting
United States	MedPharmics, LLC	Albuquerque	New Mexico
United States	St. Davids Medical Center	Austin	Texas
United States	Tekton Research, Inc	Austin	Texas
United States	Velocity Clinical Research	Cincinnati	Ohio
United States	Lakeview Regional Medical Center	Covington	Louisiana
United States	MedPharmics	Covington	Louisiana
United States	St. Tammany Parish Hospital	Covington	Louisiana
United States	Velocity Clinical Research, Covington	Covington	Louisiana
United States	North Oaks Medical Center	Hammond	Louisiana
United States	North Oaks Obstetrics & Gynecology	Hammond	Louisiana
United States	Meridian Clinical Research	Hastings	Nebraska
United States	Clinical Research Prime	Idaho Falls	Idaho
United States	MedPharmics, LLC	Lafayette	Louisiana
United States	MedPharmics, LLC (Recruitment Call Center)	Lafayette	Louisiana
United States	Chemidox Clinical Trials Inc	Lancaster	California
United States	Chemidox Clinical Trials Inc.	Lancaster	California
United States	Be Well Clinical Studies	Lincoln	Nebraska
United States	Bryan Women's Care Physicians (Maternal Visits & Obstetric Exams)	Lincoln	Nebraska
United States	Frontier Pediatric Care (Follow-Up Visits for Infant Participants)	Lincoln	Nebraska
United States	Boeson Research	Missoula	Montana
United States	Community Hospital	Missoula	Montana
United States	The Birth Center	Missoula	Montana
United States	MedPharmics, LLC	Mobile	Alabama
United States	Velocity Clinical Research	Mobile	Alabama
United States	Meridian Clinical Research, LLC	Norfolk	Nebraska
United States	Sentara Leigh Hospital	Norfolk	Virginia
United States	The Group for Women	Norfolk	Virginia
United States	Tidewater Physicians for Women	Norfolk	Virginia
United States	MedPharmics, LLC	Phoenix	Arizona
United States	Velocity Clinical Research, Covington	Phoenix	Arizona
United States	Velocity Clinical Research, Phoenix	Phoenix	Arizona
United States	Clinical Research Prime Rexburg	Rexburg	Idaho
United States	MedPharmics, LLC	Slidell	Louisiana
United States	Velocity Clinical Research	Slidell	Louisiana
United States	Velocity Clinical Research, Slidell	Slidell	Louisiana
United States	Coastal Pediatric Research	Summerville	South Carolina
United States	Lowcountry Women's Specialists	Summerville	South Carolina
United States	Summerville Medical Center	Summerville	South Carolina
United States	Emerson Clinical Research Institute	Washington	District of Columbia
United States	Emerson Clinical Research Institute	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  South Africa,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentages of nonpregnant women reporting prompted local reactions within 7 days following primary and booster doses of investigational product (pain at the injection site, redness, and swelling).	Describe prompted local reactions for nonpregnant women following investigational product administration.	Day 7
Primary	Percentages of nonpregnant women reporting prompted systemic events within 7 days following primary and booster doses of investigational product (fever, nausea/vomiting, diarrhea, headache, fatigue/tiredness, muscle pain, and joint pain).	Describe prompted systemic events for nonpregnant women following investigational product administration.	Day 7
Primary	Percentages of nonpregnant women reporting adverse events (AEs) through 1 month following administration of the primary and booster doses of investigational product.	Describe AEs for nonpregnant women occurring through 1 month following administration of investigational product.	1 month following administration of investigational product
Primary	Percentages of nonpregnant women reporting SAEs through 6 months following administration of the primary dose of investigational product.	Describe SAEs for nonpregnant women through 6 months following administration of investigational product.	6 months following administration of investigational product
Primary	Percentages of sentinel-cohort maternal participants (Stage 2 only) with clinical laboratory abnormalities following administration of investigational product at the 2-week follow-up visit.	Describe clinical laboratory abnormalities for maternal participants (Stage 2 only) following administration of investigational product at 2-week follow-up visit.	2 weeks following administration of investigational product
Primary	Percentages of maternal participants reporting prompted local reactions within 7 days following administration of investigational product (pain at the injection site, redness, and swelling).	Describe prompted local reactions for maternal participants within 7 days following administration of investigational product (pain at the injection site, redness, and swelling).	Day 7
Primary	Percentages of maternal participants reporting prompted systemic events within 7 days following administration of investigational product (fever, nausea/vomiting, diarrhea, headache, fatigue/tiredness, muscle pain, and joint pain).	Describe prompted systemic events for maternal participants within 7 days following administration of investigational product (fever, nausea/vomiting, diarrhea, headache, fatigue/tiredness, muscle pain, and joint pain).	Day 7
Primary	Percentages of maternal participants reporting AEs through 1 month after administration of investigational product.	Describe AEs through 1 month after administration of investigational product.	1 month after administration of investigational product
Primary	Percentages of maternal participants with SAEs, MAEs, and obstetric complications (prepartum, intrapartum, and postpartum) throughout the study (Visit 1 through the 12-month postdelivery study visit).	Describe SAEs, MAEs, and obstetric complications (prepartum, intrapartum, and postpartum) for maternal participants throughout the study (Visit 1 through the 12-month postdelivery study visit).	12 months after delivery
Primary	Percentages of maternal participants with each delivery outcome (live birth, delivery mode).	Describe delivery outcomes (live birth, delivery mode) for maternal participants.	Delivery
Primary	Percentages of infant participants with specific birth outcomes.	Describe specific birth outcomes for infant participants.	Birth
Primary	Percentages of infant participants with AEs from birth to 6 weeks of age.	Describe AEs for infant participants from birth to 6 weeks of age.	6 weeks of age
Primary	Percentages of infant participants with SAEs, AEs of special interest (major congenital anomalies, developmental delay, and suspected or confirmed GBS infection), and MAEs through 12 months of age.	Describe SAEs, AEs of special interest (major congenital anomalies, developmental delay, and suspected or confirmed GBS infection), and MAEs for infant participants through 12 months of age.	12 months of age
Primary	Percentages of nonpregnant women reporting SAEs approximately 7 to 12 months following the booster doses of investigational product.	Describe SAEs for nonpregnant women 7 to 12 months following administration of investigational product.	7 to 12 months following administration of investigational product
Primary	Percentages of nonpregnant women reporting medically attended adverse events (MAEs) through 6 months following administration of the primary dose of investigational product.	Describe MAEs for nonpregnant women through 6 months following administration of investigational product.	6 months following administration of investigational product
Primary	Percentages of nonpregnant women reporting medically attended adverse events (MAEs) approximately 7 to 12 months following the booster doses of investigational product.	Describe MAEs for nonpregnant women 7 to 12 months following administration of investigational product.	7 to 12 months following administration of investigational product
Secondary	Group B streptococcus (GBS) serotype-specific IgG geometric mean concentrations (GMCs) 1 month after vaccination in nonpregnant women.	Describe GBS serotype-specific IgG geometric mean concentrations (GMCs) 1 month after vaccination in nonpregnant women.	1 month after vaccination
Secondary	GBS serotype-specific IgG GMCs measured at 2 weeks after vaccination in maternal participants.	Describe GBS serotype-specific IgG GMCs measured at 2 weeks after vaccination in maternal participants.	2 weeks after vaccination
Secondary	GBS serotype-specific IgG GMCs in infant participants measured at birth.	Describe GBS serotype-specific IgG GMCs in infant participants measured at birth.	Birth
Secondary	GBS serotype-specific OPA GMTs in infant participants measured at birth.	Describe GBS serotype-specific OPA GMTs in infant participants measured at birth.	Birth
Secondary	GBS serotype-specific IgG GMCs measured at 1 month after vaccination in maternal participants.	Describe GBS serotype-specific IgG GMCs measured at 1 month after vaccination in maternal participants.	1 month after vaccination
Secondary	GBS serotype-specific IgG GMCs measured at delivery in maternal participants.	Describe GBS serotype-specific IgG GMCs measured at delivery in maternal participants.	Delivery
Secondary	GBS serotype-specific OPA GMTs measured at 1 month after vaccination in maternal participants.	Describe GBS serotype-specific OPA GMTs measured at 1 month after vaccination in maternal participants.	1 month after vaccination
Secondary	GBS serotype-specific OPA GMTs measured at delivery in maternal participants.	Describe GBS serotype-specific OPA GMTs measured at delivery in maternal participants.	Delivery
Secondary	GBS serotype-specific IgG geometric mean concentrations (GMCs) measured before a booster vaccination in nonpregnant women	Describe GBS serotype-specific IgG GMCs measured before a booster vaccination in nonpregnant women	Before booster vaccination
Secondary	GBS serotype-specific IgG geometric mean concentrations (GMCs) measured 1 month after a booster vaccination in nonpregnant women	Describe GBS serotype-specific IgG GMCs measured 1 month after a booster vaccination in nonpregnant women	1 month after booster vaccination
Secondary	GBS serotype-specific IgG geometric mean concentrations (GMCs) measured 3 months after a booster vaccination in nonpregnant women	Describe GBS serotype-specific IgG GMCs measured 3 months after a booster vaccination in nonpregnant women	3 months after booster vaccination
Secondary	GBS serotype-specific IgG geometric mean concentrations (GMCs) measured 6 months after a booster vaccination in nonpregnant women	Describe GBS serotype-specific IgG GMCs measured 6 months after a booster vaccination in nonpregnant women	6 months after booster vaccination

External Links

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