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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 Adults 18 To 49 Years Of Age

Primary Purpose

Group B Streptococcal Infections

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Multivalent group B streptococcus vaccine

Placebo

About this trial

This is an interventional prevention trial for Group B Streptococcal Infections

Eligibility Criteria

18 Years - 49 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Healthy adults (male and female) 18 to 49 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 for all female subjects who are of childbearing potential.

Exclusion Criteria:

Male subjects and female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for at least 3 months after the last dose of investigational product.
Acute or chronic medical or psychiatric condition 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. Chronic medical conditions include human immunodeficiency virus, chronic hepatitis B virus (HBV) infection (HBV surface antigen positive), and/or hepatitis C virus infection.
History of severe adverse reaction and/or severe allergic reaction (eg, anaphylaxis) to any vaccine.
History of microbiologically proven invasive disease caused by group B streptococcus (Streptococcus agalactiae).
Previous vaccination with any licensed or investigational group B streptococcus vaccine, or planned receipt during the subject's participation in the study (through the last blood draw).

Sites / Locations

Clinical Research Atlanta
Kentucky Pediatric / Adult Research
J. Lewis Research, Inc. / Foothill Family Clinic
J. Lewis Research, Inc. / Foothill Family Clinic South

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Placebo Comparator

Arm Label

Lowest dose formulation a

Middle dose formulation a

Highest dose formulation a

Lowest dose formulation b

Middle dose formulation b

Highest dose formulation b

Placebo

Arm Description

Multivalent group B streptococcus vaccine

Saline control

Outcomes

Primary Outcome Measures

Percentage of Participants With Clinical Laboratory Abnormalities at 1-Week After Vaccination as Measured by Food and Drug Administration (FDA) Grade

Hemoglobin:Grade(G)1: 11-13.5g/dL, G2:9.5-12.4g/dL,G3:8-10.4 g/dL, G4:<8.0 g/dL; leukocyte increase:G1: 10.8-15*10^9/Liter[L],G2:>15-20*10^9/L, G3:>20-25*10^9/L, G4:>25*10^9/L,leukocyte decrease: G1: 2.5-3.5*10^9/L, G2: 1.5-<2.5*10^9/L, G3: 1-<1.5*10^9/L, G4:<1*10^9/L; neutrophil decrease:G1: 1.5-2*10^9/L, G2:1-<1.5*10^9/L, G3:0.5-<1*10^9/L,G4:<0.5*10^9/L; platelets:G1: 125-140*10^9/L, G2:100-124*10^9/L, G3:25-99*10^9/L, G4:<25*10^9/L; eosinophils: G1: 0.65-1.5*10^9/L, G2:>1.5-5*10^9/L, G3:>5*10^9/L, G4: hypereosinophilic;alanine aminotransferase,aspartate aminotransferase:G1: 1.1-2.5 *ULN, G2:2.6-5.0*ULN, G3:5.1-10*ULN, G4:>10*ULN; alkaline phosphatase:G1: 1.1-2*ULN, G2:2.1-3*ULN, G3:3.1-10*ULN, G4:>10*ULN; Bilirubin:G1: 1.1-1.5*ULN, G2: 1.26-2*ULN,G3: 1.51-3.0*ULN,G4:>1.75*ULN;blood urea nitrogen:G1:23-26mg/dL,G2:27-31mg/dL,G3:>31mg/dL, G4:dialysis;creatinine:G1:1.5-1.7mg/dL,G2:1.8-2mg/dL,G3:2.1-2.5 mg/dL,G4:dialysis.Categories with>=1 participant with abnormality are reported only.

Percentage of Participants With Local Reactions by Maximum Severity Within 14 Days After Vaccination

Local reactions were collected by using an e-diary and included redness, swelling and pain at injection site. Redness and swelling were graded as: mild (2.5-5.0 centimeter [cm]), moderate (greater than [>] 5.0-10.0 cm) and severe (>10.0 cm), grade 4 for redness (necrosis or exfoliative dermatitis) and grade 4 for swelling (necrosis). Pain at injection site was graded as: mild (did not interfere with activity), moderate (repeated use of nonnarcotic pain reliever >24 hours or interfered with activity), severe (any use of narcotic pain reliever or prevented daily activity which resulted in missed days of work or school or was otherwise incapacitating, or included use of narcotics for analgesia), and grade 4 (required emergency room visit or hospitalization). The maximum severity (highest grading) of each location reaction within 14 days of vaccination was derived.

Percentage of Participants With Systemic Events by Maximum Severity Within 14 Days After Vaccination

Fever:38.0-38.4 degree Celsius (C),38.5-38.9 degree C,39.0-40.0 degree C,>40.0 degree C;nausea/vomiting:mild(not interfered with activity/1-2times in 24 hours[hr]),moderate(some interference with activity/>2times in 24hr),severe(prevented daily activity;required intravenous hydration); diarrhea:mild(2-3 loose stools in 24hr),moderate(4-5 loose stools in 24hr),severe(>=6 loose stools in 24 hr); headache:mild(not interfered with activity),moderate(repeated use of non-narcotic pain reliever >24 hr/some interference with activity),severe(significant;any use of narcotic pain reliever/prevented daily activity);fatigue,muscle and joint pain:mild(not interfered with activity), moderate(some interference with activity),severe(significant;prevented daily activity).Prevented daily activity=missed days of work, school/otherwise incapacitating/use of narcotics for analgesia.Nausea/vomiting,diarrhea,headache,fatigue/tiredness,muscle and joint pain: grade 4=emergency room visit or hospitalization.

Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination

An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or that was considered to be an important medical event. AEs included both non-serious AEs and SAEs.

Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Month After Vaccination

An AE was any untoward medical occurrence in a participant in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or that was considered to be an important medical event.

Percentage of Participants With Medically Attended Adverse Events (MAEs) Within 6 Months After Vaccination

Secondary Outcome Measures

GBS6 Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at 1 Month After Vaccination

Serotypes used for evaluation were: Ia, Ib, II, III, IV, and V.

Full Information

NCT ID

NCT03170609

First Posted

May 26, 2017

Last Updated

June 13, 2019

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT03170609

Brief 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 Adults 18 To 49 Years Of Age

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 ADULTS 18 TO 49 YEARS OF AGE

Study Type

Interventional

2. Study Status

Record Verification Date

June 2019

Overall Recruitment Status

Completed

Study Start Date

June 5, 2017 (Actual)

Primary Completion Date

June 25, 2018 (Actual)

Study Completion Date

June 25, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This is the Phase 1/2 first-in-human, randomized, placebo-controlled, observer-blinded study evaluating the investigational multivalent group B streptococcus vaccine. Healthy adults aged 18 to 49 years of age with no history of group B streptococcal vaccination will be randomized to receive either a single intramuscular dose of multivalent group B streptococcus vaccine (various formulations at 3 dose levels) or a placebo (saline control).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Group B Streptococcal Infections

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Sequential Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

365 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lowest dose formulation a

Arm Type

Experimental

Arm Description

Multivalent group B streptococcus vaccine

Arm Title

Middle dose formulation a

Arm Type

Experimental

Arm Description

Multivalent group B streptococcus vaccine

Arm Title

Highest dose formulation a

Arm Type

Experimental

Arm Description

Multivalent group B streptococcus vaccine

Arm Title

Lowest dose formulation b

Arm Type

Experimental

Arm Description

Multivalent group B streptococcus vaccine

Arm Title

Middle dose formulation b

Arm Type

Experimental

Arm Description

Multivalent group B streptococcus vaccine

Arm Title

Highest dose formulation b

Arm Type

Experimental

Arm Description

Multivalent group B streptococcus vaccine

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Saline control

Intervention Type

Biological

Intervention Name(s)

Multivalent group B streptococcus vaccine

Intervention Description

Various formulations at three dose levels

Intervention Type

Biological

Intervention Name(s)

Placebo

Intervention Description

Saline Control

Primary Outcome Measure Information:

Title

Percentage of Participants With Clinical Laboratory Abnormalities at 1-Week After Vaccination as Measured by Food and Drug Administration (FDA) Grade

Description

Time Frame

1 week after vaccination

Title

Percentage of Participants With Local Reactions by Maximum Severity Within 14 Days After Vaccination

Description

Time Frame

Within 14 days after vaccination

Title

Percentage of Participants With Systemic Events by Maximum Severity Within 14 Days After Vaccination

Description

Time Frame

Within 14 days after vaccination

Title

Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination

Description

Time Frame

Within 1 month after vaccination

Title

Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Month After Vaccination

Description

Time Frame

Within 6 months after vaccination

Title

Percentage of Participants With Medically Attended Adverse Events (MAEs) Within 6 Months After Vaccination

Description

Time Frame

Within 6 months after vaccination

Secondary Outcome Measure Information:

Title

GBS6 Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at 1 Month After Vaccination

Description

Serotypes used for evaluation were: Ia, Ib, II, III, IV, and V.

Time Frame

1 month after vaccination

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

49 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy adults (male and female) 18 to 49 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 for all female subjects who are of childbearing potential. Exclusion Criteria: Male subjects and female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for at least 3 months after the last dose of investigational product. Acute or chronic medical or psychiatric condition 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. Chronic medical conditions include human immunodeficiency virus, chronic hepatitis B virus (HBV) infection (HBV surface antigen positive), and/or hepatitis C virus infection. History of severe adverse reaction and/or severe allergic reaction (eg, anaphylaxis) to any vaccine. History of microbiologically proven invasive disease caused by group B streptococcus (Streptococcus agalactiae). Previous vaccination with any licensed or investigational group B streptococcus vaccine, or planned receipt during the subject's participation in the study (through the last blood draw).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Clinical Research Atlanta

City

Stockbridge

State/Province

Georgia

ZIP/Postal Code

30281

Country

United States

Facility Name

Kentucky Pediatric / Adult Research

City

Bardstown

State/Province

Kentucky

ZIP/Postal Code

40004

Country

United States

Facility Name

J. Lewis Research, Inc. / Foothill Family Clinic

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84109

Country

United States

Facility Name

J. Lewis Research, Inc. / Foothill Family Clinic South

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84121

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

IPD Sharing URL

https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

Citations:

PubMed Identifier

32891191

Citation

Absalon J, Segall N, Block SL, Center KJ, Scully IL, Giardina PC, Peterson J, Watson WJ, Gruber WC, Jansen KU, Peng Y, Munson S, Pavliakova D, Scott DA, Anderson AS. Safety and immunogenicity of a novel hexavalent group B streptococcus conjugate vaccine in healthy, non-pregnant adults: a phase 1/2, randomised, placebo-controlled, observer-blinded, dose-escalation trial. Lancet Infect Dis. 2021 Feb;21(2):263-274. doi: 10.1016/S1473-3099(20)30478-3. Epub 2020 Sep 3.

Results Reference

derived

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=C1091001&StudyName=A+Phase+1%2C+Randomized%2C+Observer+Blinded+Trial+To+Evaluate+The+Safety%2C+Tolerability%2C+And+Immunogenicity+Of+A+Multivalent+Group+B+Streptococcus+Vaccine+In+Healthy+Adults+Aged+18+To+49+Years

Description

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

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=C1091001&StudyName=A+Phase+1%2F2%2C+Randomized%2C+Placebo-controlled%2C+Observer-blinded+Trial+To+Evaluate+The+Safety%2C+Tolerability%2C+And+Immunogenicity+Of+A+Multivalent+Group+B+Streptococcus+Vaccine+In+Healthy+Adults+18+To+49+Years+Of+Age

Description

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

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