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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

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ClinicalTrials.gov Identifier: NCT03170609
Recruitment Status : Completed
First Posted : May 31, 2017
Results First Posted : July 2, 2019
Last Update Posted : July 2, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

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).

Condition or disease Intervention/treatment Phase
Group B Streptococcal Infections Biological: Multivalent group B streptococcus vaccine Biological: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 365 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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
Actual Study Start Date : June 5, 2017
Actual Primary Completion Date : June 25, 2018
Actual Study Completion Date : June 25, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Lowest dose formulation a
Multivalent group B streptococcus vaccine
Biological: Multivalent group B streptococcus vaccine
Various formulations at three dose levels

Experimental: Middle dose formulation a
Multivalent group B streptococcus vaccine
Biological: Multivalent group B streptococcus vaccine
Various formulations at three dose levels

Experimental: Highest dose formulation a
Multivalent group B streptococcus vaccine
Biological: Multivalent group B streptococcus vaccine
Various formulations at three dose levels

Experimental: Lowest dose formulation b
Multivalent group B streptococcus vaccine
Biological: Multivalent group B streptococcus vaccine
Various formulations at three dose levels

Experimental: Middle dose formulation b
Multivalent group B streptococcus vaccine
Biological: Multivalent group B streptococcus vaccine
Various formulations at three dose levels

Experimental: Highest dose formulation b
Multivalent group B streptococcus vaccine
Biological: Multivalent group B streptococcus vaccine
Various formulations at three dose levels

Placebo Comparator: Placebo
Saline control
Biological: Placebo
Saline Control




Primary Outcome Measures :
  1. Percentage of Participants With Clinical Laboratory Abnormalities at 1-Week After Vaccination as Measured by Food and Drug Administration (FDA) Grade [ Time Frame: 1 week after vaccination ]
    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.

  2. Percentage of Participants With Local Reactions by Maximum Severity Within 14 Days After Vaccination [ Time Frame: 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.

  3. Percentage of Participants With Systemic Events by Maximum Severity Within 14 Days After Vaccination [ Time Frame: 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.

  4. Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination [ Time Frame: 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.

  5. Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Month After Vaccination [ Time Frame: Within 6 months 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.

  6. Percentage of Participants With Medically Attended Adverse Events (MAEs) Within 6 Months After Vaccination [ Time Frame: Within 6 months 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. An MAE was defined as a non serious AE (AE other than SAE) that resulted in an evaluation at a medical facility.


Secondary Outcome Measures :
  1. GBS6 Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at 1 Month After Vaccination [ Time Frame: 1 month after vaccination ]
    Serotypes used for evaluation were: Ia, Ib, II, III, IV, and V.



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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 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.
  2. Negative urine pregnancy test at Visit 1 for all female subjects who are of childbearing potential.

Exclusion Criteria:

  1. 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.
  2. 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.
  3. History of severe adverse reaction and/or severe allergic reaction (eg, anaphylaxis) to any vaccine.
  4. History of microbiologically proven invasive disease caused by group B streptococcus (Streptococcus agalactiae).
  5. 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03170609


Locations
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United States, Georgia
Clinical Research Atlanta
Stockbridge, Georgia, United States, 30281
United States, Kentucky
Kentucky Pediatric / Adult Research
Bardstown, Kentucky, United States, 40004
United States, Utah
J. Lewis Research, Inc. / Foothill Family Clinic
Salt Lake City, Utah, United States, 84109
J. Lewis Research, Inc. / Foothill Family Clinic South
Salt Lake City, Utah, United States, 84121
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
  Study Documents (Full-Text)

Documents provided by Pfizer:
Study Protocol  [PDF] August 29, 2017
Statistical Analysis Plan  [PDF] February 7, 2018


Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03170609     History of Changes
Other Study ID Numbers: C1091001
First Posted: May 31, 2017    Key Record Dates
Results First Posted: July 2, 2019
Last Update Posted: July 2, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs