Safety and Immunogenicity of a Trivalent Group B Streptococcus Vaccine in Healthy Pregnant Women

NCT ID: NCT02046148

Last Updated: 2020-12-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-18
• Study Completion Date: 2016-03-26

Brief Summary

Evaluate the safety and immunogenicity of the trivalent group B streptococcus vaccine in healthy pregnant women. The study will also evaluate the levels of GBS serotype-specific antibodies in infants, placental transfer from the pregnant women to the infant and levels of antibodies in the breast milk.

Conditions

GBS Disease; Streptococcus Agalactiae

Keywords

Maternal vaccine; IgG; IgA; GBS; pregnant women

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

GBS Group

Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).

Group Type: EXPERIMENTAL

GBS trivalent vaccine

Intervention Type: BIOLOGICAL

Intramuscular injection - Liquid formulation of a vaccine containing polysaccharide capsules from serotypes Ia, Ib, and III of the Group B Streptococcus and conjugated to the Corynebacterium diphtheriae CRM197 carrier protein

Placebo Group

Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).

Group Type: ACTIVE_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

Intramuscular injection - Normal saline

Interventions

GBS trivalent vaccine

Intramuscular injection - Liquid formulation of a vaccine containing polysaccharide capsules from serotypes Ia, Ib, and III of the Group B Streptococcus and conjugated to the Corynebacterium diphtheriae CRM197 carrier protein

Intervention Type: BIOLOGICAL

Placebo

Intramuscular injection - Normal saline

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Healthy pregnant women 18-40 years of age, inclusive and at 24 0/7 through 34 6/7 weeks gestation.

2. Individuals who intend to breastfeed for at least 90 days postpartum.

3. Individuals who have given written consent after the nature of the study has been explained according to local regulatory requirements.

4. Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.

5. Individuals who can comprehend and comply with all study procedures and are available for follow-up.

Exclusion Criteria

1. Individuals with history of illness or an ongoing illness that, in the opinion of the investigator, may pose additional risk to the subject if she participates in the study.

2. Individuals with known hypersensitivity to any component of the vaccine.

3. Individuals who received or plan to receive any licensed vaccine within 14 days before or after the study vaccine with the exception of inactivated influenza vaccine which may be administered up to 7 days before or after study vaccine.

4. Individuals with an infection requiring systemic antibiotic or antiviral treatment within 7 days prior to Study Day 1.

5. Individuals determined as high risk for serious obstetrical complication, including:

• Gestational hypertension, as defined by American College of Obstetricians and Gynecologists guidelines (ACOG Practice Bulletin 2012)
• Gestational diabetes which is not controlled by diet and exercise as per American College of Obstetricians and Gynecologists guidelines (ACOG Practice Bulletin 2013)
• Pre-eclampsia or eclampsia as defined by American College of Obstetricians and Gynecologists guidelines (ACOG practice bulletin, 2002)
• HIV infection
• Obesity class II or greater (pre-pregnancy BMI≥35.0)
• multiple pregnancy

6. Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the subject's ability to participate in the study.

7. Individuals who are not able to comprehend and to follow all required study procedures for the whole period of the study.

8. Individuals with known or suspected impairment of the immune system including known or suspected HIV infection or HIV-related disease, a history of or an active autoimmune disorder and receipt of immunosuppressive therapy.

9. Long term use of glucocorticoids, including oral or parenteral prednisone ≥ 20 mg/day or equivalent for more than 2 consecutive weeks (or 2 weeks total) within 30 days prior to enrollment. Use of inhaled, intranasal, or topical corticosteroids is allowed.

10. Individuals participating in any clinical trial with another investigational product during the pregnancy or intent to participate in another clinical study at any time during the conduct of this study.

11. Pregnant with a fetus with a known or suspected congenital anomaly

12. Individuals who are acting as study personnel or immediate family members (brother, sister, child, parent) or the spouse of study personnel.

13. Individuals with a fever (oral temperature ≥ 38°C/100.4 °F) within 3 days prior to intended study vaccination.

14. Individuals with a history of culture confirmed GBS case in the infant(s) previously born to her.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Novartis Vaccines

INDUSTRY

Sponsor Role: collaborator

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Aurora, Colorado, United States

GSK Investigational Site

Baltimore, Maryland, United States

GSK Investigational Site

Durham, North Carolina, United States

GSK Investigational Site

Pittsburgh, Pennsylvania, United States

GSK Investigational Site

Charleston, South Carolina, United States

GSK Investigational Site

Nashville, Tennessee, United States

Countries

United States

References

Swamy GK, Metz TD, Edwards KM, Soper DE, Beigi RH, Campbell JD, Grassano L, Buffi G, Dreisbach A, Margarit I, Karsten A, Henry O, Lattanzi M, Bebia Z. Safety and immunogenicity of an investigational maternal trivalent group B streptococcus vaccine in pregnant women and their infants: Results from a randomized placebo-controlled phase II trial. Vaccine. 2020 Oct 14;38(44):6930-6940. doi: 10.1016/j.vaccine.2020.08.056. Epub 2020 Sep 1.

Reference Type: DERIVED

PMID: 32883555 (View on PubMed)

Other Identifiers

V98_12

Identifier Type: OTHER

Identifier Source: secondary_id

205235

Identifier Type: -

Identifier Source: org_study_id