Clinical trials: GBS
Group B Streptococcal Infections
Phase I/II Study to a Assess the GBS-06 Vaccine Manufactured by Inventprise, Inc., in Healthy, Non-Pregnant, Adult Women of Childbearing Age.
To assess the safety and tolerability of IVT GBS-06 vaccine administered as a single-dose regimen, at three dosage levels in healthy, non-pregnant, adult women of childbearing age (WOCBA).
- Trial name
- NCT06611371
- Testing
- IVT GBS-06
- Where
- 2 sites in United States, South Africa
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Inventprise Inc.
Infections, Streptococcal, Streptococcal Infections
Safety and Immunogenicity of the Liquid Formulation of Group B Streptococcus Trivalent Vaccine and of the Lyophilized Formulation of Group B Streptococcus Trivalent Vaccine
The purpose of the present study is to assess and compare in healthy non-pregnant women 18 to 40 years of age the safety and immunogenicity of a liquid formulation of Group B Streptococcus (GBS) Trivalent Vaccine (not requiring…
- Trial name
- NCT02270944
- Testing
- GBS Vaccine
- Where
- 9 sites in United States, Belgium and 1 more
- Volunteers
- 1,053 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Group B Streptococcal Infection
Intrapartum Effect of Vancomycin on Rectovaginal GBS Colonization
The aim of this project is to identify the duration of vancomycin administration at which group B streptococcus (GBS) colonization is eradicated from the vaginal and recto-vaginal mucosa.
- Trial name
- NCT02814318
- Testing
- Vaginal and rectovaginal swab cultures
- Where
- 2 sites in United States
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- TriHealth Inc.
Neuromyelitis Optica Spectrum Disorders (NMOSD), Multiple Sclerosis
Cohort Study on Neuroimmune Diseases in the Reproductive Age
Neuroimmune diseases are more prevalent among women of reproductive age. Studies have shown that neuroimmune diseases may impact fertility.
- Conditions
- Neuromyelitis Optica Spectrum Disorders (NMOSD), Multiple Sclerosis, Autoimmune Encephalitis, Myasthenia Gravis
- Trial name
- RANID (NCT07653984)
- Where
- China
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
Invasive Group B Streptococcus (GBS) Disease
A Phase I, Randomized, Single-blind, Controlled, Single Center Study to Evaluate the Safety and Immunogenicity of a Dose Range of Glycoconjugate Antigen Vaccine of Group B Streptococcus in Healthy Women 18- 40 Years of Age
The goals of the proposed study are to evaluate the safety, tolerability and immunogenicity of a GBS vaccine. Previous studies suggest that immune responses against GBS can protect humans from infection.
- Trial name
- NCT00645346
- Testing
- GBS glycoconjugate vaccine
- Where
- Switzerland
- Volunteers
- 130 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Group B Streptococcus Carrier in Childbirth, Group B Streptococcal Infection, Late-Onset
Maternal, Neonatal and Infant Outcomes at Kawempe National Referral Hospital
Maternal immunisation is an evolving field that deserves special attention given its potential to have a significant positive impact on the health of women and children globally, and the potential safety and risk considerations…
- Conditions
- Group B Streptococcus Carrier in Childbirth, Group B Streptococcal Infection, Late-Onset, Group B Streptococcal Infection, Early-Onset, Group B Streptococcus Neonatal Sepsis
- Trial name
- PREPARE (NCT04653948)
- Where
- Uganda
- Volunteers
- 3,423 people, healthy volunteers welcome
- Sponsor
- St George's, University of London
Group B Streptococcus
Developing a Controlled Human Infection Model for Group B Streptococcus (CHIM_GBS)
Group B Streptococcus (GBS) is the leading cause of neonatal sepsis and meningitis. In 2015, it was estimated that worldwide there were at least 320,000 infants with invasive GBS disease, 90,000 infant deaths and 10,000 cases of…
- Trial name
- TIMING (NCT04059510)
- Testing
- rectovaginal swab, pregnancy test, Menstrual cup
- Where
- United Kingdom
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- St George's, University of London
Group B Streptococcal Infection
Study of a Group B Streptococcus Vaccine in Pregnant Women Living With HIV and in Pregnant Women Who do Not Have HIV
A randomised, placebo-controlled, double-blind study to evaluate the safety, tolerability and immunogenicity of the GBS-NN/NN2 (Recombinant protein vaccine against Group B Streptococcus) vaccine in women living with HIV and women…
- Trial name
- NCT04596878
- Testing
- GBS-NN/NN2
- Where
- 3 sites in South Africa, Uganda
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Minervax ApS
Group B Streptococcus (GBS) Disease
A Study to Assess the Persistence of a GBS Antibody in Women Previously Immunized With a GBS Vaccine
This study looks at the body's immune responses to a GBS vaccine 2 years after the orginal vaccine(s) were given in the V98P1 study. Blood will be drawn and evaluated for GBS antibody levels.
- Trial name
- NCT01052935
- Testing
- Group B streptococcus (GBS) vaccine
- Where
- Switzerland
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Novartis
Group B Streptococcal Infection
Effect of Probiotics on GBS Colonization Status During Pregnancy: A Pilot Randomized Controlled Trial
Group B Streptococcus (GBS) is the leading cause of neonatal morbidity and mortality in Canada. It may be passed from a study participant colonized in the genital tract by GBS to their baby during vaginal birth.
- Trial name
- NCT02528981
- Testing
- Probiotic
- Where
- Canada
- Volunteers
- 114 people, healthy volunteers welcome
- Sponsor
- Toronto Metropolitan University
Group B Streptococcus Infection
Study to Assess a Booster Dose of GBS-NN/NN2 Vaccine
This is an open label booster vaccine follow-up study. Participants who had received a primary course of GBS-NN/NN2 or placebo in Study MVX0002 will be invited to return to receive a booster dose (or first dose in the case of…
- Trial name
- NCT05005247
- Testing
- GBS-NN/NN2
- Where
- United Kingdom
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Minervax ApS
Group B Strep Infection
Group B Streptococcus Vaccine in Healthy Females
A Phase I, randomised, single centre, double-blind, placebo-controlled, parallel group study to evaluate the safety, tolerability and immunogenicity of two doses of Group B Streptococcus vaccine.
- Trial name
- MVX0002 (NCT03807245)
- Testing
- GBS-NN/NN2 with Alhydrogel® 25, GBS-NN/NN2 with Alhydrogel® 50
- Where
- United Kingdom
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Minervax ApS
Group B Streptococcal Infection
Immunogenicity and Safety of GBS-NN/NN2 in Pregnant Women
This is a phase II, multicentre, multinational, randomized, parallel group, placebo-controlled study of four vaccination regimens in healthy pregnant women.
- Trial name
- NCT05154578
- Testing
- GBS-NN/NN2 Vaccine
- Where
- 10 sites in Denmark, South Africa and 1 more
- Volunteers
- 269 people, healthy volunteers welcome
- Sponsor
- Minervax ApS
Group B Streptococcus
Membrane Sweeping in Group B Streptococcus (GBS) Positive Patients
Sweeping or stripping of the membranes (in this paper referred to as "membrane sweeping") is a widely utilized technique to hasten delivery for women at 37+ weeks gestation.
- Trial name
- NCT01180023
- Testing
- Sweeping
- Where
- United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- George Washington University
Infection, Pregnancy
Effects of Oral Probiotic Supplementation on Group B Strep (GBS) Rectovaginal Colonization in Pregnancy
The investigators wish to determine if oral probiotic supplementation during the second half of pregnancy decreases maternal GBS recto-vaginal colonization at 35-37 weeks' gestational age, thereby decreasing need for maternal…
- Trial name
- NCT01479478
- Testing
- Probiotic dietary supplement
- Where
- 3 sites in United States
- Volunteers
- 251 people, healthy volunteers welcome
- Sponsor
- Stanford University
Streptococcus Agalactiae Infection
GBS-NN/NN2 (50 µg of Each Fusion Protein [GBS-NN and GBS-NN2] in Combination With 500 µg Aluminum as Alhydrogel®) Given With and Without the Tdap Vaccine in Healthy Non-pregnant Women 18 to 49 Years of Age
The main objectives of the study are to demonstrate the non-inferiority of the immune response induced by co administered GBS-NN/NN2 and tetanus, diphtheria, and acellular pertussis (Tdap) compared to the separate administration…
- Trial name
- NCT06494475
- Testing
- GBS-NN/NN2 vaccine, Tdap vaccine
- Volunteers
- healthy volunteers welcome
- Sponsor
- Minervax ApS
Streptococcus Agalactiae
Feasibility Study for Identifying Anti Capsular Antibody Protection Against Invasive Group B Streptococcus (GBS) Disease in Newborns of 0-6 Days Age (Early Onset Disease [EOD]) as Well as Among Infants of 7-90 Days Age (Late Onset Disease [LOD])
The purpose of this study is to evaluate antibody levels against Group B streptococcus in mothers and the risk of developing invasive Group B streptococcus disease in newborns of less than 6 days age as well as infants of age…
- Trial name
- NCT01888471
- Testing
- Blood sample, Vaginal swab sample
- Where
- South Africa
- Volunteers
- 3,033 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Group B Streptococcus, Invasive Bacterial Diseases (IBD)
Preparing for Maternal GBS Vaccine Trials in Africa
Infections are one of the key causes of newborn deaths. Among them, Group B Streptococcus (GBS) is the leading cause of sepsis and bacterial meningitis in the first 90 days of life.
- Conditions
- Group B Streptococcus, Invasive Bacterial Diseases (IBD), Maternal Immunization
- Trial name
- PROTECT (NCT06833957)
- Where
- 10 sites in Kenya, Malawi and 2 more
- Volunteers
- 18,100 people, healthy volunteers welcome
- Sponsor
- Barcelona Institute for Global Health
Invasive Group B Streptococcus (GBS) Disease
A Phase I, Randomized, Single-blind, Controlled, Single Center Study to Evaluate the Safety and Immunogenicity of a Dose Range of a Monovalent Glycoconjugate Antigen Vaccine of Group B Streptococcus in Healthy Women 18-40 Years of Age
The goals of the proposed study are to evaluate the safety, tolerability and immunogenicity of a GBS vaccine. Previous studies suggest that immune responses against GBS can protect humans from infection.
- Trial name
- NCT00657683
- Testing
- Monovalent GBS-CRM glycoconjugate vaccine
- Where
- Switzerland
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Streptococcus Agalactiae Infection, Neonatal Sepsis
A Follow-up Trial of GBS-NN/NN2 Vaccine in Healthy Pregnant Women
The main objective of the study is to evaluate the persistence of the immunoglobulin G (IgG) antibody responses, specific to Alpha-like protein CN (AlpCN), Ribosomal Protein N (RibN), Alpha-like protein 1N (Alp1N), and Alpha-like…
- Conditions
- Streptococcus Agalactiae Infection, Neonatal Sepsis, Pneumonia, Meningitis
- Trial name
- NCT06592586
- Testing
- GBS-NN/NN2 vaccine
- Where
- 6 sites in Denmark, South Africa
- Volunteers
- 137 people, healthy volunteers welcome
- Sponsor
- Minervax ApS