Clinical trials: Group B Streptococcus
Pregnancy
Quasi Experiment of Prenatal Probiotics Against Group B Streptococcus Colonization
This pilot quasi experiment was designed to determine the feasibility of a randomized controlled trial of the oral probiotic combination of Florajen3 (>7.5 x109 L. acidophilus, >6.0 x109. B. lactis, and >1.5 x109 B.
- Trial name
- NCT02249325
- Testing
- Probiotic dietary supplement
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Marquette University
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
Streptococcus Infection, Pregnancy
Rapid Diagnostic Test for Detection of Group B Streptococcus in Pregnancy
This study evaluates the use of a new method of growing and detecting Group B streptococcus in pregnant women. This new method utilizes sandwiched-membrane petri technology and has the advantage of detecting GBS in less than 6…
- Trial name
- GBS (NCT01445717)
- Where
- United States
- Volunteers
- 358 people, healthy volunteers welcome
- Sponsor
- The University of Texas Health Science Center, Houston
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
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
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
Group B Streptococcal Infections
A TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A BOOSTER DOSE OF A GROUP B STREPTOCOCCUS 6 VALENT POLYSACCHARIDE CONJUGATE VACCINE (GBS6) IN HEALTHY ADULTS
This study is an extension to the completed first-in-human C1091001 study (NCT03170609) and is to evaluate the safety and immunogenicity of a single booster vaccine dose of GBS6, administered approximately 2 years or more after a…
- Trial name
- NCT04258995
- Testing
- Group B streptoccous 6-valent polysaccharide conjugate vaccine (GBS6)
- Where
- 4 sites in United States
- Volunteers
- 151 people, healthy volunteers welcome
- Sponsor
- Pfizer
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
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
Bacterial Infections, Group B Streptococcus
Evaluation of Two Type III GBS Polysaccharide-Tetanus Toxoid Conjugate Vaccines
The purpose of this study is to test the safety and favorable immune response to an anti-streptococcal vaccine (a vaccine that treats a common bacterial infection) in healthy non-pregnant women.
- Trial name
- NCT00008853
- Testing
- GBS III-TT-SSI, GBS III-TT-MPHL
- Where
- United States
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Streptococcal Infection, Gram-positive Bacterial Infection
Immune Response Induced by a Vaccine Against Group B Streptococcus and Safety in Pregnant Women and Their Offsprings
The study investigated the immune response induced by the Group B streptococcus vaccine in healthy pregnant women. In addition, the study investigated the amount of vaccine induced antibodies which were transferred to the newborn.
- Conditions
- Streptococcal Infection, Gram-positive Bacterial Infection, Bacterial Infection
- Trial name
- NCT01446289
- Testing
- Group B Streptococcus Trivalent Vaccine
- Where
- 5 sites in Belgium, Canada
- Volunteers
- 86 people, healthy volunteers welcome
- Sponsor
- Novartis
Immunisation During Pregnancy, Group B Streptococcus
Group B Streptococcus: Attitudes to Immunisation in Pregnancy
Group B Streptococcus (GBS) is the commonest cause of severe infection and meningitis in babies under 3 months in the United Kingdom (UK).
- Trial name
- NCT01982084
- Where
- 4 sites in United Kingdom
- Volunteers
- 758 people, healthy volunteers welcome
- Sponsor
- University of Oxford
GBS Rectovaginal Colonization, Neonatal Sepsis
Probiotics and GBS Colonization in Pregnancy
Multicentric, randomized, placebo-controlled, double-blind, parallel group study aimed at evaluating the feasibility and effect of the use of probiotic starting from the 30th week, on vaginal / rectal colonization of GBS in women…
- Trial name
- NCT05156333
- Testing
- Respecta
- Where
- 3 sites in Italy
- Volunteers
- 402 people, healthy volunteers welcome
- Sponsor
- University of Modena and Reggio Emilia
Streptococcus Agalactiae
Evaluation of the Consumption of a Probiotic on the Load of S. Agalactiae.
The objective of this study is to evaluate the effects of oral administration of Lactobacillus BSL_PS71 on the presence of S. agalactiae in vaginal microbiota of healthy women.
- Trial name
- NCT04165551
- Testing
- Probiotic
- Where
- Spain
- Volunteers
- 3 people, healthy volunteers welcome
- Sponsor
- Biosearch S.A.
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
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
Dengue, Chikungunya
Risk Assessment of Community Spread of Multiple Endemic Infectious Diseases in a One Health Perspective
RACSMEI addresses the high burden of infectious diseases in low- and middle-income countries, including Cambodia, where limited surveillance and laboratory capacity often obscure etiologies and transmission dynamics.
- Conditions
- Dengue, Chikungunya, Zika Virus Infection, Japanese Encephalitis
- Trial name
- RACSMEI (NCT07358910)
- Where
- Cambodia
- Volunteers
- 10,000 people, healthy volunteers welcome
- Sponsor
- Institut Pasteur du Cambodge
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
Neonatal Infections, Streptococcus Agalactiae
Real-Time PCR for the Detection of Vaginal Group B Streptococcus Carriage: a Medico-Economic Study
Group B streptococcus infections may be serious for the neonates. The infection can occur during the birth, by contact with the genital area.
- Trial name
- BBFAST (NCT00920530)
- Where
- France
- Volunteers
- 224 people, healthy volunteers welcome
- Sponsor
- Centre Hospitalier Universitaire de Saint Etienne
Group B Streptococcal Infection
Oral Probiotics Reduce Group B Streptococci Colonization in Pregnant Women
The purpose of this study is to examine whether daily use of oral gelatin capsules containing dried viable Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14 can reduce the GBS colonization rate of vagina and rectum in…
- Trial name
- NCT01577108
- Testing
- Probiotic
- Where
- Taiwan
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- China Medical University Hospital