Ongoing Clinical Trials for Peptostreptococcus Infection
There is currently 1 clinical trial ongoing for conditions related to Peptostreptococcus infection, focusing on preventing Group B Streptococcus infection in pregnant women through vaccination. The trial is examining long-term immunity and booster dose safety in women who previously participated in vaccine studies.
Clinical trial locations
Study of GBS-NN/NN2 vaccine to prevent Group B streptococcus infection in healthy pregnant women: evaluating long-term immunity and booster dose safety during subsequent pregnancy
This trial is taking place in Denmark and focuses on evaluating a vaccine designed to protect against Group B Streptococcus infection. The vaccine, called GBS-NN/NN2, is being studied to understand how long the immune protection lasts after the initial vaccination and how safe and effective a booster dose is when given during a subsequent pregnancy.
Who can participate:
- Women who previously participated in earlier vaccine trials (MVX0004 or MVX0005) and received at least one dose of the GBS-NN/NN2 vaccine
- Adult women aged 18 years or older
- Those who can read, understand, and sign the informed consent document
- Women willing to attend all scheduled clinic visits and follow study procedures
- Those who agree to provide access to their medical records from previous trials
- Women who are available throughout the entire study duration and can be reached by phone
Who cannot participate:
- Women who are currently pregnant or breastfeeding at the time of enrollment
- Those with a history of severe allergic reactions to vaccines or vaccine components
- Women with an active infection or fever above 38°C at the time of vaccination
- Those who received any other vaccine within 30 days before the study
- Women with a history of Group B Streptococcus infection
- Those currently participating in another clinical trial
- Women with serious chronic medical conditions that could interfere with the study
- Those using medications that affect the immune system
- Women with blood disorders or conditions that increase bleeding risk
What the trial involves:
The main goal of this study is to monitor how long the protective antibodies from the vaccine remain in the body and to assess the safety of giving a booster dose during a future pregnancy. Participants will have their blood tested once a year to measure antibody levels throughout the trial period, which runs until 2029.
If a participant becomes pregnant during the trial without receiving a booster dose, blood samples will be collected at delivery, and a cord blood sample will be taken from the baby at birth to measure antibody levels. If a participant becomes pregnant and receives a booster dose, more extensive monitoring will occur, including blood samples before vaccination, one month after, at delivery, and six months after delivery.
Women receiving the booster dose will need to report any injection site reactions or health changes for seven days after vaccination, and any unexpected health events will be monitored for 28 days. Mothers and babies will be monitored for up to six months after delivery.
For infants whose mothers received the booster dose, monitoring includes cord blood collection at birth, blood samples at one month and three months of age, health measurements at birth, and a developmental checkup at six months of age.
The investigational vaccine:
GBS-NN/NN2 is an experimental vaccine given as an injection into the muscle. It works by helping the body create antibodies that can protect against Group B Streptococcus bacteria. The vaccine aims to provide protection not only to the mother but also to pass protective antibodies to the baby before birth, helping to prevent infection in newborns.
Summary
Currently, there is one clinical trial available for patients affected by conditions related to Peptostreptococcus infection, specifically focusing on Group B Streptococcus prevention in pregnant women. The trial is being conducted in Denmark and represents a follow-up study for women who previously participated in earlier vaccine research. The study emphasizes long-term immunity monitoring and the potential benefits of booster vaccination during subsequent pregnancies. This research is particularly important because Group B Streptococcus can cause serious infections in newborns, and effective vaccination strategies could provide significant protection for both mothers and babies.