Study on the Safety and Immune Response of GBS-NN/NN2 and Tdap Vaccines in Preventing Group B Strep Infection in Healthy Women Aged 18-49

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What is this study about?

This clinical trial is focused on studying the prevention of Group B streptococcus infection, a type of bacterial infection that can be serious. The study involves two vaccines: the GBS-NN/NN2 vaccine and the Tdap vaccine. The GBS-NN/NN2 vaccine is designed to protect against Group B streptococcus, while the Tdap vaccine is used to protect against three diseases: diphtheria, tetanus, and pertussis (whooping cough). The trial will also use a substance called 0.9% sodium chloride, which is a common salt solution.

The purpose of the study is to compare the immune response, which is how the body defends itself against infections, when the GBS-NN/NN2 and Tdap vaccines are given together versus when they are given separately. The study will also look at how safe the GBS-NN/NN2 vaccine is and how the body reacts to it, both when it is given alone and when it is given with the Tdap vaccine. Participants in the study will receive the vaccines through an injection into the muscle, known as an intramuscular injection.

During the study, participants will receive the vaccines and will be monitored for any reactions or side effects. The study will track the participants’ health and immune responses over a period of time to gather information on the effectiveness and safety of the vaccines. The trial aims to ensure that the combination of these vaccines does not reduce the immune response compared to when they are given separately. This information will help in understanding the best way to use these vaccines to prevent infections.

1 joining the trial

Upon joining the trial, you will be asked to provide personal signed informed consent. This means you agree to participate after understanding the trial’s purpose and procedures.

You will need to confirm that you meet the eligibility criteria, such as being a healthy woman aged 18 to 49, and agree to comply with all trial procedures.

2 first vaccination

You will receive the first dose of the GBS-NN/NN2 vaccine, which contains 50 micrograms of each fusion protein combined with 500 micrograms of aluminum as Alhydrogel®. This will be administered as an intramuscular injection.

You may also receive the Tdap vaccine, which is a combination vaccine for diphtheria, tetanus, and pertussis, depending on the group you are assigned to.

3 monitoring and diary

For 28 days after each dose, you will be required to complete an electronic diary (eDiary) using your personal mobile phone. This will help track any reactions or side effects you may experience.

You will be monitored for any local or systemic adverse events (AEs) within 7 days after each dose, and any unsolicited AEs within 28 days after each dose.

4 second vaccination

You will receive a second dose of the vaccine, following the same procedure as the first vaccination.

Monitoring and diary completion will continue as described previously.

5 third vaccination

A third dose of the vaccine will be administered, again following the same procedure.

Monitoring and diary completion will continue as described previously.

6 final monitoring

At 28 days after the third vaccination, your antibody levels will be measured to assess the immune response to the vaccines.

You will continue to be monitored for any serious adverse events (SAEs) until the end of the trial.

Who Can Join the Study?

Women aged 18 to 49 years with a body mass index (BMI) between 17.5 and 40 kg/m².
Able to read, understand, and capable of giving personal signed informed consent.
Willing and able to comply with all trial procedures, including completing an electronic diary (eDiary) using their own mobile phone for 28 days after each dose.
Healthy females at enrollment, as determined by medical history, physical examination, and the clinical judgment of the investigator, or participants with well-controlled, well-treated underlying conditions that will not impact the trial assessments.
Women of childbearing potential must meet one of the following criteria:
- Documented to be surgically sterile or post-menopausal.
- Willing to practice true abstinence throughout the trial and have a negative pregnancy test on Day 1.
- Having same-sex partners only.
- Using at least one highly effective contraceptive method, such as hormonal methods (e.g., contraceptive implants, injectables, oral contraceptives) or non-hormonal methods (e.g., intrauterine device, intrauterine hormone-releasing system) throughout the trial and have a negative pregnancy test on Day 1.
Expected to be available for the duration of the trial and can be contacted by telephone during trial participation.

Who Cannot Join the Study?

Only females can participate in the study. Males are not eligible.
Participants must not be part of a vulnerable population. This means they should not be in a group that might have difficulty giving informed consent or be at risk of being coerced into participating.
Participants should not have any medical conditions that might interfere with the study or put them at risk.
Participants should not be taking any medications or treatments that could affect the study results.
Participants should not have a history of severe allergic reactions to any vaccines or components of the vaccines used in the study.
Participants should not be pregnant or planning to become pregnant during the study period.
Participants should not have any acute illness or fever at the time of enrollment.
Participants should not have received any other vaccines within a certain period before the study starts.
Participants should not have participated in another clinical trial recently.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Universitair Ziekenhuis Gent	Gent	Belgium
Ko-Med Centra Kliniczne Sp. z o.o.	Zamosc	Poland
Umfiorqmpq Og Aawwxbg	Edegem	Belgium

Trial status

Country	Status	Recruitment Start
Belgium	Not yet recruiting	17.12.2024
Poland	Not yet recruiting	17.12.2024

Trial locations

Investigated drugs:

GBS-NN/NN-2 is a vaccine designed to protect against Group B Streptococcus, a type of bacteria that can cause infections in adults and newborns. In this clinical trial, the vaccine is being tested to see how well it works when given to healthy women who are not pregnant. The study aims to find out if the vaccine can trigger a strong immune response, which means it helps the body build defenses against the bacteria. The trial also looks at how safe the vaccine is and whether it causes any side effects when given alone or together with another vaccine.

TDaP Vaccine is a combination vaccine that protects against three serious diseases: tetanus, diphtheria, and pertussis (whooping cough). This vaccine is commonly given to children and adults to help prevent these infections. In the trial, the TDaP vaccine is being administered to see how it interacts with the GBS-NN/NN-2 vaccine. The researchers want to know if giving both vaccines at the same time affects how well they work or if it changes the safety profile of either vaccine.

Group B Streptococcus Infection – Group B Streptococcus (GBS) infection is caused by the bacterium Streptococcus agalactiae. It is commonly found in the intestines, vagina, and rectal area of healthy adults. In newborns, it can lead to serious infections such as sepsis, pneumonia, and meningitis. The infection can be transmitted from mother to child during childbirth. In adults, it may cause urinary tract infections, skin infections, and more severe conditions in those with weakened immune systems. The progression of the disease depends on the individual’s health and the site of infection.

Trial ID:

2023-508563-73-00

Protocol code:

MVX009

Trial Phase:

Therapeutic use (Phase IV)

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Study on the Safety and Immune Response of GBS-NN/NN2 and Tdap Vaccines in Preventing Group B Strep Infection in Healthy Women Aged 18-49

What is this study about?

Who Can Join the Study?

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