Ongoing Clinical Trials for Pertussis (Whooping Cough)
Currently, there are 3 ongoing clinical trials investigating pertussis vaccination strategies, primarily focusing on protecting infants through maternal vaccination during pregnancy. These trials are taking place in Belgium and Finland, studying how timing and maternal immunization affect long-term immunity in children. (Also known as: Whooping Cough)
Clinical trial locations
- Belgium
- Finland
Study on How Vaccines Affect Infant Immunity to Whooping Cough in Babies Born to Vaccinated Mothers Using Diphtheria, Tetanus, and Pertussis Vaccine Combination
This trial is examining how babies develop immunity to whooping cough when their mothers receive vaccination during pregnancy. The study uses two combination vaccines: Vaxelis, which protects against multiple diseases including diphtheria, tetanus, pertussis, hepatitis B, polio, and Haemophilus influenzae type b, and Triaxis, which targets diphtheria, tetanus, and pertussis with reduced antigen content.
Main inclusion criteria: The study includes women aged 18 to 45 years who are eligible for Tdap vaccination and whose last pertussis vaccination was more than 12 months ago. For infants, participants must be approximately 2 months old (plus or minus 1 week), born after 35 weeks of pregnancy, with a birth weight above 2.5 kg. Both boys and girls can participate. Parents must sign a consent form for their infant’s participation.
Main exclusion criteria: Participants cannot have a history of severe allergic reactions to any vaccine or ongoing infections at the time of the study. Those taking immune-suppressing medications or having poorly controlled chronic illnesses are excluded. Participants must not have received other vaccines within a specified period before the study or participated in another recent clinical trial. History of drug or alcohol abuse, immune system disorders, and mental health conditions that could affect understanding or following study procedures also exclude participation.
Study focus: The research aims to identify factors that influence how well infants develop immunity to whooping cough when their mothers are vaccinated during pregnancy. The study follows infants from birth to examine how antibodies transfer from mother to baby and how the infant’s immune system responds to vaccines. The goal is to improve understanding of maternal vaccination strategies and their impact on infant health outcomes.
Investigational drug: The maternal pertussis vaccine is administered to pregnant women as an injection. The vaccine stimulates the mother’s immune system to produce antibodies that are then passed to the baby before birth, helping protect the newborn during the first few months of life before they can receive their own vaccinations.
Study on the Best Timing for Pertussis Vaccination in Pregnant Women Using Diphtheria, Tetanus, and Pertussis Vaccine
This clinical trial is investigating the optimal timing for giving the pertussis vaccine to pregnant women. The study uses Triaxis, a combination vaccine protecting against diphtheria, tetanus, and pertussis, to determine how vaccination timing during pregnancy affects both maternal and infant immune responses.
Main inclusion criteria: Participants must be pregnant and able to provide informed consent, meaning they understand the study and agree to participate. They must be willing to receive the Tdap vaccine during pregnancy and be available for follow-up visits and phone calls until 6 months after giving birth. Receiving influenza and COVID-19 vaccines during pregnancy is permitted, following Belgian health recommendations. Only female participants are included.
Main exclusion criteria: The study excludes women who are not pregnant, not within the specified age range, or not female. Those who are part of vulnerable populations that the study does not include are also excluded.
Study focus: The research evaluates how vaccination timing during pregnancy influences immune responses in pregnant women. This includes measuring antibody levels at different times: before vaccination, after vaccination, at delivery, and six months postpartum. The study also measures antibody levels in the baby’s blood at birth to understand how well protective proteins transfer from mother to baby through the placenta. Additionally, researchers examine antibodies in breast milk six months after giving birth to determine how vaccination timing affects the baby’s protection after birth.
Investigational drug: The pertussis vaccine is designed to protect against whooping cough. In this trial, the focus is on understanding how the timing of vaccination during pregnancy affects the immune system, helping determine the best time for pregnant women to receive the vaccine for maximum protection of both mother and baby. The vaccine works by stimulating the body’s immune system to produce antibodies against the pertussis bacteria.
Study of Long-term Pertussis Immunity in Children at Age 4 Years Following Maternal Vaccination During Pregnancy
This trial examines long-term immunity against whooping cough in children at age 4 years, comparing those whose mothers received vaccination during pregnancy with those whose mothers did not. The study involves children who previously participated in an earlier phase of research when they were 6 months old.
Main inclusion criteria: Children must have participated in the original MIFI study and completed at least 6 months of that study. Participants must be approximately 48 months (4 years) old, and both boys and girls can participate. The child must be from a family involved in the previous pertussis immunity study, and the mother must have been involved in the original vaccination study during pregnancy. Children must be generally healthy and able to attend study visits, and parents or legal guardians must provide informed consent.
Main exclusion criteria: Children not aged 48 months at the time of participation are excluded, as are those whose mothers did not receive vaccination status documentation during pregnancy. Known allergies to vaccine components, previous severe vaccine reactions, compromised immune systems, or taking immune-suppressing medications exclude participation. Other exclusion criteria include acute illness or fever at the time of study procedures, current participation in other trials, inability to comply with study visits, history of pertussis infection, receipt of blood products or antibody treatments in the past 3 months, and any medical condition that could interfere with study results or pose risks.
Study focus: The research measures long-term differences in immunity against pertussis between the two groups of children. The study involves administering Tetravac, a combination vaccine containing inactivated components protecting against diphtheria, tetanus, pertussis, and polio. Each participant receives a single 0.5-milliliter dose injected into the muscle, followed by a 28-day observation period to monitor immune response.
Investigational drug: The pertussis vaccine is administered to help protect against whooping cough. In this trial, it is given to children whose mothers received vaccination during pregnancy to study how maternal vaccination affects long-term immunity in children. The vaccine works by stimulating the immune system to produce antibodies, and maternal vaccination during pregnancy allows antibodies to pass to the baby before birth, potentially providing early protection.
Summary
These three ongoing clinical trials represent important research into pertussis vaccination strategies, with a strong focus on maternal immunization and infant protection. Two of the three trials are being conducted in Belgium, highlighting this country’s concentration in pertussis research, while Finland hosts the long-term follow-up study. A common theme across all trials is the investigation of maternal vaccination during pregnancy as a strategy to protect infants who are most vulnerable to severe whooping cough complications.
The trials examine different aspects of maternal pertussis vaccination: one focuses on factors influencing infant immunity development in babies born to vaccinated mothers, another investigates the optimal timing of vaccination during pregnancy, and the third evaluates long-term immunity in children at age 4 years. The vaccines being studied include Vaxelis, Triaxis, Tetravac, and the Tdap vaccine, all containing pertussis components combined with protection against other diseases such as diphtheria, tetanus, and in some cases, polio, hepatitis B, and Haemophilus influenzae type b.
These studies collectively aim to provide valuable insights that could improve vaccination strategies for pregnant women and better protect infants from this highly contagious respiratory disease during their most vulnerable early months of life.
