Vaccine studies

The RS virus is a common respiratory virus. It is highly contagious and causes infections in people of all ages. In practice, all children contract the virus during their first two years of life. The RS virus can cause pneumonia, bronchitis, and middle ear infections. For children under the age of six months, the risk of severe RSV infections is particularly high, and these are the major cause of hospitalization in this age group.

In this study, pregnant women are vaccinated with a new RSV vaccine. It is hoped that the antibodies generated by the vaccine will pass through the placenta into the bloodstream of the fetus and thus protect the infant against RSV infections after birth. If an effective and safe vaccine for RS virus were to be found, it would be possible to reduce the incidence of severe RS virus infections in infants requiring intensive care or causing death, and also the incidence of common flu-like diseases caused by RS virus in older children and adults. 

What is being studied?

The vaccine being studied here is an intramuscular vaccine (injected into the muscle). Its purpose is to protect infants against RS virus before birth, making use of the mother’s immune system.

The study is intended to explore:

• whether the vaccination of a expectant mother can protect the baby from a disease caused by the RS virus?

• what the amount of RS virus antibodies is in the mother’s body, how antibodies are transferred to the child, and how they are preserved in the child’s bloodstream.

• whether the vaccine causes any adverse effects?

Who is conducting the study?

The study was devised and funded by the manufacturer of the vaccine, GlaxoSmithKline (GSK). The study is being conducted in 23 countries. In Finland, the responsible researcher for this study is the Director of MeVac, Anu Kantele, Professor of Infectious Diseases (University of Helsinki, HUS, Inflammation Center, Infectious Diseases). The research is carried out in Finland at the Meilahti Vaccine Research Center and in the Tampere vaccine research clinics.

What kind of participants are we looking for?

In order to participate in the study, you must fulfil these criteria:

• You want to participate in the study

• You are basically healthy and aged between 18 and 49.

• You are pregnant.

• Your pregnancy is “normal” in the sense that it is not a high-risk pregnancy such as having twins, and your BMI before pregnancy has been 18.5–39.9 kg/m2).

• You will commit to participating in all parts of the study (examination visits, follow-ups, sampling).

• You will also commit to your newborn infant participating in the study. Please discuss the matter with your spouse.

Protection for the child to be born

The study may give protection to your child, but it requires commitment from you. Participation in the study takes just over a year and involves approximately nine appointments at the Meilahti Vaccine Research Center and a single blood sample taken in connection with giving birth. The purpose of the examination visits is to monitor the health of the mother and the baby, to collect blood samples, and to fill in research forms. Also, you as the mother are required to keep an electronic symptoms journal at home. Your health will be monitored during your pregnancy and for six months after childbirth. The child’s condition will be monitored throughout the first year of their life. If the infant contracts a respiratory infection during the first nine months following their birth, a sample with a cotton swab will be taken from the nostrils to identify the pathogen.

There are 10,000 participants in this study worldwide, of which 6,667 will be randomly assigned to receive the research vaccine, while 3,333 will receive the placebo vaccine.  

What does the research vaccine contain?

The vaccine contains a protein resembling the antigen on the surface of the RS virus that activates the body’s immune system. Thus, the vaccine does not contain either live viruses or deactivated whole viruses. It also does not contain any adjuvant or enhancing agent. The placebo vaccine is a sugar-saline solution.

Contact information:

MeVac – Meilahti Vaccine Research Center
Biomedicum Helsinki 1, Haartmaninkatu 8
vaccine@hus.fi
Tel.: 050 311 6365

For this study, we are looking for persons over the age of 50 who have had shingles.

Shingles

The varicella virus (VZV), or chicken pox virus, causes two separate illnesses. Chicken pox presents soon after an initial infection, while shingles generally presents much later, as the varicella virus already present in the system is activated. Shingles typically presents as an asymmetric skin rash with blisters. The rash typically persists for two to four weeks and causes a burning or piercing pain.

Vaccine

The research vaccine is a vaccine that has been granted marketing authorization for preventing shingles and related complications such as neuralgia in patients over 50 years old.

Purpose of the study

The purpose of this study is to examine the recurrence of shingles in the research group given the shingles vaccine compared with the control group given the placebo vaccine. Two doses of shingles vaccine and two doses of placebo vaccine, respectively, will be given in the study. 

Participation in the study will take about 2–4 years, involving at least three clinic appointments and monthly contacts. 

The health checkup and all examination appointments are free of charge for test subjects. 

For more information on the study, please contact the Vaccine Research Center directly. By submitting your details, you are not yet committing to participating in the study.

You may be suitable for the study if:

• you are at least 50 years old 
• you are basically healthy 
• you have already had shingles once 
• you have not received a chicken pox or shingles vaccine before 
• you are not taking long-term antiviral medication for preventing shingles

Contact information:
vaccine@hus.fi
tel. 050 311 6365

The RS virus is a common respiratory virus that is easily transmitted and causes infections in people of all ages. Practically all children are infected by this virus before the age of two. The RS virus can cause pneumonia, bronchitis, and middle ear infections. Children under the age of six months are particularly vulnerable to severe RSV infections, which are the most common cause for hospitalization in this age group.

In this study, pregnant women are vaccinated with a new RSV research vaccine. This prompts the body to produce antibodies that then, it is hoped, will pass through the placenta into the bloodstream of the fetus and thus protect the infant against RSV infection after birth. An effective and safe vaccine can reduce the incidence of severe early childhood infections leading to intensive care or death.

What is being studied?

The vaccine being studied here is an intramuscular vaccine (injected into the muscle). Its purpose is to protect infants against RS virus before birth, making use of the mother’s immune system.

The study is intended to explore:

• whether vaccination can reduce the incidence of RS virus infections among infants
• whether vaccination can reduce the incidence of severe RS virus infections requiring hospitalization among infants
• whether the vaccine causes any adverse effects for mothers or infants.

Who is conducting the study?

The vaccine manufacturer, Pfizer, has devised and funded this worldwide study, which will involve a total of approximately 6,900 pregnant women and their expected babies in 17 countries.  In Finland, the study is being run by the Director of MeVac, Anu Kantele, Professor of Infectious Diseases at the University of Helsinki. The study in Finland takes place at the Meilahti Vaccine Research Center (MeVac) and at the research clinics of the Vaccine Research Center at the University of Tampere.

What kind of participants are we looking for?

You can enter the study if you fulfil these criteria:

• You want to participate in the study.
• You are basically healthy and aged between 18 and 49.
• You are pregnant, and your due date is between November 15, 2021 and April 2, 2021. The vaccine will be given between weeks 24 and 36 of your pregnancy.
• Your pregnancy is “normal” in the sense that you are not expecting twins and no complications have arisen.
• Your pregnancy is not the result of in vitro fertilization.
• You will commit to participating in all parts of the study (examination and follow-up visits and sampling).
• You will also commit to your newborn infant participating in the study. Please discuss the matter with your spouse beforehand if you feel the need to do so.

Protection for the mother and the child to be born

The research vaccine may protect the mother and the newborn infant, but you must commit to participate in the study for its full duration. Participation in the study takes approximately 10 months for the mother and about one year for the newborn infant. The study involves six examination appointments at the research center, at the maternity hospital, or by phone. The purpose of the examinations is to monitor the health of the mother and the infant. Two venous blood samples are taken from the mother during the study period, and a blood sample is taken from the umbilical cord after birth. The mother’s health is monitored for six months after delivery, and the mother is required to keep an electronic symptom journal at home. The child’s health, with particular reference to respiratory infections, is monitored for the duration of the study. If either the mother or the infant contracts a respiratory infection during the study, a cotton swab sample will be taken from the nostrils to identify the pathogen.

What does the research vaccine contain?

The vaccine contains a protein from the surface of the RS virus, which is expected to activate the immune system of the vaccinated person. The product does not include live or dead viruses nor any adjuvant or enhancing agent. The placebo vaccine is a saline solution. You have an equal chance of being given the research vaccine or the placebo vaccine.

In previous studies, the research vaccine has been given to more than 2,000 test subjects, including 400 pregnant women, with no significant side effects.

Contact information:
MeVac – Meilahti Vaccine Research Center
Biomedicum Helsinki 1, Haartmaninkatu 8
www.hus.fi/rokotetutkimus
vaccine@hus.fi
Tel. 050 311 6365

The purpose of the study is to explore how repeated vaccinations affect immune response in health care personnel.

Pneumococcal disease, which may be caused by any of more than 90 types of pneumococcus bacteria, is one of the many illnesses that can be protected against by vaccination.

For more on our pneumococcal vaccine study, see here.

In this study, children between the ages of 6 months and 12 years are vaccinated with a new mRNA corona vaccine (Pfizer). This is a phase 2/3 vaccine study.  In the earlier phases of the study, it has already been investigated what the appropriate dose size of the vaccine is in children of different ages, as well as the safety of the vaccine and the immune response it generates.

We are looking for children between the ages of 6 months and 4 years.

Read more about our coronavirus vaccine study for children.

Contact information:
vaccine@hus.fi
Tel. 050 311 6365

A randomized, placebo-controlled phase II study to evaluate safety, immunogenicity, diagnostic methodology, and estimate vaccine efficacy of an oral enterotoxigenic Escherichia coli (ETEC) Vaccine (ETVAX) for prevention of clinically significant ETEC diarrhea in healthy adult travelers visiting West Africa (OEV123, EudraCT-no 2016-002690-35)

The Meilahti Vaccine Research Center (MeVac) and the University of Helsinki were involved in a joint research project with Scandinavian Biopharma to test the oral Etvax® traveler’s diarrhea vaccine in 743 Finns traveling to Grand-Popo, Benin for two weeks. The purpose of the vaccine is to protect recipients from diarrhea caused by E. coli bacteria (ETEC).  Finns participating in the study had a unique opportunity to contribute to a healthier world, and it was gratifying to see how eager hundreds of Finns were to seize this opportunity. 

Diarrhea continues to be a major problem worldwide; more than four billion cases of illnesses involving diarrhea occur worldwide every year. Diarrhea is a symptom of illness most commonly experienced by infants and small children; indeed, diarrhea is the second most common cause of death for children under the age of five worldwide. Although ETEC is one of the most common causes of traveler’s diarrhea, there is not a single vaccine for it on the market. 

The responsible researcher for this study is Anu Kantele, Professor of Infectious Diseases (Meilahti Vaccine Research Center (MeVac), University of Helsinki, HUS Infectious Diseases Clinic, Travel Clinic of the Aava Medical Center). The study was funded by the vaccine manufacturers, Scandinavian Biopharma AB, and by the PATH organization funded by the Bill and Melinda Gates Foundation.

The RS virus is a common respiratory virus. It is highly contagious and causes infections in people of all ages. In practice, all children contract the virus during their first two years of life. 

The RS virus can cause pneumonia, bronchitis, and middle ear infections. For children under the age of six months, the risk of severe RSV infections is particularly high, and these are the major cause of hospitalization in this age group.

In this study, pregnant women are vaccinated with a new RSV vaccine. It is hoped that the antibodies generated by the vaccine will pass through the placenta into the bloodstream of the fetus and thus protect the infant against RSV infections after birth. If an effective and safe vaccine for RS virus were to be found, it would be possible to reduce the incidence of severe RS virus infections in infants requiring intensive care or causing death, and also the incidence of common flu-like diseases caused by RS virus in older children and adults.

What is being studied?

The vaccine being studied here is an intramuscular vaccine (injected into the muscle). Its purpose is to protect infants against RS virus before birth, making use of the mother’s immune system.

The study is intended to explore:

• whether vaccinating a pregnant woman can stimulate the antibody production sufficiently to protect the unborn child
• how long the protection provided by the vaccine will last
• whether the vaccine causes any adverse effects.

Who is conducting the study?

The study was devised and funded by the manufacturers of the vaccine, GlaxoSmithKline (GSK). The study is being conducted in ten countries. In Finland, the responsible researcher for this study is the Director of MeVac, Anu Kantele, Professor of Infectious Diseases (University of Helsinki, HUS, Inflammation Center, Infectious Diseases). The research team also includes: Oskari Heikinheimo, Professor of Gynecology and Obstetrics; Santtu Heinonen, Pediatric Specialist; Karin Blomgren, ENT Specialist, Docent; and the rest of the Meilahti Vaccine Research Center team.

What kind of participants are we looking for?

In order to participate in the study, you must fulfil these criteria:

• You want to participate in the study.
• You are basically healthy and aged between 18 and 40.
• You are pregnant, and your due date is between March 1 and May 31, 2020.
• Your pregnancy is “normal” in the sense that it is not an at-risk pregnancy such as having twins, and you have not been diagnosed with diabetes while pregnant.
• You will commit to participating in all parts of the study (examinations, follow-ups, sampling).
• You will also commit to your newborn infant participating in the study. Please discuss the matter with your spouse.

The study may give protection to your child, but it requires commitment from you.

Participation in the study takes just over a year and involves 9–10 appointments at the Meilahti Vaccine Research Center and one appointment at the Women’s Hospital in connection with the delivery of your child. The purpose of the examinations is to monitor the health of the mother and the child, to collect blood and urine samples, and to fill in research forms. Also, you as the mother are required to keep an electronic symptoms journal at home. Your health will be monitored during your pregnancy and for six months after childbirth. The health of the child, with particular reference to respiratory infections, will be monitored for the first year of the child’s life. If either the mother or the infant contract a respiratory infection, a cotton swab will be taken from the nostrils to identify the pathogen.

There are 150 participants in this study worldwide, of which 100 will be randomly assigned to receive the research vaccine, while 50 will receive the placebo vaccine.

What does the research vaccine contain?

The vaccine contains a protein resembling the antigen on the surface of the RS virus that activates the body’s immune system. Thus, the vaccine does not contain either live viruses or deactivated whole viruses. It also does not contain any adjuvant or enhancing agent. The placebo vaccine is a saline solution.

Contact information:

vaccine@hus.fi, tel. 050 311 6365