A Phase 2, Randomized, Observer-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Reactogenicity, Safety, and Immunogenicity of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus, in Pregnant Women, and Safety, and Immunogenicity in Infants Born to Vaccinated Mothers.
This important study is investigating a new vaccine (called mRNA-1345) designed to protect babies from Respiratory Syncytial Virus (RSV). RSV is a very common infection, especially in young children, which can sometimes lead to serious breathing problems. We are inviting pregnant women to take part in this study. The main goals are to understand how safe the vaccine is for both the mother and her baby, to monitor any side effects, and to see how well the mother's body produces protective antibodies against RSV. We also want to check how many of these protective antibodies pass to the baby and how long they last, helping to shield them from the virus after birth. Some participants will receive the vaccine, while others will receive a dummy injection (placebo) to compare the results fairly.
At a glance
What is this study about?
This study is all about finding a new way to protect babies from a common chest infection called Respiratory Syncytial Virus, or RSV. RSV can be quite mild, like a cold, but it can also cause serious breathing difficulties, especially in very young babies. There isn't currently a widely available vaccine that protects babies from RSV from birth.
Researchers are testing a new vaccine called mRNA-1345. This vaccine uses a special approach to teach the mother's body to make protective substances (called antibodies) against RSV. The hope is that these antibodies will then pass to the baby while they are still in the womb, giving them some protection against RSV right from the start of their life.
By taking part, you would be contributing to understanding if this vaccine is safe and effective. We will be carefully monitoring both the mothers and their babies for any effects after vaccination, and also looking at how well the immune system responds to the vaccine. This information is key to developing new ways to keep babies healthy.
Key takeaways
- This study tests a new vaccine to protect babies from RSV via their mothers.
- It's a vaccine in development (Phase 2), so safety and effectiveness are being carefully checked.
- Participation involves clinic visits and monitoring for about 12 months after birth.
- Some participants will receive the vaccine, others a placebo.
- You can stop participating at any time.
- Your involvement helps gather important information for future public health.
Who may be eligible?
This study is looking for women who are pregnant and are 18 years old or older. You will be carefully screened to make sure it's safe for you to take part.
There will be specific health criteria that you need to meet to be eligible. For example, certain medical conditions or medications might mean you can't join the study, as the safety of both you and your baby is our highest priority.
If you're interested, the study team will discuss all the requirements with you in detail to see if this study is suitable for you.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you currently pregnant?
- Are you 18 years old or older?
- Are you able to attend regular clinic appointments for about a year?
- Do you understand that you might receive a placebo instead of the vaccine?
- Are you willing to have blood samples taken from yourself and your baby?
What does participation involve?
If you decide to join this study, your participation would involve several visits to the clinic over about a year. You would receive either the new vaccine or a dummy injection (placebo).
We would closely monitor you for any side effects for the first 7 days, and then for any other health issues over the next few weeks and months. This involves keeping a diary and having regular check-ups. We'd also collect blood samples at different times to see how your body is responding to the vaccine.
After your baby is born, we would continue to monitor both you and your baby for up to 12 months. This includes checking your baby's health and development, and taking small blood samples from them at certain points to see if the protective antibodies have passed from you to them and how long they last. The total duration of your involvement, from vaccination to your baby's last follow-up, would be about 12 months.
Potential risks and benefits
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Common questions
What is RSV?
RSV stands for Respiratory Syncytial Virus. It's a very common virus that causes cold-like symptoms, but it can be serious for babies and young children, leading to breathing problems.
Why is this vaccine given during pregnancy?
The idea is that vaccinated mothers pass protection (antibodies) to their babies before birth, helping to protect the baby from RSV from the moment they are born.
Will I definitely get the actual vaccine?
Because this is a study, some participants will receive the new vaccine, and others will receive a dummy injection (placebo) to fairly compare the effects. You won't know which one you've received.
How long will I be involved in the study?
If you join, you and your baby will be followed for about 12 months after your baby is born.
What if I change my mind during the study?
You are free to leave the study at any time, for any reason, and it will not affect your medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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