mRNA Vaccine for RSV

Phase 1

Recruiting

Research Sponsored by GlaxoSmithKline

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or female participants aged between 18 and 45 years at the time of enrollment.

Female participants of non-childbearing potential are eligible.

Must not have

Previous receipt of investigational or approved RSV prevention products.

Clinically significant pulmonary, cardiovascular, hepatic, or renal abnormalities.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 8 and day 30 (post-dose 1), day 37, day 59, month 7, month 13, and month 19 (post-dose 2) compared with baseline (day 1, pre-dose 1)

Summary

"This trial aims to evaluate how safe and effective different versions of an RSV mRNA vaccine are in healthy adults aged 18-45."

Who is the study for?

Healthy adults aged 18-45 who can consent, have a BMI of >=18 and <40 kg/m^2, are not pregnant or breastfeeding, agree to use contraception if applicable, and have no history of severe allergies or reactions to vaccines. Participants must not be using other investigational drugs or have certain chronic diseases.

What is being tested?

The trial is testing the safety and immune response to different doses of an mRNA-based RSV vaccine in healthy participants. It compares several formulations against a placebo to find out which one works best without causing significant problems.

What are the potential side effects?

Possible side effects may include typical vaccine reactions such as soreness at the injection site, fever, fatigue, headache, muscle pain. Since it's investigational, there might be unknown risks that will be monitored throughout the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 45 years old.

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I am a woman who cannot become pregnant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have previously received an RSV vaccine or treatment.

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I do not have major lung, heart, liver, or kidney problems.

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I do not have uncontrolled neurological disorders, seizures, HIV, HBV, or HCV.

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I have a condition that weakens my immune system.

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I have or might have had inflammation of the heart.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 8 and day 30 (post-dose 1), day 37, day 59, month 7, month 13, and month 19 (post-dose 2) compared with baseline (day 1, pre-dose 1)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 8 and day 30 (post-dose 1), day 37, day 59, month 7, month 13, and month 19 (post-dose 2) compared with baseline (day 1, pre-dose 1)

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 8 and day 30 (post-dose 1), day 37, day 59, month 7, month 13, and month 19 (post-dose 2) compared with baseline (day 1, pre-dose 1) for reporting.