Fibrodyplasia Ossificans Progressiva (FOP)
Conditions
Brief summary
Primary Safety: Nature, frequency and severity of systemic events, including flare-ups, fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain., Primary Efficacy: SARS-CoV-2 WT neutralising antibody titres rate and SARS-CoV-2-spike protein–specific binding IgG antibody titres rate on day 1, day 29 and day 43
Detailed description
Secundary Safety: Nature, frequency and severity of local reactions. Solicited adverse events include: pain, redness and swelling at the injection site and pain and swelling at the regional lymph nodes, Secundary Safety: Use of corticosteroids, antipyretics and painkillers, Secundary Efficacy: B-cell and T-cell responses on day 1, day 29 and day 43
Sponsors
Amsterdam UMC Stichting
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Safety: Nature, frequency and severity of systemic events, including flare-ups, fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain., Primary Efficacy: SARS-CoV-2 WT neutralising antibody titres rate and SARS-CoV-2-spike protein–specific binding IgG antibody titres rate on day 1, day 29 and day 43 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secundary Safety: Nature, frequency and severity of local reactions. Solicited adverse events include: pain, redness and swelling at the injection site and pain and swelling at the regional lymph nodes, Secundary Safety: Use of corticosteroids, antipyretics and painkillers, Secundary Efficacy: B-cell and T-cell responses on day 1, day 29 and day 43 | — |
Countries
Netherlands
Outcome results
None listed