Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will assess the effect of a different dose of the seasonal flu vaccine 2013-2015 on the immune response to improve the investigators understanding of cellular and humoral immune responses induced. The scope of this study is to determine the profile of cellular activation and antibody production in the ageing immune system following flu immunization.
This study will enroll 100 male or female subjects ≥65 year old and 90 transplant recipients. These persons will be deemed to be " at risk " in case of influenza infection and should be vaccinated according to Swiss Federal Office of Public Health. A medical doctor from the CHUV will inform the patients about the present study and ask them whether they would be willing to participate in the study.
All subjects will be distributed between the two groups according to a computer-generated randomization sequence. The randomization will be done in blocks to ensure balance across groups. The participants and site staff will not be blinded due to the different administration assignments.
Group 1 subjects will receive a single dose and group 2 subjects a double dose of MUTAGRIP® manufactured by Sanofi Pasteur containing A/California/7/2009 (H1N1); A/Texas/50/2012 (H3N2); B/Massachusetts/2/2012. Vaccine immunogenicity and safety will be assessed 1, 2, 4 and 24 weeks after vaccination.
Study duration per volunteer is 6 months after vaccination.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Active Comparator | Single dose of MUTAGRIP® containing A/California/7/2009 (H1N1); A/Texas/50/2012 (H3N2); B/Massachusetts/2/2012. |
|
| Group 2 | Experimental | Double dose of MUTAGRIP® (one dose into the right deltoid area and the other one into the left deltoid area) containing A/California/7/2009 (H1N1); A/Texas/50/2012 (H3N2); B/Massachusetts/2/2012. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single dose MUTAGRIP® influenza vaccine | Drug | All subjects will receive either a single or double doses of MUTAGRIP® containing A/California/7/2009 (H1N1); A/Texas/50/2012 (H3N2); B/Massachusetts/2/2012. The double dose regimen will be administered at the same time. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Immunogenicity | Humoral immune responses (antibodies directed against all three strains A/California/7/2009 (H1N1); A/Texas/50/2012 (H3N2); B/Massachusetts/2/2012). | weeks 2, 4 and 24 after vaccination |
| Change from Baseline in Immunogenicity | Cellular immune responses directed against all three strains A/California/7/2009 (H1N1); A/Texas/50/2012 (H3N2); B/Massachusetts/2/2012. | weeks 1, 2, 4 and 24 after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Events as a Measure of Safety and Tolerability | To evaluate safety and tolerability of the influenza vaccine (split virion, inactivated), MUTAGRIP®, administered in single or double dose. | 24 weeks after vaccination |
Not provided
Elderly:
Inclusion Criteria:
Solid-organ transplant recipients Inclusion criteria Age ≥18 year old Solid organ transplantation >3 months before vaccination Stable patient followed at the outpatient clinic of the Transplantation Center Able to give informed consent. Necessity to receive influenza seasonal vaccination. Availability for the duration of the study and willingness to attend all scheduled visits.
Exclusion criteria Previous life-threatening reaction to influenza vaccine (i.e. Guillain-Barre Syndrome) Ongoing therapy for rejection Febrile illness in the past two weeks
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Giuseppe Pantaleo, Prof. | Vaccine and Immunotherapy Center (VIC) of the Centre Hospitalier Universitaire Vaudois (CHUV), Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vaccine and Immunotherapy Center (VIC) of the Centre Hospitalier Universitaire Vaudois (CHUV) | Lausanne | Canton of Vaud | 1011 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30181045 | Derived | Mombelli M, Rettby N, Perreau M, Pascual M, Pantaleo G, Manuel O. Immunogenicity and safety of double versus standard dose of the seasonal influenza vaccine in solid-organ transplant recipients: A randomized controlled trial. Vaccine. 2018 Oct 1;36(41):6163-6169. doi: 10.1016/j.vaccine.2018.08.057. Epub 2018 Sep 1. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Double dose of MUTAGRIP® influenza vaccine | Drug | All subjects will receive either a single or double doses of MUTAGRIP® containing A/California/7/2009 (H1N1); A/Texas/50/2012 (H3N2); B/Massachusetts/2/2012. The double dose regimen will be administered at the same time. |
|