BNT162b2 Vaccination With 2 Doses in COVID-19 Negative Volunteers and With a Single Dose in COVID… (NCT04824638) | Clinical Trial Compass
CompletedPhase 2
BNT162b2 Vaccination With 2 Doses in COVID-19 Negative Volunteers and With a Single Dose in COVID-19 Positive Volunteers
France267 participantsStarted 2021-03-08
Plain-language summary
As previously shown, individuals who experienced COVID-19 have developed some protective immunity to reinfection. The magnitude and duration of protection from reinfection conferred by the infection may be weaker after an asymptomatic infection as it is after a symptomatic COVID-19 episode. Moreover, it is known that immunity decreases among older adults compared to younger individuals often referred to as ''immune senescence,'' and leading to a decreased efficacy of vaccination.
This study raises the question of whether a single administration of BNT162b2 in participants with prior SARS-CoV-2 infection leads to sufficient and durable immune response.
We propose to evaluate the level of the single BNT162b2 vaccine dose response according to the severity of the previous SARS-CoV-2 infection in young and elderly participants with the same immunogenicity analyses to assess this response in participants receiving the two-dose vaccination regimen.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 18 to 45 years old or at least 65 years old,
✓. Healthy adults or stable medical condition for adults with pre-existing medical conditions. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during 3 months before enrolment, nor expected to require any significant change in therapy or hospitalization for worsening disease in foreseeable future.
✓. Group 1: Healthy adults with no previous history of SARS COV2 infection (PCR-, antigenic test- or chest TDM- or serology SARS-CoV-2-) Group 2: Healthy adults with history of infection with SARS COV 2 (PCR+, antigenic test+ or chest TDM+ or serology SARS-CoV-2 of more than 5 months) OR have been a household contact subject and have presented COVID-19 symptoms \[Experienced at least TWO of the following systemic symptoms: Fever (≥ 38ºC), chills, myalgia, headache, sorethroat, new olfactory and taste disorder(s), gastrointestinal symptoms (diarrhea and/or vomiting) or at least ONE of the following respiratory signs/symptoms: cough, shortness of breath or difficulty breathing, OR clinical or radiographical evidence of pneumonia\] since at least 5 months ago and have had a positive SARS-CoV-2 serology between this episode and pre-inclusion.
✓. A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies:
✓. Understands and agrees to comply with the study procedures (visits, phone calls) based on Investigator judgement
What they're measuring
1
IgG humoral response to vaccine 28 days post vaccination
Timeframe: at Day 57 for patients of the group1 and at Day 29 for patient of the group 2
. Written and informed consent signed by the person and the investigator (no later than the day of pre-inclusion and prior to any examination realized in the frame of the trial) (article L1122-1-1 of the Public Health Code)
✓. Affiliated or beneficiary of a social security scheme (article L1121-11 of the Public Health Code) (AME is not a social security scheme)
✓. who agrees to be registered in the national file of persons who lend themselves to biomedical research (article L1121-16 of the Public Health Code).
Exclusion criteria
✕. Participant is ill or febrile (body temperature ≥ 38.0°C) within 72 prior hours or and/or symptoms suggestive of COVID-19 or being contact subject within the past 14 days at enrolment visit.
✕. Participants with positive PCR, antigenic test or chest TDM or serology to SARS-CoV-2 at the enrolment visit, only for the group1.
✕. Participants who already received another anti-SARS-CoV-2-vaccine
✕. Participants who received BCG given within the last year.
✕. Use of immunosuppressive drugs like e.g. corticosteroids at a dosage \> 10mg equivalent prednisone /day (excluding topical preparations and inhalers) within 3 months prior to enrolment or 6 months for chemotherapies
✕. Received immunoglobulin or other blood product within 3 months prior to enrolment or planned receipt of immunoglobulin or a blood product through study completion.
✕. Received any vaccination within 4 weeks prior to first injection or plan to receive a licensed vaccine within 4 weeks after the last injection.
✕. History of severe adverse reactions to vaccine administration, including anaphylaxis and related symptoms, such as rash, respiratory difficulty, laryngeal oedema and abdominal pain to vaccines, or history of allergic reaction likely to be exacerbated by any component of the anti-SARS-CoV-2-vaccine.