A Trial Investigating the Safety and Effects of One or Two Additional Doses of Comirnaty or One Dose of BNT162b2s01 in BNT162-01 or BNT162-04 Trial Subjects
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|ClinicalTrials.gov Identifier: NCT04949490|
Recruitment Status : Recruiting
First Posted : July 2, 2021
Last Update Posted : September 16, 2021
Trial to evaluate the safety and immunogenicity of one or two boosting doses of Comirnaty or one dose of BNT162b2s01 (Variant of concern (VOC) strain B.1.351) in BNT162-01 trial participants, or two boosting doses of Comirnaty in BNT162-04 trial participants.
Trial participants from BNT162-01 who received two injections of 30 μg Comirnaty will be randomized 2:1 to one booster injection (BNT162b2s01: Comirnaty). Trial participants in either the trial BNT162-01 or BNT162-04 who did not receive the full two vaccinations of 30 μg Comirnaty will be offered two injections of 30 μg Comirnaty as per the conditional marketing authorization. All potential rollover volunteers must enroll in this trial within less than 18 months of their last injection of a BNT162 candidate vaccine in the parent BNT162-01 or BNT162-04 trials.
|Condition or disease||Intervention/treatment||Phase|
|COVID-19 SARS-CoV-2 Infection||Biological: BNT162b2s01 Biological: BNT162b2||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||549 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II, Open-label, Rollover Trial to Evaluate the Safety and Immunogenicity of One or Two Boosting Doses of Comirnaty or One Dose of BNT162b2s01 in BNT162-01 Trial Subjects, or Two Boosting Doses of Comirnaty in BNT162-04 Trial Subjects|
|Actual Study Start Date :||July 26, 2021|
|Estimated Primary Completion Date :||July 2023|
|Estimated Study Completion Date :||July 2023|
|Experimental: Group A, BNT162b2s01 30 µg (1 dose)||
intramuscular (IM) injection
|Experimental: Group A, BNT162b2 30 µg (1 dose)||
Other Name: Comirnaty
|Experimental: Group B, BNT162b2 30 µg (2 doses)||
Other Name: Comirnaty
- The proportion of participants in each treatment group with at least one serious adverse event (SAE) or the proportion of adverse events of special interest (AESIs) [ Time Frame: up to 26 weeks after the first IMP injection ]occurring up to 26 weeks after the first investigational medicinal product (IMP) injection. For all Group A and Group B participants.
- The frequency of solicited local reactions (pain, tenderness, erythema/redness, induration/swelling) at the injection site recorded up to 7 days after each IMP injection [ Time Frame: up to 7 days after each IMP injection ]For Group A and for a selected subset of Group B participants.
- The frequency of solicited systemic reactions (vomiting, diarrhea, headache, fatigue/tiredness, fever, chills, nausea, new or worsened muscle pain, new or worsening joint pain) recorded up to 7 days after each IMP injection [ Time Frame: up to 7 days after each IMP injection ]For Group A and for a selected subset of Group B participants.
- The proportion of participants with at least one unsolicited treatment emergent adverse event (TEAE) occurring up to 28 days after IMP injection in each treatment group [ Time Frame: up to 28 days after IMP injection ]For Group A and for a selected subset of Group B participants.
- Antibody titers to recombinant S1 and receptor binding domain (RBD) protein derived from reference and SARS-CoV-2 Republic of South Africa (SA) variant (B.1.351) will be assessed at baseline (Day 1) and then Day 8, Weeks 4, 12, and 26 [ Time Frame: day 1 and day 8; weeks 4, 12, and 26 ]For Group A participants.
- Antibody titers to recombinant S1 and RBD protein derived from reference and SARS-CoV-2 SA variant (B.1.351) will be assessed at baseline (Day 1) and then Day 8, Weeks 3, 4, 7, 12, and 26 [ Time Frame: day 1 and day 8; weeks 3, 4, 7, 12, and 26 ]For Group B participants.
- SARS-CoV-2 functional cross-neutralization of SA variant (B.1.351) to reference strain [ Time Frame: up to 26 weeks after the first IMP injection ]For Group A only.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04949490
|Contact: BioNTech clinical trials patient information||+49 6131 9084 ext email@example.com|
|Contact: BioNTech clinical trial information desk||+49 6131 9084 ext firstname.lastname@example.org|
|CRS Clinical Research Services Berlin GmbH||Recruiting|
|Berlin, Germany, 13353|
|University Hospital Frankfurt, Infectiology||Not yet recruiting|
|Frankfurt, Germany, 60590|
|University Hospital Heidelberg, Clinical Pharmacology||Recruiting|
|Heidelberg, Germany, 69117|
|CRS Clinical Research Services Mannheim GmbH||Recruiting|
|Mannheim, Germany, 68167|
|Study Director:||BioNTech Responsible Person||BioNTech SE|