A Study to Learn About New COVD-19 RNA Vaccine Candidates for New Varients in Healthy Individuals

Sponsor

BioNTech SE (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05997290

Collaborator

Pfizer (Industry)

400

Enrollment

Locations

Arm

9.8

Anticipated Duration (Months)

26.7

Patients Per Site

2.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this clinical protocol is to learn about the safety, tolerability, and immunogenicity of new BNT162b2 RNA-based vaccine candidates targeting new variants of SARS-CoV-2 in healthy people.

Substudy A:

This study will evaluate the safety, tolerability, and immunogenicity of BNT162b2 (Omi XBB.1.5) given as a single 30 µg dose,
in people who are 12 years of age and older,
who previously received at least 3 doses of a US-authorized mRNA COVID-19 vaccine, with the most recent dose being an Omicron BA.4/BA.5-adapted bivalent vaccine received at least 150 days before the study vaccination (Visit 1).
The study is about 6 months long for each participant.
Participants will have at least 5 visits to the clinic.
At each clinic visit a blood sample will be taken.
At least 1 nasal swab will taken.

Condition or Disease	Intervention/Treatment	Phase
SARS-CoV-2 Infection COVID-19	Biological: BNT162b2 (Omi XBB.1.5)	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

400 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Phase 2/3, controlled studyPhase 2/3, controlled study

Masking:

None (Open Label)

Masking Description:

Open-label

Primary Purpose:

Prevention

Official Title:

A PHASE 2/3 PROTOCOL TO INVESTIGATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF BNT162b2 RNA-BASED VACCINE CANDIDATES FOR SARS-CoV-2 NEW VARIANTS IN HEALTHY INDIVIDUALS

Anticipated Study Start Date :

Aug 10, 2023

Anticipated Primary Completion Date :

Jun 4, 2024

Anticipated Study Completion Date :

Jun 4, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SSA: Group 1 Participants 12 years of age and older will receive 30 µg of BNT162b2 (Omi XBB.1.5) at Visit 1.	Biological: BNT162b2 (Omi XBB.1.5) BNT162b2 monovalent (Omicron XBB.1.5)

Arm

Intervention/Treatment

Experimental: SSA: Group 1

Participants 12 years of age and older will receive 30 µg of BNT162b2 (Omi XBB.1.5) at Visit 1.

Biological: BNT162b2 (Omi XBB.1.5)

BNT162b2 monovalent (Omicron XBB.1.5)

Outcome Measures

Primary Outcome Measures

SSA: Percentage of participants reporting local reactions [For up to 7 days following the study vaccination]
Pain at the injection site, redness, and swelling, as self-reported in electronic diaries.
SSA: Percentage of participants reporting systemic events [For up to 7 days following the study vaccination]
Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain, as self-reported in electronic diaries
SSA: Percentage of participants reporting adverse events [Through 1 month after the study vaccination]
As elicited by the investigational staff
SSA: Percentage of participants reporting serious adverse events [Through 6 months after the study vaccination]
As elicited by the investigational staff
SSA: Geometric Mean Titers (GMT) of SARS-CoV-2 Omicron XBB.1.5- and Omicron BA.4/BA.5-neutralizing antibody levels for BNT162b2 (Omi XBB.1.5) 30 µg [At 1 month after the study vaccination]
As measured at the central laboratory
SSA: Geometric Mean Fold Rise (GMFR; change between 2 timepoints) of SARS-CoV-2 Omicron XBB.1.5-and Omicron BA.4/BA.5-neutralizing antibody levels for BNT162b2 (Omi XBB.1.5) 30 µg [From before study vaccination (Day 1) to 1 month after study vaccination]
As measured at the central laboratory
SSA: Percentages of participants with seroresponse to BNT162b2 (Omi XBB.1.5) 30 µg in terms of GMTs of SARS-CoV-2 Omicron XBB.1.5- and Omicron BA.4/BA.5-neutralizing antibody levels [At 1 month after the study vaccination]
As measured at the central laboratory

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

SSA

Inclusion Criteria:

Received at least 3 prior doses of a US-authorized mRNA COVID-19 vaccine, with the most recent dose being a US-authorized Omicron BA.4/BA.5-adapted bivalent vaccine received at least 150 days before Visit 1 (Day 1).
12 years of age and older
Healthy participants (stable pre-existing disease permitted).
Willing and able to comply with all scheduled visits/contacts, study procedures and lifestyle considerations.
Capable of giving, or parent(s)/legal guardian capable of giving, signed informed consent.

Exclusion Criteria

History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study vaccines.
Immunocompromised with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
Women who are pregnant or breastfeeding.
Any medical or psychiatric condition, or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
History of myocarditis or pericarditis.
Receipt of systemic treatment with known immunosuppressant medications (including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease), or radiotherapy, within 60 days before enrollment or planned receipt through conclusion of the study.
Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, used for the treatment or prevention of COVID-19 or those that are considered immunosuppressive, from 60 days before study vaccination or planned receipt throughout the study.
Participation in other studies involving receipt of other study intervention within 28 days before enrollment. Anticipated participation in other studies involving other study intervention from enrollment through the end of this study.
Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	West Coast Research	Dublin	California	United States	94568
2	Bayview Research Group, LLC	Valley Village	California	United States	91607
3	Diablo Clinical Research, Inc.	Walnut Creek	California	United States	94598
4	Clinical Research Consulting	Milford	Connecticut	United States	06460
5	Indago Research & Health Center, Inc	Hialeah	Florida	United States	33012
6	Clinical Neuroscience Solutions, Inc. dba CNS Healthcare	Jacksonville	Florida	United States	32256
7	Acevedo Clinical Research Associates	Miami	Florida	United States	33142
8	Clinical Research Atlanta	Stockbridge	Georgia	United States	30281
9	M3 Wake Research, Inc.	Raleigh	North Carolina	United States	27612
10	Centricity Research Columbus Ohio Multispecialty	Columbus	Ohio	United States	43213
11	Senders Pediatrics	South Euclid	Ohio	United States	44121
12	DM Clinical Research - Bellaire	Houston	Texas	United States	77081
13	IMA Clinical Research San Antonio	San Antonio	Texas	United States	78229
14	J. Lewis Research, Inc. / Foothill Family Clinic	Salt Lake City	Utah	United States	84109
15	J. Lewis Research, Inc. / Foothill Family Clinic South	Salt Lake City	Utah	United States	84121