Phase 2
Completed N=1,541
A Study of Ad26.COV2.S Administered as Booster Vaccination in Adults Who Have Previously Received Primary Vaccination With Ad26.COV2.S or BNT162b2
Coronavirus Disease
Source: ClinicalTrials.gov NCT04999111 ↗
Enrolled (actual)
1,541
Serious AEs
2.3%
Results posted
Jan 2023
Primary outcomePrimary: Cohort 1: Percentage of Participants With Serological Response Against SARS-CoV-2 Original Strain 14 Days After Ad26.COV2.S Booster Vaccination After Completing Primary Vaccination With Ad26.COV2.S — 63.4; 57.9; 64.5 Percentage of participants
Summary
The purposes of this study are to demonstrate the non-inferiority (NI) of the neutralizing antibody response to the original strain 14 days after booster vaccination with Ad26.COV2.S at the different dose levels, administered greater than or equal to (>=) 6 months after single-dose primary vaccination with Ad26.COV2.S, compared to the neutralizing antibody response to the original strain induced by single-dose primary vaccination with Ad26.COV2.S; To demonstrate the NI of the neutralizing antibody response to the leading variant of high consequence or concern 14 days after booster vaccination with Ad26.COV2.S at the 5*10^10 virus particle (vp) dose level, administered >= 6 months after single-dose primary vaccination with Ad26.COV2.S (5*10^10 vp dose level), compared to the neutralizing antibody response to the leading variant of high consequence or concern induced by single-dose primary vaccination with Ad26.COV2.S at the 5*10^10 vp dose level, if feasible; To demonstrate the NI of the neutralizing antibody response to the original strain 14 days after booster vaccination with Ad26.COV2.S at the different dose levels administered >=6 months after completing a 2-dose primary vaccination with Pfizer BNT162b2, compared to the neutralizing antibody response to the original strain induced by 2-dose primary vaccination with Pfizer BNT162b2; To demonstrate the NI of neutralizing antibody response to the leading variant of high consequence or concern 14 days after booster vaccination with Ad26.COV2.S at the 5*10^10 vp dose level, administered >= 6 months after completing a 2-dose primary vaccination with Pfizer BNT162b2, compared to the neutralizing antibody response to the leading variant of high consequence or concern induced by 2-dose primary vaccination with Pfizer BNT162b2, if feasible.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cohort 1: Percentage of Participants With Serological Response Against SARS-CoV-2 Original Strain 14 Days After Ad26.COV2.S Booster Vaccination After Completing Primary Vaccination With Ad26.COV2.S |
63.4; 57.9; 64.5 | — |
| PRIMARY Cohort 1: Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against SARS-CoV-2 Original Strain 14 Days After Ad26.COV2.S Booster Vaccination After Completing Primary Vaccination With Ad26.COV2.S |
1130; 915; 734 | — |
| PRIMARY Cohort 1: Percentage of Participants With Serological Response Against SARS-CoV-2 Original Strain 28 Days After Primary Vaccination With Ad26.COV2.S |
15.4; 16.8; 11.7 | — |
| PRIMARY Cohort 1: GMTs of Neutralizing Antibodies Against SARS-CoV-2 Original Strain 28 Days After Primary Vaccination With Ad26.COV2.S |
98; 100; 76 | — |
| PRIMARY Cohort 1: Percentage of Participants With Serological Response Against the Delta Variant 14 Days After Ad26.COV2.S Booster Vaccination (5*10^10 vp Dose Level) After Completing Primary Vaccination With Ad26.COV2.S |
56.7 | — |
| PRIMARY Cohort 1: GMTs of Neutralizing Antibodies Against the Leading Variant of High Consequence or Concern (Delta Variant) 14 Days After Ad26.COV2.S Booster Vaccination (5*10^10 vp Dose Level) After Completing Primary Vaccination With Ad26.COV2.S |
471 | — |
| PRIMARY Cohort 1: Percentage of Participants With Serological Response Against SARS-CoV-2 Leading Variant of High Consequence or Concern (Delta Variant) 28 Days After Primary Vaccination With Ad26.COV2.S |
8.8 | — |
| PRIMARY Cohort 1: GMTs of Neutralizing Antibodies Against the Leading Variant of High Consequence or Concern (Delta Variant) 28 Days After Primary Vaccination With Ad26.COV2.S (5*10^10 vp Dose Level) |
NA | — |
| PRIMARY Cohort 2: Percentage of Participants With Serological Response Against SARS-CoV-2 Original Strain, 14 Days After Ad26.COV2.S Booster Vaccination After Completing 2-dose Primary Vaccination With BNT162b2 |
97.0; 90.5; 89.8 | — |
| PRIMARY Cohort 2: GMTs of Neutralizing Antibodies Against SARS-CoV-2 Original Strain 14 Days After Ad26.COV2.S Booster Vaccination After Completing 2-dose Primary Vaccination With BNT162b2 |
4439; 3566; 3218 | — |
| PRIMARY Cohort 2: Percentage of Participants With Serological Response Against SARS-CoV-2 Original Strain 2 Weeks to 2 Months After Completing 2-dose Primary Vaccination With BNT162b2 (Pfizer BNT162b2 External Samples) |
— | — |
| PRIMARY Cohort 2: GMTs of Neutralizing Antibodies Against SARS-CoV-2 Original Strain 2 Weeks to 2 Months After Completing 2-dose Primary Vaccination With BNT162b2 (Pfizer BNT162b2 External Samples) |
1281 | — |
| PRIMARY Cohort 2: Percentage of Participants With Serological Response Against SARS-CoV-2 Delta Variant 14 Days After Booster Vaccination (5*10^10 vp Dose Level) After Completing 2-dose Primary Vaccination With BNT162b2 |
93.6 | — |
| PRIMARY Cohort 2: GMTs of Neutralizing Antibodies Against the SARS-CoV-2 Leading Variant of High Consequence or Concern (Delta Variant) 14 Days After Booster Vaccination (5*10^10 vp Dose Level) After Completing 2-dose Primary Vaccination With BNT162b2 |
2318 | — |
| PRIMARY Cohort 2: Percentage of Participants With Seropositive Response to Vaccination Against the SARS-CoV-2 Delta Variant 2 Weeks to 2 Months After Completing Primary Vaccination With 2-dose BNT162b2 (Pfizer BNT162b2 External Samples) |
83.8 | — |
| PRIMARY Cohort 2: GMTs of Neutralizing Antibodies Against the SARS-CoV-2 Delta Variant 2 Weeks to 2 Months After Completing 2-dose Primary Vaccination With BNT162b2 (Pfizer BNT162b2 External Samples) |
502 | — |
| SECONDARY Cohorts 1 and 2: Number of Participants With Solicited Local Adverse Events (AEs) After Ad26.COV2.S Booster Vaccination |
197; 149; 51; 256; 243; 61 | — |
| SECONDARY Cohorts 1 and 2: Number of Participants With Solicited Systemic AEs After Ad26.COV2.S Booster Vaccination |
188; 160; 60; 267; 234; 67 | — |
| SECONDARY Cohorts 1 and 2: Number of Participants With Unsolicited AEs After Ad26.COV2.S Booster Vaccination |
37; 35; 14; 55; 56; 16 | — |
| SECONDARY Cohorts 1 and 2: Number of Participants With Serious Adverse Events (SAEs) After Ad26.COV2.S Booster Vaccination |
11; 7; 2; 9; 4; 2 | — |
| SECONDARY Cohorts 1 and 2: Number of Participants With Adverse Events of Special Interest (AESIs) After Ad26.COV2.S Booster Vaccination |
2; 5; 0; 1; 0; 0 | — |
| SECONDARY Cohort 1: Percentage of Participants With Serological Response Against SARS-CoV-2 Original Strain, Delta, and Beta Variant 14 Days After Ad26.COV2.S Booster Vaccination After Primary Vaccination With Ad26.COV2.S |
63.4; 57.9; 64.5; 56.7; 49.2; 51.6 | — |
| SECONDARY Cohort 1: Percentage of Participants With Serological Response Against SARS-CoV-2 Leading Variant of High Consequence or Concern (Omicron Variant) 14 Days After Ad26.COV2.S Booster Vaccination After Primary Vaccination With Ad26.COV2.S |
9.6; 8.2; 6.4 | — |
| SECONDARY Cohort 1: GMTs of Neutralizing Antibodies Against the Original Strain, Delta and Beta Strain 14 Days After Ad26.COV2.S Booster Vaccination |
1130; 915; 734; 471; 391; 316 | — |
| SECONDARY Cohort 1: GMTs of Neutralizing Antibodies Against the Leading Variant of High Consequence or Concern (Omicron Variant) 14 Days After Ad26.COV2.S Booster Vaccination |
69; 71; NA | — |
| SECONDARY Cohort 1: Percentage of Participants With Serological Response Against SARS-CoV-2 Original Strain, Delta, and Beta Variant 28 Days After Ad26.COV2.S Booster Vaccination After Primary Vaccination With Ad26.COV2.S |
68.8; 63.6; 75.0; 59.4; 36.4; 62.5 | — |
| SECONDARY Cohort 1: Percentage of Participants With Serological Response Against SARS-CoV-2 Leading Variant of High Consequence or Concern (Omicron Variant) 28 Days After Ad26.COV2.S Booster Vaccination After Primary Vaccination With Ad26.COV2.S |
9.4; 6.9; 4.30 | — |
| SECONDARY Cohort 1: GMTs of Neutralizing Antibodies Against the Original Strain, Delta and Beta Strain 28 Days After Ad26.COV2.S Booster Vaccination |
993; 893; 887; 455; 328; 333 | — |
| SECONDARY Cohort 1: GMTs of Neutralizing Antibodies Against the Leading Variant of High Consequence or Concern (Omicron Variant) 28 Days After Ad26.COV2.S Booster Vaccination |
77; NA; NA | — |
| SECONDARY Cohort 1: Percentage of Participants With Antibodies Binding to SARS-CoV-2 Relevant Variants of Concern or Individual SARS-CoV-2 Proteins by Enzyme-linked Immunosorbent Assay (ELISA) |
100.0; 96.6; 100.0 | — |
| SECONDARY Cohort 1: Number of Participants With Antibodies Binding to SARS-CoV-2 Relevant Variants of Concern or Individual SARS-CoV-2 Proteins by Meso Scale Discovery (MSD) |
— | — |
| SECONDARY Cohort 2: Percentage of Participants With Serological Response to Vaccination Against the Original Strain, Delta and Beta Variant 14 Days After Ad26.COV2.S Booster Vaccination After Primary Vaccination With BNT162b2 |
97.0; 90.5; 89.8; 93.6; 91.2; 86.4 | — |
| SECONDARY Cohort 2: Percentage of Participants With Serological Response to Vaccination Against the Leading Variant of High Consequence or Concern (Omicron Variant) 14 Days After Ad26.COV2.S Booster Vaccination After Primary Vaccination With BNT162b2 |
72.5; 62.0; 56.2 | — |
| SECONDARY Cohort 2: Antibody GMTs of Neutralizing Antibodies Against the Original Strain, Delta and Beta Variant 14 Days After Ad26.COV2.S Booster Vaccination After Completing Primary Vaccination With BNT162b2 |
4439; 3566; 3218; 2318; 1872; 1761 | — |
| SECONDARY Cohort 2: Antibody GMTs of Neutralizing Antibodies Against the Leading Variant of High Consequence or Concern (Omicron Variant) 14 Days After Ad26.COV2.S Booster Vaccination After Completing Primary Vaccination With BNT162b2 |
509; 386; 336 | — |
| SECONDARY Cohort 2: Percentage of Participants With Serological Response to Vaccination Against the Original Strain, Delta and Beta Variant 28 Days After Ad26.COV2.S Booster Vaccination After Primary Vaccination With BNT162b2 |
100.0; 97.0; 95.7; 97.1; 97.0; 87.0 | — |
| SECONDARY Cohort 2: Percentage of Participants With Serological Response to Vaccination Against the Leading Variant of High Consequence or Concern (Omicron Variant) 28 Days After Ad26.COV2.S Booster Vaccination After Primary Vaccination With BNT162b2 |
77.1; 57.6; 69.6 | — |
| SECONDARY Cohort 2: GMTs of Neutralizing Antibodies Against the Original Strain, Delta and Beta Strain 28 Days After Ad26.COV2.S Booster Vaccination After Completing Primary Vaccination With BNT162b2 |
6221; 4808; 4410; 3414; 2348; 1803 | — |
| SECONDARY Cohort 2: GMTs of Neutralizing Antibodies Against the Leading Variant of High Consequence or Concern (Omicron Variant) 28 Days After Ad26.COV2.S Booster Vaccination After Completing Primary Vaccination With BNT162b2 |
752; 452; 391 | — |
| SECONDARY Cohort 2: Percentage of Participants With Antibodies Binding to SARS-CoV-2 Relevant Variants of Concern or Individual SARS-CoV- 2 Proteins by ELISA |
100.0; 100.0; 100.0 | — |
| SECONDARY Cohort 2: Number of Participants With Antibodies Binding to SARS-CoV-2 Relevant Variants of Concern or Individual SARS-CoV- 2 Proteins by MSD |
— | — |
| SECONDARY Cohorts 1 and 2: Number of Participants With Antibodies Binding to the SARS-CoV-2 Nucleocapsid (N) Protein at Day 1 as Assessed by N-Serology |
— | — |
Eligibility Criteria
Inclusion Criteria
- Cohort 1: Participant received Ad26.COV2.S in VAC31518COV3001. The interval between the Ad26.COV2.S primary vaccination should preferably be greater than or equal to (>=) 6 months prior to study vaccination on VAC31518COV2008, however a window of maximum -20 days is allowed; Cohort 2: Participant completed primary vaccination with a 2-dose regimen of BNT162b2 vaccine. The last dose of BTN162b2 should preferably be >=6 months prior to study vaccination on COV2008, however a window of a maximum of -20 days is allowed
- Participant must provide consent indicating that he or she understands the purpose, procedures and potential risks and benefits of the study, and is willing to participate in the study
- Participant agrees to not donate bone marrow, blood, and blood products from the study vaccine administration until 3 months after receiving the study vaccine
- Participant must be willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study
- Participant must be able to read, understand, and complete questionnaires in the electronic clinical outcome assessment (eCOA) (that is, the Coronavirus disease (COVID-19) signs and symptoms surveillance question, the e-Diary, and the electronic patient-reported outcomes (ePROs). Participants with visual impairment are eligible for study participation and may have caregiver assistance in completing the eCOA questionnaires
Exclusion Criteria
- Participant has a clinically significant acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or temperature >= 38.0 degree Celsius (C) (100.4 degree Fahrenheit [F]) within 24 hours prior to the planned study vaccination; randomization at a later date is permitted at the discretion of the investigator. Please notify the sponsor (or medical monitor) of this decision
- Participant has a known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients (including specifically the excipients of the study vaccine
- Participant received treatment with immunoglobulins (Ig) in the 3 months or exogenous blood products (autologous blood transfusions are not exclusionary) in the 4 months before the planned administration of the study vaccine or has any plans to receive such treatment during the study
- Participant has a known history of confirmed severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection
- Participant has a history of heparin-induced thrombocytopenia or thrombosis in combination with thrombocytopenia
- Participant has a history of acute polyneuropathy (example. Guillain-Barre syndrome)
- History of capillary leak syndrome
Data sourced from ClinicalTrials.gov (NCT04999111). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.