NCT04535453

A Study to Evaluate a Range of Dose Levels and Vaccination Intervals of Ad26.COV2.S in Healthy Adults and Adolescents

A Randomized, Double-blind, Placebo-controlled Phase 2a Study to Evaluate a Range of Dose Levels and Vaccination Intervals of Ad26.COV2.S in Healthy Adults Aged 18 to 55 Years Inclusive and Adults Aged 65 Years and Older and to Evaluate 2 Dose Levels of Ad26.COV2.S in Healthy Adolescents Aged 12 to 17 Years Inclusive

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 635 (actual)
• Sponsor: Janssen Vaccines & Prevention B.V. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Accepted

Summary

The primary purpose of this study is to assess humoral immune responses of 3 dose levels of Ad26.COV2.S administered intramuscularly (IM) as a 2-dose schedule (56 days apart); Ad26.COV2.S administered IM as a single vaccination; safety and reactogenicity of Ad26.COV2.S administered IM as a 2-dose or a single-dose schedule in adults (18-65 years or older) and to assess the safety and reactogenicity of Ad26.COV2.S, administered IM as single dose in adolescents (12-17 years) and to test both compressed and expanded 2-dose schedules of Ad26.COV2.S (28 and 84 days apart) in adults (18-55 years and 65 years or older).

Detailed description

The aim of the COVID-19 vaccine clinical development program is to develop a safe and effective vaccine for the prevention of COVID-19. Currently, there is only limited availability of authorized/licensed vaccines for the prevention of coronavirus disease-2019 (COVID-19). Ad26.COV2.S (also known as Ad26COVS1) is a monovalent vaccine composed of a recombinant, replication incompetent adenovirus type 26 (Ad26) vector, constructed to encode the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) virus spike (S) protein, which will be assessed in this study. Also, different vaccination intervals and multiple lower dose levels compared to the dose levels in the first in human study (VAC31518COV1001 \[NCT04436276\]) will be assessed. For adults, the study consists of: screening phase (28 days), vaccination phase (1-3 months) depending on the vaccination interval, and follow-up (12 months). The study duration is approximately 15 months (Groups 1-6, 8, 10 and Group 7 \[to participants for whom vaccination 2 was delayed\]), 14 months (Group 7), and 16 months (Group 9) in adult groups and approximately 13 months for adolescents group (Groups A to C). The adverse events and other safety assessments including vital signs measurements (heart rate, supine systolic and diastolic blood pressure, respiratory rate, and body temperature), and physical examinations will be assessed during the study. Note: The Informed Consent Form dated 27-Oct-2020 is final version of the study MASTER ICF, used by local countries to prepare the local language version of the ICF, which have been approved by the Ethics Committees. And the highlighted text in the ICF document are the guidance for country specific adaptation.

Conditions

• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	Ad26.COV2.S	All participants, both adults and adolescents, will receive intramuscular (IM) injections of Ad26.COV2.S.
OTHER	Placebo	Adult participants in Groups 4, 5, 6, 8, and 10, and adolescent participants in Group C will receive at least one injection of placebo.

Timeline

• Start date: 2020-08-28
• Primary completion: 2022-03-09
• Completion: 2022-03-09
• First posted: 2020-09-02
• Last updated: 2023-06-22
• Results posted: 2023-06-22

Locations

13 sites across 4 countries: Germany, Netherlands, Spain, United Kingdom

Regulatory

• FDA-regulated drug study