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Virus Therapy

COVID-19 Vaccine for COVID-19 (HORIZON 1 Trial)

Phase 2

Waitlist Available

Research Sponsored by Janssen Vaccines & Prevention B.V.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at birth (postnatal [pn] day 1 [day 7 up to day 163]), 2 months (up to pn day 61 [day 67 up to day 223]) and 6 months (up to pn day 183 [day 189 up to day 345])

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a single-dose COVID-19 vaccine given to pregnant women. It aims to see if the vaccine is safe and effective for them and their babies. The vaccine uses a modified virus to help the body learn to fight COVID-19. The single-dose vaccine shows effectiveness against severe COVID-19 disease and COVID-19-related death, and against both beta and delta variants, providing real-world evidence for its use globally.

Eligible Conditions

Coronavirus Prevention

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at birth (postnatal [pn] day 1 [day 7 up to day 163]), 2 months (up to pn day 61 [day 67 up to day 223]) and 6 months (up to pn day 183 [day 189 up to day 345])

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at birth (postnatal [pn] day 1 [day 7 up to day 163]), 2 months (up to pn day 61 [day 67 up to day 223]) and 6 months (up to pn day 183 [day 189 up to day 345])

This trial's timeline: 3 weeks for screening, Varies for treatment, and at birth (postnatal [pn] day 1 [day 7 up to day 163]), 2 months (up to pn day 61 [day 67 up to day 223]) and 6 months (up to pn day 183 [day 189 up to day 345]) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Adult Participants With AEs Leading to Study Discontinuation

Number of Adult Participants With Adverse Events of Special Interest (AESIs) From First Vaccination Until EOS

Number of Adult Participants With Medically Attended Adverse Events (MAAEs) Until 6 Months Post First Vaccination

+5 more

Secondary study objectives

Group 4: Number of Adult Participants With AESIs Post Booster Vaccination Until EOS

Group 4: Number of Adult Participants With AEs Leading to Study Discontinuation Post Booster Vaccination Until EOS

Group 4: Number of Adult Participants With MAAEs Until 6 Months Post Booster Vaccination

+17 more

Side effects data

From 2023 Phase 3 trial • 44325 Patients • NCT04505722

53%

Vaccination site pain(Solicited)

43%

Headache (Solicited)

42%

Fatigue(Solicited)

37%

Myalgia(Solicited)

16%

Nausea(Solicited)

Pyrexia(Solicited)

Vaccination site erythema (Solicited)

Vaccination site swelling(Solicited)

Chills

Headache

Fatigue

100%

80%

60%

40%

20%

Study treatment Arm

Double-blind Phase: Ad26.COV2.S 5*10^10 vp

Combined Double-blind and Open-label Phase: All Participants

Double-blind Phase: Placebo

OL Phase: Ad26.COV2.S 5*10^10 vp + Ad26.COV2.S 5*10^10 vp Booster

Open Label Phase: mRNA 2 Dose Schedule + Ad26.COV2.S 5*10^10 vp Booster

OL Phase: Non-mRNA Any Schedule +Ad26.COV2.S vp Booster OR mRNA Other Schedule +Ad26.COV2.S Booster

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Groups 1-4: Ad26.COV2.S (One Dose)Experimental Treatment1 Intervention

Participants who are previously vaccinated (Group 1-3) and participants who are vaccine naïve (Group 4) will receive single dose of Ad26.COV2.S vaccine at standard dose level on Day 1. Participants from group 4 who are no longer pregnant may receive single booster dose of Ad26.COV2.S vaccine at standard dose level.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ad26.COV2.S

2021

Completed Phase 3

~84000

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